29034 Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Parts 482 and 485 

[CMS–3244–F] 

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: Final rule. 

SUMMARY: This final rule revises the 

requirements that hospitals and critical 

access hospitals (CAHs) must meet to 

participate in the Medicare and 

Medicaid programs. These changes are 

an integral part of our efforts to reduce 

procedural burdens on providers. This 

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: These regulations are effective 

on July 16, 2012. 

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; and Sarah Fahrendorf, (410) 

786–3112. 

SUPPLEMENTARY INFORMATION: 

Executive Summary for This Final Rule 

A. Purpose 

In Executive Order 13563, ‘‘Improving 

Regulations and Regulatory Review’’, 

the President recognized the importance 

of a streamlined, effective, and 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. This final rule 

responds directly to the President’s 

instructions in Executive Order 13563 

by reducing outmoded or unnecessarily 

burdensome rules, and thereby 

increasing the ability of hospitals and 

CAHs to devote resources to providing 

high quality patient care. 

B. Summary of the Major Provisions 

Revisions To Allow Flexibility and 

Eliminate Burdensome Conditions of 

Participation (CoPs): We have reduced 

burden to providers and suppliers by 

modifying, removing, or streamlining 

current regulations that we have 

identified as excessively burdensome. 

• Single governing body for multiple 

hospitals: We will allow one governing 

body to oversee multiple hospitals in a 

multi-hospital system and have added a 

requirement for a member, or members, 

of the hospital’s medical staff to be 

included on the governing body as a 

means of ensuring communication and 

coordination between a single governing 

body and the medical staffs of 

individual hospitals in the system. 

• Reporting of Restraint-Related 

Deaths: We have replaced the 

requirement that hospitals must report 

deaths that occur while a patient is only 

in soft, 2-point wrist restraints with a 

requirement that hospitals must 

maintain a log (or other system) of all 

such deaths. This log must be made 

available to CMS immediately upon 

request. We have indicated that the log 

is internal to the hospital and that the 

name of the practitioner responsible for 

the care of the patient may be used in 

the log in lieu of the name of the 

attending physician if the patient was 

under the care of a non-physician 

practitioner and not a physician. 

• Role of other practitioners on the 

Medical Staff: We have broadened the 

concept of ‘‘medical staff’’ and have 

allowed hospitals the flexibility to 

include other practitioners as eligible 

candidates for the medical staff with 

hospital privileges to practice in the 

hospital in accordance with State law. 

All practitioners will function under the 

rules of the medical staff. This change 

will clearly permit hospitals to allow 

other practitioners (e.g., APRNs, PAs, 

pharmacists) to perform all functions 

within their scope of practice. We have 

required that the medical staff must 

examine the credentials of all eligible 

candidates (as defined by the governing 

body) and then make recommendations 

for privileges and medical staff 

membership to the governing body. 

• Medical staff leadership: We have 

allowed podiatrists to be responsible for 

the organization and conduct of the 

medical staff. This change will allow 

podiatrists to assume a new leadership 

role within hospitals, if hospitals so 

choose. 

• Nursing care plan: We have 

allowed hospitals the options of having 

a stand-alone nursing care plan or a 

single interdisciplinary care plan that 

addresses nursing and other disciplines. 

• Administration of medications: We 

have allowed hospitals to have an 

optional program for patient(s)/support 

person(s) on self-administration of 

appropriate medications. The program 

must address the safe and accurate 

administration of specified medications; 

ensure a process for medication 

security; address self-administration 

training and supervision; and document 

medication self-administration. 

• Administration of blood 

transfusions and intravenous 

medications: We have eliminated the 

requirement for non-physician 

personnel to have special training in 

administering blood transfusions and 

intravenous medications and have 

revised the requirement to clarify that 

those who administer blood 

transfusions and intravenous 

medications do so in accordance with 

State law and approved medical staff 

policies and procedures. We believe that 

this clarification will make the 

requirement consistent with current 

standards of practice. 

• Orders by other practitioners: We 

have allowed for drugs and biologicals 

to be prepared and administered on the 

orders of practitioners (other than a 

doctor), in accordance with hospital 

policy and State law, and have also 

allowed orders for drugs and biologicals 

to be documented and signed by 

practitioners (other than a doctor), in 

accordance with hospital policy and 

State law. 

• Standing Orders: We have allowed 

hospitals the flexibility to use standing 

orders and have added a requirement for 

medical staff, nursing, and pharmacy to 

approve written and electronic standing 

orders, order sets, and protocols. We 

have required that orders and protocols 

must be based on nationally recognized 

and evidence-based guidelines and 

recommendations. 

• Verbal Orders: We have eliminated 

the requirement for authentication of 

verbal orders within 48-hours and have 

deferred to applicable State law to 

establish authentication timeframes. 

• Authentication of Orders: We have 

made permanent the previous 

temporary requirement that all orders, 

including verbal orders, must be dated, 

timed, and authenticated by either the 

ordering practitioner or another 

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. 


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Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 29035 

• Infection Control Log: We have 

eliminated the obsolete requirement for 

a hospital to maintain an infection 

control log. Hospitals are already 

required to monitor infections and do so 

through various surveillance methods 

including electronic systems. 

• Outpatient services director: We 

have removed the burdensome and 

outdated requirement for a single 

Director of Outpatient Services position 

that oversees all outpatient departments 

in a hospital. Hospitals already have 

separate directors for individual 

outpatient departments, so having a 

single overall Director position is 

duplicative and unnecessary. 

• Transplant Center Process 

Requirements: We have eliminated a 

duplicative requirement for an organ 

recovery team that is working for the 

transplant center to conduct a ‘‘blood 

type and other vital data verification’’ 

before organ recovery when the 

recipient is known. The verification will 

continue to be completed at two other 

times in the transplant process. 

• CAH Provision of Services: We have 

eliminated the burdensome requirement 

that CAHs must furnish diagnostic and 

therapeutic services, laboratory services, 

radiology services, and emergency 

procedures directly by CAH staff. This 

will allow CAHs to provide such 

services under arrangement. 

Clarifying Changes: We have clarified 

several requirements in the hospital and 

CAH CoPs to ensure that they are 

consistent with the statute as well as 

with other, more current CoP 

requirements. 

• Pharmaceutical Services: We have 

made a technical change to replace the 

term ‘‘quality assurance program’’ with 

the more current term ‘‘quality 

assessment and performance 

improvement program.’’ 

• Infection Control: We have made a 

technical change to replace the term 

‘‘quality assurance program’’ with the 

more current term ‘‘quality assessment 

and performance improvement 

program.’’ 

• CAH Personnel Qualifications: We 

have aligned the definition of ‘‘clinical 

nurse specialist’’ that is in the rule with 

the definition that is in the statute. 

• CAH Surgical Services: We have 

clarified that ‘‘surgical services’’ are an 

optional service for CAHs. 

Other Options Considered: We 

discussed alternative options for 

revisions that we considered, but did 

not propose. In the proposed rule, we 

also solicited comments and suggestions 

from both stakeholders and the general 

public on additional reforms that would 

reduce burden on hospitals and CAHs. 

In this rule, we have included our 

responses to the comments received on 

those alternatives, as well as a summary 

of additional recommendations 

submitted by commenters. 

C. Summary of Costs and Benefits 

1. Overall Impact 

The rule will reduce the total 

regulatory burden for hospitals and 

CAHs by nearly $940 million initially 

and by almost $5 billion over the next 

five years. Changes to the following 

CoPs accounted for the greatest 

potential savings in the final rule: 

§ 482.22, Medical staff ($330 million); 

§ 482.23, Nursing services ($110 

million); § 482.24, Medical record 

services ($170 million); and § 482.54, 

Outpatient services ($300 million). Our 

estimates were based on input from 

stakeholders as well as on our own 

experience with hospitals. 

The potential savings will be achieved 

through a number of significant 

regulatory changes. For example, 

changes to the Medical staff CoP will 

allow hospitals to broaden the concept 

of ‘‘medical staff’’ through the 

appointment of non-physician 

practitioners to the medical staff so that 

they may perform the duties for which 

they are qualified through training and 

education and as allowed within their 

State scope-of-practice laws. For 

hospitals that choose this option, 

significant savings might be achieved as 

non-physician practitioners will enable 

physicians to more effectively manage 

their time so that they may focus on the 

more medically complex patients. 

Changes to the Nursing services CoP 

will allow hospitals to have a standalone nursing care plan or a single 

interdisciplinary care plan that 

addresses nursing and other disciplines. 

Providing hospitals with the option for 

a single, interdisciplinary care plan for 

each patient that addresses nursing and 

other disciplines, will not only support 

and improve the coordination of patient 

care, it will also result in significant cost 

reductions and efficiencies. 

The revisions will also allow 

hospitals much greater flexibility and 

freedom to determine the best ways to 

oversee and manage outpatients by 

removing the outdated requirement for 

a single Director of Outpatient Services. 

This simple, but necessary change to the 

Outpatient services CoP will bring 

hospitals both cost savings and more 

efficient ways to manage hospital 

resources. Finally, we will now allow 

CAHs to provide diagnostic and 

therapeutic services, laboratory services, 

radiology services, and emergency 

procedures under arrangement. For 

these small hospitals, this change will 

not only allow them to solve some of 

their pressing staffing problems in these 

service areas, it will allow them to 

increase access to these critical services 

for their patient populations. 

While we feel confident that our 

estimates reflect a reasonable approach 

to hospital and CAH cost savings, much 

will depend on the future staffing and 

management decisions that individual 

hospitals and CAHs choose to make. 

2. Section-by-Section Economic Impact 

Estimates for 2012 

Section 

Annual 

savings 

($M) 

Five year 

savings 

($M) 

Patient’s Rights—Eliminate and replace burdensome reporting process for deaths involving 

only soft wrist restraints ......................................................................................................... 482 .13 $5.1 $25.5 

Medical Staff—Flexibility to consider other practitioners as eligible candidates for the medical staff .................................................................................................................................. 482 .22 330.0 1,650.0 

Nursing Services—Eliminate requirement for nursing care plan when an interdisciplinary 

plan is already in place .......................................................................................................... 482 .23 110.0 550.0 

Medical Record Services—Less burdensome process to authenticate verbal orders ............. 482 .24 80.0 400.0 

Medical Record Services—Allow the use of pre-printed and electronic standing orders for 

patient orders ......................................................................................................................... 482 .24 90.0 450.0 

Infection Control—Eliminate log of incidents related to infections and communicable diseases ...................................................................................................................................... 482 .42 6.6 33.0 

Outpatient Services—Allow one or more individuals to be responsible for the supervision of 

outpatient services ................................................................................................................. 482 .54 300.0 1,500.0 

Transplant Organ recovery—Remove duplicative blood typing requirement ........................... 482 .92 0.2 1.0 


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29036 Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 

Section 

Annual 

savings 

($M) 

Five year 

savings 

($M) 

CAH Provision of Services—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 .......................................................... 485 .635 15.8 79.0 

Total .................................................................................................................................... .......................... 937.7 4,688.5 

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 

CNS Certified Nurse Specialist 

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 

IG Interpretive Guidelines 

IOM Institute of Medicine 

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 

SOM State Operations Manual 

TJC The Joint Commission 

UMRA Unfunded Mandates Reform Act 

Table of Contents 

This final rule is organized as follows: 

I. Background 

A. Introduction 

B. Statutory and Regulatory Authority for 

Hospital CoPs 

II. Provisions of the Proposed Rule and 

Response to Comments 

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) 

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. Provisions of the Final Rule 

IV. Collection of Information Requirements 

V. Regulatory Impacts 

I. Background 

A. Introduction 

This final 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 final rule we seek to 

reduce the regulatory burden placed on 

hospitals. We have identified a number 

of existing hospital Conditions of 

Participations (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. The 

January 2011 Executive Order directs 

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 

provisions of this final rule are intended 

to meet the letter and spirit of Executive 

Order 13563, 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. 

B. Statutory and Regulatory Authority 

for 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), 

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

440.140, 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 drive (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. 


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Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 29037 

The CoPs are organized according to 

the types of services a hospital may 

offer, and include specific 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. CMSapproved 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.). 

II. Provisions of the Proposed Rule and 

Response to Comments 

On October 24, 2011, we published a 

proposed rule entitled ‘‘Reform of 

Hospital and Critical Access Hospital 

Conditions of Participation’’ (76 FR 

65891). The proposed rule identified 

several priority areas in the CoPs for 

both hospitals (42 CFR Part 482) and 

CAHs (42 CFR Part 485) and set forth 

revisions intended to eliminate or 

significantly reduce those instances 

where the CoPs are duplicative, 

unnecessary, and/or burdensome. 

We received approximately 1,729 

public comments in response to the 

proposed rule. Many comments were 

supportive; however, there were some 

commenters that opposed the proposed 

provisions. Approximately 1,100 of the 

comments were part of a write-in 

campaign from anesthesiologists that 

supported what they described as CMS’ 

upholding of physician supervision 

requirements, but objected to what the 

letters described as an effort to replace 

physicians with nurses. 

In general, the comments can be 

classified into roughly three categories: 

comments from hospitals, comments 

from physicians, and those from nonphysician practitioners. Commenters 

representing the hospital industry, as 

well as accrediting organizations, 

expressed overwhelming support for the 

proposals and agreement with our 

efforts to bring the CoPs in line with 

current medical practice, eliminate 

burdensome and obsolete requirements, 

and provide hospitals with operational 

flexibility. Physician groups mostly 

disagreed with staffing proposals, and 

expressed disagreement with what they 

viewed as the Agency’s endorsement of 

the replacement of physicians with 

nurses and non-physician practitioners. 

While commenters representing nonphysician practitioners expressed 

support for most of the proposals, they 

urged us to go further with changes that 

they believe would allow them to 

practice to the full extent allowed under 

their respective State laws and 

regulations. In the following section, we 

provide a brief summary of the 

proposed provisions, followed by 

responses to public comments received 

on each issue. For a detailed discussion 

of the proposals, see the October 24, 

2011 proposed rule (76 FR 65891). 

A. Revisions To Allow Flexibility and 

Eliminate Burdensome CoPs 

1. Governing Body (§ 482.12) 

We proposed to revise and clarify the 

governing body requirement to reflect 

current hospital organizational 

structure, whereby multi-hospital 

systems have integrated their governing 

body functions to oversee care in a more 

efficient and effective manner. 

Specifically, we proposed to revise the 

introductory text of § 482.12 to state that 

‘‘There must be an effective governing 

body that is legally responsible for the 

conduct of the hospital.’’ We noted that 

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. 

Comment: Many commenters wrote in 

support of the CMS proposal to allow a 

single governing body for all hospitals 

within a multi-hospital system and they 

characterized the current requirement 

for a separate governing body for each 

hospital as redundant and obsolete. 

Several comments suggested the change 

would provide hospitals with greater 

flexibility and help them operate more 

efficiently and effectively. Others noted 

that the change would simplify 

governance and administrative 

processes. These commenters also 

suggested the change would enhance 

the continuity and consistency of 

policies and practices across all 

hospitals within a multi-hospital 

system. One commenter suggested the 

change might streamline the workflow 

for nurses. Many commenters also 

remarked that the proposal was 

appropriate given the more integrated 

organizational models adopted by many 

hospitals. 

Some comments detailed the greater 

efficiencies and cost savings that would 

result, including savings in areas such 

as finance, human resources, 

information technology, and 

purchasing. Many commenters 

specifically remarked that the change 

would end the redundant and 

inefficient practice of multi-hospital 

systems’ holding duplicative, separate 

meetings for each of the hospital boards. 

Some comments stressed the 

advantages that a single governing body 

would have in terms of enhancing 

mutual accountability, interdependence 

and timely oversight. Commenters 

remarked that the single governing body 

structure could facilitate shared 

learning, promulgation of best practices 

and help hospitals standardize 

performance metrics and eliminate 

variances. Another commenter stated 

that its policy of allowing a single 

governing body for a multi-hospital 

system has not had an adverse impact 

on quality and safety. 

Response: We agree with the 

commenters that this change will 

positively affect hospitals. With the 

addition of a few changes pertaining to 

board membership, discussed below, we 

are finalizing this proposal for a single 

governing body. We will be finalizing 

the proposed language that refers to a 

hospital, generally, and removing the 

language referring to the hospital ‘‘as an 

institution.’’ 

Comment: Several commenters 

requested that CMS specify in 

regulatory text that, ‘‘hospital systems 

with more than one CMS Certification 

Number may have a single governing 

body.’’ 

Response: While we agree with the 

commenters’ intent, and we recognize 

that the language suggested was 

excerpted from the preamble text of our 

proposed rule, we are not making this 

change in regulatory text. Rather, we 

will address this clarification in 

forthcoming sub-regulatory guidance. 

Our decision against using the term 

‘‘CMS Certification Number’’ in the final 

regulatory text is merely a precaution 

intended to provide flexibility, should 

the terminology be changed. 

Comment: Several commenters 

requested that CMS take a stronger 

position in favor of hospitals’ adoption 

of a single governing body for their 

multi-hospital systems. Specifically, 

these commenters asked CMS to 

expressly state that, ‘‘multi-hospital 

systems can be effectively led by a 

single governing body.’’ On the other 

hand, we received comments requesting 

that CMS expressly state that ‘‘multiple 


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29038 Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 

hospitals cannot be effectively governed 

by a single governing body’’ and that 

‘‘each hospital, including hospitals in a 

multi-hospital system, should have its 

own governing body.’’ Still other 

commenters asked CMS to reaffirm the 

important role of local sub-boards. 

Response: While we believe that 

multi-hospital systems might gain 

important efficiencies and achieve 

significant progress in quality programs 

under the governance of a single 

governing body, we also agree that local 

sub-boards might be a valuable resource 

in hospital governance. We believe there 

is an important and essential symbiotic 

relationship that should exist between a 

hospital’s governing body and its 

medical staff. The dynamics of this 

relationship generate critical checks and 

balances that serve to promote and 

protect patient health and safety. We 

believe that the ongoing, timely 

communication between a governing 

body and its medical staff is essential to 

the successful coordination and 

advancement of patient care, regardless 

of whether the adopted governance 

model is one of a single governing body 

for all hospitals in a multi-hospital 

system, one of a single governing body 

with local sub-boards at each hospital in 

the system, or one of a separate 

governing body for each hospital. The 

intent of the proposed revision was to 

provide hospitals with some regulatory 

flexibility with regard to hospital 

governance and to acknowledge that 

alternative methods of governance exist 

that might prove as effective as the 

traditional methods currently required 

by the CoP. When practically applied in 

the ‘‘real world’’ of hospitals, each 

model of hospital governance has the 

potential to be flawed and dysfunctional 

just as each has the potential to be 

engaged and effective. We remind the 

commenters that the proposed revision 

to this requirement is an option that 

each multi-hospital system is free to 

choose or not to choose for itself. 

Because we have not seen sufficient 

evidence presented that would indicate 

that one model works more effectively 

than another, we do not believe that it 

would be appropriate for CMS to 

endorse one model of hospital 

governance over another. 

Comment: Several of the commenters 

who expressed a clear preference for a 

hospital-specific governing body asked 

CMS to require that, at minimum, a 

member of the medical staff serve on the 

governing body. The commenters 

suggested that CMS’ proposal to allow 

for a single governing body within a 

multi-hospital system would diminish 

communication and coordination 

between the governing body and the 

medical staff as it presently takes place 

at the individual hospital level. 

Commenters stated that an effective 

governing body needs to have an 

informed understanding of the care 

coordination challenges at each member 

hospital and that this can only be 

achieved when the lines of 

communication are open between the 

governing body and the medical staff. 

To counter the potential disruption of 

communication that may be caused by 

the proposal to allow multi-hospital 

governing bodies, commenters 

suggested that CMS require that a 

member of the medical staff serve on the 

governing body. Commenters added that 

such a model would further inform 

patient health and safety initiatives 

within the hospital. 

Commenters also expressed concern 

that, even under the current 

requirements which require a governing 

body at each institution, hospital 

physicians are generally not well 

represented on hospital governing 

bodies. Commenters stressed the 

importance of physician input at the 

governing body level, particularly as 

they believe it is essential in the context 

of CMS’ proposal to permit a single 

governing body for a multi-hospital 

system. 

Response: We agree with the 

commenters’ suggestion, and we are 

modifying our final regulatory language 

to require that a hospital’s governing 

body must include at least one medical 

staff member. We agree with the 

commenters that strong coordination 

between a hospital’s governing body 

and medical staff is paramount to the 

delivery of quality care. 

We note that these two, separate 

Conditions of Participation at § 482.12 

(Governing body) and § 482.22 (Medical 

staff) have a long, overlapping, and 

interrelated history. In 1986, CMS 

discontinued a requirement for a joint 

committee to formalize liaison between 

the medical staff and the hospital’s 

administration. At that time, we decided 

to leave decisions about liaison and 

coordination activities to internal 

hospital management (51 FR 22010, 

22017, June 17, 1986). Because we are 

now making changes to the hospital’s 

management structure by allowing a 

single governing body for multiple 

hospitals within a system, we believe 

that, in accordance with the comments 

we received on medical staff 

representation on the governing body, a 

formalized link between these 

interdependent entities is appropriate. 

While it may already be a requirement 

at some hospitals or simply a 

convention that others follow, we are 

not aware that this linked structure is 

the norm. We believe that adding the 

requirement for hospitals to have a 

medical staff member serve on the 

governing body will build in an 

important element of continuity and 

ensure regular communication between 

a hospital’s governing body and its 

medical staff(s), particularly in light of 

our decision to permit a single 

governing body for hospitals in multihospital systems. 

We also believe that requiring a 

hospital’s governing body to include a 

medical staff member will directly 

address a widely voiced concern for 

stronger communication between a 

hospital governing body and the 

medical staffs of its member hospitals. 

In the case of a multi-hospital system 

with one governing body, we wish to 

clarify that we are not requiring that the 

governing body include a member of 

each separately certified hospital’s 

medical staff, so long as at least one 

governing body member is a member of 

the medical staff of one system hospital. 

The governing body is free to select as 

many of its members from its medical 

staff(s) as it chooses. However, we 

would expect a multi-hospital system’s 

single governing body to carefully 

consider the unique needs of the patient 

populations served by each of its 

member hospitals and their medical 

staffs when determining the number and 

composition of medical staff members to 

be appointed to the governing body. We 

recognize that physicians may be in a 

minority position on a hospital 

governing body even with this new 

requirement. That said, we believe that 

a physician who specifically represents 

medical staff members will hold some 

measure of enhanced standing within 

the governing body. 

