Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Proposed Rules 65891 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 482 and 485 

[CMS–3244–P] 

RIN 0938–AQ89 

Medicare and Medicaid Programs; 

Reform of Hospital and Critical Access 

Hospital Conditions of Participation 

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), Department 

of Health and Human Services. 

ACTION: Proposed rule. 

SUMMARY: This proposed rule would 

revise the requirements that hospitals 

and critical access hospitals (CAHs) 

must meet to participate in the Medicare 

and Medicaid programs. These 

proposed changes are an integral part of 

our efforts to reduce procedural burdens 

on providers. This proposed rule 

reflects the Centers for Medicare and 

Medicaid Services’ (CMS’) commitment 

to the general principles of the 

President’s Executive Order 13563, 

released January 18, 2011, entitled 

‘‘Improving Regulation and Regulatory 

Review.’’ 

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on December 23, 2011. 

ADDRESSES: In commenting, please refer 

to file code CMS–3244–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 regulation 

to http://www.regulations.gov. Follow 

the ‘‘Submit a comment’’ instructions. 

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–3244– 

P, P.O. Box 8010, Baltimore, MD 21244– 

8010. 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–3244– 

P, Mail Stop C4–26–05, 7500 Security 

Boulevard, Baltimore, MD 21244–1850. 

4. By hand or courier. Alternatively, 

you may deliver (by hand or courier) 

your written comments ONLY to the 

following addresses prior to the close of 

the comment period: 

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, call 

telephone number (410) 786–9994 in 

advance to schedule your arrival with 

one of our staff members. 

Comments erroneously 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. 

Jeannie Miller, (410) 786–3164. 

Lisa Parker, (410) 786–4665. 

Mary Collins, (410) 786–3189. 

Diane Corning, (410) 786–8486. 

Sarah Fahrendorf, (410) 786–3112. 

SUPPLEMENTARY INFORMATION: 

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this proposed rule to assist 

us in fully considering issues and 

developing policies. You can assist us 

by referencing the file code (CMS–3244– 

P) and the specific ‘‘issue identifier’’ 

that precedes the section on which you 

choose to comment. 

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 

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. 

Acronyms 

AHA American Hospital Association 

AOA American Osteopathic Association 

APRN Advanced Practice Registered Nurse 

BBA Balanced Budget Act 

CAH Critical Access Hospital 

CCN CMS Certification Number 

CDC Centers for Disease Control and 

Prevention 

CfC Condition for Coverage 

CoP Condition of Participation 

CMS Centers for Medicare & Medicaid 

Services 

DNV Det Norske Veritas 

EACH Essential Access Community 

Hospital 

H&P History and Physical Examination 

HAI Healthcare-Associated Infection 

HFAP Healthcare Facilities Accreditation 

Program 

HHS U.S. Department of Health and Human 

Services 

MRHFP Medicare Rural Hospital Flexibility 

Program 

OBRA Omnibus Budget Reconciliation Act 

OPO Organ Procurement Organization 

PA Physician Assistant 

RIA Regulatory Impact Analysis 

RFA Regulatory Flexibility Act 

RPCH Rural Primary Care Hospital 

SBA Small Business Administration 

SBREFA Small Business Regulatory 

Enforcement Fairness Act 

UMRA Unfunded Mandates Reform Act 

Table of Contents 

This proposed rule is organized as follows: 

I. Background 

A. Introduction 

B. Legal Basis and Purpose of Hospital 

CoPs 

C. Relationship of This Rulemaking to 

Future Reforms 

II. Provisions of the Proposed Regulation 

A. Revisions To Allow Flexibility and 

Eliminate Burdensome CoPs 

1. Governing Body (§ 482.12) 

2. Patient’s Rights (§ 482.13) 

3. Medical Staff (§ 482.22) 

4. Nursing Services (§ 482.23) 

5. Medical Record Services (§ 482.24) 

6. Infection Control (§ 482.42) 

7. Outpatient Services (§ 482.54) 

8. Transplant Center Process 

Requirements—Organ Recovery and 

Receipt (§ 482.92) 


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65892 Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Proposed Rules 

9. Definitions (§ 485.602) and Provision of 

Services (§ 485.635) 

B. Clarifying Changes 

10. Pharmaceutical Services (§ 482.25) and 

Infection Control (§ 482.42) 

11. Personnel Qualifications (§ 485.604) 

12. Surgical Services (§ 485.639) 

C. Other Options Considered 

III. Collection of Information Requirements 

IV. Response to Comments 

V. Regulatory Impacts 

VI. Regulations Text 

I. Background 

A. Introduction 

This proposed rule reflects the 

Centers for Medicare and Medicaid 

Services’ (CMS’) commitment to the 

general principles of the President’s 

Executive Order 13563, released January 

18, 2011, entitled ‘‘Improving 

Regulation and Regulatory Review.’’ In 

this proposed rule we seek to reduce the 

regulatory burden placed on hospitals. 

We have identified a number of existing 

hospital CoPs that we believe could be 

reformed, simplified, or eliminated in 

order to reduce unnecessary burden and 

costs placed on hospitals and critical 

access hospitals (CAHs) under existing 

regulations. Earlier this year, the 

President reaffirmed his commitment to 

Executive Order 12866, which was 

issued in 1993 and has long governed 

the process of regulatory development 

and review. He also issued Executive 

Order 13563 directing agencies to select 

the least burdensome approaches, to 

minimize cumulative costs, to simplify 

and harmonize overlapping regulations, 

and to identify and consider flexible 

approaches that maintain freedom of 

choice for the American public. 

Executive Order 13563 also requires 

agencies to engage in a process of 

reviewing existing regulations to see if 

those rules make sense and continue to 

be justified. The reforms contemplated 

in this proposed rule are intended to 

meet the letter and spirit of the 

requirement in the President’s Executive 

Order 13563, issued January 18, 2011, 

entitled ‘‘Improving Regulation and 

Regulatory Review,’’ for reviewing 

existing regulations to see if those rules 

make sense and continue to be justified. 

They also meet the objectives of section 

610 of the Regulatory Flexibility Act 

(RFA), which also requires agencies to 

review the impact of existing rules on 

small businesses or other small entities 

for possible reforms to reduce burden 

and costs. 

Under this initiative, we are 

conducting a retrospective review of the 

CoPs that we apply to hospitals, in order 

to remove or revise obsolete, 

unnecessary, or burdensome provisions. 

Most of the existing hospital 

requirements have developed over 

decades, reflecting new statutory 

requirements, changes in technology or 

medical practice, and the evolution of 

the health delivery system. The goal of 

this retrospective review is to reduce 

system costs by removing obsolete or 

burdensome requirements. 

B. Legal Basis and Purpose of Hospital 

CoPs 

Sections 1861(e)(1) through (8) of the 

Social Security Act (the Act) provide 

that a hospital participating in the 

Medicare program must meet certain 

specified requirements. Section 

1861(e)(9) of the Act specifies that a 

hospital also must meet such other 

requirements as the Secretary finds 

necessary in the interest of the health 

and safety of individuals furnished 

services in the institution. Under this 

authority, the Secretary has established 

regulatory requirements that a hospital 

must meet to participate in Medicare at 

42 CFR part 482, CoPs for Hospitals. 

Section 1905(a) of the Act provides that 

Medicaid payments from States may be 

applied to hospital services. Under 

regulations at 42 CFR 440.10(a)(3)(iii) 

and 42 CFR 440.20(a)(3)(ii), hospitals 

are required to meet the Medicare CoPs 

in order to participate in Medicaid. 

On May 26, 1993, CMS published a 

final rule in the Federal Register 

entitled ‘‘Medicare Program; Essential 

Access Community Hospitals (EACHs) 

and Rural Primary Care Hospitals 

(RPCHs)’’ (58 FR 30630) that 

implemented sections 6003(g) and 6116 

of the Omnibus Budget Reconciliation 

Act (OBRA) of 1989 and section 4008(d) 

of OBRA 1990. That rule established 

requirements for the EACH and RPCH 

providers that participated in the sevenstate demonstration program that was 

designed to improve access to hospital 

and other health services for rural 

residents. 

Sections 1820 and 1861(mm) of the 

Act, as amended by section 4201 of the 

Balanced Budget Act (BBA) of 1997, 

replaced the EACH/RPCH program with 

the Medicare Rural Hospital Flexibility 

Program (MRHFP), under which a 

qualifying facility can be designated as 

a CAH. CAHs participating in the 

MRHFP must meet the conditions for 

designation specified in the statute and, 

under section 1820(c)(2)(B)(i)(I) of the 

Act, must meet the CoPs located at 42 

CFR part 485, subpart F. Among such 

requirements, a CAH must be located in 

a rural area (or an area treated as rural) 

and must be located more than a 35- 

mile (or in the case of mountainous 

terrain or in areas with only secondary 

roads available, more than a 15-mile 

drive) from a hospital or another CAH 

unless otherwise designated as a 

necessary provider prior to January 1, 

2006. 

The CoPs are organized according to 

the types of services a hospital may 

offer, and include specific, process 

oriented requirements for each hospital 

service or department. The purposes of 

these conditions are to protect patient 

health and safety and to ensure that 

quality care is furnished to all patients 

in Medicare-participating hospitals. In 

accordance with Section 1864 of the 

Act, State surveyors assess hospital 

compliance with the conditions as part 

of the process of determining whether a 

hospital qualifies for a provider 

agreement under Medicare. However, 

under section 1865 of the Act, hospitals 

can elect to be reviewed instead by 

private accreditation organizations 

approved by CMS as having standards 

and survey procedures that are at least 

equivalent to those used by CMS and 

State surveyors. CMS-approved hospital 

accreditation programs include those of 

The Joint Commission (TJC), the 

American Osteopathic Association/ 

Healthcare Facilities Accreditation 

Program (AOA/HFAP), and Det Norske 

Veritas Healthcare (DNV) (See 42 CFR 

part 488, Survey and Certification 

Procedures.). 

C. Relationship of This Rulemaking to 

Future Reforms 

The reforms we propose in this rule 

are intended to reduce the cost and 

burden of existing CoPs. They are based 

in large part on ideas that have been 

provided to us by hospitals and 

organizations representing hospitals, by 

health care professionals, and by other 

stakeholders, as well as through recent 

research and our own evaluation of 

current practices. We are committed to 

working with, and welcome suggestions 

for future rulemaking from, affected 

parties to identify other reforms to the 

CoPs that would reduce unnecessary 

burden on hospitals, while allowing 

hospitals maximum flexibility in 

meeting the Federal requirements 

necessary to fulfill our quality of care 

responsibilities. 

II. Provisions of the Proposed 

Regulations 

In accordance with the President’s 

Executive Order 13563, we are 

reviewing regulations in an effort to 

reduce burden, maximize patient safety, 

and reflect current industry standards. 

We have identified several priority areas 

in the CoPs for both hospitals (42 CFR 

part 482) and CAHs (42 CFR part 485) 

to update and revise. Our identification 

and prioritization of these areas was a 

result of outreach to hospital 


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stakeholders, such as the American 

Hospital Association (AHA) and TJC; 

and internal discussions among various 

components at CMS. We believe that 

these proposed revisions may eliminate 

or significantly reduce those instances 

where the CoPs are duplicative, 

unnecessary, and/or burdensome. 

A. Revisions To Allow Flexibility and 

Eliminate Burdensome CoPs 

1. Governing Body (§ 482.12) 

We propose to revise the ‘‘Governing 

body’’ requirements as follows: The 

Governing body CoP (§ 482.12) states 

that the hospital must have an effective 

governing body that is legally 

responsible for the conduct of the 

hospital as an institution. We have 

interpreted the governing body CoP as 

requiring that each hospital facility have 

a separate governing body (http://www.

cms.gov/manuals/downloads/

som107ap_a_hospitals.pdf). 

Based on our experience with 

hospitals and the input provided by 

stakeholders through anecdotal 

evidence, we believe that hospitals in a 

multi-hospital system (defined here as 

those having more than one CMS 

Certification Number (CCN)) can be 

effectively governed by a single 

governing body. Thus, we propose to 

revise and clarify the governing body 

requirement to reflect current hospital 

organizational structure whereby multihospital systems have integrated their 

governing body functions to oversee 

care in a more efficient and effective 

manner. Specifically, we propose to 

revise § 482.12 to state that ‘‘There must 

be an effective governing body that is 

legally responsible for the conduct of 

the hospital.’’ 

We would retain the current provision 

that requires the persons legally 

responsible for the conduct of the 

hospital to carry out the functions 

specified in Part 482 of our regulations 

that pertain to the governing body if the 

hospital does not have an organized 

governing body. 

2. Patient’s Rights (§ 482.13) 

On December 8, 2006, we published 

a final rule in the Federal Register 

entitled ‘‘Medicare and Medicaid 

Programs; Hospital Conditions of 

Participation: Patients’ Rights’’ (71 FR 

71378). In that final rule we revised the 

hospital standards for the use of 

restraint and seclusion, and set forth 

new standards for staff training and 

death reporting. In particular, section 

482.13(g) of the final rule requires 

hospitals to report no later than the 

close of business on the next business 

day following knowledge of the 

patient’s death: (1) Each death that 

occurs while the patient is in restraint 

or seclusion; (2) each death that occurs 

within 24 hours after the patient has 

been removed from restraint or 

seclusion; and (3) each death known to 

the hospital that occurs within one 

week after restraint or seclusion where 

it is reasonable to assume that the 

restraint or seclusion contributed 

directly or indirectly to the patient’s 

death. 