Comment: We received numerous 

comments opposing our proposal for a 

single governing body. Many of these 

comments came from State and national 

physician associations as well as from a 

number of community hospitals. In 

particular, comments opposing a single 

governing body expressed concern that 

such a structure would further weaken 

governing boards’ understanding of the 

daily operations and medical staff 

affairs of each hospital and thereby lead 

to a reduction in both the quality of care 

and patient safety protections. One 

community health network reported 

that it had seen ‘‘remote management’’ 

lead to waste of resources in the 

healthcare delivery system. 

Some commenters expressed 

particular concern about the 

implications that a single governing 

body would have in a hospital system 

comprised of diverse institutions. For 

example, commenters stated that a 


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single hospital system can encompass 

remote, rural areas as well as urban and 

suburban areas, and may also include 

specialty hospitals, such as a pediatric 

hospital. The commenters suggested 

that, if hospital systems like these 

moved to governance by a single, 

overarching governing body, a single 

body would not be able to properly 

address the needs of each separate 

hospital, particularly the needs of any 

hospital especially different from others 

in the system. 

Some commenters suggested that a 

single governing body would be more 

appropriate to large hospital systems 

with similar hospital members and that 

CMS should pare back its proposal by 

only making the single body option 

available in certain cases, to be limited 

by geography or specialty. 

A number of commenters opposed our 

proposal on the grounds that it could 

prove problematic for non-profit 

hospitals in light of the new 

requirements for these hospitals that are 

included in section 9007(a) of the 

Affordable Care Act (ACA). The 

commenters pointed out that this 

section of ACA revised section 501(r) of 

the Internal Revenue Code (26 U.S.C.A. 

§ 501(r)) to require a non-profit hospital 

to establish and maintain their taxexempt status by, among other things, 

conducting a community health needs 

assessment every three years. They 

stated that a non-profit hospital would 

not be able to conduct this required 

assessment through its own governing 

body (which they see as ‘‘the natural 

convener of this activity in conjunction 

with the medical staff’’) since they 

believe that our proposed governing 

body requirement, if finalized, may 

cause the hospital to lose its own 

governing body and be under the 

governance of a multi-hospital system’s 

single governing body. The commenters 

also cited the requirements at § 501(c)(3) 

of the Internal Revenue Code regarding 

the tax-exempt status of non-profit 

hospitals and they stated that in order 

to meet the requirements of this section, 

a hospital must demonstrate that it 

provides a community benefit, which is 

defined by Internal Revenue Service 

(IRS) guidance as ‘‘based on part on 

whether a wide range of members of the 

community have a seat on the 

governance board.’’ The commenters 

stated that they believe ‘‘CMS’ proposal 

to allow a single governing body for a 

multi-hospital system that is divorced 

from the very community it is meant to 

represent’’ would prevent these nonprofit hospitals from meeting not only 

this IRS threshold for tax exemption, 

but also other State-specific 

requirements for tax-exempt status. 

Response: We appreciate the concerns 

of the commenters. We do not believe 

that a multi-hospital system’s governing 

body can properly function without its 

gathering information and input from 

the administrative and medical staff of 

each member hospital, or from the local 

sub-boards if the system utilizes this 

model for hospital governance. We note 

that the regulations, as finalized here, 

are intended to provide multi-hospital 

systems with an option, but not a 

requirement, to use a single governing 

body. In those instances where a system 

believes that its interests are best served 

by using a single governing body, under 

the new CMS regulations, that system 

will have the flexibility to do so, just as 

another multi-hospital system will have 

the flexibility to continue following the 

current requirement for a separate 

governing body for each hospital in its 

system if it determines that course 

would best serve its interests. 

Comment: Several commenters asked 

CMS for clarity as to how a single 

governing body would operate within a 

multi-hospital system spanning 

different States. 

Response: We would expect multihospital systems to follow the laws, 

regulations, and local ordinances of the 

States in which each member hospital 

operates. A hospital system’s adoption 

of a single governing body, as permitted 

under this revised federal regulation, 

would not in any way preempt any 

relevant State requirements. Hospitals 

must continue to comply with all 

applicable State and local laws. 

Comment: We also received a number 

of comments that asked how the new 

option for a single governing body 

would be implemented. One commenter 

asked how this would work for a multihospital system composed of more than 

one corporate entity. Another 

commenter asked whether survey 

decisions at each member hospital 

would be independent and whether this 

would impact the status of separately 

licensed, separately participating 

member hospitals in the system. 

Another commenter inquired about the 

integration of CAHs within a multihospital system, asking whether the 

proposal would allow for a system with 

both CAHs and hospitals to have one 

governing body or for systems with 

differing payment structures. Finally, 

we were asked to clarify between the 

CMS governance standard at § 482.12 

and the requirements pertaining to colocated hospitals. 

Response: We note that permitting a 

single governing body for multiple 

hospitals in a system does not relieve 

each separately certified hospital from 

the obligation to separately demonstrate 

its compliance with all of the hospital 

CoPs. Each separately certified hospital 

will continue to be separately, 

independently assessed for its 

compliance, through either State Survey 

Agency or approved national 

accreditation program surveys. Several 

of the commenters’ statements suggested 

that there may have been some 

confusion around this point. 

We offer hospital facilities 

considerable flexibility regarding how 

and whether they choose to participate 

in the Medicare program. Based on the 

geographic and other institutional 

limitations set out in our ‘‘providerbased’’ regulation at § 413.65, which 

addresses provider-based status for 

hospital facilities in multiple locations, 

hospital governing bodies make 

business decisions about how they want 

to participate in Medicare, and they 

indicate on their Medicare enrollment 

application the choices they have made. 

It is not uncommon to find multiple 

hospital campuses with one owner 

located in the same general geographic 

area enrolled in Medicare as one 

hospital. It also is not uncommon to see 

a hospital system choosing to enroll its 

various facilities as separate hospitals, 

even where their geographic proximity 

would permit them to be enrolled as one 

hospital. We are aware that various 

factors enter into consideration when 

governing bodies make these business 

decisions. For example, some governing 

bodies prefer to enroll various campuses 

as separate hospitals, out of a concern 

that problems at one hospital’s campus 

might jeopardize the Medicare 

participation of the other campuses if 

they were a multi-campus hospital 

covered under one Medicare provider 

agreement. In other cases, a governing 

body may see the benefits of integrating 

medical and nursing staff of multiple 

campuses into one integrated hospital. 

In still other cases, the deciding factor 

might be the implications for Medicare 

reimbursement of graduate medical 

education, the ease of adding satellite 

locations, etc. We defer to the governing 

bodies of hospitals to weigh the 

pertinent factors, the permissible 

options, and to make business decisions 

in their best interests when applying to 

participate in Medicare. 

Our hospital certification decisions 

and issuance of a provider agreement 

and CMS Certification Number (CCN) 

follow from these business decisions by 

a hospital’s governing body. We often 

certify as one ‘‘hospital’’ entities whose 

locations are identified on the 

application as one primary location and 

one or more ‘‘provider-based’’ satellite 

locations, and issue one provider 

agreement to that hospital. Once so 


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certified, the resulting ‘‘hospital’’ must 

then separately demonstrate its 

compliance with the hospital CoPs, 

independent of any other facility. While 

a system consisting of multiple, 

separately certified hospitals with a 

single governing body may promote 

similar, or even identical, compliance 

policies across its separately certified 

member hospitals, it must make clear 

which hospitals the policies apply to, 

and each separately certified hospital is 

accountable for implementing the 

applicable policies, including securing 

the policy approvals of its separate 

medical staff where required under the 

regulations. As an example, we could 

envision a hospital system with a single 

governing body establishing a uniform 

approach to developing hospital quality 

assessment and performance 

improvement (QAPI) programs. The 

system might even choose to measure 

some common quality indicators and 

pursue similar performance 

improvement activities and projects 

across its member hospitals. However, 

each member hospital would be 

responsible for maintaining and making 

available to us evidence of its hospitalspecific QAPI program; presentation of 

only system-level information would 

not be acceptable. 

With respect to the commenter’s 

statement about separate licensure, we 

are unclear as to what clarification the 

commenter is seeking, but we note that 

§ 413.65(d)(1) addresses State licensure 

requirements in order for facilities to be 

provider-based to a hospital’s main 

campus. Those regulations provide for 

flexibility where separate licenses are 

required under State law. 

A CAH must be separately evaluated 

for its compliance with the CAH CoPs 

found in 42 CFR Part 485, Subpart F. It 

would not be possible to evaluate the 

CAH’s compliance as part of an 

evaluation of a hospital’s compliance. 

However, this does not preclude a 

multi-hospital system’s single governing 

body from also serving as the CAH’s 

governing body, so long as the 

governing body clearly identifies the 

policies and decisions that are 

applicable to the CAH. 

We recognize the importance of these 

inquiries and will address these in more 

detail in forthcoming interpretive 

guidance (IG) after the publication of 

this final rule. 

2. Patient’s Rights (§ 482.13) 

Section 482.13(g) requires hospitals to 

report deaths associated with the use of 

seclusion or restraint. We proposed to 

modify the reporting requirements for 

hospitals when the circumstances of a 

patient’s death involve only the use of 

soft two-point wrist restraints and no 

use of seclusion. At § 482.13(g)(2), we 

proposed that hospitals would be 

required to report to CMS the type of 

deaths described here (those involving 

soft two-point wrist restraints and no 

use of seclusion) by having hospital staff 

record the information about the death 

into a log or other system. At 

§ 482.13(g)(4), we proposed that each 

entry in the record must be made no 

later than seven days after the date of 

death of the patient and that the record 

must include the patient’s name, date of 

birth, date of death, attending physician, 

primary diagnosis(es), and medical 

record number. We also proposed that 

hospitals must make this information 

available to CMS in either written or 

electronic form immediately upon 

request. 

For deaths involving all other types of 

restraints and all forms of seclusion, we 

noted that we would retain the current, 

more extensive death reporting 

requirements to CMS by telephone no 

later than the close of business on the 

next business day following knowledge 

of the patient’s death. In addition to 

reporting the deaths by telephone, we 

proposed to revise § 482.13(g)(1) to 

provide additional reporting options, 

which would include the use of 

facsimile and electronic reporting. 

Comment: Many commenters favored 

the proposal to modify the reporting 

requirements for hospitals when the 

circumstances of a patient’s death 

involve only the use of soft two-point 

wrist restraints. The favorable 

comments included those received from 

individual clinical professionals, 

hospitals and hospital associations, 

large healthcare systems, and several 

nursing groups. Several other 

commenters agreed with the revisions 

but recommended that the required logs 

be made publicly available. 

Response: We appreciate the 

comments supporting the proposed 

change and the comments that 

suggested we add additional 

requirements and oversight. Changing 

the current reporting requirement to one 

that requires hospital staff to enter 

information into a log or other system 

those patient deaths that involve the use 

of only soft two-point wrist restraints 

will reduce unnecessary burden without 

negatively impacting patient safety. We 

believe the change will represent a 

welcome reduction in burden for 

hospitals and their staff, particularly in 

settings with a large number of patients 

in intensive care. 

We disagree with adding new 

requirements for hospitals to publicize 

the details from the log (or other 

system). The log will contain protected 

health information from the patient’s 

medical record, such as the patient’s 

name, date of birth, and primary 

diagnosis, all of which are protected by 

the Health Insurance Portability and 

Accountability Act (HIPAA) Privacy 

Rule found at 45 CFR part 160 and part 

164, subparts A and E. To further clarify 

that the method of reporting these 

deaths will be a hospital’s maintenance 

of a log (or other system), to which a 

hospital must make an entry no later 

than seven days after an applicable 

patient’s death, we are adding the word 

‘‘internal’’ preceding ‘‘log or other 

system’’ in this final rule. We believe 

that this will clarify and emphasize that 

the log, or system that a hospital 

chooses to utilize for its reporting of 

these types of deaths, is one that will be 

maintained internally by the hospital 

and that CMS is not requiring public 

release of information about such deaths 

nor are we requiring hospitals to submit 

the information in the internal log (or 

other system) to CMS. However, in this 

final rule, hospitals will be required to 

make the information contained in the 

internal log or other system immediately 

available to CMS upon request as was 

initially proposed. 

As discussed below, it is also 

important to remember that not all 

deaths of patients who die while in 

restraints, or shortly after their removal, 

are associated with the use of restraints. 

This is especially true in the context of 

soft two-point wrist restraints, which we 

note are often applied to acutely ill and 

medically unstable patients, prior to 

their eventual death, in order to prevent 

inadvertent patient removal of lifesustaining devices such as central lines 

and endotracheal tubes. The use of 

restraints in these cases is incidental to 

the patient’s death and is not the cause 

of that death. Therefore, we do not 

believe that making public the 

information in the internal log (or other 

system) would contribute to ongoing 

quality improvement efforts. 

Comment: Some commenters wanted 

CMS to require hospitals to make the 

data available to protection and 

advocacy (P&A) agencies and to report 

the deaths to P&As as well as to CMS 

using a log or other system, as set forth 

at proposed § 482.13(g)(4). A few 

commenters called for CMS to require 

hospitals to provide P&As access to the 

hospitals’ logs specifically in 

accordance with applicable federal and 

State laws. Some commenters further 

requested that CMS create an explicit 

reference in § 482.13 to the 

Developmental Disabilities Assistance 

and Bill of Rights Act of 2000, 

particularly with respect to the role of 

P&A agencies and their access to 


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information concerning the deaths of 

disabled individuals. 

Many commenters urged CMS to 

continue working to prevent future 

deaths by improving the data collection 

and analysis of restraint- and seclusionrelated deaths, including those reported 

using the log or other system. 

Response: We believe that data 

collection and analysis will be greatly 

improved by making changes to the way 

hospitals report data to CMS, and, at 

this time, we do not believe that 

expanding the requirements beyond 

what we have proposed would improve 

patient safety. 

We are always looking for ways to 

improve and to increase the efficiency 

of communication that already occurs 

between CMS and P&As. We believe 

that the current, extensive reporting 

requirements may have impeded data 

collection and analysis. Adjusting the 

reporting requirements for a significant 

subset of restraint-related deaths, where 

only soft, two-point wrist restraints 

were used, will help to streamline data 

collection and sharpen our analytical 

focus. 

Finally, we decline the commenters’ 

request for an explicit reference to the 

Developmental Disabilities Assistance 

and Bill of Rights Act, as we believe 

such a reference is inappropriate in 

§ 482.13. We note that the Conditions of 

Participation at § 482.11(a) already 

requires compliance with applicable 

Federal laws related to health and safety 

of patients, and we expect hospitals to 

ensure that any such requirements are 

met. However, as a practical matter, we 

must stress that CMS does not enforce 

other agencies’ laws or rules, as would 

be the case with the above-referenced 

statute. CMS would only cite the facility 

for noncompliance with the 

aforementioned CoP at § 482.11 if the 

agency having jurisdiction makes a final 

determination that there was a violation. 

Comment: Some commenters 

requested that CMS expand the 

proposed reporting requirements at 

§ 482.13(g)(4)(ii) by requiring hospitals 

to also record the length of time the 

patient was kept in the restraints as well 

as the reasons for and consequences of 

the restraint use. 

Response: We are requiring that 

hospitals document the patient’s 

primary diagnoses along with the 

medical record number and other 

details. We believe that the data 

recorded in the internal logs will be 

sufficiently rich to conduct analysis of 

deaths where only soft, two-point wrist 

restraints were used. We do not believe 

that additional descriptions around the 

use of the restraints are necessary at this 

time. As we have stated elsewhere in 

this discussion and in our proposed 

rule, we are not aware of any research— 

or even any anecdotal information— 

suggesting a cause-and-effect 

relationship between the use of soft, 

two-point wrist restraints and patient 

deaths. 

Comment: Some commenters 

suggested flexibility in reporting the 

deaths involving soft two-point 

restraints. They recommended that we 

allow for fax and electronic reporting of 

soft two-point restraint deaths. 

Response: We proposed that hospitals 

must maintain a log or other system of 

deaths involving only soft two-point 

restraints that can be made available to 

CMS immediately upon request, and 

that the required information about 

these deaths must be entered into the 

log no later than seven days after the 

date of the death of the patient. The 

words ‘‘log or other system’’ at 

§ 482.13(g)(2) were chosen to create 

flexibility, such that a hospital could 

adopt a written or electronic means of 

tracking these deaths. However, since 

we did not propose to require hospitals 

to submit these reports to CMS, except 

upon request, we wish to clarify that 

routine faxing and electronic reporting 

of the deaths at § 482.13(g)(2) directly to 

CMS is not necessary. Finally, we 

would note that the regulatory text now 

adds significant flexibility to the 

reporting options at § 482.13(g)(1) for all 

other deaths, permitting such reports to 

be made ‘‘by telephone, facsimile, or 

electronically, as determined by CMS.’’ 

Comment: One commenter 

recommended that we revise the overall 

requirement for death reporting in this 

rule. Two other commenters stated that 

the reporting requirements should be in 

accordance with State law. One 

commenter stated that reporting all 

deaths of patients who were restrained 

does not produce an accurate number of 

deaths caused by restraints. The 

commenter also noted that some 

patients may be near death when they 

are put into restraints and 

recommended that we clarify in the 

final rule that these individuals should 

not be included in the reporting 

requirement. 

Response: The requirements for 

reporting deaths of persons who were 

placed in restraints and/or seclusion 

were established by section 3207 of the 

Children’s Health Act of 2000 (Pub. L. 

106–310, codified as section 592 of the 

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

290ii–1). Eliminating all reporting for 

this class of restraint deaths and relying 

on State law would be contrary to 

federal law, which requires hospitals 

and many other categories of healthcare 

facilities to report all restraint-related 

deaths. As stated in the proposed rule, 

we believe that a regulation requiring 

hospital staff to record information 

regarding the patient death into a log or 

other system (and which is made 

available to CMS immediately upon 

request) is entirely appropriate for these 

types of patient deaths and that it will 

satisfy this requirement for reporting 

deaths involving soft two-point 

restraints. 

Regarding which restraint deaths that 

should be reported, we agree that not all 

deaths that occur while a patient is 

restrained are proximately caused by the 

restraints themselves, and we have 

proposed these revisions so as to reflect 

this fact (revising the reporting 

requirements for soft two-point 

restraints). In proposing this revision, 

we looked at all death reporting that is 

required of Medicare-participating 

hospitals. For deaths involving all other 

types of restraints and all forms of 

seclusion, we are retaining the current 

reporting requirements. We proposed to 

add flexibility to those requirements by 

allowing the reports to be faxed or 

submitted electronically. 

However, as we reviewed the public 

comments regarding these proposed 

revisions, it became apparent to us that 

our proposed language might still cause 

some confusion regarding which 

restraint deaths truly must be reported 

to CMS through the ongoing submission 

of data and which restraint deaths can 

be reported by recording the 

information in an internal log or other 

system that the hospital would make 

immediately available to CMS upon 

request. We came to the conclusion that 

the proposed regulatory language was 

still not sufficiently clear. We learned 

that, due to our use of the phrase 

‘‘report to CMS’’ in proposed 

§ 482.13(g)(2), many hospitals assumed 

that they would still be required to 

report the information through 

submission of data to CMS for those 

deaths related to soft, two-point wrist 

restraints. This was not our intention 

and does not achieve our purpose of 

reducing unnecessary regulatory 

burden. Therefore, in this final rule we 

have revised the proposed language to 

delete the phrase, ‘‘report to CMS,’’ and 

now will require that for those deaths 

related only to soft, two-point wrist 

restraints the hospital staff must record 

the information regarding the patient’s 

death in an internal log or other system. 

We are finalizing as proposed the 

requirement that this information must 

be entered no later than seven days after 

the death and that the information in 

the internal log or other system must be 

made available to CMS immediately 

upon request in either written or 


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electronic form. We are also finalizing 

the requirement that each entry must 

document the patient’s name, date of 

birth, date of death, name of attending 

physician or other licensed independent 

practitioner who is responsible for the 

care of the patient as specified under 

§ 482.12(c), medical record number, and 

primary diagnosis(es). 

Additionally, and in order to maintain 

consistency with these changes, we are 

revising the regulatory language 

proposed at § 482.13(g)(3). The language 

finalized here revises paragraph (g)(3) to 

contain two separate provisions and 

will now require that hospital staff must 

document in the patient’s medical 

record the date and time the death was: 

(1) Reported to CMS for deaths 

described in paragraph (g)(1) or (2) 

recorded in the internal log or other 

system for deaths described in 

paragraph (g)(2). 

Comment: Some commenters 

recommended that we have a common 

reporting system. They stated that all 

deaths should be reported consistently, 

in the same manner and within the 

same timeframe, by the close of the 

following business day. They stated that 

having two separate reporting 

mechanisms would be confusing and 

would upset the existing, wellestablished uniform reporting protocols. 

Some commenters quoted our 

responses in the 2006 final rule on 

Patient’s Rights where we said ‘‘a 

uniform definition of restraint across 

care settings is a good approach, adds 

clarity, and avoids confusion * * * 

This definition renders unnecessary the 

otherwise impossible task of naming 

each device and practices that can 

inhibit a patient’s movement’’ (71 FR 

71388). These commenters suggested 

the CMS was disrupting this uniformity 

with the new revisions contained in this 

final rule. 

Another commenter suggested that 

the new requirement for an internal log 

or other system would be more 

burdensome than the present 

requirements for reporting the death to 

CMS by telephone. The commenter 

wondered whether the new 

requirements would mean the 

maintenance of a separate log by an 

assigned individual to research the 

patient’s medical records to obtain all 

the necessary information. Another 

commenter asked whether the new 

requirement for an internal log would 

include hospital databases where 

reports could be generated and sent to 

CMS. 

Response: We believe that the 

commenters have taken the responses to 

comments in the 2006 final rule out of 

the context in which they were 

discussed, that is, a uniform definition 

of restraint. For the sake of clarity, we 

note that we have not made a change to 

the definition of ‘‘restraint.’’ We still 

maintain that ‘‘a uniform definition of 

restraint across care settings’’ is the best 

approach and we are not changing that 

in this rule. What we are finalizing is a 

change to the reporting requirements 

and not to the definition of restraint. We 

have received extensive feedback from 

those who would be implementing the 

new reporting requirements, and this 

feedback has largely been favorable. 

We believe the new requirements will 

relieve some burden on hospitals and 

their resources. We already expect 

hospitals to be tracking the details of 

deaths where the patient had been 

restrained by soft, two-point wrist 

restraints. Under the new requirements, 

this information will no longer need to 

be reported to CMS by telephone no 

later than the close of business the next 

business day following knowledge of 

the patient’s death. 

As suggested by one commenter, the 

requirements for the internal log or 

other system could be satisfied by the 

maintenance of a database where reports 

could quickly be generated if requested 

by CMS. 

Comment: One commenter asked why 

a death that could be related to soft 

wrist restraints calls for less 

accountability and why a hospital could 

take a week to report the death. 

Response: Hospitals remain 

accountable for the appropriate medical 

treatment of their patients and for all 

deaths that occur in their facilities. Not 

all circumstances involving restraints 

and associated deaths are the same. As 

discussed in the proposed rule, 

critically ill patients are often restrained 

in soft two-point restraints to prevent 

them from removing life-saving tubes 

and lines. And as we have stated 

elsewhere in this discussion and in our 

proposed rule, we are 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. Since such deaths are 

incidental to the use of these types of 

restraint, we believe that the revised 

reporting requirements that we are 

finalizing here are appropriate to the 

goal of ensuring hospital accountability 

for patient safety without continuing to 

impose undue regulatory burden in 

these instances. 

Regarding the 7-day timeframe for 

documenting the entry about this type 

of patient death that we are finalizing in 

this rule, this modification affects only 

that segment of patient deaths where no 

seclusion is used and the only restraints 

used are soft, two-point wrist restraints. 

Even though this rule will allow for this 

timeframe, which we believe is entirely 

appropriate for those deaths where the 

use of restraints is incidental and not 

the cause of the patient’s death, we do 

not expect a hospital to take the full 

seven days to document the entry on 

each of these deaths into its internal log 

or other system. Since the provision 

requires a hospital to provide the 

information in its internal log or other 

system to CMS immediately upon 

request, we would expect a hospital to 

enter the information as soon as 

possible in order to ensure that it has 

the most up-to-date information on 

these patient deaths in its system. 

However, to continue to require 

hospitals to report the deaths of these 

patients by the end of the next business 

day requires a significant amount of 

effort, and does not improve patient 

safety. Therefore, we are finalizing the 

7-day timeframe requirement for 

documenting the entry in the log or 

other system as proposed. 

Comment: One commenter 

recommended that we require hospitals 

to retain the death reporting log for at 

least six years. 

Response: We disagree with requiring 

hospitals to retain the internal log for a 

minimum of six years, which, we note, 

is longer than the current requirements 

for medical records. However, State law 

may require longer periods of record 

retention for patient medical records or 

documents. 

Comment: Several commenters stated 

that having a time frame longer than 24 

hours to submit information may be 

more effective at reducing burden than 

having two separate methods and 

timeframes. Still other commenters 

stated that having a longer timeframe to 

submit a report will not decrease 

burden. 

Response: We disagree with both 

comments. We believe that the proposed 

revisions to the death reporting 

requirement will provide flexibility to 

eliminate burden while ensuring patient 

safety. And we point out that the 

provision we are finalizing does not 

require the submission of information 

for the deaths related to soft, two-point 

wrist restraints only; the revised 

provision requires only the recording of 

information about these types of deaths 

in an internal log or other system. 

Comment: A commenter asked CMS 

to consider setting minimum timeframes 

for both the renewal of a restraint order 

and the monitoring of those patients in 

restraints who are non-violent or nonself destructive. The commenter 

suggested that undefined timeframes 

could exacerbate situations already 


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lacking in the practice of re-evaluations 

for continued restraint. The commenter 

also suggested that the absence of set 

timeframes contributes to problems 

concerning quality of care and patient 

autonomy and harms altruistic efforts, 

generally. The commenter stated that 

extended periods of restraint and 

seclusion pose a serious safety issue for 

non-violent or non-self-destructive 

patients, including those in vulnerable 

populations, and advocated for greater 

standardization in the guidelines. 

Response: These comments are 

outside the scope of this rule. While we 

thank the commenter for his or her 

opinions on this matter, we have not 

seen any evidence that such 

requirements for these types of orders 

improve patient safety. We believe that 

establishing arbitrary minimum 

timeframes for the renewal of orders for 

both restraints and subsequent 

monitoring of non-violent, non-self 

destructive patients could impede a 

hospital’s flexibility in establishing its 

own policies and procedures for these 

orders, based on what the hospital 

knows would best meet the needs of its 

specific patient populations. 

Additionally, timeframe requirements 

could also increase provider burden in 

this area if the CMS timeframes are 

more restrictive than a hospital’s current 

practice. 

Comment: One commenter requested 

that CMS make a clarifying statement 

regarding the requirements at 

§ 482.13(e)(5) that would identify which 

practitioners may order restraint or 

seclusion. The commenter noted that 

the current requirements use the term 

‘‘licensed independent practitioner’’ 

and that this has been interpreted by 

many to mean that a physician assistant 

may not order restraint and/or 

seclusion. The commenter expressed 

disagreement with these interpretations 

and suggested instead that, where 

permitted by State law, a physician 

could delegate the ordering of such 

measures to a physician assistant. The 

commenter requested that CMS provide 

a clarifying statement that (1) PAs are 

authorized to order restraint and 

seclusion and (2) are subject to training 

requirements. 

Response: The commenter is correct 

in pointing out that the current 

requirements use the term ‘‘licensed 

independent practitioner.’’ According to 

the State Operations Manual (SOM), the 

IGs for § 482.13(e)(5) state, ‘‘For the 

purpose of ordering restraint or 

seclusion, an LIP is any practitioner 

permitted by State law and hospital 

policy as having the authority to 

independently order restraints or 

seclusion for patients.’’ Therefore, if an 

individual PA was authorized by State 

law and hospital policy to 

independently order restraints or 

seclusion for patients, then that PA 

could do so within the hospital. 

However, since PAs have traditionally 

defined themselves as ‘‘physiciandependent’’ practitioners (as opposed to 

APRNs, who see themselves as 

independent practitioners), it is unlikely 

that a PA would be authorized by State 

law and hospital policy to 

‘‘independently’’ order restraints or 

seclusions for patients as would be 

likely for licensed independent 

practitioners such as physicians, 

APRNs, and clinical psychologists. The 

supervising physician-PA team concept 

(and PA practice dependence on the 

supervising physician) is supported by 

the American Academy of Physician 

Assistants’ description of the PA 

profession: ‘‘Physician assistants are 

health professionals licensed or, in the 

case of those employed by the federal 

government, credentialed to practice 

medicine with physician supervision’’ 

(American Academy of Physician 

Assistants. (2009–2010). Policy Manual. 

Alexandria, VA.). Moreover, a PA would 

not be allowed to order restraints or 

seclusion if the only authority to do so 

was delegated by a physician since this 

physician-delegated authority would 

establish that the PA was not 

independently authorized by State law 

and hospital policy, which we stated is 

a prerequisite for this type of order. 

PAs (and RNs) are subject to the 

training requirements in this section, in 

addition to any special requirements 

specified by hospital policy associated 

with the one-hour face-to-face 

evaluation of a patient who is restrained 

or secluded for the management of 

violent or self-destructive behavior that 

jeopardizes the immediate physical 

safety of the patient, a staff member, or 

others. 

Comment: One commenter inquired 

whether a ‘‘geri chair’’ is considered a 

restraint that would require reporting 

according to the revised requirements. 

Response: The only reporting change 

we proposed concerns those deaths 

where no seclusion has been used and 

the only restraints used were soft twopoint wrist restraints, as set forth at 

§ 482.13(g)(2). Per current IG for 

§ 482.13(e)(1)(i)(A), found in the SOM 

(http://cms.hhs.gov/manuals/ 

Downloads/som107ap_a_hospitals.pdf), 

a geri chair or a recliner could meet the 

definition of restraint only if the patient 

cannot easily remove the restraint 

appliance and get out of the chair on his 

or her own. 

Comment: One commenter inquired 

whether certain new types of restraints 

would be considered to fall within the 

‘‘soft’’ two-point wrist restraint subset. 

The commenter described the material 

as made of nylon and a foam type of 

material, rather than the more 

commonly used cotton and wool 

materials, and that Velcro would be 

used to fasten them. The commenter 

also asked why CMS did not explicitly 

mention soft restraints which were 

applied to the ankles rather than a 

patient’s wrists. 

Response: We would not expect 

hospitals to change their reporting 

method for deaths involving any 

restraints that could be described as 

hard and rigid, such as leather 

restraints. 

CMS has specifically revised the 

reporting requirements for soft twopoint restraints that are used only on the 

wrists and not those that were applied 

to a patient’s ankles or elsewhere on the 

body. 

We wish to stress that the restraints 

we are setting out for documenting in an 

internal log are those typically used in 

critical care settings, such as intensive 

care units, where such restraints are 

medically necessary. Soft two-point 

wrist restraints are commonly used to 

prevent patients from removing 

medically necessary devices and 

equipment such as central lines, 

endotracheal tubes, and nasogastric 

tubes. 

Comment: One commenter referenced 

a 2006 report, ‘‘Hospital Reporting of 

Deaths Related to Restraint and 

Seclusion,’’ published by the DHHS 

Office of Inspector General which found 

communications lapses among CMS, the 

Food and Drug Administration (FDA)— 

which monitors deaths associated with 

a medical device, Protection and 

Advocacy Agencies (P&As), and State 

survey agencies working on behalf of 

CMS. The commenter expressed 

concern about the OIG’s findings, 

including its documenting of significant 

underreporting to CMS by hospitals of 

restraint- or seclusion-related deaths, as 

well as delays in reporting. The 

commenter inquired whether reporting 

delays had diminished since the report’s 

publication. 

Response: We have limited data, but 

we believe that the current reporting 

requirements may actually exacerbate 

hospital underreporting or untimely 

reporting of deaths associated with 

restraint or seclusion. A review of data 

collected on deaths reported in May and 

in December of 2007 indicated that only 

13.5 percent of all types of hospitals 

nationally had submitted any reports 

during those two months. Between 2008 

and 2010 our Regional Offices entered 

into our survey and certification 


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database a sampling of reports, taking 

reports from two or three months in 

each of the years. We analyzed the data 

and found results consistent with a 

pattern of underreporting. At least for 

IPPS hospitals, which provide shortterm acute care hospital services, and 

where soft wrist restraints are often used 

in critical care settings when patients 

are sedated and restrained for their own 

safety in order to preclude patient 

removal of items such as endotrachial 

tubes and central lines, we would have 

expected every such hospital to have 

had one or more cases per month of a 

patient who died while two-point soft 

wrist restraints were in use, or shortly 

thereafter. In fact, we received at least 

one report from only 41 percent of all 

IPPS and psychiatric hospitals during 

the sampled periods between 2008 and 

the present. Underreporting has proven 

to be an ongoing challenge under the 

current rule. 

We would also note that, since the 

great majority of death reports that 

hospitals do submit involve two-point 

soft wrist restraints only, most of the 

reports submitted to us are reviewed 

and filed without any further action, 

since we do not believe in such cases 

that the use of the two-point soft wrist 

restraint contributed to the patient’s 

death. In such cases we believe it would 

not be an effective use of our limited 

survey resources to conduct an on-site 

investigation as a follow-up to a death 

report where only soft two-point wrist 

restraints had been used and where 

there was no evidence that the death 

was caused by the restraints used. It is 

not surprising that many hospitals 

might fail to perceive a linkage between 

the use of a two-point soft wrist restraint 

and a patient’s death, and therefore the 

need to report such deaths to us as a 

death associated with the use of 

restraint or seclusion. We believe the 

revised reporting requirement will 

enhance patient safety by only requiring 

the prompt submission to us of a more 

narrow range of patient deaths where 

the likelihood of causation by the use of 

restraint or seclusion is greater. We also 

believe we will be able to address 

underreporting more effectively under 

the revised rule. We also believe the 

new regulatory requirement will better 

focus hospitals’ attention and corrective 

efforts in these riskier areas. 

Comment: A commenter remarked 

that, in proposing the changes to 

reporting by hospitals, CMS did not 

discuss the data from deaths related to 

other types of restraints or seclusion. 

Response: We agree with the 

commenter’s apparent suggestion that 

more study may be necessary to 

evaluate the impact from other types of 

restraints or seclusion. As in the 

drafting of this proposal, CMS has 

pursued a conservative, cautious 

approach before finalizing the new 

requirements. In the proposal, we stated 

at the onset that, ‘‘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.’’ As discussed above, in 

the context of the 2006 OIG report, 

‘‘Hospital Reporting of Deaths Related to 

Restraint and Seclusion,’’ CMS has 

found this subset of restraint-related 

deaths to represent a substantial 

percentage of reported deaths to CMS. 

We do not believe there is a causal 

relationship between the use of soft twopoint wrist restraints and patient deaths. 

Moreover, no public comments were 

submitted that provided any evidence or 

research to the contrary. We believe the 

new reporting requirements will allow 

CMS to focus more closely on data from 

deaths related to other types of 

restraints or seclusion where there is a 

greater likelihood of finding harm due 

to the restraints or seclusion. 

Comment: A commenter suggested 

that CMS should add language limiting 

its proposed change in the reporting 

requirements to the use of 2-point soft 

wrist restraints ‘‘in intensive and critical 

care units’’ and ‘‘to prevent patients 

from removing medically necessary 

devices and equipment restraints.’’ 

Response: We believe that the revised 

reporting requirements are appropriate 

and that the commenter’s suggested 

additions could be problematic. We 

agree that soft two-point wrist restraints 

are generally used in intensive and 

critical care units and that they are used 

to prevent patients from removing 

medically necessary devices and 

equipment restraints. However, we 

would not expect hospitals to limit the 

use of such restraints to intensive and 

critical care units alone. 

Comment: A commenter suggested 

that CMS change its proposed language 

to be more inclusive of non-physician 

providers. The commenter 

recommended that § 482.13 (g)(4)(ii) be 

re-worded to read: Each entry must 

document the patient’s name, date of 

birth, date of death, attending physician 

‘‘or other clinician’s’’ name, medical 

record number, and primary diagnoses. 

Response: We appreciate the 

commenter’s suggestion. We agree that 

the proposed regulatory text does not 

take into consideration that patients 

who are not Medicare patients may be 

under the care of a non-physician 

practitioner or licensed independent 

practitioner, as that term is used here, 

if allowed under State law and hospital 

policy. Therefore, we are making a 

change to the regulatory text at 

§ 482.13(g)(4)(ii) so that it will now 

read, ‘‘name of attending physician or 

other licensed independent practitioner 

who is responsible for the care of the 

patient as specified under § 481.12(c).’’ 

This will make the regulatory text here 

consistent with other provisions in this 

section. For Medicare patients, the 

requirements of § 482.12(c) will still 

apply. 

3. Medical Staff (§ 482.22) 

The CMS CoP on ‘‘Medical staff,’’ at 

§ 482.22, concerns the organization and 

accountability of the hospital medical 

staff. We proposed three revisions to the 

Medical staff CoP. 

First, we proposed to redesignate 

§ 482.22(a)(2) as § 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’s scope-ofpractice law, 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. 

Second, we also proposed to require 

that those physicians and nonphysicians, that have been granted 

practice privileges within their scope of 

practice, but without appointment to the 

medical staff, are subject to the 

requirements contained within this 

section. 

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 the State in which the 

hospital is located, a doctor of dental 

surgery or dental medicine. We 

proposed to allow a hospital the option 

of also assigning the leadership of the 

medical staff to a doctor of podiatric 

medicine when permitted by the State 

law of the State in which the hospital 

is located. 

Comment: Overall, the majority of 

comments were overwhelmingly 

supportive of the proposed changes to 

the Medical staff CoP at § 482.22(a) that 

would broaden the concept of ‘‘medical 

staff’’ to include other practitioners who 

are granted hospital privileges to 

practice in the hospital in accordance 

with State law, not only those who are 

actually appointed to sit on the medical 

staff. However, a significant number of 


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commenters, while supportive of the 

proposed changes, recommended that 

CMS go further with its revisions in this 

area. Specifically, they would like to see 

the requirements finalized with these 

additional revisions incorporated into 

the regulatory text: 

• Medical staffs must be 

representative of all types of health 

professionals who have privileges, 

including Advanced Practice Registered 

Nurses (APRNs) and Certified Nurse 

Midwives/Certified Midwives (CNMs/ 

CMs), and who provide services to a 

hospital’s patients, and as they are 

authorized to provide services under 

State law and to the extent of their full 

scope of practice; 

• Non-physician members of the 

medical staff must be accorded the same 

rights and protections as physician 

members, including full voting 

privileges, membership on committees, 

ability to appeal, and due process; 

• The credentialing and privileging 

process and the selection process for 

medical staff membership must be 

transparent and follow established 

criteria; 

• Each application for privileges must 

be completely reviewed and a 

determination made within a 60-day 

period; and 

• The applicant must be notified of 

the determination in writing with an 

explanation of the determination. 

One commenter asked for the 

‘‘specific inclusion of registered 

dieticians as non-physician 

practitioners included and affected by 

the proposed regulation.’’ Another 

commenter voiced support for the 

proposal to allow hospitals to grant 

privileges to non-physicians, regardless 

of whether they are also appointed to 

the hospital’s medical staff, but believed 

that expressly limiting the nonphysician practitioner’s scope of 

practice to what is allowed by the State 

in which the hospital is located (as we 

have proposed here) has the potential to 

greatly limit the value to be gained from 

that practitioner. The commenter stated 

further that it is well documented that 

more than half of the States have 

implemented regulations and 

restrictions that impede the full 

realization of the potential of APRNs, 

and that the quality of care by APRNs 

does not vary by State. The commenter 

affirmed that APRN care is of the same 

quality as that provided by physicians 

for the same services, and that there is 

no clinical reason for these variations in 

State scopes of practice. Finally, this 

commenter urged CMS to establish a 

standard that recognizes non-physician 

practitioners should be privileged to 

practice to the full extent of their 

professional education and capabilities 

by deleting the reference to State 

licensing in the proposed requirements. 

The commenter believes that this would 

be a way to break down unwarranted 

barriers to full utilization of APRNs and 

other non-physician practitioners in 

hospitals and that such a change in the 

final rule would be consistent with 

recommendations in The Future of 

Nursing: Leading Change, Advancing 

Health (Institute of Medicine, October 

2010). It should be noted here that many 

of the other commenters who asked for 

CMS to go further in the revisions to the 

medical staff requirements also cited 

this IOM report. The IOM report 

includes a recommendation specific to 

CMS, which urges that we amend or 

clarify our requirements to ensure that 

advanced practice registered nurses are 

eligible for clinical privileges, admitting 

privileges, and membership on medical 

staff. 

Conversely, we also received a 

significant number of comments from 

those who were adamantly opposed to 

the proposed changes. A majority of the 

dissenting opinions took the form of 

comments expressing serious concerns 

about allowing non-physician 

practitioners to obtain hospital 

privileges without becoming members 

of the medical staff. These commenters 

continued by stating that, ‘‘allowing 

some providers to circumvent medical 

staff oversight will detrimentally impact 

patient safety and quality afforded to 

Medicare beneficiaries and all patients.’’ 

Many of the comments opposed to the 

proposed changes specifically focused 

on the proposal to allow physicians to 

be granted hospital practice privileges 

without requiring them to be appointed 

to the medical staff. The commenters 

stated that this proposed change would 

allow a hospital to exclude certain 

physicians from the medical staff, 

would effectively divide a hospital’s 

physicians into two groups (those on the 

medical staff and those who are not), 

and would undermine what the 

commenters see as the medical staff’s 

chief function: self-governance. The 

commenters maintain that appointment 

to the medical staff provides a physician 

with a voice in the governance of the 

medical staff and patient care, including 

the specific needs of that physician’s 

patient population. Further, the 

commenters stated that the medical staff 

appointment ‘‘engenders a mutual 

responsibility for the activities and work 

of the medical staff—such as quality 

improvement—promoting a mutual 

objective to oversee and protect the 

health and safety of patients.’’ The 

commenters believe that this mutual 

objective of the medical staff is 

responsible for both professional 

standards and patient care. 

These same commenters believe that 

the proposed changes would allow 

hospitals to circumvent the protections 

that the medical staff bylaws provide for 

physicians (for example, judicial 

enforcement of any procedural rights 

contained in the bylaws). The 

commenters state that the changes 

‘‘could allow hospitals to avoid lawsuits 

by physicians who would otherwise be 

protected by the contractual 

relationship created by virtue of their 

appointment to the medical staff.’’ In 

other words, the commenters believe 

that the protections afforded to 

physicians by the medical staff bylaws 

are only available to those physicians 

who are appointed to the medical staff 

and that merely being granted clinical 

privileges to practice is not enough to 

guarantee these protections. 

The commenters also voiced concern 

over what they saw in the proposed rule 

as an opportunity for hospitals to 

privilege physicians outside the 

authority of the medical staff. In their 

comments, they state that they are 

opposed to our proposal to allow a 

governing body to grant privileges in 

accordance with ‘‘hospital policies and 

procedures,’’ and not upon the 

recommendations of the medical staff 

‘‘in accordance with medical staff 

bylaws, rules, and regulations,’’ as is 

currently required in the regulations. 

They believe that, if allowed, this could 

have a negative impact on peer review 

of physicians in hospitals. The 

commenters expressed concern that 

those who are privileged but not 

appointed to the medical staff would 

not have the same due process 

protections of peer review accorded to 

members of the medical staff members. 

Commenters questioned whether these 

physicians would then be subject to a 

hospital-driven review process that is 

dictated only by a hospital’s 

administration without any medical 

staff input or with input from only a few 

hospital-selected medical staff members. 

They also are concerned that a 

privileging process that is allowed to be 

un-tethered from the medical staff could 

lead to various fraudulent practices by 

hospitals to which the commenters are 

opposed. Examples cited by 

commenters include the practice of 

‘‘economic credentialing,’’ which the 

commenters described as the use of 

economic criteria (for example, 

potential to generate the most revenue 

for the hospital based on increased 

referrals) unrelated to the quality of care 

or professional competence to 

determine a practitioner’s qualifications 

for privileges, and ‘‘horse trading,’’ 


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which they described as a practice 

whereby two or more hospitals 

informally agree on the privileging 

status of applicants based on the 

hospitals’ mutual interests. The 

commenters requested clarification from 

CMS on all of these points and urged us 

to ensure that the proposed 

requirements would retain the authority 

of the medical staff, in accordance with 

its bylaws, rules, and regulations, to 

make medical staff appointment and 

privileging recommendations and that 

these changes would not hinder or 

obstruct medical staff peer review 

efforts. The commenters also 

encouraged CMS to look at the proposed 

regulatory language with regard to 

medical staff oversight of non-medical 

staff practitioners. They pointed out that 

there is no specific mention in the rule 

of the applicability of the medical staff 

bylaws and oversight to these types of 

practitioners, both physicians and nonphysicians alike. 