Included under these broad reporting 

requirements are those deaths in which 

no seclusion is used, and the only 

restraints used are soft, two-point wrist 

restraints. The patients typically 

needing soft two-point wrist restraints 

are individuals in critical care settings, 

such as intensive care units, where such 

restraints are medically necessary. For 

example, soft two-point wrist restraints 

can be used to prevent patients from 

removing medically necessary devices 

and equipment such as central lines, 

endotracheal tubes, and nasogastric 

tubes. CMS is not aware of any 

research—or even any anecdotal 

information—suggesting a cause-andeffect relationship between the use of 

soft, two-point wrist restraints and 

patient deaths. 

CMS is therefore proposing to modify 

the reporting requirements for hospitals 

when the circumstances of a patient’s 

death involve only the use of soft twopoint wrist restraints and no use of 

seclusion. At § 482.13(g)(4) we propose 

that hospitals would be required to 

notify CMS of the deaths described at 

§ 482.13(g)(2) (soft two-point wrist 

restraints and no use of seclusion) 

within seven days after the date of death 

through a log or other system. We 

propose that the record would include, 

at a minimum, the patient’s name, date 

of birth, date of death, attending 

physician, primary diagnosis(es), and 

medical record number. We propose 

that hospitals make the log or other 

system accessible to CMS upon request 

at all times. We are unable to eliminate 

the reporting requirement for these 

deaths due to statutory provisions in the 

Children’s Health Act that require such 

deaths to be reported. 

For deaths involving all other types of 

restraints and all forms of seclusion, we 

would retain the current, more 

extensive reporting requirements, 

including notice to CMS by telephone, 

no later than the close of business on 

the next business day following 

knowledge of the patient’s death. 

We are proposing to introduce a 

measure of flexibility to these 

requirements and redesignate them at 

§ 482.13(g)(1), by providing additional 

reporting options, as determined by 

CMS, which would include the use of 

facsimile, as well as an option for 

electronic reporting. In the event that 

electronic reporting technology 

develops more rapidly than the 

requirements for this section, we have 

proposed the term ‘‘electronically’’ 

rather than ‘‘email’’ to build in a small 

measure of flexibility. 

3. Medical Staff (§ 482.22) 

The CMS condition of participation 

on ‘‘Medical Staff,’’ at § 482.22, 

concerns the organization and 

accountability of the hospital medical 

staff. CMS first adopted the term 

‘‘medical staff’’ in 1986 when it began 

using the term at § 482.22 in place of 

‘‘physicians,’’ to allow hospitals 

maximum flexibility in the granting of 

privileges and the organization of their 

professional staff (51 FR 22010). These 

changes were introduced to reflect the 

trend of extending patient care 

responsibilities to practitioners other 

than doctors of medicine or osteopathy. 

CMS has more recently modernized its 

approach to medical staff requirements 

with respect to telemedicine services 

through the rule ‘‘Medicare and 

Medicaid Programs: Changes Affecting 

Hospital and Critical Access Hospital 

Conditions of Participation: 

Telemedicine Credentialing and 

Privileging,’’ that became effective July 

5, 2011 (76 FR 25563). 

CMS is now proposing to further 

modernize hospitals’ medical staffing 

policies. We believe these changes 

would provide hospitals the clarity and 

flexibility they need under federal law 

to maximize their staffing opportunities 

for all practitioners, and particularly for 

non-physician practitioners, under their 

individual States’ laws. 

First, we propose to redesignate 

§ 482.22(a)(2) to § 482.22(a)(5) and 

revise it by adding language to clarify 

that a hospital may grant privileges to 

both physicians and non-physicians to 

practice within their State scope of 

practice, regardless of whether they are 

also appointed to the hospital’s medical 

staff. That is, technical membership in 

a hospital’s medical staff would not be 

a prerequisite for a hospital’s governing 

body to grant practice privileges to 

practitioners. 

Hospitals wishing to bring on 

additional practitioners without also 

making them members of the medical 

staff would follow the same 

requirements specified in current 

regulation. That is, the medical staff 

would examine the credentials of each 

candidate and make recommendations 

to the governing body. Medical staff 

conducting the evaluations would 

operate under their own hospitals’ 


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policies and procedures. Moreover, the 

medical staff would continue to be 

limited by State law, and thus would 

not be permitted to grant a practitioner 

candidate any privileges beyond those 

allowed in the State where the hospital 

is located, where he or she would 

ultimately practice. 

We believe this proposed language 

would provide hospitals with the clarity 

they need to explore new and expanded 

approaches to care giving. Hospitals 

would be able to increase the number of 

practitioners who could perform various 

functions and duties, up to the 

regulatory boundaries allowed under 

their State licensing and scope of 

practice laws. 

These proposed revisions are in 

response to requests received from 

stakeholders prior to the beginning of 

this rulemaking process. Many of these 

stakeholders expressed the opinion that 

some CMS requirements, particularly 

those related to medical staff, may stand 

in direct conflict with functions 

permitted under State practice acts and 

laws. In such cases, our requirements 

would be unnecessarily restricting the 

scope of practice of certain categories of 

non-physician practitioners (for 

example, Advanced Practice Registered 

Nurses (APRNs), Physician Assistants 

(PAs), Physical Therapists (PTs), 

Speech-language Pathologists (SLPs), 

and Doctors of Pharmacy (PharmDs)). 

Thus, stakeholders maintain, current 

regulatory impediments may be unduly 

limiting access to care and/or delaying 

treatment for patients and causing 

undue burden to practitioners (for 

example, the need to seek out 

physicians to co-sign orders). Our 

proposed changes would remove these 

barriers and allow hospitals to move 

forward in new ways to improve patient 

care, subject to State law. 

The second area we propose to 

address relates to the general 

management and oversight of 

practitioners. Prior to the beginning of 

this rulemaking process, we received 

questions from some hospitals about the 

appropriate credentialing and 

privileging process for APRNs. We 

believe the changes we are proposing at 

§ 482.22(a)(5) would address them. For 

example, some hospitals have 

questioned whether APRNs should be 

managed by the human resources 

department, as most registered nurses 

are, or by the medical staff, as most PAs 

are. We believe that, to the extent 

allowed under their States’ law, most 

hospitals already manage and oversee 

the services of APRNs through their 

medical staffs. In fact, technically, our 

current regulations already allow 

hospitals to appoint non-physician 

practitioners as members of their 

medical staffs, if the State law in which 

their hospital operates permits it. 

However, the numerous questions we 

have received in this area indicate that 

our current regulation is unclear. 

Therefore, we are proposing language to 

revise the section by clarifying that 

being a member of a hospital’s medical 

staff is not a prerequisite to being 

granted privileges in the hospital, 

regardless of whether a practitioner is a 

physician or a non-physician. 

One of our chief concerns, in the 

context of proposing this change, is to 

ensure that all practitioners working at 

a hospital would continue to follow the 

rules set forth for ‘‘Medical Staff’’ at 

§ 482.22. Thus, we are proposing 

language within this provision that 

would require those physicians and 

non-physicians, who have been granted 

practice privileges within their scope of 

practice but without appointment to the 

medical staff, to be subject to the 

requirements contained within this 

section. That is, they would be subject 

to the same hospital requirements, 

medical staff bylaws, and medical staff 

oversight as outlined under this CoP 

and to which appointed medical staff 

members are also subject. Alternatively, 

a hospital could establish categories 

within its medical staff to create 

distinctions between practitioners who 

have full membership and a new 

category for those who could be 

classified as having an ‘‘associate,’’ 

‘‘special,’’ or ‘‘limited’’ membership. 

Such a structure is neither required nor 

suggested; we are providing it here as an 

example of one possible way for a 

hospital to align all of its practitioners 

under the ‘‘Medical Staff’’ rules. 

We believe these proposed changes 

would complement and build upon 

present state and federal reform 

initiatives, including those set forth in 

the Affordable Care Act (ACA), to 

address the healthcare workforce 

shortages. We especially believe these 

proposed changes would support efforts 

to provide better health care in 

medically underserved communities. 

These changes would provide more 

flexibility to small hospitals and to 

critical access hospitals (CAHs) in rural 

areas and regions with a limited supply 

of primary care and specialized 

providers. They would also provide 

needed flexibility to hospitals located in 

impoverished urban centers. These 

changes would also provide States with 

additional regulatory flexibility to 

support their efforts to address the 

shortage of primary care providers. 

The third area in which we are 

proposing changes concerns the more 

direct responsibilities for the 

organization and accountability of the 

medical staff. These requirements are 

set forth at § 482.22(b)(3). Presently, the 

hospital may assign these management 

tasks to either an individual doctor of 

medicine or osteopathy or, when 

permitted by State law of the State in 

which the hospital is located, a doctor 

of dental surgery or dental medicine. 

CMS proposes to expand the list to 

include doctors of podiatric medicine 

(DPMs). We believe this change would 

permit a podiatric physician to serve as 

the president, or its equivalent, of a 

hospital’s medical staff in a significant 

number of states. CMS is aware that in 

such states, the laws underscore the 

widely held conclusion that the 

education, training, and experience of 

podiatric physicians are similar to that 

of their allopathic and osteopathic 

colleagues with respect to serving in 

such a hospital leadership position. 

With this proposed change, CMS wishes 

to ensure its hospital leadership 

requirements are not in conflict with 

State laws that would otherwise allow 

podiatric physicians to serve in this 

capacity. Moreover, CMS recognizes 

that the act of being selected as the 

president of the medical staff reflects 

the high level of confidence in which a 

candidate is held by his or her peers. 

4. Nursing Services (§ 482.23) 

We propose to revise the hospital 

nursing service requirements at § 482.23 

(b)(4), ‘‘Nursing services,’’ which 

currently requires a hospital to ensure 

that the nursing staff develop, and keep 

current, a nursing care plan for each 

patient. We propose that for those 

hospitals that use an interdisciplinary 

plan of care in providing patient care, 

the care plan for nursing services be 

developed and kept current as part of 

the hospital’s overall interdisciplinary 

care plan. 

An interdisciplinary care plan 

optimizes the involvement of the 

various healthcare disciplines (such as 

nursing, respiratory care, occupational 

therapy, and pharmacy) to identify and 

document patient treatment goals and 

objectives, interventions, and progress 

in meeting those goals and objectives. 

We propose to revise our requirements 

to be less burdensome and more in line 

with current practice by proposing that, 

for those hospitals that use an 

interdisciplinary care plan, the nursing 

services care plan could be integrated 

into the overall hospital 

interdisciplinary care plan. This would 

decrease the burden of the nursing staff 

having to develop two care plans, one 

to fulfill the nursing services 

requirement and the other to fulfill the 

particular hospital’s requirement for an 


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interdisciplinary care plan, and would 

improve the quality of patient care by 

the effective and timely communication 

of information pertaining to the nursing 

care of the patient. 

We propose to revise the current 

Nursing services CoP at § 482.23(c) by 

adding new provisions that would allow 

for drugs and biologicals to be prepared 

and administered on the orders of 

practitioners other than those specified 

under § 482.12(c). We are also proposing 

a further revision to § 482.23(c) that 

would add a new provision allowing 

orders for drugs and biologicals to be 

documented and signed by practitioners 

other than those specified under 

§ 482.12(c). We would allow for these 

two revisions only if such practitioners 

are acting in accordance with State law, 

including scope of practice laws, and 

only if the hospital has granted them 

privileges to do so. 

These proposed revisions are in 

response to requests that CMS received 

from stakeholders prior to our beginning 

the rulemaking process. Many of these 

stakeholders expressed the opinion that 

some of the CMS requirements impede 

the scope of practice of certain 

categories of practitioners (for example, 

APRNs, PAs, and Doctors of Pharmacy 

(PharmDs)). They maintain that such 

regulatory impediments may limit 

access to care or delay treatment for 

patients; may cause undue burden to 

practitioners (for example, the need to 

seek out physicians to co-sign orders); 

and may stand in direct conflict with 

functions allowed under State practice 

laws. 

In proposing these changes, we are 

aware that some States may not allow 

specific practitioners to exercise such 

privileges. We are also aware that some 

States may limit the categories of 

practitioners from which a registered 

nurse (as part of his or her scope of 

practice) may receive and carry out 

orders. However, we believe that these 

proposed revisions would not only 

allow hospitals to more fully use these 

practitioners in the care of patients, but 

that changes to what we view as 

unnecessary regulatory prohibitions 

would serve to greatly reduce the 

regulatory burden for hospitals and 

allow for more efficient care practices. 

Within this section of the Nursing 

services CoP, we are also proposing 

changes that would allow hospitals to 

use standing orders. At § 482.23(c)(1)(ii), 

we propose to allow for the preparation 

and administration of drugs and 

biologicals on the orders contained 

within pre-printed and electronic 

standing orders, order sets, and 

protocols for patient orders, but only if 

such orders meet the requirements of 

§ 482.24(c)(3), as discussed below. 

Much of the evidence on the 

effectiveness of hospital standing orders 

is in the context of their use by Rapid 

Response Teams (RRTs) and then only 

when applied in a very limited and 

focused manner. A search of the 

medical literature revealed that there 

may be additional areas where standing 

orders have some efficacy in the 

hospital setting. (http://www.

innovations.ahrq.gov/content.aspx?

id=1750; http://www.cdc.gov/mmwr/

PDF/rr/rr5416.pdf). 

These areas include: 

• Emergency department (ED) 

admission/triage in particular for certain 

conditions such as acute asthma, acute 

myocardial infarction, and stroke (we 

would expect that standing orders 

would be authenticated by an ED 

physician or nonphysician practitioner 

when subsequent orders during the ED 

visit are authenticated for the patient); 

• Improving immunization rates 

(beyond those for influenza and 

pneumococcal as currently allowed 

under the CoPs); and 

• Postoperative recovery areas. 

Although the current hospital CoPs 

already allow for nurse-initiated 

influenza and pneumococcal 

vaccinations (under medical staffapproved hospital policy), an expanded 

use of standing orders for other 

immunizations, which have clearly 

established and nationally recognized 

guidelines (for example, CDC guidelines 

for Hepatitis B vaccination of at-risk 

newborns), may be a mechanism, under 

the CoPs, for improved patient care. 

We propose to eliminate the 

requirement, currently at § 482.23(c)(3), 

that non-physicians must have special 

training in administering blood 

transfusions and intravenous 

medications. We believe that this 

training is standard practice, and thus 

does not need to be prescribed in these 

regulations. 

At § 482.23(c)(4) we propose that 

those who administer blood 

transfusions and intravenous 

medications do so in accordance with 

State law and approved medical staff 

policies and procedures. We propose to 

retain § 482.23(c)(4) and redesignate it at 

§ 482.23(c)(5), without any content 

change. 

We also propose additional revisions 

at proposed § 482.23(c)(6) that would 

allow hospitals the flexibility to develop 

and implement policies and procedures 

for a patient and his or her caregivers/ 

support persons to administer specific 

medications (non-controlled drugs and 

biologicals).This proposal would be 

consistent with the current practice of 

giving patients access at the bedside to 

urgently needed medications, such as 

nitroglycerine tablets and inhalers, and 

selected non-prescription medications, 

such as lotions and rewetting eye drops. 

These proposed changes would apply to 

the self-administration of both hospitalissued medications and the patient’s 

own medications brought into the 

hospital. 

Hospitals that choose to develop and 

implement a program that allows for 

patients and caregivers/support persons 

to administer certain medications would 

be expected to address the program in 

their hospital policies and procedures. 

We would expect a collaborative effort 

by the hospital’s medical staff, nursing 

department, and pharmacy department 

to develop these policies and 

procedures. A hospital would need to: 

assure that a practitioner had issued an 

order, consistent with hospital policy, 

permitting self-administration of 

medications; assess patient and 

caregiver/support person capacity to 

self-administer specific medications; 

provide patient and caregiver/support 

person instruction regarding the safe 

and accurate administration of the 

specified drugs and biologicals (for 

specific hospital-issued medications 

and, if determined to be needed, for a 

patient’s own medications brought in 

from home); ensure the security of 

medications for each patient; identify a 

patient’s own medications and visually 

evaluate those medications for integrity; 

and document the administration of 

each medication in the patient’s medical 

record. 

We believe that this provision, 

allowing for patient self-administration 

of medication, particularly those 

medications brought in from the 

patient’s home, may provide hospitals 

with a means to make care more patientcentered and adaptable to patient and 

caregiver/support person needs. 

Medical Record Services (§ 482.24) 

On November 27, 2006, CMS 

published a final rule that made 

revisions to specific provisions of the 

hospital CoPs at 42 CFR part 482 (71 FR 

68694). The current requirements, as 

finalized at § 482.24(c)(1)(i) in the 2006 

rule, specify that all orders, including 

verbal orders, must be dated, timed, and 

authenticated promptly by the ordering 

practitioner. Also included in the rule 

was an exception to this requirement at 

§ 482.24(c)(1)(ii), which allows, for the 5 

year period following January 26, 2007, 

all orders, including verbal orders, to be 

dated, timed, and authenticated by the 

ordering practitioner or another 

practitioner who is responsible for the 

care of the patient as specified under 


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§ 482.12(c) and who is authorized to 

write orders by hospital policy in 

accordance with State law. When the 

rule was published in late 2006, the 5- 

year sunset provision was included with 

the thought that such an exception 

would not be needed five years hence 

since various technologies (for example, 

computerized physician order entry and 

authentication from a distance through 

a telecommunication medium) would 

have evolved and proliferated to the 

extent where in-person authentication 

by a practitioner would no longer be 

common or necessary. Though 

technologies have certainly advanced in 

the five years since publication of the 

rule, there is still not universal 

application and use of these 

advancements in hospitals or among 

practitioners. 

Additionally, § 482.24(c)(1)(iii) 

establishes that all verbal orders must be 

authenticated based upon Federal and 

State law; in the absence of a State law 

designating a specific timeframe for the 

authentication of verbal orders, this 

provision then specifies that all verbal 

orders must be authenticated within 48 

hours. Many stakeholders in the 

hospital community, including The 

Joint Commission and the American 

Hospital Association, have pointed out 

to us that this requirement is not only 

a particularly burdensome one for 

hospitals, but also one that does not 

have any appreciable benefit for patients 

with regard to safe care. We are 

proposing to consolidate three existing 

provisions into one new provision at 

§ 482.24(c)(2). Specifically, we would 

remove existing paragraphs (c)(1)(i) 

through (c)(1)(iii) and add a new 

§ 482.24(c)(2). Existing paragraph (c)(2) 

would be redesignated as (c)(3). This 

new provision would retain the 

requirement that all orders, including 

verbal orders, must be dated, timed, and 

authenticated promptly by the ordering 

practitioner, but would add the 

exception currently contained at 

§ 482.24(c)(1)(ii) by allowing for 

authentication by either the ordering 

practitioner or ‘‘another practitioner 

who is responsible for the care of the 

patient as specified under § 482.12(c) 

and authorized to write orders by 

hospital policy in accordance with State 

law.’’ In this way we would remove the 

sunset provision and the 48-hour 

timeframe requirement for 

authentication of orders and instead 

defer to hospital policy and State law 

for establishment of any timeframe. If 

there was no State law establishing such 

a timeframe, then a hospital would be 

allowed to establish their own 

timeframe for authentication of orders, 

including verbal orders. 

Due to the risk of error involved in the 

use of verbal orders, we encourage 

hospitals to keep the use of such orders 

to a minimum and to establish policies 

that discourage their use. When verbal 

orders must be used, hospitals should 

have their own policies in place (e.g., 

‘‘read-back and verify’’ requirements) to 

ensure accuracy in the transcribing of 

orders, particularly those involving 

medication dosages. 

As discussed above in the Nursing 

services CoP section, we are proposing 

changes to that CoP as well as to the 

Medical records services CoP that 

would allow hospitals to use standing 

orders as long as certain provisions were 

met. In this rule, we propose new 

provisions to § 482.24(c)(3) that would 

allow a hospital to use pre-printed and 

electronic standing orders, order sets, 

and protocols for patient orders only if 

the hospital: (1) Establishes that such 

orders and protocols have been 

reviewed and approved by the medical 

staff in consultation with the hospital’s 

nursing and pharmacy leadership; (2) 

demonstrates that such orders and 

protocols are consistent with nationally 

recognized and evidence-based 

guidelines; (3) ensures that the periodic 

and regular review of such orders and 

protocols is conducted by the medical 

staff, in consultation with the hospital’s 

nursing and pharmacy leadership, to 

determine the continuing usefulness 

and safety of the orders and protocols; 

and (4) ensures that such orders and 

protocols are dated, timed, and 

authenticated promptly in the patient’s 

medical record by the ordering 

practitioner or another practitioner 

responsible for the care of the patient as 

specified under § 482.12(c) and 

authorized to write orders by hospital 

policy in accordance with State law. 

For additional guidance on the use of 

standing orders, stakeholders should 

review the CMS memorandum (CMS 

S&C–09–10) issued on October 24, 2008 

(http://www.cms.gov/Survey

CertificationGenInfo/downloads/

SCLetter09-10.pdf), where we pointed 

out our strong support of the use of 

evidence-based protocols, developed by 

the medical staff and based on 

recognized standards of practice, that 

advance the quality of care provided to 

patients. CMS, through the CoPs, 

requires hospitals and practitioners to 

take a thoughtful and responsible 

approach when using pre-printed and 

electronic standing orders, order sets, 

and protocols, particularly those orders 

that may be initiated as part of an 

emergency response or as part of an 

evidence-based treatment regimen 

where it is not practicable for a nurse to 

obtain the order and authentication 

from the physician or practitioner prior 

to the provision of care. In all cases 

protocols and standing orders must be 

medically necessary for the patients to 

whom they are applied, and the treating 

physician must be able to modify, 

cancel, void or decline to authenticate 

orders that were not medically 

necessary in a particular situation. 

Under no circumstances should a 

hospital use standing orders in a 

manner that requires any staff not 

authorized to write patient orders to 

make clinical decisions outside of their 

scope of practice in order to initiate 

such orders. Hospital policies and 

procedures that discuss the use of 

standing orders should address welldefined clinical scenarios as a standard 

of practice for the use of such orders. 

We would expect the policies and 

procedures to also address the process 

by which a standing order is developed; 

approved; monitored; initiated by 

authorized staff; and subsequently 

authenticated by physicians or 

practitioners responsible for the care of 

the patient. Under the CoPs, all orders, 

whether written or verbal, must be 

authenticated and documented in the 

patient’s medical record by a 

practitioner responsible for the care of 

the patient. 

We would also expect to see specific 

criteria for a nurse or other authorized 

personnel to initiate the execution of a 

particular standing order clearly 

identified in the protocol for the order, 

for example, the specific clinical 

situations, patient conditions, or 

diagnoses by which initiation of the 

order would be justified. Policies and 

procedures should also address the 

instructions that the medical, nursing, 

and other applicable professional staff 

receive on the conditions and criteria 

for using standing orders as well as any 

individual staff responsibilities 

associated with the initiation and 

execution of standing orders. An order 

that has been initiated for a specific 

patient must be added to the patient’s 

medical record at the time of initiation, 

or as soon as possible thereafter. 

Likewise, standing order policies and 

procedures must specify the process 

whereby the physician or other 

practitioner responsible for the care of 

the patient acknowledges and 

authenticates the initiation of all 

standing orders after the fact, with the 

exception of influenza and 

pneumococcal polysaccharide vaccines, 

which do not require such 

authentication in accordance with 

§ 482.23(c)(2). 


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The policies and procedures must 

also establish a process for monitoring 

and evaluating the use of standing 

orders, including proper adherence to 

the order’s protocol. There must also be 

a process for the identification and 

timely completion of any requisite 

updates, corrections, modifications, or 

revisions to pre-printed and electronic 

standing orders, order sets, and 

protocols. 

We believe that these proposed 

changes would do much to advance the 

practice of evidence-based medicine 

and would ensure more consistent care 

for all patients. 

6. Infection Control (§ 482.42) 

CMS introduced Infection Control as 

a CoP in 1986 amidst growing 

recognition that infections and 

communicable diseases were potentially 

exposing hospital patients to significant 

pain and risk, and driving up direct 

hospital charges (51 FR 22010, 22027). 

The regulation increased hospital 

accountability and sought to identify, 

prevent, control, investigate, and report 

infections and communicable diseases 

of patients and hospital personnel. The 

regulation also established a 

requirement for hospitals to keep a log 

to identify problems and for 

improvement to be made when 

problems were identified. 

Since this requirement was published, 

advances in infection control 

surveillance systems have made the 

need for a separate infection log 

obsolete. We have also received 

complaints from stakeholders that the 

log requirement is too prescriptive and 

burdensome. We therefore propose to 

eliminate the current requirement at 

§ 482.42(a)(2), proposing instead to 

allow hospitals flexibility in their 

approach to the tracking and 

surveillance of infections. The modern 

surveillance systems already in use 

include infection detection, data 

collection and analysis, monitoring, and 

evaluation of preventive interventions. 

These activities are already required at 

§ 482.42(a)(1), which we propose to 

retain under § 482.42(a). Specifically, 

the infection control officer or officers 

are required to develop a system for 

identifying, reporting, investigating, and 

controlling infections and 

communicable diseases of patients and 

personnel. The requirements at 

§ 482.42(a), together with modern 

surveillance practices, have made the 

requirement for a separate infection 

control log unnecessarily redundant and 

burdensome. 

7. Outpatient Services (§ 482.54) 

Under the CoPs, the provision of 

outpatient services is an optional 

hospital service. However, if a hospital 

provides outpatient services, the 

services must meet the needs of patients 

according to acceptable standards of 

practice as required at § 482.54. The 

current provision at § 482.54(b)(1) also 

requires the hospital to assign an 

individual to be responsible for 

outpatient services. 

We are aware that increasingly more 

hospital services are offered as 

outpatient services today than when this 

particular CoP was first developed. As 

hospitals have expanded the outpatient 

services offered to patients, many 

hospitals have determined that it is in 

the best interests of patient safety and 

management practices to appoint more 

than one individual to oversee the 

various services offered and also to fully 

integrate their outpatient services with 

inpatient services. Additionally, these 

hospitals have realized that as they have 

expanded the variety of outpatient 

services offered, a single outpatient 

services leader may not possess the 

training and expertise to oversee the 

myriad services that the hospital is 

capable of providing in the outpatient 

setting. For example, a hospital that 

offers pediatric, gynecological, and 

orthopedic outpatient services may find 

it advantageous and more efficient to 

have each of these outpatient 

departments managed by a professional 

with a background and expertise in the 

relevant specialty and who is also 

responsible for these hospital 

departments in the inpatient setting. 