With regard to the discussion of nonphysician practitioners and medical 

staff privileges in the proposed rule, 

these same commenters objected to 

what they saw as ‘‘CMS’s explicit 

endorsement of the replacement of 

physicians with non-physician 

practitioners throughout the rule.’’ They 

commented that they believe that CMS’s 

stated intent of the revisions to the 

medical staff CoP was to replace 

physicians with non-physicians, and 

this would be ‘‘contrary to the purpose 

of the CoPs, namely, to provide a safe 

hospital setting.’’ While the commenters 

recognized the value that non-physician 

practitioners provide to the healthcare 

team, they maintained that physicians 

are the practitioners who are best 

qualified to lead that team, particularly 

in a hospital setting where patients are 

treated for complex and critical illnesses 

and injuries. They further objected to 

what they saw in the proposed rule as 

CMS’ explicit encouragement of the 

expansion of scope of practice laws by 

States. The commenters pointed out that 

this conflicts with the express 

regulatory language of the proposed 

rule, which defers to existing State 

scope of practice laws, and they 

cautioned that any expansion of these 

laws should be based on a review of the 

evidence and on the training and 

education of non-physician 

practitioners to determine if such 

expansions are truly in the best interests 

of patient health and safety. 

Finally, the commenters urged CMS 

to consider their assertion that medical 

staff appointment and privileges are not 

‘‘either/or’’ propositions. They pointed 

out that the American Medical 

Association (AMA) has long given its 

members guidance on medical staff 

categories of membership and cite the 

following examples: ‘‘Active,’’ 

‘‘affiliate,’’ ‘‘administrative,’’ ‘‘call 

coverage,’’ ‘‘telemedicine,’’ and 

‘‘temporary’’ (Evolving Relationship 

between Hospitals and Medical Staff. 

Brian M. Peters, Esq. (2001). AHLA 

Seminar Materials. Post & Schell, PC). 

They stated that while these categories 

‘‘differ in their level of responsibility 

and oversight,’’ the categories do ‘‘share 

the comity of membership in the 

medical staff, which we believe 

engenders a shared accountability.’’ 

While the commenters noted that CMS 

mentions medical staff categories in the 

preamble, they point out that most 

medical staffs already employ categories 

and these are specified in the medical 

staff bylaws. Again, the commenters 

urged CMS to remove its proposed 

requirement at § 482.22 that would 

allow for the exclusion of some 

physicians from both the participation 

in, and the protections, of the medical 

staff. 

Response: We appreciate the support 

for the proposed changes. We also thank 

the commenters for their 

recommendations to make additional 

revisions to the medical staff 

requirements that would allow APRNs 

and other non-physician practitioners to 

practice to the full extent of their 

education and training. We have also 

noted the recommendations of the IOM 

report regarding our requirements and 

the eligibility of APRNs for hospital 

privileges and medical staff 

membership. 

Upon review of our proposed medical 

staff requirements and the public 

comments received, we realized that we 

might not have achieved what we 

originally intended with these changes, 

that is, to provide hospitals with the 

flexibility they would need to explore 

new approaches to care giving by 

allowing them the ability to increase the 

numbers and types of practitioners who 

could be granted hospital privileges to 

treat and care for patients. As we 

proposed in these revisions, any 

regulatory limits on these privileges 

would be imposed by the State licensing 

and scope-of-practice laws of the State 

in which the hospital is located. We 

sought to relieve regulatory burden by 

clarifying and revising the current 

requirements so that hospitals would 

still be allowed to appoint nonphysician practitioners to their medical 

staffs, but that medical staff membership 

would not be a prerequisite to being 

granted privileges in the hospital, 

regardless of whether a practitioner was 

a physician or a non-physician. Based 

on the public comments received, we 

are revising our proposed Medical staff 

requirements in this final rule to better 

address the many valid issues that were 

raised by both those who supported this 

section of the proposed rule and those 

who opposed it. 

While we agree with the IOM report’s 

recommendation that we amend our 

requirements to ensure that advanced 

practice registered nurses are eligible for 

hospital privileges and membership on 

medical staff, we respectfully disagree 

with the commenters’ suggestions that 

we need to add additional requirements 

that would guarantee both nonphysician practitioner representation on 

the medical staff as well as specific 

rights for those non-physician 

practitioners. In addition, we also 

disagree with the recommendations 

offered in the comments that we add 

very specific and highly prescriptive 

requirements pertaining to a hospital’s 

credentialing and privileging process. 

The current requirements already 

provide for a transparent process based 

on established criteria. Although the 

current requirements provide a level of 

specific guidance to hospitals and their 

medical staffs regarding the privileging 

and medical staff appointment process, 

we do not believe that there is sufficient 

evidence to indicate that a hospital 

medical staff and, subsequently, patient 

health and safety would benefit from the 

addition of more rigid and prescriptive 

provisions, such as the commenters’ 

specific recommendations to require a 

60-day timeframe for a hospital to 

review and determine privileges for an 

individual practitioner applicant, or to 

require that the hospital notify the 

practitioner applicant in writing with an 

explanation of its determination. 

We also disagree with the one 

commenter’s recommendation that we 

specifically include registered dieticians 

in the category of non-physician 

practitioners affected by this rule. We 

assume that the commenter means that 

hospitals should be required to 

recognize registered dieticians as 

members of their medical staffs. We 

point out that the final rule does not 

specifically name any category of nonphysician practitioner in the regulatory 

text. While we frequently mentioned 

APRNs and PAs in our discussions 

regarding the composition of the 

medical staff in both the proposed and 

final rules, we have done this only 

because these categories of nonphysician practitioners have scopes of 

practice within the hospital setting that 

are often second only to physicians in 

terms of how broad those scopes of 

practice are. For this reason, these 

categories of non-physician 

practitioners seem the most logical and 


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appropriate choices of categories 

eligible for appointment to a hospital’s 

medical staff. The current requirements 

and the revisions contained in this rule 

are written to allow a hospital’s 

governing body the greatest flexibility in 

determining which categories of nonphysician practitioners that it chooses to 

be eligible for appointment to the 

medical staff. Once the hospital’s 

governing body determines which 

categories are eligible for appointment, 

the new requirements in this final rule 

will ensure that the medical staff 

examines the credentials of all eligible 

candidates and that it makes its 

recommendations for medical staff 

appointments to the governing body in 

accordance with State law, including 

scope-of-practice laws, and the medical 

staff bylaws, rules, and regulations. The 

rule is intended to encourage hospitals 

to be inclusive when they determine 

which categories of non-physician 

practitioners will be eligible for 

appointment to their medical staff. 

Under the new requirements, an 

individual hospital would be allowed to 

include registered dieticians as a 

category of non-physician practitioners 

eligible for medical staff appointment as 

long as their inclusion is in accordance 

with the laws of the State in which the 

hospital is located. 

We also respectfully disagree with the 

comments recommending that we use 

our rulemaking authority to recognize 

non-physician practitioner professional 

education and capabilities in our 

requirements by removing our deference 

to State licensing and scope of practice 

laws. As we stated in a recent rule 

addressing credentialing and privileging 

and telemedicine services, ‘‘CMS 

recognizes that practitioner licensure 

laws and regulations have traditionally 

been, and continue to be, the 

provenance [sic] of individual States, 

and we are not seeking to pre-empt State 

authority in this matter. We believe that 

the proposed requirements regarding 

State licensure leave room for the laws 

that exist today as well as any changes 

to these laws that may occur in the 

future, including any increase in the 

number of States that decide to engage 

in compacts, privilege to practice or 

reciprocity agreements, endorsements, 

and other arrangements regarding 

practitioner licensure (76 FR 25557).’’ 

We would also note that generally, 

federal agencies do not issue rules 

preempting State law unless Congress 

explicitly or implicitly requires such 

preemption. Therefore, we will continue 

to defer to individual State practitioner 

licensing and scope of practice laws 

with regard to hospital privileges and 

medical staff appointments. 

Finally, we do not agree with 

commenters’ assertion that our goal is to 

‘‘replace physicians with nonphysicians.’’ Our overall intent in 

revising the proposed requirements in 

this final rule continues to be what we 

initially expressed in the proposed rule, 

namely, to provide the flexibility that 

hospitals need under federal law to 

maximize their medical staff 

opportunities for all practitioners, 

particularly for non-physician 

practitioners, but within the regulatory 

boundaries of their State licensing and 

scope-of-practice laws. We believe the 

greater the flexibility that hospitals, 

medical staffs, and individual 

physicians have to enlist the services of 

non-physician practitioners to carry out 

the patient care duties for which they 

are trained and licensed, the better the 

quality of care will be for patients. 

Therefore, in this final rule, we are both 

modifying the proposed changes to the 

Medical staff requirements as well as 

revising portions of the current 

requirements of this section in the 

following manner: 

• Removing the proposed concept of 

physicians and other practitioners being 

privileged to practice without 

appointment to the medical staff; 

• Removing the proposed regulatory 

language that the granting of privileges 

is done in accordance with ‘‘hospital 

policies and procedures;’’ 

• Aligning the new regulatory 

language at § 482.22 (a) with that 

currently found in the Governing body 

CoP (§ 482.12(a)(1)) regarding the 

governing body requirement to 

determine, in accordance with State 

law, the categories of practitioners who 

are eligible for medical staff 

appointment; 

• Revising existing § 482.22(a)(2) to 

require the medical staff to examine the 

credentials of all eligible candidates and 

make recommendations for medical staff 

membership to the governing body in 

accordance with State law, including 

scope of practice laws, and with 

medical staff bylaws, rules, and 

regulations; and 

• Revising existing § 482.22(a)(2) to 

require that a candidate recommended 

by the medical staff and appointed by 

the governing body be subject to all 

medical staff bylaws, rules, and 

regulations in addition to the 

requirements in this section. 

We believe that these changes would 

not only satisfy the recommendations of 

the IOM report, but would also directly 

address the issues raised by commenters 

who opposed our proposed revisions. 

The regulatory language that we are 

finalizing here emphasizes the 

collaborative nature that must exist 

between the medical staff and the 

governing body of a hospital. It is a 

system of checks and balances between 

the governing body and the medical 

staff (and, to a certain degree, also 

between an individual practitioner and 

the hospital’s medical staff and 

governing body). Each has its own areas 

of authority. The medical staff has 

oversight of all practitioners practicing 

as part of the medical staff through 

processes such as peer review and reprivileging. The governing body has the 

authority to establish the categories of 

practitioners (regardless of the terms 

used to describe those categories) who 

are eligible for privileges and medical 

staff appointment, but must rely on the 

medical staff to apply the criteria for 

privileging and appointment to those 

eligible candidates and to make their 

recommendations before the governing 

body makes a final decision to appoint 

or not appoint a practitioner to the 

medical staff. With the changes 

contained in this final rule, we are 

ensuring that these areas of authority 

remain intact. 

The changes also leave room for a 

hospital or a governing body, after 

considering the recommendations of its 

medical staff, to appoint non-physician 

practitioners to the medical staff and to 

grant them privileges that are in 

alignment with their professional 

education and training to the full extent 

allowed under State licensing and 

scope-of-practice laws. We encourage 

medical staff and hospitals to take 

advantage of the expertise and skills of 

these non-physician practitioners when 

making recommendations and 

appointments to the medical staff. We 

agree with commenters that an 

appointment to the medical staff 

engenders a sense of mutual 

responsibility for the activities and work 

of the medical staff for physicians; 

however, we believe that these 

sentiments are also engaged when nonphysician practitioners are appointed 

members of a hospital’s medical staff. 

We encourage physicians and hospitals 

to enlist qualified non-physician 

practitioners to fully assist them in 

taking on the work of overseeing and 

protecting the health and safety of 

patients. This applies not only to the 

‘‘work’’ of the medical staff—such as 

quality innovation and improvement, 

best practices application, and 

establishment of professional 

standards—but also to the everyday 

duties of caring for patients. As many of 

the commenters expressed, we also 

believe that an interdisciplinary team 


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approach to patient care is the best 

model for patients. However, we also 

agree that physicians, owing to their 

training and expertise, must be the 

leaders in overall care delivery for 

hospital patients. The changes that we 

are making to the requirements clarify 

and affirm these precepts. However, this 

should not be construed to limit the 

authority of a physician to delegate 

tasks to other qualified healthcare 

personnel or to limit the authority of a 

non-physician practitioner to be 

responsible for the care of an individual 

patient, or patients, as allowed in 

accordance with State laws, medical 

staff bylaws, and hospital policies. 

Comment: A significant number of 

comments were supportive of the 

proposed changes to the Medical staff 

CoP at § 482.22(b) that would expand 

the list of physicians who would be 

eligible to assume direct leadership 

responsibilities for the organization and 

accountability of the medical staff to 

include doctors of podiatric medicine 

(DPMs), when permitted by the State 

law of the State in which the hospital 

is located. This proposal would permit 

a DPM to fill this role, in addition to the 

categories of physicians that are allowed 

to assume this leadership position 

under the current requirements: an 

individual doctor of medicine or 

osteopathy or, when permitted by the 

State law of the State in which the 

hospital is located, a doctor of dental 

surgery or dental medicine. Many of 

these commenters cited the similarities 

in education, training, and experience 

that DPMs share with their allopathic 

and osteopathic colleagues as reasons 

for their support of this proposed 

change to the medical staff leadership 

requirements. 

One commenter expressed support for 

the proposal to include DPMs as eligible 

leaders of the medical staff and 

recommended that CMS extend this 

provision to other non-physician 

practitioners. However, the commenter 

pointed out that the non-physician 

practitioners eligible to fill the medical 

staff leadership role in a hospital should 

be limited to APRNs. The commenter 

recommended that PAs should be 

excluded from eligibility for the medical 

staff leadership role in hospitals because 

they believe that PAs lack the level of 

education, training, and experience that 

APRNs possess. 

There were also a significant number 

of commenters who opposed this 

proposed change. These commenters 

expressed concern over the precedent 

that this sets and maintained that 

practitioners who are not medical 

doctors or doctors of osteopathy should 

not be authorized to hold leadership 

positions on the medical staff of a 

hospital. The commenters also believe 

that in many hospitals, ‘‘a ‘Chief 

Medical Officer,’ someone hired by the 

hospital who is not a physician, is 

appointed to serve in a leadership 

position that would otherwise be held 

by a member of the medical staff.’’ They 

stated that they believe our proposal to 

include DPMs could result in more of 

this type of activity and asked that we 

carefully consider the intended results 

of our proposed change to this 

provision. 

Response: We appreciate the 

comments that supported the proposed 

change. We also thank the commenters 

who expressed an opinion that was in 

opposition to our proposed revisions to 

this provision of the Medical Staff CoP. 

However, we do not see a connection 

between our proposal to include DPMs 

as potential candidates for medical staff 

leadership in any hospital where they 

are members of the medical staff and the 

alleged practice to which the 

commenters referred. Nor do we believe 

that the commenters opposing this 

proposal have provided any evidence 

that would lead us to believe that DPMs 

are not qualified to lead the medical 

staff of a hospital and that to do so 

would place the health and safety of 

patients at risk. Section 1861(r) of the 

Act includes DPMs under the definition 

of physician and nothing in the statute 

precludes a DPM from leading a medical 

staff if the medical staff selects one for 

this position and the governing body 

approves of the medical staff’s selection. 

As we stated in the preamble of the 

proposed rule, we believe that DPMs 

possess the education, training, and 

experience that makes them qualified to 

hold such a leadership position if the 

hospital and its medical staff chooses to 

exercise this option. In addition, while 

we recognize the education, training, 

and experience that non-physician 

practitioners bring to the care of 

hospital patients, we disagree with the 

commenter who recommended that 

APRNs be included in the list of eligible 

medical staff leaders, since this category 

of practitioner does not meet the 

statutory definition of physician. 

However, as we have noted above, we 

continue to encourage and support the 

inclusion of APRNs, PAs, and other 

non-physician practitioners on hospital 

medical staffs, as we believe they can 

assist physicians with the oversight and 

improvement of patient care. Therefore, 

we are finalizing this requirement as 

proposed. 

4. Nursing Services (§ 482.23) 

We proposed 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 proposed that for those 

hospitals that use an interdisciplinary 

plan of care in providing patient care, 

the care plan for nursing services may 

be developed and kept current as part of 

the hospital’s overall interdisciplinary 

care plan. 

We proposed 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 also proposed 

further revision to § 482.23(c) to 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 

proposed to allow for these two 

revisions only if such practitioners were 

acting in accordance with State law, 

including scope-of-practice laws, and 

only if the hospital had granted them 

privileges to do so. 

Within this section of the Nursing 

services CoP, we also proposed changes 

that would allow hospitals to use 

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

proposed 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. 

We also proposed to eliminate the 

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

that non-physicians must have special 

training in administering blood 

transfusions and intravenous 

medications. 

At § 482.23(c)(4) we proposed that 

those who administer blood 

transfusions and intravenous 

medications do so in accordance with 

State law and approved medical staff 

policies and procedures. We proposed 

to retain § 482.23(c)(4) and redesignate 

it at § 482.23(c)(5), without any content 

change. 

We also proposed additional revisions 

at § 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 self-administer 

specific medications (non-controlled 

drugs and biologicals). We proposed 

requirements that a hospital would have 

to meet if it chooses to implement such 

a policy. 


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Nursing Services 482.23(b)(4)—Use of 

an Interdisciplinary Plan of Care 

Comment: A majority of commenters 

supported the revisions to this provision 

that would allow for the incorporation 

of the nursing care plan into the larger 

interdisciplinary care plan. A few 

commenters asked that we clarify what 

would be required regarding 

documentation of the interdisciplinary 

plan. 

Several commenters recommended 

that CMS add a requirement that all 

hospitals implement a hospital-wide 

staffing plan that would establish an 

appropriate number of registered nurses 

on each unit to meet the needs of the 

patients and the expectations of those 

units. They stated that the plan should 

take into account factors present on 

each unit during each shift, such as: the 

number of patients and the level and 

variability of intensity of care; the level 

of education, training, and experience of 

RNs providing direct patient care; and 

non-patient care-related duties that 

nurses oversee. 

Response: We appreciate the 

comments supporting the rule as well as 

the suggestions for additional staffing 

requirements. The required 

documentation for the interdisciplinary 

care plan should follow the current 

documentation policies that hospitals 

are using to document the services 

provided by other disciplines to 

patients, such as services provided by 

physical therapists, occupational 

therapists, speech-language 

pathologists, and others. Documentation 

should follow the standards of practice 

for those disciplines in addition to any 

specific requirements that a hospital 

might want to establish. The 

documentation must also comply with 

the requirements of the CoP at § 482.24, 

Medical records services. 

Regarding the recommendations for 

additional staffing requirements, the 

regulation already requires the hospital 

to have adequate numbers of nurses to 

provide nursing care as needed, and 

makes it the responsibility of the 

director of nursing services to determine 

the types and number of nursing 

personnel and staff necessary to provide 

nursing care for all areas of the hospital. 

Therefore, we do not see the need to 

require any additional or more 

prescriptive regulations to address the 

nursing issues expressed by the 

commenters. 

Comment: One commenter stated that 

the Nursing Care Plan should not be 

merged with the service notes and 

treatment plans of other professionals 

for reasons of patient safety, 

transparency, authority and 

accountability to professional practice 

standards. The commenter believes that 

entries made by an RN should not be 

replaced with entries made by other 

disciplines. Another commenter stated 

that the interdisciplinary care plan 

should be the responsibility of nurses, 

who are better trained and positioned to 

ensure that the plan is patient-centered 

and well-coordinated between 

disciplines. Another commenter 

recommended that we change 

482.23(b)(4) to ensure that the nursing 

staff provides evidence in the medical 

record that the unique and changing 

needs of the patient are considered and 

met. They stated that this medical 

record documentation can be part of a 

nursing care plan, an interdisciplinary 

care plan, or a clinical pathway, or 

through other methods approved by the 

hospital. 

Response: While we understand to a 

certain degree the concerns expressed 

regarding the care plan, we do not 

understand the one commenter’s 

concern that nursing entries would be 

replaced by entries made by other 

disciplines. The provision does not 

require a hospital to replace its nursing 

care plan with an interdisciplinary care 

plan nor does it require (or even permit) 

nursing entries to be replaced by entries 

made by another discipline. We 

proposed that the nursing care plan be 

permitted to be part of an 

interdisciplinary care plan based on 

hospital policy. The hospital is 

responsible for ensuring that the nursing 

staff develops and keeps current a 

nursing care plan for each patient and 

the hospital can determine if the 

nursing care plan is a part of a larger, 

coordinated interdisciplinary care plan. 

As proposed, the requirement was an 

option intended to provide flexibility 

for hospitals that believed patient care 

plans should reflect coordination of care 

by the various disciplines providing 

services to patients. 

Additionally, we disagree with 

changing the regulation by adding 

language that requires nurses to provide 

evidence in the medical records 

regarding how the needs of patients are 

met. In addition to the current 

requirement that an RN must supervise 

the nursing staff and evaluate the 

nursing care for each patient, the 

hospital must ensure that the nursing 

staff develops, and keeps current, a 

nursing care plan for each patient even 

if it is part of a larger, coordinated 

interdisciplinary care plan. We believe 

that the current requirements 

adequately ensure that the unique needs 

of each patient are addressed. 

Comment: A few commenters 

recommended that we require hospitals 

to conduct, no less than annually, an 

evaluation of the staffing plans based 

upon an assessment of patient outcome 

data that is nursing sensitive and that 

hospital staffing plans be made available 

to the public. The commenters also 

recommended that a perioperative RN 

should be present in each operating 

room acting as a circulator throughout 

the duration of each surgical procedure. 

Response: We agree with the 

commenters that hospitals should 

evaluate their nurse staffing plans and 

ensure that the appropriate staff is 

available to provide quality health care 

to all patients. We believe that it is 

implicit in the requirement for the 

director of nursing to determine the 

types and numbers of nursing personnel 

necessary that the director of nursing 

would periodically re-evaluate staffing 

plans to ensure that the nursing care 

needs of patients are met. 

Comment: One commenter 

recommended that the interdisciplinary 

team should include the patient/patient 

advocate/power of attorney in addition 

to the traditional healthcare team of 

providers to participate in the plan of 

care. 