Rather than have just one individual, 

who may only have qualifications and 

experience in one of these areas, as the 

person responsible for only the 

outpatient services of all three 

specialties, hospitals would be able to 

make more efficient use of department 

directors who would oversee both 

inpatient and outpatient services for a 

particular specialty. In fact, the current 

regulations at § 482.54(a) require 

outpatient services to be, ‘‘integrated 

with inpatient services.’’ 

Under the current requirement at 

§ 482.54(b)(1), hospitals that are using 

multiple leaders must hire another 

director to oversee these highly 

qualified and expert directors who are 

already exercising responsibility for 

their respective areas, often for both 

inpatient and outpatient services. We 

have reason to believe, and feedback 

from stakeholders has confirmed that 

this situation may be causing 

unnecessary staff costs, increased 

administrative burden, and confused 

chains of command within a hospital 

regarding its management of patient 

services. 

Therefore, in this proposed rule, we 

are proposing revisions to this CoP that 

would allow hospitals greater flexibility 

in determining the management 

structure of outpatient services that 

would be tailored to the scope and 

complexity of the services offered by an 

individual hospital. We propose to 

change the existing provision at 

§ 482.54(b) by revising the provision at 

§ 482.54(b)(1) to allow hospitals to 

assign one or more individuals to be 

responsible for outpatient services. We 

also propose to revise the current 

provision at § 482.54(b)(2), which 

currently requires a hospital to have 

appropriate professional and 

nonprofessional personnel available at 

each location where outpatient services 

are offered, by proposing to add a 

measure of flexibility such that 

hospitals would make their personnel 

decisions based on the scope and 

complexity of outpatient services 

offered. 

8. Transplant Center Process 

Requirements—Organ Recovery and 

Receipt (§ 482.92) 

On March 30, 2007, CMS published a 

final rule entitled ‘‘Medicare Program: 

Hospital Conditions of Participation: 

Requirements for Approval and ReApproval of Transplant Centers To 

Perform Organ Transplants’’ (72 FR 

15198). This final rule set forth hospital 

CoPs for the approval and re-approval of 

transplant centers at 42 CFR part 482, 

subpart E, including § 482.92, the 

section involving blood type and other 

vital data verification. Likewise, CMS 

addressed the regulatory requirements 

for organ procurement organizations in 

the 2006 final rule entitled ‘‘Medicare 

and Medicaid Programs; Conditions for 

Coverage for Organ Procurement 

Organizations (OPOs),’’ which 

published in the May 31, 2006 Federal 

Register (71 FR 30982). This rule set 

forth the Conditions for Coverage (CfCs) 

for OPOs, and it, too, included 

requirements for blood type verification. 

The transplant center and OPO rules 

were designed to work in tandem to 

achieve CMS’ goals of safe, effective, 

and efficient care for all patients. 

However, since the time of publication, 

CMS has become aware of the potential 

for duplicative, overlapping efforts 

related to blood type verification. This 

proposed rule would address this 

unnecessary duplication by removing 

certain blood type verification 

requirements for transplant centers set 

forth at § 482.92(a). 


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As further described below, the 

requirements set forth in the transplant 

center rule at § 482.92(a) and in the OPO 

rule at § 486.344(d)(2)(ii) and 

§ 486.344(e) are redundant and 

burdensome for providers as presently 

structured. Each blood type and other 

data verification requires 

documentation which must be 

physically signed and retained. For 

cases where the recovery is conducted 

by a surgeon on call for the OPO 

recovering for his/her own program, 

both the OPO and transplant center 

rules apply. As a practical matter, this 

has meant one set of paperwork for each 

entity, and, in some cases, a third set of 

paperwork maintained with the 

surgeon’s records. The transplant 

hospital must maintain a copy of its 

signed verification and make it available 

for the onsite surveyors of its organ 

transplant program. OPOs maintain 

blood matching documentation for their 

onsite surveyors as well. In practice, for 

such cases, this means organ recovery 

teams must produce and protect two 

sets of paperwork alongside the 

recovered organs. 

In addition, because the ultimate 

recipient is not always known at the 

time of organ recovery, as there may be 

several potential matches pending the 

final receipt of lab work confirming the 

compatibility of various blood antigens, 

the management of paperwork verifying 

the blood types for each intended organ 

recipient becomes even more 

burdensome. 

In order to reduce the amount of 

verification paperwork, CMS proposes 

to amend the existing regulations 

governing transplant centers by 

removing the provision at § 482.92(a) 

which requires the transplant team to 

verify blood type before organ recovery. 

We would redesignate current 

paragraph (b) and (c) as (a) and (b), 

respectively. 

CMS is proposing this change in an 

effort to reduce administrative burden 

for transplant centers and the surgeons 

recovering for these centers. We believe 

this change will also remove any legal 

ambiguities which may arise on behalf 

of ‘‘on-call’’ organ recovery surgeons 

and team members who fall under both 

the rules of the OPOs they are removing 

the organs for and the rules of the 

transplant hospitals where they are 

privileged. The change also would 

produce cost savings because the 

‘‘extra’’ verifications will no longer be 

conducted. 

Because the blood type verification is 

conducted at numerous points in time 

and by multiple physicians and 

clinicians, CMS does not expect that 

this proposed change would impact 

transplant recipients in an adverse 

manner. In fact, we believe the changes 

are wholly in keeping with our 

overarching aims to (1) ensure timely 

care for patients who are waiting for 

organs for transplantation; and (2) 

establish sufficient quality and 

procedural standards to ensure that 

transplants are performed in a safe and 

efficient manner. CMS believes the 

overall impact of this change would be 

to free up time and resources for 

transplant recovery teams and centers. 

This change is thus expected to benefit 

all parties involved in the practice of 

organ transplantation. 

Definitions (§ 485.602) and Provision of 

Services (§ 485.635) 

The current CoP at § 485.602 and 

§ 485.635(b) require CAHs to furnish 

certain types of services directly rather 

than through contracts or under 

arrangements. Specifically, the CoP at 

§ 485.635(b) requires CAH staff to 

provide, as direct services, (1) 

diagnostic and therapeutic services that 

are commonly furnished in a 

physician’s office or at another entry 

point into the health care system; (2) 

laboratory services; (3) radiology 

services; and (4) emergency procedures. 

In our view, the current regulation 

does not provide sufficient flexibility for 

the CAH to address efficiencies and 

alleviate work force shortages by 

affiliating with other providers and 

entities, as well as by utilizing 

temporary agencies. Healthcare facilities 

in rural settings often face challenges 

due to limited resources, small size, and 

location with regard to recruiting and 

retaining appropriately qualified health 

care professionals as employees. Their 

inability to use contracted services in 

some situations in lieu of hiring 

employees to provide certain services, 

places an increased burden on CAHs. In 

particular, it may be more efficient for 

a CAH to contract with a provider in the 

quantity that the CAH requires, to 

effectively address the needs of its 

patients. Under the current CoP, 

however, the CAH cannot pursue this 

option for the required services in these 

specialty areas. 

We believe that what is most 

important in terms of quality and safety 

of care is that these required services are 

made available by the CAH, not that the 

qualified professionals providing those 

services be employees of the CAH. The 

proposed revisions to § 485.635(b) 

would eliminate the requirement that 

CAH staff must provide certain services 

directly and changes the heading of the 

standard, ‘‘Direct services,’’ to ‘‘Patient 

services.’’ We also propose to revise the 

language in paragraphs § 485.635(b)(1) 

through (b)(4), ‘‘that the CAH staff 

furnishes as direct services.’’ We believe 

the proposed revisions will provide 

CAHs with additional flexibility, 

increase the ability of CAHs to provide 

services that are required to ensure 

access to care, decrease burden on 

CAHs, and positively impact the costs of 

health care delivery. We also propose to 

eliminate the definition of ‘‘Direct 

Services’’ at § 485.602 since it will no 

longer be applicable. 

The governing body, or the person 

principally responsible for the operation 

of the CAH under § 485.627(b)(2), would 

continue to be responsible for all 

services furnished by the CAH whether 

or not they are furnished directly, under 

arrangements, or under agreements. The 

governing body or responsible person 

must ensure that all furnished services 

enable the CAH to comply with all 

applicable conditions of participation 

and standards for the contracted 

services. 

We believe that changing this 

requirement will alleviate an 

unnecessary burden on CAHs and 

provide greater access to quality health 

care. 

B. Clarifying Changes 

10. Pharmaceutical Services (§ 482.25) 

and Infection Control (§ 482.42) 

We propose to make a minor technical 

change to the requirement at 

§ 482.25(b)(6). The current requirement 

states that drug administration errors, 

adverse drug reactions, and 

incompatibilities must be reported to 

the hospital’s quality assurance 

program, if appropriate. Additionally, 

we propose to make a minor technical 

change to the requirement at 

§ 482.42(b)(1). The current requirement 

states that the chief executive officer, 

the medical staff, and the director of 

nursing services must ensure that the 

hospital-wide quality assurance 

program and training programs address 

problems identified by the infection 

control officer or officers. Therefore, in 

both § 482.25(b)(6) and § 482.42(b)(1) we 

propose to replace the term ‘‘quality 

assurance program’’ with the more 

current term ‘‘quality assessment and 

performance improvement program.’’ 

This change would clarify that we 

expect drug errors, adverse reactions, 

and incompatibilities to be addressed in 

a hospital’s QAPI program, as required 

at § 482.21. 

11. Personnel Qualifications (§ 485.604) 

Many of the former EACH/RPCH CoPs 

were adopted for the new CAH program 

(see 62 FR 46008, August 29, 1997), 

including the definition for clinical 


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nurse specialist. In this NPRM we are 

proposing to revise the definition of a 

clinical nurse specialist at § 485.604(a) 

to reflect the definition in the statute at 

§ 1861(aa)(5)(B). Specifically, we 

propose to change the definition at 

§ 485.604(a) to state that a clinical nurse 

specialist is a registered nurse licensed 

to practice nursing in the State in which 

the clinical nurse specialist services are 

performed, that holds an advanced 

degree in a defined clinical area of 

nursing from an accredited educational 

institution. 

12. Surgical Services (§ 485.639) 

The current surgical services CoP was 

promulgated in 1995 (60 FR 45814, 

September, 1, 1995) to ensure adequate 

health and safety protection for patients. 

However, the provision of surgical 

services is not a required CAH service 

under the Act at section 1820(c); 

therefore, we are proposing to make 

changes to this CoP to clarify that it is 

an optional service for CAHs. The 

proposed technical change to the CoP 

introductory text is as follows: 

‘‘If a CAH provides surgical services, 

surgical procedures must be performed 

in a safe manner by qualified 

practitioners who have been granted 

clinical privileges by the governing 

body of the CAH or responsible 

individual in accordance with the 

designation requirements under 

paragraph (a) of this section.’’ 

C. Other Options Considered 

In addition to the proposals discussed 

above, we considered the alternative 

options, described below, for revising 

the CoPs. 

Medical Staff (§ 482.22) 

Similar to the changes proposed in 

this rule that would allow a multihospital system the option of having a 

single governing body legally 

responsible for the conduct of the 

hospital (§ 482.12), we considered 

changes to the Medical staff CoP at 

§ 482.22 that would allow a multihospital system the option of having a 

single organized medical staff 

responsible for the quality of medical 

care provided to patients by all of the 

hospitals in the system. Stakeholders 

have reported that multi-hospital 

systems have both integrated their 

governing body functions and their 

medical staff functions to oversee 

patient care in a more efficient manner. 

The current language of § 482.22 

states that the hospital ‘‘must have an 

organized medical staff that operates 

under bylaws approved by the 

governing body and is responsible for 

the quality of medical care provided to 

patients by the hospital.’’ We do not 

believe that the current Medical staff 

CoP language implies that we require a 

single and separate medical staff for 

each hospital within a multi-hospital 

system. Therefore, we have retained the 

current requirement without revision. 

However, based on the anecdotal 

evidence and input provided by 

stakeholders on this issue, we request 

comment on whether we need to 

propose any clarifying language. 

Based on stakeholder feedback, we 

considered revising the overall 

organizational structure of the CoPs to 

condense current requirements for 

departmental leadership responsibilities 

into a single, non-specific CoP that 

would allow hospitals to appoint 

hospital leaders based on hospitalestablished qualifications and needs 

specific to each hospital. However, we 

believe that the department-specific 

organization of the current CoPs, and 

the current specialty-departmentspecific leadership requirements, are 

appropriate, and can be compatible with 

the leadership standards of our 

stakeholders. We are specifically 

seeking comment on this issue. 

Medical Record Services (§ 482.24) 

We considered modifying the 

regulatory requirement at current 

§ 482.24(c)(2) to clarify the intent of the 

rule in situations where a patient has 

received a medical history and physical 

examination (H&P) by either a nonhospital practitioner or a practitioner 

with hospital privileges prior to the 

patient’s hospital visit. When an H&P 

has been completed for a patient within 

the most recent 30-day period prior to 

the patient’s admission or registration, 

the current regulation requires a 

hospital to ensure documentation of, 

‘‘[a]n updated examination of the 

patient, including any changes in the 

patient’s condition. * * *’’ 

We believe that some stakeholders 

may be interpreting our current 

requirements in a way that would 

require a hospital to conduct a full 

update to an H&P that was conducted 

within 30 days prior to the patient’s 

admission or registration. As put forth 

in our November 27, 2006 final rule 

related to this issue (‘‘Medicare and 

Medicaid Programs; Hospital Conditions 

of Participation: Requirements for 

History and Physical Examinations; 

Authentication of Verbal Orders; 

Securing Medications; and 

Postanesthesia Evaluations,’’ 71 FR 

68673, 68675) and as stated in our 

current Interpretive Guidelines (CMS. 