Response: The regulations at 42 CFR 

482.13 establish the right of the patient, 

or the patient’s representative, as 

applicable, to participate in the 

development and implementation of his 

or her plan of care and to be informed 

of the patient’s healthcare status and to 

make informed decisions about his or 

her care. We believe it would be 

redundant to also include these rights in 

the regulatory text related to the nursing 

or interdisciplinary plan of care. 

Nursing Services 482.23(c)(1)(i)—Drugs 

and Biologicals May Be Prepared and 

Administered on the Orders of Other 

Practitioners (in Accordance With State 

Law and Scope of Practice Laws) 

Nursing Services 482.23(c)(1)(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 

Nursing Services 482.23(c)(3)(iii)— 

Orders for Drugs and Biological May Be 

Documented and Signed by Other 

Practitioners 

Comment: A significant number of 

commenters supported the proposed 

changes that would allow drugs and 

biologicals to be prepared and 

administered on the orders of other 

practitioners not specified under 

§ 482.12(c) if the practitioners are acting 

in accordance with State law, including 

scope-of-practice laws, and if the 


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hospital has granted them the privileges 

to write orders. 

Commenters were also very 

supportive of the inclusion and 

allowance for standing orders in the 

proposed revisions to the Nursing 

services requirements. We also received 

comments specifically supporting the 

use of standing orders to encourage 

immunizations, notwithstanding the 

regulations at § 482.23(c)(3), which 

allow for nurse-initiated administration 

of influenza and pneumococcal 

polysaccharide vaccines per physicianapproved hospital policy after an 

assessment of contraindications. 

Commenters were enthusiastic about the 

positive effect that they believed the use 

of standing orders would have for the 

broader patient population in general 

and for hospital infection control efforts 

specifically in terms of a possible 

increase in the immunization rate. 

Similarly, there was extensive support 

for the proposed revisions to allow for 

‘‘other practitioners not specified under 

§ 482.12(c)’’ to document and sign 

orders for drugs and biologicals, 

provided that such practitioners meet 

the provisions discussed above. Many 

commenters stated that they believe the 

changes will allow other qualified 

practitioners the flexibility to address 

the immediate needs of patients without 

delay and that it will increase efficiency 

and the quality of patient care at the 

same time. One commenter stated that 

the changes will ‘‘lessen the impact of 

the current shortage of general 

practitioner MDs, thereby allowing 

patients fuller access to care’’ by 

allowing other qualified practitioners 

the ‘‘ability to write orders and to 

practice to the full extent of their scope 

of practice and State law.’’ 

Response: We thank the commenters 

for their support of the proposed 

revisions to these provisions in the 

Nursing services CoP. We agree that the 

changes will help to eliminate 

unnecessary delays in treatment, 

improve access to care for hospital 

patients, and improve immunization 

rates for the broader patient population. 

We appreciate the support from 

commenters on the proposed standing 

orders provisions contained in this 

section and will discuss the comments 

on these changes in the Medical record 

services section that follows this 

section. However, we should point out 

that the changes finalized here and in 

the Medical record services section 

regarding the use of orders (including 

pre-printed and electronic standing 

orders, orders sets, and protocols) do 

not allow for the use of nurse-initiated 

orders (beyond, or in addition to, those 

currently allowed for influenza and 

pneumococcal vaccination) without an 

authenticated physician or practitioner 

order. We should also note that while 

the provisions finalized here will allow 

for a qualified non-physician 

practitioner to write orders and to 

practice to the full extent of his or her 

State scope of practice, some insurers, 

including Medicare, may only pay for 

the services ordered by a physician or 

for the services ordered incident to a 

physician’s services. 

Comment: Several commenters took 

exception to the fact that the proposed 

language in these provisions does not 

defer to medical staff bylaws, rules, and 

regulations. Other commenters also 

expressed serious concerns about what 

they categorized as ‘‘the proposal to 

expand the types of practitioners who 

are able to administer drugs and 

biologics, particularly as [such proposal] 

relates to anesthesia and pain 

management.’’ The commenters believe 

that expanding the number of nonphysician providers able to administer 

certain drugs, such as opioids, would 

only exacerbate the problem of 

prescription drug overdoses. They urge 

CMS to withdraw the proposal on the 

grounds that ‘‘non-physician providers 

may not have sufficient education or 

training in the proper prescribing of 

opioids, including patient selection and 

risk assessment.’’ 

Response: We thank the commenters 

for noting our failure to properly defer 

to medical staff bylaws, rules, and 

regulations with regard to this issue and 

we agree that, in addition to our 

deference to State laws and hospital 

policies, the provisions must also defer 

to the bylaws, rules, and regulations of 

the hospital’s medical staff. Therefore, 

we are revising the proposed 

requirements to include this reference 

in this final rule. 

Regarding the comments that 

expressed concern over non-physician 

providers ‘‘administering’’ certain 

medications related to anesthesia and 

pain management, such as opioids, we 

believe that the commenters may have 

been confused over the language of the 

proposed requirements. We point out 

that the requirements that we are 

finalizing in this rule are with regard to 

allowing drugs and biologicals to 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-ofpractice laws, and medical staff bylaws, 

rules, and regulations. However, the 

commenters also mentioned the 

prescribing of opioids by practitioners 

other than physicians and believe that 

these practitioners may lack the 

education and training to adequately 

and safely prescribe (or order) these 

types of drugs for patients. We 

respectfully disagree and maintain that 

if these practitioners, in ordering drugs 

and biologicals, are acting in accordance 

with the State laws (including scope-ofpractice laws) of the State in which the 

hospital is located, and if the hospital, 

through its policies, and the medical 

staff, through its bylaws, rules, and 

regulations, authorize them to do so, 

then they have been determined 

competent to order these medications. 

Nursing Services 482.23(c)(3)— 

Administration of Blood Transfusion 

and Intravenous Medications (in 

Accordance With State Law and 

Approved Policies and Procedures) by 

Trained Non-Physician Practitioners 

Comment: Many commenters agreed 

with the deletion of the requirement 

that non-physicians have special 

training in administering blood 

transfusions and IV medications. 

However, several commenters stated 

that, given the immediate and 

significant risk to a patient if these 

procedures are done incorrectly, the 

only personnel permitted to do them 

should be an RN, APRN, PA, or 

physician. They also argued that this 

personnel requirement should be added 

to the regulatory language. Another 

commenter stated that we should clarify 

in the final rule that this revision 

includes all categories of APRNs 

(CRNAs, CNMs, CNSs, and NPs) who 

are acting in accordance with State law 

and hospital policy. 

Response: We appreciate all of the 

comments supporting the proposed 

change. However, we want to clarify 

that only the non-physician personnel 

who have received training in 

administering blood transfusions and 

intravenous medications, in accordance 

with State law and approved medical 

staff policies and procedures, will be 

allowed to provide these services. We 

disagree with the suggestion that we 

specify the exact practitioner-types who 

are qualified to provide these services 

because we believe that these defined 

criteria will prevent unqualified 

personnel from administering blood 

transfusions and IV medications. 

Comment: A few commenters 

opposed our eliminating the 

requirement that non-physicians have 

special training in administering blood 

transfusions. One commenter stated that 

while nurses may receive training in 

administering intravenous medication 

in nursing school, the training is often 

not comprehensive. Generic training on 

IV drug administration may not give 

individuals the appropriate awareness 


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of difficulties with administering 

special medications intravenously. 

Since intravenous drugs typically pose 

greater risks than orally administered 

drugs and they are typically used in 

patients who are ill, this change could 

have an adverse effect on patient safety. 

One commenter recommended that 

CMS allow registered nurses to explain 

and receive informed consent for blood 

transfusions. They stated that most 

facilities already use RNs to discuss the 

risks and benefits of blood transfusion 

with a patient. They also recommended 

that RNs be allowed to document a 

patient’s informed consent without 

requiring the services of a physician 

because the current practice is 

cumbersome and causes undue delay in 

treatment. 

Response: We respectfully disagree 

with the commenters. We proposed that 

blood transfusions and intravenous 

medications be administered in 

accordance with State law and approved 

medical staff policies and procedures. 

The majority of commenters stated that 

this training is standard practice and 

does not need to be prescribed in these 

regulations. Regarding the 

recommendation that CMS allow 

registered nurses to explain and obtain 

informed consent for a blood 

transfusions, the current requirements 

do not preclude nurses from performing 

this task. Informed consent is discussed 

in three locations in the CMS hospital 

CoPs: § 482.13(b)(2) pertaining to 

patients’ rights; § 482.24(c)(2)(v), 

pertaining to medical records services; 

and § 482.51(b)(2), pertaining to surgical 

services. The corresponding guidelines 

to these three provisions contain 

extensive discussions regarding what 

constitutes a properly executed 

informed consent form, as well as 

information on what additional 

information might also be contained in 

a well-designed informed consent form. 

Hospitals must establish their own 

policies regarding informed consent, 

including which procedures require 

informed consent and who may obtain 

the informed consent. 

Nursing Services 482.23(c)(6)—Patient 

Self-Administration of Both HospitalIssued Medications and the Patient’s 

Own Medications Brought Into the 

Hospital 

Comment: The majority of comments 

received were in support of this revision 

that would allow a patient (or his or her 

caregiver/support person where 

appropriate) to self-administer both 

hospital-issued medications and his or 

her own medications brought into the 

hospital. However, many commenters 

advised that patient self-administration 

would only be successful if the hospital 

had a process in place to evaluate each 

patient to determine if selfadministration was appropriate for that 

particular patient. One commenter 

stated that ‘‘used properly and with the 

right patients, self-administration can be 

an extraordinarily helpful tool for 

teaching self-care as a patient and his or 

her family begin the transition back 

home,’’ and further emphasized 

allowing for some flexibility in the 

implementation of this process so that 

nurses, physicians, and other 

practitioners would be fully able to 

exercise their clinical judgment when 

deciding which patients were 

appropriate for self-administration of 

medications. Many commenters 

believed that this type of medication 

regimen reinforcement prior to 

discharge could help to reduce and 

prevent costly patient readmissions 

secondary to medication errors and noncompliance. 

A number of commenters expressed 

their belief that patient selfadministration of medications would 

actively engage the patient in his or her 

plan of care and could serve to keep the 

patient more fully involved in the 

treatment process, which could in turn 

reduce the length of stay for the patient 

and subsequently prevent the patient’s 

readmission. 

Response: We thank the commenters 

for their support of these revisions. We 

agree with the commenters who stated 

that a hospital program for patient selfadministration of medications could be 

extremely beneficial for the appropriate 

patients if the proper precautions were 

taken in designing and implementing 

such a program. With regard to the 

comments that pointed out that teaching 

patient adherence to the proper 

medication regimen prior to discharge 

could have a positive impact on 

reducing hospital patient lengths of stay 

and readmission, we also agree, and 

encourage hospitals considering 

adoption of a medication selfadministration policy to look to the 

medical literature for examples of best 

practices and their use in successful 

patient self-medication programs. 

Comment: Several commenters 

opposed the proposal allowing for 

patient self-administration of 

medications. Some of these commenters 

expressed serious concerns about the 

proposal and focused on those aspects 

of the revisions related to the nursing 

education of patients and the 

subsequent nursing oversight of patients 

self-administering medications as well 

as the nursing documentation of patient 

self-administration. The commenters 

were concerned that these aspects of the 

policy would place undue burden on a 

nurse’s already limited time for patient 

care. Commenters questioned how 

nurses would document patient selfadministration in the patient’s medical 

record if they did not administer or 

witness the administration of the 

medication. 

A few commenters stated that they 

opposed the proposed revisions because 

of their concerns about medication 

safety, including the proper storage and 

security of medications, especially 

controlled substances; the time needed 

for hospital pharmacists to identify and 

label medications brought from home; 

control over which medications (and the 

dosages) the patient is taking; 

maintenance of needed supply of 

medications brought from home and 

procedures in event of shortage; 

administration of medications not 

approved for use in hospital; and 

quality and integrity of medications 

brought from home, including issues 

with expired medications brought from 

home. One commenter stated that we 

should clarify that a patient should not 

be allowed to bring their own drugs, 

except in rare and unavoidable 

circumstances. Other commenters stated 

that the proposed requirements were 

naı ̈ve and that they were clearly not 

developed by clinical professionals. 

These commenters also believe that 

these requirements would endanger the 

safety of the most vulnerable hospital 

populations: the elderly and the 

chronically ill. They pointed out that 

medication errors and compliance with 

medication regimens are often the cause 

for hospital admissions and 

readmissions. 

Response: We appreciate the concerns 

that commenters have expressed and we 

have made some revisions to certain 

areas of the proposed requirements that 

we believe will address some of these 

concerns. Specifically, we have revised 

§ 482.23(c)(6)(i)(D), § 482.23(c)(6)(i)(E), 

§ 482.23(c)(6)(ii)(D), and 

§ 482.23(c)(6)(ii)(E) in this final rule by 

now requiring the hospital to have 

policies and procedures in place to 

address the security of the medication(s) 

for each patient and to document the 

administration of each medication, as 

reported by the patient (or the patient’s 

caregiver/support person where 

appropriate), in the patient’s medical 

record for both hospital-issued 

medications and those brought from 

home. We believe that these changes 

will clarify the questions that we 

received through the comments 

regarding the security of specific 

medications as well as the procedures 

for documenting the self-administration 


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of medications when a nurse does not 

witness it. 

We believe that the security of a 

patient’s self-administered medications 

is extremely important, but it is an issue 

that does not lend itself well to a onesize-fits-all requirement similar to the 

one we originally proposed that would 

require a hospital to have policies and 

procedures in place to ensure the 

security of the medication(s) of each 

patient. We are aware that there are 

Federal and State laws, including the 

current Pharmaceutical services CoP at 

§ 482.25, that require a higher level of 

security for certain medications (for 

example, controlled substances). We 

expect hospitals to comply with these 

already-established requirements and 

laws and we do not expect hospitals to 

include these medications and other 

similar medications and drugs as part of 

a patient self-administration program. 

Indeed, a hospital may find that there 

are other medications that it believes 

should be excluded from patient selfadministration due to concerns over its 

own capacity to address the security of 

these medications for patients. A 

hospital may choose to have a policy 

where it maintains a list of medications 

that it excludes from self-administration 

entirely; to have a policy that addresses 

the security of a particular medication 

on a patient-by-patient basis; or to 

establish a policy that is a combination 

of both these approaches to medication 

security. 

Hospitals are also free to establish 

different levels of patient selfadministration (e.g., with or without a 

nurse present to supervise the selfadministration) that could be 

determined either by the practitioner 

issuing the order to permit selfadministration of specific medications 

or by the nurse after he or she conducts 

the assessment of the patient (or 

caregiver/support person) to determine 

his or her capacity for selfadministration of the specific 

medications ordered. We would expect 

a nurse to exercise his or her clinical 

judgment and to inform the practitioner 

responsible for the care of the patient 

about any reservations the nurse might 

have regarding an individual patient’s 

(or caregiver’s/support person’s) 

capacity to safely self-administer 

medications. We would also expect that 

a nurse would document the assessment 

of a patient’s capacity to self-administer 

medications, highlighting the 

affirmative or negative findings along 

with any discussions that the nurse 

might have with the practitioner 

responsible for the care of the patient 

regarding the patient’s capacity to selfadminister. 

Regarding documentation of selfadministered medications, we believe 

our original proposed requirement for 

documentation was too rigid and 

introduced the possibility that a nurse 

would have to document un-witnessed 

patient self-administration of a 

medication in the same manner he/she 

would if he/she had witnessed it or had 

administered the medication to a patient 

himself/herself. That is why we are 

finalizing our revisions to the proposed 

requirements in this rule that will allow 

for a nurse to document the 

administration of the medication as 

reported by the patient (or the patient’s 

caregiver/support person where 

appropriate). We believe that this 

represents a more realistic approach to 

documentation that does not require a 

nurse to document an action by the 

patient that she did not witness. Instead, 

the nurse now will have the option in 

these cases of documenting the patient’s 

attestation of the medication selfadministration. 

Regarding the commenters’ other 

concerns (which were largely focused 

on self-administration of medications 

brought from home), we note that this 

requirement will be an optional method 

for the administration of medications 

and that hospitals will still have the 

flexibility to prohibit patient selfadministration of medications in any 

form. A hospital must determine for 

itself, through its medical staff and its 

nursing and pharmacy leadership, and 

in consultation with legal counsel and 

risk management, whether it believes 

that it can establish a medication selfadministration program that will be safe 

as well as beneficial for patients. 

Studies indicate that a well-designed 

and implemented medication selfadministration program can be both safe 

and beneficial for patients. In addition 

to presenting their own 2006 study in 

the Journal of Clinical Nursing 

(Grantham G, McMillan V, Dunn SV, 

Gassner L–A, Woodcock P (2006) 

Patient self-medication—a change in 

hospital practice. J Clin Nurs Aug;15(8): 

962–970) Grantham et al. reviewed the 

literature for previous studies of 

hospital patient self-administration 

programs. These studies generally found 

that effective self-administration 

programs are associated with high levels 

of patient satisfaction as well as with 

increases in patients’ knowledge, selfesteem, and independence. The authors 

also noted in their review of the 

literature that there is ‘‘some evidence 

to suggest that patients who selfadminister medications in hospital have 

fewer medication errors and 

medication-related problems 

postdischarge.’’ Regarding the results of 

their own study, Grantham et al 

concluded that their program ‘‘achieved 

high levels of nursing and patient 

satisfaction, contributed to efficient 

patient discharge and was safe.’’ 

Should a hospital choose to establish 

such a program, we would expect it to 

comply with all of the requirements 

finalized here as well as with other 

existing laws and regulations pertaining 

to medications and their administration 

to patients. 

Additional Comments Received Beyond 

the Scope of This Rulemaking 

Comment: A commenter suggested 

that CMS should extend Part B coverage 

to all vaccines recommended by the 

CDC’s Advisory Committee on 

Immunization Practices. 

Response: We appreciate this 

comment, however no such changes 

will be made to this provision. This 

comment is outside the scope of this 

section and outside of the proposed 

rule. 

5. Medical Record Services (§ 482.24) 

The current requirements, at 

§ 482.24(c)(1)(i), specify that all orders, 

including verbal orders, must be dated, 

timed, and authenticated promptly by 

the ordering practitioner. Current 

regulations also include 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 

§ 482.12(c) and who is authorized to 

write orders by hospital policy in 

accordance with State law. This 

requirement has now expired and is no 

longer in effect. 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. 

We proposed 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 


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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.’’ We also proposed to 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. We 

noted that 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. 

We proposed changes to the Medical 

records services CoP that would allow 

hospitals to use standing orders as long 

as certain provisions were met. We 

proposed 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) Established that such 

orders and protocols had been reviewed 

and approved by the medical staff in 

consultation with the hospital’s nursing 

and pharmacy leadership; (2) 

demonstrated that such orders and 

protocols are consistent with nationally 

recognized and evidence-based 

guidelines; (3) ensured that the periodic 

and regular review of such orders and 

protocols was 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) ensured that such orders and 

protocols were 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. 

Comment: Concerning proposed 

§ 482.24(c)(3)(i) and (iii), some 

commenters recommended removing 

the language, ‘‘in consultation with the 

hospital’s’’ after ‘‘staff’’ so that the 

sections would read, ‘‘medical staff, the 

hospital’s nursing and pharmacy 

leadership.’’ Nursing and pharmacy 

leadership would then be full partners 

in both approving pre-printed and 

electronic standing orders, order sets, 

and protocols for patient orders and 

ensuring there is a periodic and regular 

review of these orders. One commenter 

pointed out that these types of orders 

are often multi-disciplinary and 

comprehensive and patients would 

benefit from a more broad-based 

development and implementation of 

these orders and protocols. 

Response: We agree that the nursing 

and pharmacy leadership of a hospital 

should be full partners in approving 

pre-printed and electronic standing 

orders, order sets, and protocols and in 

ensuring that these orders are 

periodically reviewed to determine the 

continuing usefulness and safety of the 

orders and protocols. Therefore, in this 

final rule, we have removed the 

language, ‘‘in consultation with’’ and 

added, ‘‘and,’’ after ‘‘medical staff.’’ 

Thus, the language in both 

§§ 482.24(c)(3)(i) and (iii) reads, 

‘‘medical staff, and the hospital’s 

nursing and pharmacy leadership.’’ 

Comment: We received some 

comments that requested further 

guidance or clarification concerning the 

proposed changes in this section. One 

commenter noted that the proposed 

requirements related to verbal orders 

and standing orders did not address 

residents. The commenter requested 

that CMS use IGs to thoroughly consider 

issues related to residents and ensure 

that the requirements do not become an 

impediment to the residents’ education. 

The commenter also requested that the 

interpretative guidelines address certain 

specific issues. 

Response: CMS will develop IG 

documents after the publication of this 

final rule to assist hospitals, surveyor, 

and the public in implementing this 

final rule. In developing that guidance, 

we will consider the commenters’ 

recommendations. 

Comment: We received one comment 

requesting that we remove the word, 

‘‘promptly,’’ in § 482.24(c)(2) and 

replace it solely by reference to 

timeframes established by hospital 

policy. 

Response: We do not agree with the 

commenter. With the removal of the 48- 

hour requirement for the authentication 

of orders from the hospital CoPs, the 

timeframe for authenticating orders 

would be determined by hospital policy 

in accordance with State law. However, 

we believe that quality patient care 

requires that authentication of orders 

should be done in a timely manner. 

Hence, we have left the word 

‘‘promptly’’ in this provision. 

Authentication of Orders by ‘‘Other 

Practitioners’’ 

Comment: We received numerous 

comments on our proposal at 

§ 482.24(c)(2) that would allow other 

practitioners who were responsible for 

the care of a patient as specified in 

§ 482.12(c) and authorized to write 

orders by hospital policy in accordance 

with State law to authenticate an 

ordering practitioner’s orders, including 

verbal orders, beyond the sunset date of 

the current regulation. Some of the 

commenters noted that the requirement 

to have the ordering physician 

authenticate the order was overly 

burdensome to hospitals, doctors, and 

the nursing staff and did not result in 

any benefit for patient safety. They 

indicated that this change would give 

hospitals more flexibility so that they 

could focus on efficient, safe, high 

quality and patient-centered care. Some 

commenters noted that it was 

particularly important in certain cases, 

such as situations where there are 

residents who rotate between multiple 

institutions, restrictions on duty hours, 

and in situations where practitioners 

practice in rural areas. 

Response: We thank the commenters 

for their support for the proposed 

changes to this section. 