‘‘State Operations Manual.’’ Pub 100– 

07, Appendix A, http://cms.gov/ 

manuals/Downloads/ 

som107ap_a_hospitals.pdf), a hospital 

may adopt a policy allowing submission 

of an H&P prior to the patient’s hospital 

admission or registration by a 

practitioner who may not be a member 

of the hospital’s medical staff or who 

does not have admitting privileges by 

that hospital, or by a qualified licensed 

individual who does not practice at that 

hospital but is acting within his/her 

scope of practice under State law or 

regulation. When an H&P is completed 

within the 30 days before admission or 

registration, the hospital must ensure 

that an updated medical record entry 

documenting an examination for any 

changes in the patient’s condition is 

placed in the patient’s medical record. 

This examination must be conducted by 

a practitioner who is credentialed and 

privileged by the hospital’s medical staff 

to perform an H&P. 

The update note to the H&P must 

document an examination for any 

changes in the patient’s condition since 

the time that the patient’s H&P was 

performed that might be significant for 

the planned course of treatment. If, 

upon examination, the licensed 

practitioner finds no change in the 

patient’s condition since the H&P was 

completed, he/she may indicate in the 

patient’s medical record that the H&P 

was reviewed, the patient was 

examined, and that ‘‘no change’’ has 

occurred in the patient’s condition since 

the H&P was completed. We note that 

we do not specify the extent of the 

examination that must be conducted; 

rather, we defer to the clinical judgment 

of hospital staff to determine the extent 

of the necessary H&P update. We 

believe that our interpretation of the 

H&P update requirement assures that all 

patients undergoing surgery or 

anesthesia are properly evaluated for all 

contraindications in accordance with 

the clinical judgment of hospital staff 

without an undue duplication of 

services and documentation. Therefore, 

we do not believe that the regulation 

should be amended. We are specifically 

seeking comment on this issue. 

Physical Environment (§ 482.41) 

Currently, hospitals are required to 

meet the standards of the 2000 edition 

of the Life Safety Code (LSC), which is 

not the most recent edition. Many 

accrediting bodies, as well as state and 

local jurisdictions, require hospitals to 

comply with more recent versions, such 

as the 2003, 2006, or 2009 edition of the 

LSC. Complying with both the 2000 

edition of the LSC, for Federal purposes, 

and a more recent edition, for 

accreditation or other purposes, can be 

challenging for hospitals when there are 


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inconsistencies between the two 

versions. 

We expect the 2012 edition of the LSC 

to be released in Fall 2011. Based on the 

content of the 2012 edition, we will 

decide whether it or another more 

recent edition, is appropriate for 

incorporation into the regulations for 

hospitals and other affected providers 

and suppliers. Any regulatory changes 

would be addressed through separate 

notice-and-comment rulemaking. We 

are specifically seeking comment on this 

issue. 

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): 

According to CMS, there are about 

4,900 hospitals (not including CAHs) 

that are certified by Medicare and/or 

Medicaid. We will use those figures to 

determine the burden for this rule. In 

addition, throughout this section, we 

estimate costs based on average hourly 

wages for different healthcare providers 

and attorneys. Unless indicated 

otherwise, we obtained these average 

hourly wages from the United States 

Bureau of Labor Statistics’ ‘‘May 2010 

National Occupational Employment and 

Wage Estimates United States’’ (http:// 

www.bls.gov/oes/current/oes_nat.htm 

accessed on September 28, 2011). We 

also added 30 percent to the indicated 

average hourly wage to allow for 

overhead and fringe benefits. 

A. ICRs Regarding Condition of 

Participation: Patient’s Rights (§ 482.13) 

Proposed § 482.13(g) would remove 

the current requirement for hospitals to 

notify CMS by telephone no later than 

the close of business the next business 

day following knowledge of a patient’s 

death for patients who die when no 

seclusion has been used and the only 

restraints used on the patient were soft, 

non-rigid, cloth-like materials, which 

were applied exclusively to the patient’s 

wrist(s). This requirement would 

include patients who died within 24 

hours of having been removed from 

these types of restraints. In those cases, 

the hospital must report to CMS by 

recording in a log or other system the 

information required at proposed 

§ 482.13(g)(2)(i) and (ii). We are 

proposing this change only for deaths 

where the patient died while either in 

soft two-point wrist(s) restraints or 

within 24 hours of having been removed 

from soft two-point wrist(s) restraints 

provided that: (a) There is no reason to 

believe the death was caused by those 

restraints, (b) that those were the only 

restraints used, and (c) that no seclusion 

was used. 

We believe that we previously 

underestimated the burden and costs 

associated with the current reporting 

requirement. After discussions with 

other CMS staff, we now believe that 

this reporting would be done by a nurse 

rather than a clerical person and that 

there are substantially more deaths that 

occurred to patients while they were in 

soft, non-rigid, cloth-like material, 

which were applied exclusively to a 

patient’s wrist(s), or within 24 hours of 

being removed from this type of 

restraints. 

We will be revising the current 

burden estimates for OMB control 

number 0938–0328 to reflect the burden 

estimated to be associated with the 

current regulations and would adjust for 

any burden reductions resulting from 

this provision once the current proposal 

is finalized. For a more detailed 

discussion of estimated burden and cost 

savings, please see the Regulatory 

Impact Analysis section of this rule. 

B. ICRs Regarding Condition of 

Participation: Nursing Services 

(§ 482.23) 

The current hospital CoPs require that 

hospitals ensure that the nursing staff 

develops, and keeps current, a nursing 

care plan for each patient (42 CFR 

482.23(b)(4)). Proposed 482.23(b)(4) 

would allow those hospitals that have 

interdisciplinary care plans (ICPs) to 

have their nursing care plans developed 

and kept current as part of the hospital’s 

ICPs. Based on our experience with 

hospitals, a nurse would develop and 

maintain the nursing care plan for each 

patient. The nurse would also be 

responsible for identifying the sections 

of each nursing care plan that needed to 

be integrated into the hospital’s ICP and 

transferring that information into the 

ICP. Thus, allowing hospitals to include 

the nursing care plan in the ICP for each 

patient would save the nurse the time 

she or he is currently spending 

identifying and transferring information 

from the separate nursing care plan into 

the ICP and maintaining the separate 

nursing care plan. 

In the currently approved OMB 

control number 0938–0328, we 

indicated that the creation and 

maintenance of a nursing care plan 

constituted a usual and customary 

business practice and did not assign a 

burden for this requirement in 

accordance with 5 CFR 1320.3(b)(2). 

Since completing that package, we have 

reconsidered our estimate of that 

analysis. While we continue to believe 

that creating and maintaining a health 

care plan for each patient is a usual and 

customary practice for hospitals, we do 

not believe that is usual and customary 

for hospitals to develop and maintain a 

separate nursing care plan when they 

also develop and maintain an ICP. 

We will be revising the current 

burden estimates for OMB control 

number 0938–0328 to reflect the burden 

estimated to be associated with the 

current regulations and would adjust for 

any burden reductions resulting from 

this provision once the current proposal 

is finalized. For a more detailed 

discussion of estimated burden and cost 

savings, please see the Regulatory 

Impact Analysis section of this rule. 

C. ICRs Regarding Condition of 

Participation: Medical Record Services 

(§ 482.24) 

In the currently approved OMB 

control number 0938–0328, we 

indicated that most of the patientrelated activities, such as authentication 

of verbal orders and using standing 

orders, constituted a usual and 

customary business practice and did not 

assign a burden for this requirement in 

accordance with 5 CFR 1320.3(b)(2). 

However, we have reconsidered our 

analysis. We believe that the 

authentication of verbal orders should 

be governed by state law and not 

mandated by the Federal government. In 

addition, while writing orders is 

generally a usual and customary 

business practice in hospitals, hospitals 

can also choose how those orders will 

be conveyed. We believe that some 

hospitals are not currently using 


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standing orders as often as they would 

choose to due to our CoPs. Therefore, by 

allowing authentication of verbal orders 

to be governed by state law and 

expanding the use of standing orders, 

we believe that these provisions would 

result in a burden reduction. 

We will be revising the current 

burden estimates for OMB control 

number 0938–0328 to reflect the burden 

estimated to be associated with the 

current regulations and would adjust for 

any burden reductions resulting from 

this provision once the current proposal 

is finalized. For a more detailed 

discussion of estimated burden and cost 

savings, please see the Regulatory 

Impact Analysis section of this rule. 

D. ICRs Regarding Condition of 

Participation: Infection Control 

(§ 482.42) 

The current hospital CoPs require that 

‘‘the infection control officer or officers 

must maintain a log of incidents related 

to infections and communicable 

disease’’ (42 CFR 482.42(a)(2)). We are 

proposing to eliminate this requirement 

for keeping a dedicated log of incidents 

related to infections and communicable 

diseases, proposing instead to allow 

hospitals flexibility in their approach to 

the tracking and surveillance of 

infections. 

In the currently approved OMB 

control number 0938–0328, we did not 

assign a burden for creating and 

maintaining this log. However, we have 

reconsidered our analysis. We believe 

there are many alternatives available 

that present an even greater opportunity 

to monitor and analyze infection control 

activities than keeping a log as currently 

required by the CoPs. In addition, we 

believe that the log is a format that 

hospitals are using only because of the 

CMS requirement and that they are 

producing data in this fashion in 

addition to the format they are using for 

their own purposes. Thus, while 

identifying and monitoring infections 

that patient have during hospitalization 

would be usual and customary for 

hospitals, we believe that requiring 

hospitals to keep a log rather than 

decide how they could best keep track 

of this information is burdensome for 

hospitals. 

We will be revising the current 

burden estimates for OMB control 

number 0938–0328 to reflect the burden 

estimated to be associated with the 

current regulations and will adjust for 

any burden reductions resulting from 

this provision once the current proposal 

is finalized. For a more detailed 

discussion of estimated burden and cost 

savings, please see the Regulatory 

Impact Analysis section of this rule. 

E. ICRs Regarding Condition of 

Participation: Transplant Center Process 

Requirements—Organ Recovery and 

Receipt (§ 482.92) 

We propose removing 482.92(a) 

entirely. The elimination of this section 

would remove the burden on the part of 

transplant centers by eliminating a 

requirement to review and compare 

blood type and other vital data before 

organ recovery takes place. 

In the currently approved OMB 

control number 0938–1069, we 

indicated that the verification by the 

transplant hospital recovery physician 

when the recipient was known 

constituted a usual and customary 

business practice and did not assign a 

burden for this requirement in 

accordance with 5 CFR 1320.3(b)(2). 

However, since that PRA package was 

approved by OMB, several members of 

the transplant community have 

repeatedly told CMS that this 

verification was unnecessary and 

burdensome because OPOs already 

perform this type of verification prior to 

organ recovery in accordance with 

486.344(d)(2)(ii). Therefore, we have 

reconsidered our estimate of the burden 

for this requirement. 

We will be revising the current 

burden estimates for OMB control 

number 0938–0328 to reflect the burden 

estimated to be associated with the 

current regulations and would adjust for 

any burden reductions resulting from 

this provision once the current proposal 

is finalized. For a more detailed 

discussion of estimated burden and cost 

savings, please see the Regulatory 

Impact Analysis section of this rule. 

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 Impacts 

A. Regulatory Impact Analysis 

1. Introduction 

We have examined the impacts of this 

rulemaking as required by Executive 

Orders 12866 (September 1993) and 

13563 (January 2011). Executive Orders 

12866 and 13563 direct 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). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, 

reducing costs, harmonizing rules, and 

promoting flexibility. A Regulatory 

Impact Analysis (RIA) must be prepared 

for rules with economically significant 

effects ($100 million or more in any one 

year). This proposed rule is an 

‘‘economically’’ significant regulatory 

action under section 3(f)(1) of Executive 

Order 12866. Accordingly, the Office of 

Management and Budget (OMB) has 

reviewed this proposed rule. 

2. Statement of Need 

In Executive Order 13563, the 

President recognized the importance of 

a streamlined, effective, efficient 

regulatory framework designed to 

promote economic growth, innovation, 

job-creation, and competitiveness. To 

achieve a more robust and effective 

regulatory framework, the President has 

directed each executive agency to 

establish a plan for ongoing 

retrospective review of existing 

significant regulations to identify those 

rules that can be eliminated as obsolete, 

unnecessary, burdensome, or 

counterproductive or that can be 

modified to be more effective, efficient, 

flexible, and streamlined. Consistent 

with this directive, CMS has conducted 

a retrospective review of the conditions 

of participation it imposes on hospitals 

to remove or revise obsolete, 

unnecessary, or burdensome provisions. 

The goal of the retrospective review is 

to identify opportunities reduce system 

costs by removing obsolete or 

burdensome requirements while 

maintaining patient care and outcomes. 

CMS had not reviewed the entire set 

of Conditions of Participation for 

Hospitals in many years. These 

requirements had grown over time and, 

while often revised, had not been 

subject to a complete review. CMS staff 

as well as CMS stakeholders, including 

TJC, the American Medical Association, 

the AHA, and many others, had 

identified problematic requirements 

over the years. Accordingly, we decided 

to conduct a retrospective review of the 

conditions of participation imposed on 

hospitals and to remove or revise 

obsolete, unnecessary, or burdensome 

provisions, and to increase regulatory 

flexibility while identifying and adding 

opportunities to improve patient care 

and outcomes. We analyzed all potential 

reforms and revisions of the CoPs for 

both the costs and the benefits that they 

would bring to hospitals and CAHs, 


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65902 Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Proposed Rules 

Based on our analysis, we decided to 

pursue those regulatory revisions that 

would reflect the substantial advances 

that have been made in healthcare 

delivery and that would benefit 

hospitals and CAHs through cost 

savings. 