Comment: We received one comment 

that expressed concerns over the 

qualifications of the practitioners who 

would have authority to authenticate 

orders. A national organization of 

pediatricians stated that, in the case of 

pediatric patients, only a practitioner 

credentialed in pediatric care should 

authenticate orders. 

Response: We understand the 

commenter’s concerns. However, 

authentication of an ordering 

practitioner’s orders must be ‘‘by 

hospital policy and in accordance with 

State law.’’ Hospitals may chose to 

restrict which practitioners it would 

authorize to authenticate another 

practitioner’s orders. For example, as 

with the commenter’s example, a 

hospital could choose to restrict 

authentication of orders for pediatric 

patients to practitioners who are 

privileged to provide pediatric care. We 

are confident that hospitals will address 

these issues in their policies. 

Comment: We received several 

comments, including comments from 

advanced practice registered nurses 

(APRNs), national associations for both 

registered nurses and APRNs, and a 

medical center that suggested that 

limiting the practitioners who could 

authenticate an ordering practitioner’s 

order to practitioners listed in 

§ 482.12(c) would exclude APRNs and 

other non-physician practitioners. Some 

of these commenters noted that health 

care is increasingly provided by 

interdisciplinary teams and that the 

previous limitation created an undue 

burden. Some commenters stated that 

since APRNs and other practitioners 

were allowed to order drugs and 

biologicals if they had been granted 

hospital privileges to do so and they 


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were acting in accordance with State 

laws, including scope-of-practice laws, 

then those practitioners should be 

allowed to authenticate orders. The 

commenters recommended either 

deleting the reference to § 482.12(c), 

adding APRNs and other advanced 

practitioners to the list in § 482.12(c), or 

explicitly stating the APRNs could 

authenticate orders for other 

practitioners. 

Response: We agree with the 

commenters that APRNs and other nonphysician practitioners should have the 

authority to authenticate orders. 

Regarding the reference to § 482.12(c), 

we must note that this paragraph 

applies only to Medicare patients and is 

based on the statutory language at 

subsections 1861(e) and (r) of the Social 

Security Act. Even with regard to 

Medicare patients, the language at 

§ 482.12(c) does not entirely exclude 

APRNs and other non-physician 

practitioners from authenticating orders. 

Section 482.12(c)(1)(i) states that, ‘‘This 

provision is not to be construed to limit 

the authority of a doctor of medicine or 

osteopathy to delegate tasks to other 

qualified health care personnel to the 

extent recognized under State law or a 

State’s regulatory mechanism.’’ If State 

law and a hospital’s policy allow PAs 

and APRNs to authenticate orders, a 

physician could delegate that authority 

to them with regard to Medicare 

patients. 

However, in analyzing these 

comments and in preparing our 

responses to them, we came to the 

conclusion that this reference to 

§ 482.12(c) was inappropriately inserted 

into this section of the CoPs, most likely 

when revisions to this section were 

finalized in the November 27, 2006 rule 

(71 FR 68694). Since § 482.12(c) is still 

statutorily required with regard to 

practitioners and the responsibilities for 

the admission and care of Medicare 

patients, we have not made any changes 

to § 482.12(c) as the commenters 

recommended. However, we do believe 

that the removal of the reference to 

§ 482.12(c) is warranted in that the 

requirements discussed here apply to all 

patients and not Medicare patients 

exclusively. Therefore, in this final rule, 

we are revising this provision to delete 

the reference to § 482.12(c) and to 

require that all orders must be 

authenticated promptly by the ordering 

practitioner or by another practitioner 

who is responsible for the care of the 

patient only if such a practitioner is 

acting in accordance with State law, 

including scope-of-practice laws, 

hospital policies, and medical staff 

bylaws, rules, and regulations. We point 

out that we are taking the opportunity 

to also revise the language pertaining to 

State law, hospital policies, and medical 

staff bylaws, rules, and regulations in 

order to make it consistent with the 

changes we have made elsewhere in this 

rule that were based on comments 

received and which are consistent with 

industry practice. 

Comment: We received a comment 

from a medical society that supported 

the easing of the timeframe for 

authentication of verbal orders; 

however, the commenters had concerns 

with the proposal to allow 

authentication of verbal orders by other 

practitioners. They were concerned 

about how orders could be interpreted 

and how this could affect patient care. 

They recommended that CMS not 

finalize the proposal to permit the 

authentication of orders by other 

practitioners. 

Response: We disagree with the 

commenter. The commenter did not 

offer any evidence that having one 

practitioner authenticate the orders of 

another practitioner would have a 

negative impact on patient care. In fact, 

most of the commenters for this 

proposed change indicated that they 

thought it would not only reduce the 

burden to hospitals, practitioners, and 

nurses, but would also improve patient 

care. 

Comment: We received one comment 

from a hospital association that stated 

the changes proposed to verbal order 

authentication provision could result in 

the unintended shift of liability to the 

hospital and hospital personnel 

receiving verbal orders and away from 

the physician/practitioner who bears 

ultimate responsibility for ensuring the 

medical necessity of the order. They 

stated that some States do not have 

specific timeframes for authentication. 

Some States defer to Federal 

regulations, and some State provisions 

contain ambiguous terms such as ‘‘in a 

manner consistent with good medical 

practice’’ or ‘‘before billed.’’ 

Response: Issues surrounding a 

hospital’s tort liability concerning 

verbal orders authentication are State 

law matters and beyond the scope of 

this rule. Moreover, a hospital is free to 

adopt a more stringent policy than that 

required under the regulations, should it 

believe it is prudent to do so. 

Comment: We received one comment 

in which the commenter supported 

expanding the eligibility of qualified 

practitioners to authenticate verbal 

orders. However, they asked for 

clarification regarding the CMS 

definition of ‘‘another practitioner who 

is responsible for the patient.’’ They 

noted that the definition of 

‘‘responsible’’ could have practice 

implications for multiple providers and 

could increase costs by adding 

unnecessary physician supervision. 

Response: CMS will develop IGs after 

the publication of this final rule to assist 

with the implementation of this final 

rule for providers, surveyors, and the 

public. We will consider the 

commenter’s request in developing 

those guidelines. In addition, we believe 

that hospitals would address which 

practitioners would be deemed 

‘‘responsible for the patient’’ in their 

policies. 

Elimination of the 48-Hour Requirement 

for Authenticating Orders 

Comment: We received several 

comments and most were supportive of 

the proposal to eliminate the 

requirement for an ordering practitioner 

to date, time, and authenticate orders 

within 48 hours. 

Response: We would like to thank the 

commenters for their support of our 

proposal. We have finalized this section 

as proposed. 

Comment: We received a few 

comments that expressed concern about 

possible errors. One commenter 

questioned who would catch any errors 

in orders if the ordering practitioner did 

not authenticate the order within 48 

hours. Some commenters were 

concerned about whether the individual 

receiving the order would accurately 

interpret the order and the impact that 

could have on patient care. Another 

commenter stated the 48-hour 

requirement did nothing for patient 

safety and the issue really was whether 

the nursing staff immediately read back 

and verified the verbal order with the 

practitioner. One of these commenters 

recommended not finalizing the 

language that would permit other 

practitioners to authenticate orders. 

Response: We agree with the 

commenters that the possibility of errors 

associated with verbal orders is an 

important issue, and that is why we 

continue to believe that hospitals 

should make efforts to minimize the use 

of verbal orders. We also agree with the 

commenter that it is expected that the 

standard practice would be for the 

person taking the order to read the order 

back to the practitioner to ensure that 

they have correctly understood it. In 

addition, this final rule does not 

mandate that a hospital allow other 

practitioners to authenticate an ordering 

practitioner’s orders. Other practitioners 

can only authenticate orders if, among 

other requirements, it is in accordance 

with hospital policy and State law. 

Therefore, we disagree with the 

commenter that recommends not 

finalizing this provision. Thus, we have 


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not made any changes to the language 

in proposed § 482.24 to add any 

additional requirements for verbal 

orders. 

Comment: A hospital association 

questioned why CMS and physicians 

continue to support time periods for 

other types of physician documentation 

(for example, history and physicals, 

anesthesia evaluations, review of 

restraint orders) but do not support the 

timeframes for verbal orders. The 

commenter gave the following reasons 

why CMS should reconsider the 

proposed policy of removing a defined 

timeframe for authentication: (1) 

Accountability of the prescribing 

physician/practitioner for medical 

necessity; (2) to validate that hospital 

staff received, transcribed and 

performed orders appropriately; and (3) 

to document that the physician/ 

practitioner reviewed the patient’s 

medical record entries, findings and 

other related documents when making 

medical decisions. 

Response: We believe that the 

hospital CoPs should ensure that 

patients receive high quality care, while 

avoiding unreasonably burdensome 

requirements for hospitals. In the case of 

the requirement for an ordering 

practitioner to authenticate orders 

within 48 hours, the majority of 

commenters noted that the requirement 

was overly burdensome to hospitals, 

physicians, and nurses without 

providing any commensurate increase 

in patient safety/quality of care. In 

addition, we do not believe that having 

another practitioner authenticate an 

order for another practitioner would 

negatively affect a patient’s care. The 

ordering practitioner, as well as the 

practitioner who authenticates the 

order, must be responsible for the 

patient’s care. As other comments 

noted, interdisciplinary teams 

increasingly provide health care. All of 

the practitioners should be 

communicating and working together in 

their care of the patient. Therefore, we 

have finalized the removal of the 

requirement for authentication of orders 

by the ordering physician within 48 

hours as proposed. 

Standing Orders 

Comment: We received numerous 

comments that were supportive of 

expanding the use of pre-printed and 

electronic standing orders, order sets, 

and protocols. Commenters noted that 

the use of standing orders contributes to 

patient safety and quality of care by 

providing evidence-based medicine and 

standardization. They indicated that 

using these types of orders would allow 

for faster implementation of care for 

patients. There would be less waste and 

procedural burden. Physicians would be 

able to spend more of their time on 

directly providing care to patients. 

Standing orders also allow other 

providers to take on additional tasks 

and simplify administrative processes. 

Response: We thank the commenters 

for their support for the proposed 

change in this section. We have 

finalized this section as proposed. 

Comment: We received a few 

comments that requested the 

development of further guidance on 

standing orders. A few commenters 

specifically wanted further guidance, 

especially for pediatric patients, 

vaccinations, and emergency 

department patients. One commenter 

noted that our proposed revisions did 

not address how the presence of 

resident physicians would affect the use 

of standing orders and requested that 

CMS address the use of standing orders 

as related to residents in the IGs. One 

commenter requested very specific 

issues be addressed in the IGs. A few 

commenters also requested that we 

provide definitions for ‘‘pre-printed, 

standing orders, order sets, and 

protocols.’’ They stated that we need to 

clarify the meaning of these terms if 

they are not used synonymously. 

Response: Although we will develop 

further IGs after the publication of this 

final rule for hospitals, surveyors, and 

the public to implement this final rule, 

there is no basis in the regulations for 

our requiring hospitals to develop 

differential policies that specifically 

address pediatric or emergency 

department patients or particular types 

of drugs, with the exception of 

pneumonia and influenza vaccinations. 

We are unclear what assertion the 

commenter is attempting to convey 

when the commenter refers to ‘‘how the 

presence of resident physicians would 

affect the use of standing orders.’’ Since 

the commenter did not explain this 

statement further, we can only assume 

that he or she meant to state that the 

presence of residents in a hospital 

would somehow affect whether a 

hospital might or might not use standing 

orders. With regard to resident programs 

and resident practice in hospitals, the 

IGs, in two separate instances, already 

discuss various aspects of resident 

practice in hospitals, though neither 

discussion addresses the use of standing 

orders by residents. Even though the IGs 

do not specifically address the use of 

standing orders by residents, we believe 

that it is useful to note where the 

current IGs do address other aspects of 

resident practice because these 

guidelines might be applicable to the 

comment as best we can discern it. 

In the context of the requirements for 

patient restraint and seclusion orders 

(contained in the Patients’ rights CoP at 

§ 482.13(e)(5)), the use of standing 

orders by residents would be 

determined and authorized by a 

hospital’s medical staff and residency 

program faculty as they see appropriate 

for the care of hospital patients and in 

accordance with any State laws 

governing the practice of residents in 

hospitals. 

Regarding the commenters’ requests 

for definitions of the various terms that 

we use in the provisions pertaining to 

standing orders, we refer the 

commenters to the proposed rule (76 FR 

65895), which contains an extensive 

discussion of pre-printed and electronic 

standing orders, order sets, and 

protocols within both the Nursing 

services section and the Medical records 

services section of the preamble. Within 

the proposed rule, we also cite CMS 

S&C–09–10, which provides additional 

guidance on the use of standing orders. 

Over the last several years, our research 

into the issue of standing orders, 

including our discussions with hospital 

stakeholders, has led us to conclude that 

there is no standard definition for 

standing orders in the hospital 

community at large. Therefore, we chose 

to establish the criteria by which a 

hospital may establish standing orders, 

whether those orders are conveyed in 

printed or electronic form, in orders 

sets, or as protocols. Since agreement on 

what is meant by the term, ‘‘standing 

orders’’ does not exist, hospitals must 

focus on their compliance with the 

requirements finalized here, as they 

establish policies and procedures to 

create and use these types of orders. 

Comment: We received a comment in 

which one commenter strongly 

disagreed with expanding the use of 

standing orders. The commenter 

believed that using standing orders 

would place the hospital staff in a 

position of having carried out orders 

from pre-printed orders, standing 

orders, order sets and protocols in good 

faith without an order from a physician, 

and that the absence of a physician 

order would potentially place the 

hospital and its staff in a legally 

compromising situation. 

Response: The legal liability a 

hospital or hospital personnel could 

experience from using standing orders is 

beyond the scope of this final rule. 

However, hospitals and other healthcare 

institutions for many years have used 

standing orders. In addition, standing 

orders and protocols must meet all of 

the requirements at § 482.24(c)(3) of this 

final rule. Those requirements include 

authentication by either the ordering 


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practitioner or another practitioner 

responsible for the patient’s care acting 

in accordance with State law, including 

scope-of-practice laws, hospital policies, 

and medical staff bylaws, rules, and 

regulations (§ 482.24(c)(3)(iv)). First and 

foremost, there must be an initiating 

order (by a practitioner authorized to 

give such an order) for specific preprinted or electronic standing orders, 

order sets, or protocols to be used for a 

particular patient. As we stated in the 

preamble to the proposed rule (76 FR 

65896), hospital standing order policies 

and procedures ‘‘should address welldefined clinical scenarios for the use of 

such orders’’ and that CMS would 

expect that these same policies and 

procedures would also address the 

process by which a standing order is 

‘‘initiated by authorized staff.’’ Within 

this same section of the proposed rule, 

we also stated, ‘‘under no circumstances 

should a hospital use standing orders 

[pre-printed or electronic standing 

orders, order sets, and protocols] 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.’’ In addition, the final rule 

allows hospitals the use of standing 

orders; it does not mandate their use. 

Therefore, hospitals concerned about 

potential legal liability associated with 

standing orders are not obligated to 

permit their use. It should also be noted 

that while standing orders may be used 

as prescribed under the provisions 

finalized here, hospitals should be 

aware that some insurers, including 

Medicare, might not pay for the services 

provided because of these orders. 

Comment: We received a few 

comments that expressed concern about 

how the proposed language, 

‘‘authenticated promptly in the patient’s 

medical record,’’ could be interpreted. 

The commenters stated that they 

believed our intent was to ensure that 

the standing order or protocol appears 

in the patient’s record. However, they 

stated that this language could be 

interpreted as requiring that each 

individual patient must have his or her 

own standing order for drugs and/or 

biologicals. They suggested that this 

interpretation would actually increase 

the burden on nurses. 

Response: We appreciate the 

commenters concern about how some 

individuals could interpret the language 

in § 482.24(c)(3)(iv). The medical record 

is expected to include the standing 

order that was used for the patient, in 

order to fully and accurately document 

the care provided. In the case of an 

electronic health record or a pre-printed 

order set, it should not prove unduly 

burdensome to incorporate the standing 

order into the patient’s record. 

Requiring a separate, subsequent 

authentication, which simply makes 

reference to the included order as the 

subject of authentication, also should 

not prove burdensome for practitioners. 

Both the current requirements and 

standards of practice regarding medical 

records dictate that any patient order 

given by a practitioner authorized to do 

so automatically becomes a required 

part of the patient’s medical record and 

must be documented to reflect this, 

regardless of whether it is contained in 

pre-printed or electronic standing 

orders, order sets, or protocols, or 

whether it is a written or verbal order. 

6. Infection Control (§ 482.42) 

We proposed to eliminate the current 

provision at § 482.42(a)(2), which 

requires the infection control officer or 

officers to maintain a log of incidents 

related to infections and communicable 

diseases. We proposed to replace this 

provision with the requirement that the 

infection control officer or officers 

develop a system for identifying, 

reporting, investigating, and controlling 

infections and communicable diseases 

of patients and personnel. 

Comment: Nearly all comments 

received stated that the present 

requirement for a separate infection 

control log is redundant and 

unnecessary, given advances in 

technology and surveillance systems. 

Many commenters also suggested that 

complying with the requirement for a 

separate infection control log merely 

diverts scarce resources from other 

efforts. Several comments noted that the 

proposed changes were both appropriate 

and timely. Several also expressed 

appreciation to CMS for the proposed 

change. 

Response: We thank commenters for 

their support of our proposal. We agree 

with the commenters and will finalize 

our proposed change to remove the log. 

We recognize that infection control 

surveillance systems have made 

substantial advances since the time 

when this CoP was first implemented. 

We agree with commenters that 

technological advances have made the 

need for a separate infection log 

obsolete. CMS believes the revised rule 

presents hospitals with an important 

opportunity to reduce operating costs 

and promote patient safety goals. 

Comment: One commenter 

specifically remarked that modern 

surveillance methodologies are targeted, 

in real time, and based on the 

epidemiology of the area being 

monitored. The commenter stressed that 

eliminating the requirement for a 

separate log will allow Infection 

Preventionists (IPs) and Hospital 

Epidemiologists (HEs) to better focus 

their efforts on useful data that will 

drive timely decisions to keep patients 

and staff safe. Similarly, several 

commenters suggested that the change 

would lead to better and more efficient 

collection of relevant data that can be 

used to enhance staff and patient safety 

in more rapid fashion. 

Response: We recognize that modern 

surveillance systems include advanced 

infection detection, data collection and 

analysis, monitoring, and evaluation of 

preventive interventions. These modern 

systems and practices are consistent 

with the requirements retained at 

§ 482.42(a). 

We are aware that many hospitals use 

automated surveillance technology 

(AST) or ‘‘data mining’’ for 

identification and control of hospitalacquired infections (HAI) and 

implementation of evidence-based 

infection control practices. We believe 

that the algorithmic analysis of 

electronic health data offers much 

promise, and we are encouraged by the 

emerging data. (Halpin H, Shortell SM, 

Milstein A, Vanneman M (2011). 

Hospital adoption of automated 

surveillance technology and the 

implementation of infection prevention 

and control programs. Am J Infect 

Control, May;39(4):270–6.) and 

(Klompas M, Yokoe DS (2009). 

Automated surveillance of health careassociated infections. Clin Infect Dis. 

May 1;48(9):1268–75.). 

We believe that eliminating the 

burden of having to maintain a separate 

log will provide hospitals with 

flexibility and free up time and 

resources that could otherwise 

contribute to patient safety efforts. 

Comment: One commenter supportive 

of the proposed change noted it would 

not alter the current workflow. 

Response: We thank the commenter 

for this feedback. This confirms our 

understanding that eliminating the 

requirement for a separate infection 

control log will not negatively disrupt 

hospital practices. 

Comment: One commenter stressed 

the importance of recognizing the 

contributions and abilities of hospitals’ 

infection control officers, noting that the 

vast majority of the officers are 

registered nurses who take their roles 

very seriously and have a very high 

level of professionalism and vigilance. 

Response: We recognize the important 

contributions to infection control made 

by registered nurses and all health 

professionals. Indeed, success depends 

on each and every person involved in 

patient care, as so well portrayed in the 


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training video ‘‘Partnering to Heal’’ 

(HHS. ‘‘Partnering to Heal.’’ Accessed 

12 January 2012 <http://www.hhs.gov/ 

ash/initiatives/hai/training/>). 

Comment: Some commenters 

expressed support for requirements 

allowing a hospital’s infection control 

officer(s) to develop a system for 

identifying, reporting, investigating and 

controlling infections and 

communicable diseases of patients and 

personnel. A few commenters remarked 

upon the importance of a hospital’s 

being able to design its own systems, 

tailoring them to its unique physical 

environment, resources, services and 

patient population. 

Response: We agree. Apart from 

proposing to remove the requirement for 

a log at § 482.42(a)(2) and to adjust the 

formatting and numbering of the 

‘‘Organization and policies’’ standard, 

we are leaving the remainder of this 

standard unchanged. We continue to 

believe that infection prevention and 

control efforts must be hospital-wide 

initiatives that take into account each 

institution’s unique circumstances. 

Comment: One commenter inquired 

into the evidentiary basis for or our 

proposal to eliminate the requirement 

for a log. 

Response: We follow the medical 

literature on infection prevention and 

control closely, including research on 

surveillance. As noted above, we are 

aware of emerging technologies, such as 

automated surveillance technology 

(AST), and of the progress that is being 

made in surveillance and infection 

prevention and control practices, 

generally. 

Both our understanding of this larger 

body of research and our own 

observations contributed to our 

conclusion that advances in infection 

control surveillance systems have made 

the need for a separate infection control 

log obsolete and to our proposal to 

eliminate the requirement for a separate 

infection control log. We also gave 

consideration to complaints from 

stakeholders that the log requirement is 

too prescriptive and burdensome. 

In deciding to finalize our proposal to 

eliminate the log requirement, we 

would also note the universal support 

for this proposal from several major 

infection control groups, such as the 

Infectious Diseases Society of America 

(IDSA), the Association for Professionals 

in Infection Control and Epidemiology 

(APIC), and the Society for Healthcare 

Epidemiology of America (SHEA). 

Comment: One commenter appeared 

to view our proposal to remove the 

requirement for a separate infection 

control log as a larger change to retool 

CMS reporting standards overall. The 

commenter speculated that our 

proposed changes would lead to the 

manipulation of data, make side by side 

comparisons nearly impossible and 

reduce transparency in recording and 

reporting. 

Response: We do not agree that the 

removal of an outdated requirement for 

a separate infection control log would 

necessitate any additional changes to a 

hospital’s infection control program. 

Our proposal to remove the separate log 

requirement is a single, targeted change 

to the infection control standard at 42 

CFR 482.42(a). 

We note that we have retained all 

other requirements at § 482.42, 

including the requirements at 

§ 482.42(a) which require an infection 

control officer or officers to develop a 

system for identifying, reporting, 

investigating, and controlling infections 

and communicable diseases of patients 

and personnel. 

To clarify further, our proposed rule 

introduced changes to Part 482 

regarding CoPs for Hospitals. In a 

separate effort, CMS continues to 

employ hospital quality measures and 

continues its ‘‘Hospital Compare’’ 

initiative. See http:// 

hospitalcompare.hhs.gov/. Neither the 

proposed rule nor this final rule touches 

upon this or any other effort by CMS. 

Comment: One commenter stated that 

our requirements should be expanded 

and improved rather than be eliminated. 

Response: We wish to clarify that we 

are not lowering our standards. As 

explained above, we believe that 

eliminating the requirement for a 

separate infection control log merely 

removes a redundancy that, in the 

modern context, adds cost but no value. 

We are mindful that healthcareassociated infections continue to be a 

major concern and are among the 

leading causes of death in the United 

States, accounting for an estimated 1.7 

million infections and 99,000 associated 

deaths in 2002 (Klevens RM, Edwards J, 

Richards C, Horan T, Gaynes R, Pollock 

D, Cardo D. Estimating Health CareAssociated Infections and Deaths in U.S. 

Hospitals, 2002. Public Health Reports 

2007; 122:160–166.). 

We would like to bring your attention 

to our efforts through the Partnership for 

Patients program, which was launched 

in the spring of 2011 with the twin goals 

of keeping patients from getting injured 

or sicker and helping patients heal 

without complication. (HHS. 

‘‘Partnership for Patients’’ <http:// 

www.healthcare.gov/compare/ 

partnership-for-patients/index.html>). 

We agree with the commenter that 

there might be room for improvement in 

the regulatory context. We may consider 

in future rulemaking further changes 

that would include an increased 

emphasis on infection control and 

prevention; further integration of 

infection control programs with the 

hospital’s QAPI program; better 

alignment of a hospital’s infection 

control efforts with nationally 

recognized guidelines; and a heightened 

role and accountability for a hospital’s 

governing body in infection control 

program implementation and oversight. 

Comment: One commenter suggested 

that CMS should also require protocols 

and staffing for antimicrobial 

stewardship as an integral component of 

infection control programs. 

The commenter stated that the issue 

of antibiotic resistance has reached a 

critical point, as bacteria are becoming 

increasingly resistant to available 

antibiotics, and new drugs are not being 

developed at a pace necessary to 

address growing unmet medical needs. 

The commenter also shared its 

forecast that the costs of including 

antimicrobial stewardship within the 

CoP related to infection control should 

be more than offset by savings 

generated. The commenter supported its 

statement by reference to a CDC 

summary of health economic research 

focused on employing antimicrobial 

stewardship programs with results 

showing significant cost savings. (CDC 

Impact of Antibiotic Stewardship 

Program Interventions on Costs. 

Retrieved Nov. 3, 2011 from http:// 

www.cdc.gov/getsmart/healthcare/ 

support-efforts/asp-int-costs.html). 

Finally, the commenter suggested 

that, in a time where critical drug 

shortages have become increasingly 

more common, an effective 

antimicrobial stewardship program 

would promote efficient administration 

of appropriate therapies. In the FDA 

report on Drug Shortages released in 

October of this year, (FDA. ‘‘A Review 

of FDA’s Approach to Medical Product 

Shortages’’ Accessed 12 January 2012 

<www.fda.gov/DrugShortageReport>), 

antibiotics were the second largest 

therapeutic drug class to experience 

shortages, second only to oncology 

agents. The commenter suggested that 

by eliminating the inappropriate use 

and reducing the over-prescribing of 

antimicrobial agents, stewardship 

programs will preserve critical therapies 

that are in short supply. 

Response: We thank the commenter 

for these suggestions. We agree that 

antimicrobial stewardship efforts are an 

important development in the context of 

infection control. We have not included 

any antimicrobial stewardship 

requirements in the present final rule. 

Such requirements were not proposed 


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and thus cannot be included at this 

juncture. However, we will consider 

these suggestions in future rulemaking. 

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 proposed 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 proposed 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 proposed 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. 

Comment: We received numerous 

comments offering support for our 

proposal to remove the requirement for 

hospitals to have a single director of 

outpatient services. Many commenters 

noted that the change would be 

appropriate, given the complexities of 

modern hospital ambulatory care 

systems, in which technologies are 

changing and hospitals are increasing 

their outpatient service offerings. Many 

commenters stressed that the proposed 

change would free up limited resources, 

and characterized the current 

requirement as a costly and unnecessary 

administrative burden. 

Some commenters also remarked that 

the change would help hospitals better 

ensure that individuals with the best 

expertise will direct each particular 

kind of care provided. Some also 

commented that the change would 

improve integration of their outpatient 

services with inpatient care while 

providing greater clarity to the 

management structure. 

Response: We agree with the 

commenters that these changes will 

align the hospital CoPs with the current 

needs and practices of hospitals, and we 

are finalizing this change as proposed. 

We believe that removing the 

requirement for a single director of 

outpatient services will allow hospitals 

to better utilize their resources, 

particularly their staffing resources, and 

align them with the array of services 

they wish to offer. 

Comment: Many commenters also 

expressly offered their support for the 

proposed regulatory language for 

hospitals to have ‘‘appropriate 

professional and non-professional 

employees at each location where 

outpatient services are offered’’ and to 

base this on ‘‘the scope and complexity’’ 

of the services. 

Response: We are pleased to have 

received favorable feedback regarding 

this language. We will finalize this 

provision as proposed. 

Comment: We received a comment 

seeking clarification about a statement 

in the proposed rule that ‘‘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.’’ This commenter 

sought clarification as to whether the 

statement encompassed outpatient 

services provided by critical access 

hospitals and other community 

partners. The commenter expressed 

strong support for continuity of care and 

for having agreements in place to 

manage outpatient services and ensure 

good communication with a patient’s 

medical home. 

Response: We wish to clarify that the 

change to remove the requirement for 

hospitals to have a single director of 

outpatient services applies only to 

hospitals; it does not apply to critical 

access hospitals (CAHs), which do not 

have a comparable requirement for a 

single outpatient services director under 

the CAH conditions of participation. We 

agree that strong coordination with a 

patient’s medical home would facilitate 

the provision of high quality, patientcentered care. 

Comment: One commenter requested 

clarification between the CMS 

regulations at § 482.54 regarding 

Outpatient services and the regulations 

at § 482.12(c) regarding the care of 

patients. This commenter noted that if 

MD/DOs are required to see every 

patient, regardless of the medical reason 

for the appointment, then patients 

would be forced to wait for an available 

appointment when instead they could 

be seen and effectively treated within 

the scope-of-practice laws by a nonphysician practitioner who is under a 

supervisory agreement with an MD/DO. 

The commenter also requested examples 

of ways in which a hospital would 

demonstrate evidence of a physician’s 

involvement. 

Response: We wish to clarify that the 

CMS requirements at § 482.12(c)(1) 

pertain only to Medicare patients. It 

should be noted that even with regard 

to Medicare patients, the requirement 

does not prohibit a patient from being 

treated by a non-physician practitioner 

who is a member of the medical staff 

and who is acting in accordance with 

his or her State scope of practice as 

allowed by medical staff bylaws, rules, 

and regulations and by hospital policy. 

Section 482.12(c)(1)(i) also contains 

language that states, ‘‘This provision is 

not to be construed to limit the 

authority of a doctor of medicine or 

osteopathy to delegate tasks to other 

qualified health care personnel to the 

extent recognized under State law or a 

State’s regulatory mechanism.’’ 

With regard to the commenter’s 

request for examples of ways in which 

evidence of a physician’s involvement 

would be demonstrated, the evidence of 

a physician’s involvement in the care of 

a Medicare patient must be found in the 

patient’s medical record. Examples of 

medical record documentation that 

support a specific physician’s 

involvement in the care of a Medicare 

patient include, but are not limited to: 

the physician’s name listed as the 

attending physician or physician of 

record; orders, progress notes, or H&Ps/ 

updates authenticated by the physician; 

and any other documentation that could 

reasonably support a specific 

physician’s involvement in the care of 

the patient. 

8. Transplant Center Process 

Requirements—Organ Recovery and 

Receipt (§ 482.92) 

The transplant center rule at 

§ 482.92(a) and the Organ Procurement 

Organizations (OPO) rule at 

§ 486.344(d)(2)(ii) and § 486.344(e) set 

forth requirements regarding blood type 

and other data verification, as well as 

documentation procedures. 

We proposed 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 proposed to redesignate paragraphs 

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

This would eliminate the requirement 

for a separate blood type and other vital 

data verification by a recovery team sent 

by a transplant center to recover an 

organ(s), if the intended recipient is 

known before organ recovery. 


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Comment: All of the comments were 

supportive of this requirement’s 

removal. The commenters indicated that 

this requirement was redundant with 

the requirements in the OPO Conditions 

for Coverage (CfCs), unnecessary, and 

would not impact patient safety. They 

also indicated that the requirement was 

difficult to monitor and that the 

intended recipient could change before 

the organ was actually transplanted. 

Response: We agree with the 

commenters that § 482.92(a) is 

redundant with the OPO CfCs. Section 

486.344(d)(2)(ii) requires OPOs to 

compare the blood type of the donor 

with the blood type of the intended 

recipient prior to organ recovery, if the 

identity of the intended recipient is 

known. We will delete the current 

§ 482.92(a) and redesignate the 

remaining subsections as (a) and (b). 

Thus, we have finalized the section as 

proposed. 

Comment: One commenter did state 

that while they supported the removal 

of this requirement, multiple checks of 

blood type were required in light of 

recent medical errors concerning organ 

transplantation. 

Response: We also agree with the 

commenter that multiple blood type 

checks are necessary to avoid errors in 

the transplantation of organs. In 

addition to the requirement for OPOs to 

check the blood type of the donor and 

the intended recipient as described 

above, transplant surgeons and another 

licensed health care professional must 

verify that the donor’s blood type and 

other vital data are compatible with the 

intended recipient after the organ 

arrives at the transplant center (current 

§ 482.92(b) and new § 482.92(a)). Thus, 

after removal of § 482.92(a), there are 

two mandatory checks to ensure that the 

blood type and other vital date of the 

donor and the intended recipient are 

compatible. This must be done for both 

deceased and living donors (§ 482.92(a) 

and (b)—as redesignated in the final 

rule). 

Additional Comments Received Beyond 

the Scope of This Rulemaking 

Comment: We received one comment 

suggesting that CMS clarify the outcome 

measures in the hospital CoPs for 

transplant centers. That commenter 

indicated that while the final rule for 

those requirements incorporated risk 

adjustment with regard to outcome 

requirements used to approve and reapprove transplant centers, they stated 

that the nature of the risk adjustment 

may not be fully appreciated. They 

believed that concerns related to the 

regulatory burden of these outcome 

requirements, while perhaps 

unwarranted, might be contributing to 

an unintended consequence of a sound 

public policy, namely a seemingly high 

organ discard rate. 

Response: We appreciate the 

comment and the comment’s concern. 

However, this comment is outside the 

scope of the proposed rule. Therefore, 

we not made any changes to the 

provision based on this comment. 

9. 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. 

We proposed to eliminate the 

requirement at § 485.635(b) that CAH 

staff must provide certain services 

directly and proposed to change the 

heading of the standard, ‘‘Direct 

services,’’ to ‘‘Patient services.’’ We also 

proposed to revise the language in 

paragraphs § 485.635(b)(1) through 

(b)(4), ‘‘that the CAH staff furnishes as 

direct services.’’ We also proposed to 

eliminate the definition of ‘‘Direct 

Services’’ at § 485.602 since it will no 

longer be applicable. 

We noted that 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. 

Comment: The majority of 

commenters supported the proposed 

change, stating that it will allow CAHs 

more flexibility in meeting the needs of 

their communities with limited 

resources. This change will better 

enable CAHs to address staffing 

challenges, provide high-quality care to 

their patients, and provide CAH patients 

better access to care. A few commenters 

stated that allowing CAHs the flexibility 

in providing these services for their 

community while still maintaining 

responsibility and oversight for the 

services can generate cost savings that 

could be reallocated to other areas, such 

as quality improvement and patient 

safety. 

One commenter expressed concerns 

that having non-employed providers 

may delay care and would urge caution 

in this area. 

Response: We appreciate the 

comments supporting the rule and the 

comment that expressed concern 

regarding any potential delay in care. As 

stated by the majority of commenters, 

we believe that this change will enable 

CAHs to address staffing issues and to 

provide better access to quality health 

care. However, with this revision to 

provide CAHs with the flexibility to 

contract or arrange for patient services, 

we expect CAHs to ensure that they 

provide services that would facilitate 

timely diagnosis and treatment of their 

patients, as envisioned by the statute. 

We expect that delivering timely 

services will be best achieved by 

providing CAH services on-site at the 

CAH as much as possible, whether 

through CAH employees or through a 

contract or arrangement. At a minimum, 

we expect the services listed under 

§ 485.635(b) to be offered by the CAH 

on-site. 

Comment: Several commenters stated 

that this change will provide for greater 

partnerships with other local providers. 

One commenter stated that if CAHs are 

allowed to contract for services 

provided, CMS should state that a high 

preference is for CAHs to contract with 

other federally funded and designated 

programs like Federally Qualified health 

Centers (FQHCs), FQHC Look-Alikes, 

Rural Health Clinics (RHCs), and the 

health departments. One commenter 

stated that a CAH that sought to expand 

outpatient services should have to 

validate that there was a community 

need for the services it planned to 

deliver and submit a letter of support 

from all essential community providers 

validating that collaborative partnership 

with essential community providers had 

been developed and would be 

maintained. The commenter also stated 

that any CAH that sought to expand 

outpatient services should submit data 

annually to CMS regarding the cost, 

utilization, and outcomes of patient 

services delivered and that CMS should 

make this data available to the general 

public on an annual basis. 

Response: We do not have the 

authority under Federal law to require 

CAHs to enter into contracts or 

arrangements for patient care services 

rather than provide them directly, or to 

require them to give preference in their 

contractual arrangements with certain 

types of Medicare-participating 

suppliers, such as FQHCs or RHCs. We 

also see no valid reason related to 

quality of care or patient safety for 

CAHs to have to bear the burden of 

justifying the need for additional 

outpatient services before the CAH may 

offer them. With respect to CAHs 

collecting and submitting data to us for 


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us to make public on their outpatient 

services, we already have in progress 

the development of measures of 

outpatient quality of care for publication 

on our Hospital Compare Web site, and 

are examining ways to include CAHs in 

future reporting. We agree with the 

commenters that removal of the 

requirement for certain services to be 

direct services will provide for greater 

partnerships with other local providers 

and suppliers, and we believe that 

CAHs will appropriately utilize the 

services of all providers and suppliers 

in their communities. 

Comment: One commenter suggested 

that we eliminate the reference to 

‘‘direct services’’ from the CAH standard 

at § 485.623(a), which states that the 

CAH is constructed to ensure access and 

to provide adequate space for the 

provision of direct services. 

Response: Since we have proposed to 

eliminate the requirement that CAHs 

must provide services directly with 

CAH staff, and we have removed the 

definition for direct services at 

§ 485.602, we agree with the commenter 

that we should remove the reference to 

‘‘direct services’’ at § 485.623(a). We 

will also make a similar change to 

remove the reference to direct services 

at § 485.635(a)(3)(i), which requires the 

CAH’s policies to describe all services 

the CAH furnishes directly and through 

agreement or arrangement. 

Additional Comments Received Beyond 

the Scope of This Rulemaking 

Comment: While we did not propose 

a change to this provision, some 

commenters requested reconsideration 

and revision of the requirement that 

CAH patient care policies and 

procedures be reviewed annually. They 

stated that policy review is extremely 

time consuming and requested that a 

biennial review, or longer which would 

be preferable. 

Response: We appreciate the 

comments. However, this comment is 

outside the scope of the proposed rule 

and no changes will be made to this 

provision. We may consider these 

comments when undertaking future 

rulemaking. 

B. Clarifying Changes 

10. Pharmaceutical Services (§ 482.25) 

and Infection Control (§ 482.42) 

In both § 482.25(b)(6) and 

§ 482.42(b)(1) we proposed to replace 

the term ‘‘quality assurance program’’ 

with the more current term ‘‘quality 

assessment and performance 

improvement program’’ to clarify that 

we expect drug errors, adverse 

reactions, and incompatibilities to be 

addressed in a hospital’s QAPI program, 

as required at § 482.21. 

Comment: We received a few 

comments agreeing with the technical 

changes to replace the quality assurance 

term with the more current term 

‘‘quality assessment and performance 

improvement program.’’ 

Response: We appreciate the support 

for these technical changes and will 

finalize the rule as proposed. 

Additional Comments Received Beyond 

the Scope of CMS–3244 

Comment: Several commenters 

recommended that we change the 

requirement to state that the 

professional responsible for the patient 

or who ordered the medications should 

also receive the report regarding 

pharmaceutical drug error, adverse 

event, or incompatibility issues. They 

stated that this would facilitate timely 

reporting to a Certified Nurse Midwife 

caring for a patient during labor and 

delivery, or to a nurse practitioner or 

physician assistant caring for a patient 

in the emergency room. Another 

commenter stated that the pharmacy 

department should be included in the 

development of criteria for pharmacist 

privileging decisions. One commenter 

questioned the timeframe for 

immediately reporting to the attending 

physician. 

Response: We appreciate the 

comments. However, these comments 

are outside the scope of the proposed 

rule and no changes will be made to this 

provision. We may consider these 

comments when undertaking future 

rulemaking. 

Comment: One commenter stated that 

we need to clarify changes to the quality 

assessment and performance 

improvement CoP. 

Response: We did not propose to 

make any changes to the quality 

assessment and performance 

improvement CoP at § 482.21. We only 

proposed to make conforming changes 

to the pharmaceutical services CoP by 

replacing the term ‘‘quality assurance 

program’’ with the current term ‘‘quality 

assessment and performance 

improvement (QAPI) program’’ that is 

under the QAPI program CoP. 

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 

nurse specialist. In this rulemaking, we 

proposed to revise the definition of a 

clinical nurse specialist (CNS) at 

§ 485.604(a) to reflect the definition in 

the statute at § 1861(aa)(5)(B). 

Specifically, we proposed 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. 

Comment: A majority of commenters 

supported the proposed change. 

However, most of these commenters 

recommended that we include in the 

definition that the CNS be a registered 

nurse with a nursing degree at the 

master’s or doctoral level from an 

accredited educational institution and 

authorized to practice based on State 

nurse licensing laws and regulations. 

They stated that this change will allow 

a CNS to practice in either the State in 

which they live or the State in which 

they provide services. Commenters also 

noted that not all advanced clinical 

degree nursing programs include the 

phrase ‘‘CNS’’ in their degree titles. 

Boards of Nursing in 38 States have 

determined the educational and practice 

requirements for individual programs 

prior to granting the title to work as a 

clinical nurse specialist in their States. 

The commenters stated that adding the 

language regarding State nurse licensing 

laws and regulations allows the State 

Boards of Nursing to determine whether 

the nurses’ educational program is 

congruent with a CNS education. A few 

commenters stated that it is critical that 

language in the final regulation provide 

recognition of all existing CNSs, and in 

particular, those who practice in the 

area of mental health. One commenter 

recommended that we require CNSs to 

be certified by a national organization. 

However, the commenter also stated 

that they recognize the need to allow 

flexibility for States that do not yet 

require certification as a requirement for 

CNS practice and, at this time, it would 

be unfair to require that all CNSs be 

certified. 

Response: We appreciate all of the 

comments supporting the proposed 

definition change as well as the 

suggestions for improving it. We will 

change the definition at § 485.604(a) to 

state that the term ‘‘clinical nurse 

specialist’’ is a registered nurse and is 

licensed to practice nursing in the State 

in which the clinical nurse specialist 

services are performed in accordance 

with State nurse licensing laws and 

regulations; and holds a master’s or 

doctoral level degree in a defined 

clinical area of nursing from an 

accredited educational institution. 

Adding the phrase ‘‘in accordance with 

State nurse licensing laws and 

regulations’’ will ensure that an existing 

CNS will continue to be evaluated based 


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on their State licensing laws and 

regulations. We agree with the 

commenter that it would be unfair to 

require national certification for CNSs 

and we will not require such 

certification. We believe that requiring 

CNSs to have a graduate level education 

and to be authorized to practice based 

on State nurse licensing laws and 

regulations reflect the statutory 

definition of a CNS. 

12. Surgical Services (§ 485.639) 

The current surgical services CoP at 

§ 485.639 was promulgated in 1995 (60 

FR 45814, September, 1, 1995) to ensure 

adequate health and safety protection 

for patients. The provision of surgical 

services is not a required CAH service 

under the Act at section 1820(c); 

therefore, we proposed to change the 

introductory text before this CoP to 

clarify that surgical services are optional 

services for CAHs. We proposed to add 

the conditional clause, ‘‘If a CAH 

provides surgical services,’’ at the 

beginning of the introductory text. Also, 

to reflect the organizational structure 

CoP at § 485.627, we proposed to 

include the phrase, ‘‘or responsible 

individual.’’ 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.’’ 

Comment: The majority of 

commenters supported the change 

clarifying the language regarding 

surgical services as an optional service. 

One commenter asked whether this rule 

change could lead to certain CAHs 

eliminating surgical services without 

giving thought to an alternative source 

for such services. 

Response: We would like to clarify 

that this is not a substantive change in 

the regulation. CAHs are currently not 

required to provide surgical services. 

We proposed to revise the introductory 

statement to the CoP to clarify that 

CAHs are not required to provide 

surgical services. However, if a CAH 

provides surgical services, the CAH 

must comply with the surgical services 

CoP at § 485.639. Current CAHs should 

already be aware that this is an optional 

service and we do not believe that 

providing this clarifying language will 

result in a CAH eliminating their 

surgical services. In fact, we believe that 

clarifying the regulations that surgical 

services are optional will assist small 

rural hospitals that may be considering 

whether to seek CAH status. Therefore, 

we will finalize our proposed technical 

change. 