3. Summary of Impacts 

These proposed reductions in process 

and procedure requirements will 

facilitate redirection of staff resources to 

higher priorities with greater benefit 

both to patients directly and through the 

increased flexibility that institutions 

will have to reengineer internal 

processes. We present a summary of 

these cost reducing changes in Table 2. 

TABLE 1—SECTION-BY-SECTION SUMMARY OF COST SAVINGS TO HOSPITALS AND CAHS

[Entries rounded to nearest $100K if under $50M and to nearest $10M if higher] 

Regulatory area Section Annual savings 

($K) 

Patient’s Rights—Death Notice Soft Restraints .............................................................................................. 482.13 9,900 

Medical Staff .................................................................................................................................................... 482.22 330,000 

Nursing Services—Care Plan .......................................................................................................................... 482.23 110,000 

Medical Record Services—Authentication ...................................................................................................... 482.24 80,000 

Medical Record Services—Standing Orders ................................................................................................... 482.24 90,000 

Infection Control—Eliminate Log ..................................................................................................................... 482.42 6,600 

Outpatient Services ......................................................................................................................................... 482.54 300,000 

Transplant Organ recovery .............................................................................................................................. 482.92 200 

CAH Direct Services ........................................................................................................................................ 485.635 15,800 

Total .......................................................................................................................................................... ............................ 942,500 

Some of these savings come simply 

from reductions in process requirements 

and reporting. The changes in the area 

of Medical staffing and several other 

areas would allow hospitals more 

flexibility in hiring and staffing 

decisions, including use of part-time 

and contract staff, to provide patient 

services efficiently and effectively. Total 

national hospital spending is about nine 

hundred billion dollars a year and about 

half of this is spent on staff 

compensation (source: AHA Hospital 

Statistics). Thus, the potential 

magnitude of the efficiencies that could 

be achieved is very large. 

Clearly, the amount of savings 

actually realized through these reforms 

will depend on the individual decisions 

of about 6,100 hospitals (including 

CAHs), over time. We cannot predict the 

extent or speed of these elective 

changes. Other factors, such as 

impending physician shortages and the 

growing use of other practitioners to 

perform many physician functions will 

play a role as will State decisions on 

laws delineating scope of practice. 

Furthermore, for the requirements 

that we propose to modify or delete, we 

are not aware of any information 

suggesting that the change we propose 

would create consequential risks for 

patients. In other words, we do not 

believe that any requirement we 

propose to eliminate has saved lives in 

recent decades. 

We welcome comments on ways to 

better estimate the likely effects of these 

reforms within the broader array of 

influences on delivery of care. 

4. Anticipated Impacts 

There are about 4,900 hospitals and 

1,200 CAHs that are certified by 

Medicare and/or Medicaid. We use 

these figures to estimate the potential 

impacts of this proposed rule. 

According to CMS’ Center for Medicaid, 

Children’s Health Insurance Program 

(CHIP), and Survey and Certification 

(CMCS), for fiscal year (FY) 2010, TJC 

accredited 3,839 hospitals and 365 

CAHs. For TJC-accredited hospitals and 

CAHs we will use the figures of 3,800 

and 400, respectively. For non TJCaccredited hospitals and CAHs, we will 

use the figures of 1,100 and 800, 

respectively. In addition, we use the 

following average hourly wages for 

nurses and physicians respectively: $45 

and $124 (BLS Wage Data by Area and 

Occupation, including both hourly 

wages and fringe benefits, at http:// 

www.bls.gov/bls/blswage.htm and 

http://www.bls.gov/ncs/ect/). The 

analysis below overlaps with the 

Collection of Information Requirements 

section for many individual items. That 

section contains more technical and 

legal detail as appropriate under the 

Paperwork Reduction Act, but that is 

not necessary or appropriate in a 

Regulatory Impact Analysis. Readers 

may wish to consult both sections on 

some topics. 

Death Notices for Soft Restraints 

(Patient’s Rights § 482.13) 

We propose to remove the current 

requirement for hospitals to notify CMS 

by telephone no later than the close of 

business the next business day 

following knowledge of a patient’s death 

for patients who die when no seclusion 

has been used and the only restraints 

used on the patient were soft, non-rigid, 

cloth-like materials, which were applied 

exclusively to the patient’s wrists. 

Reporting would also be removed for 

patients who died within 24 hours of 

having been removed from these types 

of restraints. 

We estimate that full reporting of all 

such instances would result in 882,000 

occurrences. This is much greater than 

the assumption that originally 

established this reporting requirement 

in the final rule (71 FR 71425). 

However, since the requirements have 

come into effect, we believe our initial 

estimate was low. Also, the assumption 

in the 2006 final rule was that these 

functions would be carried out by a 

clerical person. Based on our experience 

with hospitals, this assumption is 

incorrect. A registered nurse would be 

the more appropriate staff member to 

make the call and to enter the 

information into a patient’s medical 

record. The difference between the 

average hourly wage for a clerical 

person and a registered nurse ($18.88 

per hour versus $45 per hour) would 

account for a significant discrepancy in 

estimated burden between the 2006 

final rule and this proposed rule. 

Similar to the 2006 rule, we still 

estimate that it would take about fifteen 

minutes (or .25 hours) to comply with 

this requirement for each occurrence. 

The estimate of the time is also based on 

our experiences with hospitals as well 

as feedback from stakeholders that 

indicates that this estimate is 

reasonable. Therefore, we estimate that 

this reduction in burden would reduce 


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a hospital’s burden hours by 45 hours 

each year valued at $45 per hour for an 

annual savings of $2,025. Thus, we 

estimate that for all 4,900 hospitals this 

would result in a savings of about 

$9,922,500. 

Medical Staff (§ 482.22) 

Our changes and clarifications 

regarding medical staff and privileging 

would allow hospitals to substitute and 

rearrange actual delivery of care. In 

particular, use of Advanced Practice 

Nurse Practitioners (APRNs) and 

Physician Assistants (PAs) in lieu of 

higher-paid physicians could provide 

immediate savings to hospitals. We have 

no precise basis for calculating potential 

savings, which in any event depend on 

future staffing and management 

decisions, but they are very substantial. 

For purposes of this analysis we have 

reached an estimate of $330 million 

using the following assumptions: 

• All hospitals are able, under State 

scope of practice laws (that is, 4,900 

hospitals), and one third of these are 

willing (that is, 1,617), to make such 

medical staff substitutions; 

• There are on average 7,000 

inpatient hospital stays per hospital per 

year (from AHA Hospital Statistics); 

• The average hospital stay is about 5 

days (per AHA statistics); 

• On average, each patient receives 

approximately 75 minutes (1.25 hours) 

of a physician’s time (for example, inperson visits/assessments, including 

patient and family education; review of 

patient lab and other diagnostic test 

results; documentation of orders, 

progress notes, and other entries in the 

medical record; performance of minor 

procedures; and discussion of the 

patient’s condition with other staff) 

during an average 5-day stay; 

• At a minimum, 33 percent of this 

physician per patient time would now 

be covered by nonphysician 

practitioners (for example, APRNs and 

PAs); and 

• There is an average salary 

difference of $71 an hour between 

physicians and these practitioners. 

The resulting savings estimate of 

about $330 million annually (1,617 

hospitals × 7,000 inpatient hospital 

stays × 1.25 hours of physician/ 

nonphysician practitioner time × $71 

per hourly wage difference × 33 percent 

of physician time with patients covered 

by nonphysician practitioners) could 

obviously be much higher or lower if 

any of the parameters above changed. 

Additionally, we have restricted our 

estimates to inpatient hospital stays and 

we did not include a discussion of the 

approximately 620,000,000 annual 

hospital outpatient visits (AHA Hospital 

Statistics) and the impact that the 

proposed changes could have on staffing 

costs for hospitals in light of this 

number. Thus, many reasonable 

variations of our assumptions would 

lead to a similar magnitude of savings. 

We welcome comments on these 

estimates and on ways to improve them. 

Nursing Services Care Plan (§ 482.23) 

The current hospital CoPs require that 

hospitals ensure that the nursing staff 

develops, and keeps current, a nursing 

care plan for each patient. Our proposal 

would allow those hospitals that have 

interdisciplinary care plans (ICPs) to 

have their nursing care plans developed 

and kept current as part of the hospital’s 

ICPs. 

Based on our experience with 

hospitals, a nurse would develop and 

maintain the nursing care plan for each 

patient. The nurse would also be 

responsible for identifying the sections 

of each nursing care plan that needed to 

be integrated into the hospital’s ICP and 

transferring that information into the 

ICP. Thus, allowing hospitals to include 

the nursing care plan in the ICP for each 

patient would save the nurse the time 

he or she is currently spending 

identifying and transferring information 

from the separate nursing care plan into 

the ICP and maintaining the separate 

nursing care plan. We believe that many 

hospitals have already developed 

methods for eliminating this timewasting step, particularly those 

hospitals that have largely implemented 

an electronic health records system. 

Assuming that about 60 percent have 

done so, this reform would only affect 

roughly 16 million patients (40 percent 

of 40 million admissions). 

We estimate that allowing a hospital 

to use only the ICP would save the 

nurse an average of nine minutes or 0.15 

hours and would affect 16,000,000 

patients. Thus, the proposed provision 

would result in a reduction of 2,400,000 

burden hours valued at $45 per hour for 

a savings of $108,000,000. 

Medical Record Services— 

Authentication and Standing Orders 

(§ 482.24) 

We are proposing to revise the 

Medical Records CoP to eliminate the 

requirement for authentication of verbal 

orders within 48 hours if no State law 

specifying a timeframe exists. Since we 

believe that very few States have 

authentication timeframe requirements, 

we do not believe that the few States 

that may have such requirements would 

impact the potential savings we are 

estimating here. We are also proposing 

to make permanent the temporary 

provision (5-year Sunset provision due 

to expire early 2012) that allows for 

orders to be authenticated by another 

practitioner who is responsible for the 

care of the patient and who, in 

accordance with hospital policy State 

law, is authorized to write orders. 

We believe that this provision would 

result in a burden reduction. We would 

expect a registered nurse or compliance 

officer to be responsible for checking 

medical records and flagging orders 

needing authentication, particularly 

those verbal orders nearing the current 

48-hr timeframe. Based on our 

experience with hospitals and feedback 

from stakeholders on this issue, we 

believe that hospitals will save one hour 

of a nurse’s time every day for 365 

burden hours for each hospital 

annually. For all 4,900 hospitals, this 

would result in a reduction of 1,788,500 

burden hours, valued at $45 per hour for 

a savings of $80,482,500. 

We are also proposing to add new 

provisions to allow hospitals to use preprinted and electronic standing orders, 

order sets, and protocols for patient 

orders if the hospital ensures that these 

orders: have been reviewed and 

approved by the medical staff and 

nursing and pharmacy leadership; are 

consistent with nationally recognized 

guidelines; are reviewed periodically 

and regularly by medical staff and 

nursing and pharmacy leadership; and 

are dated, timed, and authenticated by 

a practitioner who is responsible for the 

care of the patient and who is 

authorized to write orders by hospital 

policy in accordance with State law. In 

addition, we proposed to allow for 

drugs and biologicals to be prepared and 

administered on the orders of other 

practitioners if they are acting in 

accordance with State law and scope of 

practice and the hospital has granted 

them the privileges to do so. 

The use of standing orders, order sets, 

and protocols reduces a hospital’s 

burden in several ways. Initially, it 

saves the physician or other practitioner 

the time it takes to write out the orders. 

It also saves the physician the time it 

would take to go back to the chart or call 

a nurse with a verbal order if the 

physician forgets a particular order. The 

nurses also save time when standing 

orders are used. The orders are more 

legible so there is less time interpreting 

and calling physicians for verification. 

Nurses also need to call physicians less 

frequently when there is a change in the 

patient’s condition or they feel there 

needs to be a change in the care the 

patient is receiving. Patients also benefit 

from standing orders because there 

would be less delay in the delivery of 

needed care to a patient. Thus, we 

believe that expanding the use of 


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65904 Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Proposed Rules 

standing orders would significantly 

reduce the hospital’s burden. 

Based on our experience with 

hospitals and on stakeholder feedback 

regarding the issue of standing orders, 

we estimate that these provisions would 

affect 13 million patients or roughly 

one-third of hospital admissions. We 

also estimate that using standing orders 

would result in a burden reduction of an 

average of 4 minutes or 0.07 hours for 

each of these patients. Thus, expanding 

the use of standing orders would result 

in a reduction of 700,000 burden hours 

valued at $124 per hour for a savings of 

$86,800,000. 

Outpatient Services (§ 482.54) 

Our proposed liberalization of 

outpatient services supervision will 

permit large savings. Under the existing 

Condition of Participation, only one 

person may direct outpatient services. 

Similar to our estimates for medical staff 

savings, what savings hospitals may 

realize would depend largely on their 

future decisions, and cannot be 

predicted with any precision. For 

purposes of estimation, we have 

developed an estimate that illustrates 

the potential. Under this estimate, we 

assume that two-thirds of the hours 

eliminated would represent net savings, 

since existing directors obviously 

perform significant coordination 

functions that would have to be 

performed however the work is 

organized. To be more specific, 

potential savings are based on the 

following: 

• Two-thirds of hospitals elected to 

redirect these overall director functions 

(3,267 hospitals); 

• On average, each position 

represents 2,000 hours per year; 

• Only two-thirds of the hours 

eliminated represented net savings; and 

• Compensation averages about $70 

an hour. 

Based on these assumptions, this 

reform would produce $305 million 

annually in staff savings (3,267 

hospitals × 2,000 hours × 2⁄3 × $70 per 

hour). A similar result would be 

obtained if four-fifths of hospitals 

redirected these functions, but the net 

hours saved were only a little more than 

half of the current hours. 

Transplant Organ Recovery (§ 482.92) 

We propose removing the current 

blood typing requirement entirely. The 

elimination of this section would 

remove transplant center burden by 

eliminating a requirement to review and 

compare blood type and other vital data 

before organ recovery takes place. The 

OPOs already perform this type of 

verification prior to organ recovery. In 

addition, since publication of the 

existing rule, the transplant community 

has repeatedly told CMS that the 

verification that we propose to delete is 

burdensome and unnecessary. 

Under the current requirements for 

this situation, the OPO performs a 

verification before organ recovery, the 

surgeon working for the transplant 

center performs a verification before 

organ recovery, and the transplant 

center surgeon performs another 

verification before the organ is 

transplanted. Under the proposed 

requirement, the OPO performs a 

verification before organ recovery and 

the transplant center surgeon performs a 

verification before the organ is 

transplanted. We would eliminate the 

verification that is conducted by the 

staff working on behalf of the transplant 

center that must occur prior to organ 

recovery. In addition, the responsibility 

for maintaining these records is very 

unclear, and has caused conflict 

between surgeons, transplant centers, 

and the hospitals where the organ 

recoveries are performed. Elimination of 

the extra verification step removes this 

source of conflict and confusion. 

Between July 1, 2009 and June 30, 

2010, the United States saw 2,293 heart 

and 1,699 lung transplants. During the 

same time frame, there were also 16,679 

transplants for kidneys, 6,301 for livers, 

and 371 for pancreases. (Scientific 

Registry of Transplant Recipients 

(SRTR) http://srtr.org/csr/current/ 

nats.aspx, date last accessed 6/9/10). 

Most organ recoveries for heart and lung 

transplants are conducted by surgeons 

working for their own transplant 

centers. By contrast, in the case of 

kidneys, livers, and pancreases, these 

organs are typically recovered by 

surgeons who are on-call for an OPO 

and who are not also working for, or 

privileged at, the same transplant center 

where the organ is delivered. For 

purposes of this analysis, we assume 

that 25 percent of kidney, liver and 

pancreas organ recoveries are conducted 

by surgeons who are working for the 

transplant centers. It is in this small 

percentage of transplant cases, roughly 

5,800, together with the total number of 

heart and lung transplants, where the 

requirement for an additional 

verification has resulted in overlapping 

and burdensome requirements. For the 

purpose of analysis, we have assumed 

that conducting the verification and 

filing the corresponding paperwork 

would take 8 minutes and that there are 

9,972 transplant cases. We therefore 

conclude that removing the duplicative 

verification requirement will result in 

an annual savings of 1,305 burden hours 

valued at $124 per hour for a monetary 

savings of $161,820. 

Infection Control Log (§ 484.42) 

We are proposing to eliminate a 

requirement for keeping a dedicated log 

of incidents related to infections and 

communicable diseases, proposing 

instead to allow hospitals flexibility in 

their approach to the tracking and 

surveillance of infections. We believe 

the changes we are proposing overall 

would result in the more efficient use of 

time. 

We believe that the current log 

requirement requires roughly 30 hours 

annually of a nurse’s time per hospital 

(i.e., an average of 600 to 900 log entries 

per year and 2–3 minutes per entry). 

Thus, for all 4,900 hospitals this change 

would result in a savings of 147,000 

burden hours valued at $45 per hour for 

a savings of $6,615,000. 

CAH Provision of Services (§ 485.635) 

Our proposed removal of the ‘‘direct 

services’’ requirement imposed on 

CAHs would eliminate the requirement 

that certain services be provided only by 

employees and not through contractual 

arrangements with entities such as 

community physicians, laboratories, or 

radiology services. Opportunities may 

be limited because CAHS are both small 

and overwhelmingly located in rural 

areas where there may not be realistic 

alternatives to direct hiring. We estimate 

that this could produce savings of 

approximately one tenth of one full-time 

equivalent staff person in payroll 

savings on average, at an average 

compensation cost of $66, for a total of 

about $16 million saved annually across 

all 1,200 CAHs. Savings might be 

considerably larger, and we welcome 

information and data on this question. 

5. Alternatives Considered 

From within the entire body of 

conditions of participation, the most 

serious candidates for reform were those 

identified by stakeholders, by recent 

research, or by experts as unusually 

burdensome if not unchanged. This 

subset of the universe of standards is the 

focus of this proposed rule. We 

welcome comments on whether we 

properly selected the best candidates for 

change, and will consider suggestions 

for additional reform candidates from 

the entire body of conditions of 

participation for hospitals and CAHs. 

A second set of alternatives arises 

because there are obviously various 

ways to draft each requirement. For 

each requirement that we have proposed 

for deletion or modification there are a 

number of possible options, including 

making no change, making the change 


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Federal Register / Vol. 76, No. 205 / Monday, October 24, 2011 / Proposed Rules 65905 

we propose, and in some but not all 

cases making some in-between change. 

Most standards have an ‘‘either-or’’ 

nature, but we welcome comments on 

possible variations. There is a final set 

of alternatives revolving around entirely 

different methods of achieving potential 

benefits, such as incentive payments 

through Medicare or other health plans 

to high-performing institutions, or 

publishing quality scores to make 

hospital strengths and weaknesses 

transparent to both the public at large 

and to practitioners. A number of such 

reforms are underway. Likewise, there 

are alternatives such as technical 

assistance through Quality Improvement 

Organizations (QIOs) funded by CMS, 

also underway under the latest QIO 

contracts. We welcome comments on 

such alternatives. 

6. Uncertainty 

Our estimates of the effects of this 

regulation are subject to significant 

uncertainty. While CMS is confident 

that these reforms would provide 

flexibilities to hospitals that would 

yield cost savings, we are uncertain 

about the magnitude of these effects. In 

addition, as we previously explained, 

we do not believe that any requirement 

we propose to eliminate achieved any 

consequential improvements in patient 

safety. Thus, we are confident that the 

rule would yield net benefits. In this 

analysis we provided some illustrative 

estimates to suggest the potential 

savings these reforms could achieve 

under certain assumptions. We welcome 

comments on ways to better estimate the 

likely effects of these reforms. 

7. Accounting Statement 

As required by OMB Circular A–4 

(available at http://www.whitehouse

.gov/omb/circulars/a004/a-4.pdf), we 

have prepared an accounting statement. 

As previously explained, achieving the 

full scope of potential savings will 

depend on future decisions by hospitals, 

by State regulators, and others. Many 

other factors will influence long-term 

results. We believe, however, that likely 

savings and benefits will reach many 

billions of dollars. Our primary estimate 

of the net savings to hospitals from 

reductions in regulatory requirements 

that we can quantify at this time, offset 

by increases in other regulatory costs, 

are approximately $940 million a year. 

We welcome comments on both the 

overall estimate and its components. 

TABLE 2—ACCOUNTING STATEMENT: CLASSIFICATION OF ESTIMATED COSTS AND SAVINGS

[$ in millions] 

Category Primary 

estimate 

Units 

Year dollars Discount 

rate 

Period 

covered 

Benefits None 

Costs 

¥$940 2012 7% 2012–16 

Annualized Monetized reductions in Costs $940 2012 3% 2012–16 

Transfers None 

B. Regulatory Flexibility Act 

The Regulatory Flexibility Act (RFA), 

as modified by the Small Business 

Regulatory Enforcement Fairness Act of 

1996 (SBREFA), requires agencies to 

determine whether proposed or final 

rules would have a ‘‘significant 

economic impact on a substantial 

number of small entities’’ and, if so, to 

prepare a Regulatory Flexibility 

Analysis and to identify in the notice of 

proposed rulemaking or final 

rulemaking any regulatory options that 

could mitigate the impact of the 

proposed regulation on small 

businesses. For purposes of the RFA, 

small entities include businesses that 

are small as determined by size 

standards issued by the Small Business 

Administration (SBA), nonprofit 

organizations, and small governmental 

jurisdictions. Individuals and States are 

not included in the definition of a small 

entity. The SBA size threshold for 

‘‘small entity’’ hospitals is $34.5 million 

or less in annual revenues. Also, all 

non-profit hospitals are small entities 

under the RFA. About three-fifths of all 

hospitals (including CAHs) are nonprofit and about one-third (many 

overlapping) have annual revenues 

below the SBA size threshold. Because 

the great majority qualifies as ‘‘small 

entities,’’ HHS policy for many years 

has been to treat all hospitals as small 

entities deserving protection under the 

RFA. Although the overall magnitude of 

the paperwork, staffing, and related cost 

reductions to hospitals and CAHs 

proposed under this rule is 

economically significant, these savings 

are likely to be only about one percent 

of total hospital costs. Total national 

inpatient hospital spending is 

approximately nine hundred billion 

dollars a year, or an average of about 

$150 million per hospital, and our 

primary estimate of the net effect of 

these proposals on reducing hospital 

costs is only about $940 million 

annually (although potentially far 

higher). This is an average of slightly 

over $150,000 in savings on average for 

the 6,100 hospitals (including CAHs) 

that are regulated through the 

Conditions of Participation. Under HHS 

guidelines for Regulatory Flexibility 

Analysis, actions that do not negatively 

affect costs or revenues by about 3 to 5 

percent a year are not economically 

significant. We believe that no hospitals 

of any size will be negatively affected. 

Accordingly, we have determined that 

this proposed rule would not have a 

significant economic impact on a 

substantial number of small entities, 

and that an Initial Regulatory Flexibility 

Analysis is not required. 

Notwithstanding this conclusion, we 

believe that this RIA and the preamble 

as a whole meet the requirements of the 

RFA for such an analysis. 

In addition, section 1102(b) of the 

Social Security 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 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 and has 

fewer than 100 beds. We do not believe 

a regulatory impact analysis is required 

here for the same reasons previously 


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described and because, in addition, our 

proposals are particularly cost-reducing 

for the smallest hospitals, including 

especially CAHs (which in most cases 

have no more than 25 beds). 

C. Unfunded Mandates Reform Act of 

1995 

Section 202 of the Unfunded 

Mandates Reform Act (UMRA) of 1995 

requires that agencies assess anticipated 

costs and benefits before issuing any 

rule whose mandates on State, local, or 

Tribal governments in the aggregate, or 

on the private sector, require spending 

in any one year of $100 million in 1995 

dollars, updated annually for inflation. 

That threshold level is currently about 

$136 million. This proposed rule would 

eliminate or reform existing 

requirements and would allow hospitals 

and CAHs to achieve substantial savings 

through staffing reforms. Accordingly, 

no analysis under UMRA is required. 

D. Federalism 

Executive Order 13132 on Federalism 

establishes certain requirements that an 

agency must meet when it publishes 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. 

We have determined that this proposed 

rule would not significantly affect the 

rights, roles, or responsibilities of the 

States. This proposed rule would not 

impose substantial direct requirement 

costs on State or local governments, 

preempt State law, or otherwise 

implicate federalism. It does, however, 

facilitate the ability of States to reform 

their scope of practice laws without 

Federal requirements reducing the 

effectiveness of such reforms. We 

understand that about half of the States 

are considering such reforms, and we 

support such efforts. 

VI. Regulations Text 

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: 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

1. The authority citation for part 482 

continues to read as follows: 

Authority: Secs. 1102, 1871 and 1881 of 

the Social Security Act (42 U.S.C. 1302, 

1395hh, and 1395rr), unless otherwise noted. 

Subpart B—Administration 

2. Section 482.12 is amended by 

revising the introductory text to read as 

follows: 

§ 482.12 Condition of participation: 

Governing body. 

There must be an effective governing 

body that is legally responsible for the 

conduct of the hospital. If a hospital 

does not have an organized governing 

body, the persons legally responsible for 

the conduct of the hospital must carry 

out the functions specified in this part 

that pertain to the governing body. 

* * * * * 

§ 482.13 Condition of participation: 

Patient’s rights. 

3. Section 482.13 is amended by— 

a. Revising paragraphs (g)(1), (g)(2), 

and (g)(3). 

b. Adding a new paragraph (g)(4). 

The revisions and additions read as 

follows: 

§ 482.13 Condition of participation: 

Patient’s rights. 

* * * * * 

(g) * * * 

(1) With the exception of deaths 

described under paragraph (g)(2) of this 

section, the hospital must report the 

following information to CMS by 

telephone, facsimile, or electronically, 

as determined by CMS, no later than the 

close of business on the next business 

day following knowledge of the 

patient’s death: 

(i) Each death that occurs while a 

patient is in restraint or seclusion. 

(ii) Each death that occurs within 24 

hours after the patient has been 

removed from restraint or seclusion. 

(iii) Each death known to the hospital 

that occurs within 1 week after restraint 

or seclusion where it is reasonable to 

assume that use of restraint or 

placement in seclusion contributed 

directly or indirectly to a patient’s 

death, regardless of the type(s) of 

restraint used on the patient during this 

time. ‘‘Reasonable to assume’’ in this 

context includes, but is not limited to, 

deaths related to restrictions of 

movement for prolonged periods of 

time, or death related to chest 

compression, restriction of breathing, or 

asphyxiation. 

(2) When no seclusion has been used 

and when the only restraints used on 

the patient are those applied exclusively 

to the patient’s wrist(s), and which are 

composed solely of soft, non-rigid, 

cloth-like materials, the hospital staff 

must report to CMS by recording in a 

log or other system, the following 

information: 

(i) Any death that occurs while a 

patient is in such restraints; and 

(ii) Any death that occurs within 24 

hours after a patient has been removed 

from such restraints. 

(3) For deaths described in paragraphs 

(g)(1) and (g)(2) of this section, staff 

must document in the patient’s medical 

record the date and time the death was 

reported to CMS. 

(4) For deaths described in paragraph 

(g)(2) of this section, entries into the log 

or other system must be documented as 

follows: 

(i) Each entry must be made not later 

than seven days after the date of death 

of the patient; 

(ii) Each entry must document the 

patient’s name, date of birth, date of 

death, attending physician’s name, 

medical record number, and primary 

diagnosis(es); and 

(iii) The information must be made 

available in either written or electronic 

form to CMS immediately upon request. 

Subpart C—Basic Hospital Functions 

4. Section 482.22 is amended by— 

a. Revising the introductory 

paragraph. 

b. Revising paragraph (a) introductory 

text. 

a. Adding a new paragraph (a)(5). 

b. Revising (b)(3). 

The revisions and additions read as 

follows: 

§ 482.22 Condition of participation: 

Medical staff. 

The hospital must have an organized 

medical staff that operates under bylaws 

approved by the governing body and is 

responsible for the quality of medical 

care provided to patients by the 

hospital. 

(a) Standard: Composition of the 

medical staff. The medical staff must be 

composed of doctors of medicine or 

osteopathy and, in accordance with 

State law, may also be composed of 

other practitioners appointed by the 

governing body. 

* * * * * 

(5) The medical staff must examine 

the credentials of candidates applying 

for practice privileges and medical staff 

membership within the hospital, as well 

as the credentials of practitioners 

applying only for hospital practice 

privileges, and make recommendations 

to the governing body for the 


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appointment of these candidates and the 

approval of these privileges in 

accordance with State law and hospital 

policies and procedures. A physician or 

nonphysician practitioner who has been 

granted practice privileges by the 

governing body for practice activities 

authorized within his or her State scope 

of practice is subject to all medical staff 

requirements contained in this section. 

(b) * * * 

(3) The responsibility for organization 

and conduct of the medical staff must be 

assigned only to: 

(i) An individual doctor of medicine 

or osteopathy, 

(ii) A doctor of dental surgery or 

dental medicine, when permitted by 

State law of the State in which the 

hospital is located; or 

(iii) A doctor of podiatric medicine, 

when permitted by State law of the State 

in which the hospital is located. 

* * * * * 

5. Section 482.23 is amended by— 

a. Revising paragraph (b)(4). 

b. Revising paragraph (c). 

The revisions and additions read as 

follows: 

§ 482.23 Condition of participation: 

Nursing services. 

* * * * * 

(b) * * * 

(4) The hospital must ensure that the 

nursing staff develops, and keeps 

current, a nursing care plan for each 

patient. The nursing care plan may be 

part of an interdisciplinary care plan. 

* * * * * 

(c) Standard: Preparation and 

administration of drugs. (1) Drugs and 

biologicals must be prepared and 

administered in accordance with 

Federal and State laws, the orders of the 

practitioner or practitioners responsible 

for the patient’s care as specified under 

§ 482.12(c), and accepted standards of 

practice. 

(i) Drugs and biologicals may be 

prepared and administered on the 

orders of other practitioners not 

specified under § 482.12(c) only if such 

practitioners are acting in accordance 

with State law, including scope of 

practice laws, and only if the hospital 

has granted them privileges to do so. 

(ii) Drugs and biologicals may be 

prepared and administered on the 

orders contained within pre-printed and 

electronic standing orders, order sets, 

and protocols for patient orders only if 

such orders meet the requirements of 

§ 482.24(c)(3). 

(2) All drugs and biologicals must be 

administered by, or under supervision 

of, nursing or other personnel in 

accordance with Federal and State laws 

and regulations, including applicable 

licensing requirements, and in 

accordance with the approved medical 

staff policies and procedures. 

(3) With the exception of influenza 

and pneumococcal polysaccharide 

vaccines, which may be administered 

per physician-approved hospital policy 

after an assessment of contraindications, 

orders for drugs and biologicals must be 

documented and signed by a 

practitioner who is authorized to write 

orders in accordance with State law and 

hospital policy, and who is responsible 

for the care of the patient as specified 

under § 482.12(c). 

(i) If verbal orders are used, they are 

to be used infrequently. 

(ii) When verbal orders are used, they 

must only be accepted by persons who 

are authorized to do so by hospital 

policy and procedures consistent with 

Federal and State law. 

(iii) Orders for drugs and biologicals 

may be documented and signed by other 

practitioners not specified under 

§ 482.12(c) only if such practitioners are 

acting in accordance with State law and 

scope of practice and only if the 

hospital has granted them privileges to 

do so. 

(4) Blood transfusions and 

intravenous medications must be 

administered in accordance with State 

law and approved medical staff policies 

and procedures. 

(5) There must be a hospital 

procedure for reporting transfusion 

reactions, adverse drug reactions, and 

errors in administration of drugs. 

(6) The hospital may allow a patient 

(or his or her caregiver/support person 

where appropriate) to self-administer 

both hospital-issued medications and 

the patient’s own medications brought 

into the hospital, as defined and 

specified in the hospital’s policies and 

procedures. 

(i) If the hospital allows a patient to 

self-administer specific hospital-issued 

medications, then the hospital must 

have policies and procedures in place 

to: 

(A) Assure that a practitioner 

responsible for the care of the patient 

has issued an order, consistent with 

hospital policy, permitting selfadministration; 

(B) Assess the capacity of the patient 

(or the patient’s caregiver/support 

person where appropriate) to selfadminister the specified medication(s); 

(C) Instruct the patient (or the 

patient’s caregiver/support person 

where appropriate) in the safe and 

accurate administration of the specified 

medication(s); 

(D) Ensure the security of the 

medication(s) for each patient; and 

(E) Document the administration of 

each medication in the patient’s medical 

record. 

(ii) If the hospital allows a patient to 

self-administer his or her own specific 

medications brought into the hospital, 

then the hospital must have policies and 

procedures in place to: 

(A) Assure that a practitioner 

responsible for the care of the patient 

has issued an order, consistent with 

hospital policy, permitting selfadministration of medications the 

patient brought into the hospital; 

(B) Assess the capacity of the patient 

(or the patient’s caregiver/support 

person where appropriate) to selfadminister the specified medication(s), 

and also determine if the patient (or the 

patient’s caregiver/support person 

where appropriate) needs instruction in 

the safe and accurate administration of 

the specified medication(s); 

(C) Identify the specified 

medication(s) and visually evaluate the 

medication(s)for integrity; 

(D) Ensure the security of the 

medication(s) for each patient; and 

(E) Document the administration of 

each medication in the patient’s medical 

record. 

6. Section 482.24 is amended by— 

a. Removing paragraphs (c)(1)(i), 

(c)(1)(ii), and (c)(1)(iii). 

b. Redesignating (c)(2) as (c)(4). 

c. Adding a new paragraph (c)(2). 

d. Adding a new paragraph (c)(3). 

The revisions and additions read as 

follows: 

§ 482.24 Condition of participation: 

Medical record services. 

* * * * * 

(c) * * * 

(2) All orders, including verbal orders, 

must be dated, timed, and authenticated 

promptly by the ordering practitioner or 

another practitioner who is responsible 

for the care of the patient as specified 

under § 482.12(c) and authorized to 

write orders by hospital policy in 

accordance with State law. 

(3) Hospitals may use pre-printed and 

electronic standing orders, order sets, 

and protocols for patient orders only if 

the hospital: 

(i) Establishes that such orders and 

protocols have been reviewed and 

approved by the medical staff in 

consultation with the hospital’s nursing 

and pharmacy leadership; 

(ii) Demonstrates that such orders and 

protocols are consistent with nationally 

recognized and evidence-based 

guidelines; 

(iii) Ensures that the periodic and 

regular review of such orders and 

protocols is conducted by the medical 

staff, in consultation with the hospital’s 


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nursing and pharmacy leadership, to 

determine the continuing usefulness 

and safety of the orders and protocols; 

and 

(iv) Ensures that such orders and 

protocols are dated, timed, and 

authenticated promptly in the patient’s 

medical record by the ordering 

practitioner or another practitioner 

responsible for the care of the patient as 

specified under § 482.12(c) and 

authorized to write orders by hospital 

policy in accordance with State law. 

* * * * * 

7. In § 482.25 paragraph (b)(6) is 

revised to read as follows: 

§ 482.25 Condition of participation: 

Pharmaceutical services. 

* * * * * 

(b) * * * 

(6) Drug administration errors, 

adverse drug reactions, and 

incompatibilities must be immediately 

reported to the attending physician and, 

if appropriate, to the hospital’s quality 

assessment and performance 

improvement program. 

* * * * * 

8. Section 482.42 is amended by 

revising paragraph (a) and (b)(1) to read 

as follows: 

§ 482.42 Condition of participation: 

Infection control. 

* * * * * 

(a) Standard: Organization and 

policies. A person or persons must be 

designated as infection control officer or 

officers to develop and implement 

policies governing control of infections 

and communicable diseases. The 

infection control officer or officers must 

develop a system for identifying, 

reporting, investigating, and controlling 

infections and communicable diseases 

of patients and personnel. 

* * * * * 

(b) * * * 

(1) Ensure that the hospital-wide 

quality assessment and performance 

improvement (QAPI) program and 

training programs address problems 

identified by the infection control 

officer or officers; and 

* * * * * 

Subpart D—Optional Hospital Services 

9. Section 482.54 is amended by 

revising paragraph (b) to read as follows: 

§ 482.54 Condition of participation: 

Outpatient services. 

* * * * * 

(b) Standard: Personnel. The hospital 

must— 

(1) Assign one or more individuals to 

be responsible for outpatient services. 

(2) Have appropriate professional and 

nonprofessional personnel available at 

each location where outpatient services 

are offered, based on the scope and 

complexity of outpatient services. 

Subpart E—Requirements for Specialty 

Hospitals 

§ 482.92 [Amended] 

10. Section 482.92 is amended by— 

a. Removing paragraph (a). 

b. Redesignating paragraphs (b) and 

(c) as (a) and (b) respectively. 

PART 485—CONDITIONS OF 

PARTICIPATION SPECIALIZED 

PROVIDERS 

11. 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)). 

Subpart F—Conditions of 

Participation: Critical Access Hospitals 

(CAHs) 

§ 485.602 [Removed] 

12. Section 485.602 is removed. 

13. Section 485.604(a) is revised to 

read as follows: 

§ 485.604 Personnel qualifications. 

* * * * * 

(a) Clinical nurse specialist. A clinical 

nurse specialist must be a person who— 

(1) Is a registered nurse and is 

licensed to practice nursing in the State 

in which the clinical nurse specialist 

services are performed; and 

(2) Holds an advanced degree in a 

defined clinical area of nursing from an 

accredited educational institution. 

* * * * * 

14. Section 485.635(b) is revised to 

read as follows: 

§ 485.635 Condition of participation: 

Provision of services. 

* * * * * 

(b) Standard: Patient services. (1) 

General: The CAH provides those 

diagnostic and therapeutic services and 

supplies that are commonly furnished 

in a physician’s office or at another 

entry point into the health care delivery 

system, such as a low intensity hospital 

outpatient department or emergency 

department. These CAH services 

include medical history, physical 

examination, specimen collection, 

assessment of health status, and 

treatment for a variety of medical 

conditions. 

(2) Laboratory services. The CAH 

provides basic laboratory services 

essential to the immediate diagnosis and 

treatment of the patient that meet the 

standards imposed under section 353 of 

the Public Health Service Act (42 U.S.C. 

236a). (See the laboratory requirements 

specified in part 493 of this chapter.) 

The services provided include: 

(i) Chemical examination of urine by 

stick or tablet method or both (including 

urine ketones); 

(ii) Hemoglobin or hematocrit; 

(iii) Blood glucose; 

(iv) Examination of stool specimens 

for occult blood; 

(v) Pregnancy tests; and 

(vi) Primary culturing for transmittal 

to a certified laboratory. 

(3) Radiology services. Radiology 

services furnished by the CAH are 

provided by personnel qualified under 

State law, and do not expose CAH 

patients or personnel to radiation 

hazards. 

(4) Emergency procedures. In 

accordance with requirements of 

§ 485.618, the CAH provides medical 

services as a first response to common 

life-threatening injuries and acute 

illness. 

15. Section 485.639 is amended by 

revising the introductory text to read as 

follows: 

§ 485.639 Condition of participation: 

Surgical services. 

If a CAH provides surgical services, 

surgical procedures must be performed 

in a safe manner by qualified 

practitioners who have been granted 

clinical privileges by the governing 

body, or responsible individual, of the 

CAH in accordance with the designation 

requirements under paragraph (a) of this 

section. 

* * * * * 

(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: September 30, 2011. 

Donald M. Berwick, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: October 6, 2011. 

Kathleen Sebelius, 

Secretary. Department of Health and Human 

Services. 

[FR Doc. 2011–27175 Filed 10–18–11; 11:15 am] 

BILLING CODE 4120–01–P 


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