Additional Comments Received Beyond 

the Scope of This Rulemaking 

Comment: A few commenters stated 

that CMS should consider modification 

to the provisions at § 485.639, 

Anesthesia services, and require 

supervision of CRNAs to be consistent 

with State licensure requirements and 

elimination of the opt-out provision at 

§ 485.639(e). Another commenter stated 

that CMS should reevaluate the 

physician supervision for CRNAs in 

CAHs and hospitals. There should be 

ongoing research regarding the need for 

the existing supervision requirements in 

the CoPs. 

Response: We appreciate the 

comments. However, this comment is 

outside the scope of the proposed rule 

and no changes will be made to this 

provision. 

C. Other Options Considered 

In the proposed rule (76 FR 65891), 

we discussed alternative options for 

revisions that we considered, but did 

not propose. We also solicited 

comments and suggestions on 

additional reforms that would reduce 

burden on hospitals. Below are our 

responses to public comments on those 

alternatives, as well as a summary of 

additional recommendations submitted 

by commenters. See the October 24, 

2011 proposed rule (76 FR 65891) for a 

detailed discussion of the other options 

we considered. 

Medical Staff (§ 482.22) 

In the proposed rule (76 FR 65899) we 

stated that we had considered changes 

to the Medical staff CoP at § 482.22 that 

would allow a multi-hospital system the 

option of having a single organized 

medical staff responsible for the quality 

of medical care provided to patients by 

all the hospitals in the system. We also 

considered, based on stakeholder 

feedback, 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. We received 

many comments on these 

considerations, and responses to 

comments received for this section can 

be found below. 

Comment: A number of commenters 

responded to our solicitation of 

comments on whether we needed to 

revise the Medical staff CoP at § 482.22 

to further clarify that each hospital must 

have its own medical staff within a 

multi-hospital system, and there may 

not be a single medical staff for all of the 

hospitals within the system. 

However, many of the comments 

reflected some confusion over our 

discussion of this issue. Some 

commenters interpreted our discussion 

as a proposal to allow a single medical 

staff for a multi-hospital system. In the 

proposed rule, we stated, ‘‘We do not 

believe that the current CoP language 

implies that we require a single and 

separate medical staff for each hospital 

within a multi-hospital system’’ (76 FR 

65899). We stated this in order to point 

out the current language’s potential 

ambiguity, not to propose a change in 

our interpretation of it. We continue to 

interpret the current CoP to require that 

each hospital, regardless of whether it is 

a part of a multi-hospital system, have 

a single and separate medical staff, as a 

matter of CMS policy. 

Nevertheless, a number of comments 

supported a revision to the current 

requirement to allow for a single 

medical staff for hospitals in a multihospital system. Some commenters 

stated that it would be more efficient 

and save on resources for hospitals, 

particularly with regard to practitioner 

credentialing and privileging. Many 

commenters pointed to the potential for 

patient safety initiatives and quality of 

care improvements across multiple 

hospitals within a system if these 

programs were developed and overseen 

by a single medical staff. A few 

commenters expressed support for the 

idea only if it applied to smaller 

hospital systems confined to a more 

limited geographic area where many of 

the medical staff would be located close 

enough to be privileged at all of the 

hospitals in the system. These 

commenters were generally opposed to 

a single medical staff for large hospital 

systems that spanned multiple States. 

A significant number of comments 

expressed opposition to the concept of 

a single medical staff responsible for the 

oversight of practitioners and the 

quality of patient care at multiple 

hospitals within a system. These 

commenters stated that such a proposal 

would undermine the fundamental idea 

behind a medical staff: self-governance. 

The commenters explained the concept 

of medical staff self-governance as one 

in which the medical staff is familiar 

with the practitioners whom it governs 

and is comprised of, understands the 

unique needs of the hospital in which 

the practitioners work, and ‘‘can nimbly 

respond to health and safety issues that 

arise with respect to those patients and 

that hospital.’’ The commenters pointed 


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out that medical staff self-governance is 

required by a hospital accrediting 

organization and is also mandated by 

some States and they questioned 

whether self-governance requirements 

would be met if a multi-hospital system 

was allowed to have a single medical 

staff overseeing an unlimited number of 

hospitals spread out over a wide 

geographic area and ‘‘without the 

meaningful input of the physicians at 

each member hospital.’’ Commenters 

further cited the negative impact that 

such a proposed change would have on 

peer review whereby the single medical 

staff at the headquarter hospital of the 

system (for example, a large urban 

tertiary care center) would review 

practitioners at a member hospital (for 

example, a rural hospital or a pediatric 

hospital) without having any first-hand 

knowledge or experience with the 

member hospital, its patient population, 

and its particular medical care needs. 

Finally, they pointed to the potential for 

conflict with current State peer review 

laws and regulations that such a change 

might create. 

Response: We appreciate all of the 

comments received on this issue and 

apologize for any confusion that may 

have been caused by the ambiguous 

statement in the preamble to the 

proposed rule. We continue to agree 

with the commenters who opposed any 

changes to the current requirement that 

might allow for a single medical staff to 

oversee all hospitals within a multihospital system. We believe that the 

concerns of the commenters are valid, 

particularly with regard to medical staff 

self-governance, peer review, and 

accountability for patient care, and 

agree with the commenters that such a 

change in current requirements and 

interpretation could negatively impact 

the health and safety of patients. 

Therefore, as we previously stated in the 

preamble discussion of the proposed 

rule, we are retaining the current 

Medical staff requirement without 

revision and maintain our historical 

position that each hospital, even those 

in a multi-hospital systems, must have 

its own medical staff with the authority 

and responsibility for the quality of 

patient care provided in that hospital. 

Comment: Some commenters 

supported keeping the hospital CoPs at 

the service/departmental level. 

Commenters suggested that the current 

departmental structure of the CoPs leads 

to a more fragmented and 

uncoordinated approach to delivering 

care; therefore, by arranging quality and 

safety requirements into systems of care, 

hospital staff would be likely to work as 

a team in developing care processes and 

systems that meet the requirements. 

Therefore, commenters urged CMS to 

move to a more system based approach 

for organizing the hospital CoPs. Other 

commenters suggested that CMS allow 

flexibility in organizational structure 

and requirements. Other commenters 

believed an organizational structure of 

the CoPs, reflecting areas of service, 

would be the most efficient; and in line 

with today’s clinical management 

philosophy. The structure would enable 

the hospitals to improve care delivery 

and the quality and safety of patient 

care. Some commenters supported 

revising the overall organizational 

structure of the CoPs to condense 

regulations for departmental leadership 

into a single non-specific regulation. 

One commenter supported elimination 

of current specialty-department-specific 

leadership requirements into a single, 

non-specific CoP. 

Response: We appreciate commenters’ 

suggestions. These comments were 

outside the scope of this final rule, and 

we may consider these suggestions in 

future notice-and-comment rulemaking. 

Medical Record Services (§ 482.24) 

In the proposed rule (76 FR 65899), 

we considered modifying the 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. We did not 

believe that the regulation should be 

amended, and specifically sought public 

comment on this issue. The following 

are responses to public comments 

received. 

Comment: Several commenters 

supported our decision to not amend 

the current history and physical 

examination (H&P) provision, or its 

associated IG, contained under the 

Medical record services CoP at 

§ 482.24(c)(2). Commenters stated that 

the language at § 482.24(c)(2) is clear 

and that it needs no further explanation. 

Other commenters agreed that it is 

appropriate to defer to the clinical 

judgment of the hospital staff to 

determine the extent of the necessary 

update. 

Response: We appreciate the support 

of commenters on this issue and we 

agree that this provision does not need 

any further regulatory clarification. As 

we stated following our explanation of 

this provision and its IG in the proposed 

rule, we do not believe that the 

regulation should be amended. 

Comment: Some commenters were 

concerned with what they saw as a rigid 

interpretation of the H&P requirement 

and stated that it causes unnecessary 

burden by not clarifying that H&Ps 

conducted within the 24 hours prior to 

an admission or registration are not 

necessary and that they should be left to 

the discretion of the clinician. One 

commenter recommended that CMS 

clarify its parameters for the timeframe 

related to an H&P update (for example, 

the value of performing updates to H&Ps 

that are completed shortly before a 

scheduled procedure requiring 

anesthesia services). In addition, it was 

suggested by a commenter that some 

surveyors continue to confuse the 

timeframe requirements for H&Ps with 

those for the pre-anesthesia evaluation. 

Another commenter suggested that CMS 

clarify this requirement to specify what 

constitutes an update of H&P to ensure 

that hospitals are complying 

appropriately with this requirement. 

One commenter noted that the current 

H&P requirement allows only 

physicians to conduct H&Ps, which 

could result in delays in diagnosis and 

treatment in areas where there are not 

enough physicians. The commenter 

recommends that § 482.24 be modified 

to include PAs and APRNs. Another 

commenter was concerned that the 

wording of the current requirements 

may not fully recognize the ability of 

nurse practitioners to perform both the 

initial H&P and the subsequent 

reassessment of the patient after 

admission or registration, provided that 

the nurse practitioner is credentialed 

and privileged to perform these patient 

evaluations. Therefore, the commenter 

continued, future regulations and IGs 

should specifically clarify the authority 

of nurse practitioners to perform these 

evaluations. Another commenter stated 

that permitting an out-of-hospital H&P 

by a non-physician to substitute as the 

basis for hospital admission and 

treatment, instead of an H&P by a 

physician on the hospital medical staff, 

would create an unacceptable danger to 

patients since these non-physicians 

would be exempt from medical staff 

credentialing, privileging, and peer 

review. The commenter further stated 

that non-physicians often lack the 

education, training, experience, or 

licensure to perform a proper H&P for 

patients who are seriously ill. Another 

commenter stated that the following 

interpretation of this regulation needs to 

be clearly communicated to all: That a 

current H&P can be included in the 

patient’s medical record if performed 

within 30 days prior to hospital 

admission; these H&Ps may be 

performed by any licensed independent 

practitioner (including Doctors of 

Podiatric Medicine) who is or is not a 

member of the medical staff, provided 


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that this does not substitute for proper 

clinical judgment related to updating 

the patient’s status; and that, after the 

patient is admitted, all necessary H&Ps 

must be performed by a properly 

privileged and credentialed member of 

the medical staff as needed. One 

commenter stated there was confusion 

over the H&P update in that some 

physicians feel this rule compels them 

to do a full H&P (the commenter stated 

that this was the advice given by legal 

counsel), especially if the first one was 

not done by them. 

One commenter supported the review 

of H&Ps conducted within the 30 days 

prior to hospitalization; however, the 

commenter encouraged CMS to allow 

organizations flexibility in documenting 

that review and that CMS should not 

prescribe the specific language or 

method to be used to indicate that the 

patient was re-examined and the results 

are noted (for example, ‘‘the H&P was 

reviewed, the patient was examined, 

and ‘no change’ has occurred since the 

H&P was completed’’). Another 

commenter was in agreement with the 

language of the H&P requirement, but 

noted if an update exam is needed it 

should be required by hospital policy 

rather than by CMS regulations. Some 

commenters noted that there is 

inconsistent application of H&P 

requirements by CMS and TJC. One 

commenter suggested that it would be 

very helpful if CMS would allow 

hospitals to address H&P requirements 

in the medical staff rules and 

regulations or policies. 

Response: While we appreciate the 

various dissenting comments and 

opinions that we received on the H&P 

requirements, we must point out that 

many of these comments contained 

inaccuracies regarding both the 

requirements and the IGs. As such, the 

comments do not offer constructive 

criticism or evidence of a compelling 

need to revise the H&P requirements or 

the H&P IGs. 

The intent behind this requirement 

has always rested firmly on the basic 

purpose of an H&P (and a subsequent 

update to an H&P)—that is, to determine 

whether there is anything in the 

patient’s overall condition that would 

affect the planned course of the patient’s 

treatment, such as an allergy to a 

medication that must be avoided, or a 

co-morbidity that requires certain 

additional interventions to reduce risk 

to the patient. To question ‘‘the value of 

performing updates to H&Ps that are 

completed shortly before a scheduled 

procedure requiring anesthesia 

services’’ is to question the value of 

performing an H&P in the first place. A 

patient’s condition can change day to 

day, moment to moment. The update 

requirement ensures that any change in 

a patient’s condition is noted and taken 

into consideration prior to a practitioner 

beginning a procedure or starting a 

treatment plan that may be affected by 

such a change. The H&P and its update 

give the practitioner as much 

information about the patient as he or 

she chooses to seek prior to beginning 

treatment. As written, the requirements 

and IGs allow the practitioner 

performing the update to exercise his or 

her independent clinical judgment with 

regard to how minimal, how focused, or 

how extensive the update to the H&P 

should be for a particular patient (71 FR 

68676; http://www.cms.gov/manuals/

downloads/som107ap_a_hospitals.pdf). 

With regard to the comment that the 

requirements limit the performance of 

the H&P and its update to physicians, 

the requirements (under the Medical 

staff bylaws provisions at 

§§ 482.22(c)(5)(i)–(ii)) have always been 

explicit that other qualified licensed 

individuals may perform these 

evaluations. Other qualified licensed 

individuals are those licensed 

practitioners (such as APRNs and PAs) 

who are permitted by their State scope 

of practice laws or regulations to 

conduct a history and physical 

examination (and any updates to it), and 

who are also formally authorized by the 

hospital to conduct an H&P and its 

updates. Therefore, we do not agree that 

we need to clarify that these types of 

practitioners can perform these duties. 

Conversely, there was the comment 

that posited the idea that allowing these 

types of practitioners to perform H&Ps 

and updates poses an ‘‘unacceptable 

danger to patients’’ since these 

nonphysician practitioners ‘‘often lack 

the education, training, experience, or 

licensure to perform a proper H&P for 

patients who are seriously ill.’’ The 

commenter also stated that nonphysician practitioners who perform 

H&Ps prior to admission (for example, 

as part of a primary care practice) and 

who are not on the medical staff would 

be exempt from medical staff 

credentialing, privileging, and peer 

review. While the fact that non-medical 

staff APRNs and PAs are exempt from 

medical staff peer review is certainly 

true (and, for that matter, so it would 

also be for non-medical staff 

physicians), it cannot be assumed that 

the quality of the H&Ps would be any 

less than those performed by medical 

staff APRNs, PAs, and physicians. 

However, the practitioner responsible 

for the care of the patient always has the 

option to perform a new H&P if he or 

she feels that the H&P done prior to 

admission or registration by the 

patient’s primary practitioner is less 

than adequate. 

Finally, the language in the IGs 

regarding what a practitioner might 

write in the medical record for a patient 

requiring an update to his or her H&P, 

but having no changes in his or her 

condition, is not intended to be 

prescriptive. It is provided as merely an 

example. 

Physical Environment (§ 482.41) 

Currently, hospitals are required to 

meet the standards of the 2000 edition 

of the Life Safety Code (LSC). In the 

proposed rule (76 FR 65899–65900), we 

noted the 2012 LSC edition was 

expected for release in fall 2011, and 

based on the 2012 edition’s content we 

would decide whether it or another 

more recent edition was appropriate for 

incorporation into regulations for 

hospitals and other affected providers 

and suppliers. We also noted any 

regulatory changes would be addressed 

through separate notice-and-comment 

rulemaking; and asked the public for 

their comments in regard to LSC (76 FR 

65900). The 2012 LSC has been 

subsequently released since the 

publication of this proposed rule. 

Comment: Many commenters 

recommended the adoption of the Life 

Safety Code (LSC) (2012 edition) in 

Physical environment § 482.41. Many 

commenters also suggested that CMS 

could ensure continued relevance of its 

LSC requirements by mandating that 

hospitals comply with the most current 

LSC requirements, rather than reference 

a specific edition of the LSC as it has 

previously done. A few commenters 

urged CMS to adopt the 2009 edition of 

the LSC. One commenter suggested 

CMS adopt the version of the LSC that 

the State Fire Marshal is using for that 

particular State. One commenter stated 

at the time CMS considers updating the 

LSC, that both the 2009 International 

Building Code and International Fire 

Code be considered as an allowable 

means of meeting the fire and life safety 

requirements at § 482.41. A few 

commenters noted that currently 

multiple authorities have jurisdiction 

over hospitals and may use different 

versions of the LSC, which creates 

substantial burden on hospitals and 

confusion in the field. Some 

commenters also recommended that the 

Health Care Facilities Code (National 

Fire Protection Association (NFPA) 99– 

2012) should also be adopted. One 

commenter asked whether a fire alarm 

system installed in 2000 would have to 

be in compliance with the maintenance, 

inspection, and testing rules of the 2000 

or the 2012 edition of the NFPA 72. 


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Response: We appreciate commenters’ 

suggestions regarding the LSC 

regulations set out under our ‘‘Physical 

environment’’ CoP at § 482.41. 

Suggestions received were outside the 

scope of this final rule and will be 

considered through separate notice-andcomment rulemaking in a LSC omnibus 

rule, targeted for publication in the near 

future. 

Public Comments Regarding Possible 

Areas for Future Rulemaking 

The proposed rule (76 FR 65904) 

solicited any additional public 

comments on the hospital CoPs which 

were beyond that of the proposed 

provisions. Many commenters provided 

public comments that were outside the 

scope of this final rule, and below is a 

summary of responses to those public 

comments received. 

Interpretive Guidelines (IGs) 

One commenter suggested that CMS 

should provide easy access to up-to-date 

hospital CoPs and IGs on the CMS Web 

site (instead of rewriting hospital CoPs 

in another format), and support a more 

robust search engine for users. Other 

commenters suggested that CMS revise 

the way in which it develops changes to 

IGs to allow for meaningful stakeholder 

and subject matter expert input, making 

the process more transparent. Other 

commenters suggested that accrediting 

bodies should have an opportunity to 

review and provide comment on new 

and modified IGs before they are 

released in a Survey and Certification 

Director’s letter. Another commenter 

suggested that the IGs should be 

reviewed annually, at a minimum, to 

allow for meaningful input. 

Commenters believed there should be a 

complete review of the CoP’s IGs, as 

they are believed to have become overly 

wordy, burdensome, and subject to 

inconsistent interpretation (for example, 

the new IG on anesthesia includes 

analgesia which goes beyond the limits 

of the regulation, etc.). One commenter 

suggested that there is a need for the IGs 

to be very explicit regarding processes 

for credentialing and privileging nonlicensed independent practitioners. In 

addition, commenters encouraged CMS 

to conduct more robust training for State 

survey personnel to ensure consistent 

interpretations of the IGs during 

surveys. 

Immediate Jeopardy 

Commenters urged that CMS further 

define immediate jeopardy, as well as 

the process in place to apply immediate 

jeopardy to value-based purchasing. 

Additionally, commenters suggested 

that CMS should explain the process in 

place to guarantee that consistent 

standards, across the nation, will be 

used to evaluate situations in which 

immediate jeopardy is suspected. 

Privacy Standards 

Commenters noted the comprehensive 

HIPAA standards, not the general CoP 

provisions, provide the appropriate 

basis for protecting the privacy and 

security of patient medical information 

without inhibiting the coordination of 

patient care. Commenters further 

recommended that CMS eliminate the 

CoP obligations for medical records 

confidentiality for providers, and 

instead rely on the Office of Civil 

Right’s interpretation, oversight and 

enforcement of the compliance 

obligations under the HIPAA privacy 

and security standards. 

Nuclear Medicine 

One commenter suggested 

modifications to Nuclear medicine at 

§ 482.53(b)(1) to remove the word 

‘‘direct’’ to reflect the delegation 

authority of the authorized user. 

Additionally, the commenter suggested 

the IGs regarding § 482.53(b)(1) should 

be enhanced focusing on the term 

‘‘authorized user’’ (for example, CMS to 

allow the authorized user be given the 

authority, as noted and consistent with 

the Nuclear Regulatory Commission 

guidelines, to delegate specific tasks, as 

they are best suited for determining 

tasks that supervised individuals can 

perform and the degree of supervision 

required; further the authorized user 

should put policies in place to clarify 

the specific tasks delegated and the 

supervision and certification necessary 

for each), certification of uniform 

competencies, radiopharmaceutical 

preparation qualifications, relevant 

practice standards, and certification 

assessments rather than layering staff. 

One commenter suggested that the 

Nuclear medicine CoP and IGs be 

updated in the future rulemaking. 

Radiologic Services 

Commenters suggested that patientdirected care is not adequately 

recognized in the CoPs, and that CMS 

should amend Radiologic services at 

§ 482.26(b)(4) to be consistent with State 

law for those services permitted to be 

self-referred by hospital patients. 

Special Provisions Applying to 

Psychiatric Hospitals 

One commenter suggested that CMS 

review the CoP at § 482.60, Special 

provisions applying to psychiatric 

hospitals. Specifically, the commenter 

suggested modifications to the current 

provisions at § 482.61(b) stating more 

flexibility for professional judgment 

regarding the breadth and depth of 

assessments should be allowed through 

the development of hospital-specific 

policies rather than requirements of 

CoPs; § 482.61(c) stating there are other 

ways to assure that patients are 

receiving appropriate treatment 

modalities with sufficient frequency and 

intensity to justify inpatient treatment 

than are currently required by the CoPs; 

and § 482.62(a) suggesting that the 

provision of interdisciplinary treatment 

can be accomplished in many ways and 

that hospitals should be encouraged to 

provide that treatment in the most 

flexible and efficient way possible, 

based on individual patient needs and 

hospital policy. 

Emergency Services 

One commenter suggested 

telemedicine modifications to 

§ 482.55(b)(2), Emergency services, to 

add ‘‘available in-person or by video 

conferencing.’’ The commenter also 

suggested incorporating a new provision 

to allow hospitals to provide access for 

stroke care through telemedicine at 

§ 482.55 to state ‘‘there must be 

adequate medical personnel, available 

in-person or by video conferencing, 

qualified in ischemic stroke diagnosis to 

order appropriate treatment including 

timely thrombolytic therapy where 

appropriate.’’ 

Intensive and Critical Care Services 

One commenter suggested adding a 

new CoP at § 482.58 for intensive and 

critical care services, to be modeled on 

the emergency services provision at 

§ 482.55. 

Discharge Planning 

One commenter recommended 

revisions at § 482.43(b)(3), Discharge 

planning, that would include the 

patient’s risk of readmission for the 

diagnosis by adding text that states 

‘‘patient’s readmission for related care 

and * * *’’. 

Regulations Governing Graduate 

Medical Education 

One commenter believed the rules 

lead to additional cost and make it more 

difficult to administer responsive, 

quality graduate medical education 

programs, especially in regards to 

integrated healthcare systems. 

Regulations Governing Quality 

Measurement 

One commenter stated that over the 

years there has been a proliferation of 

quality measures across provider types; 

therefore, this commenter suggested that 

CMS consider a periodic review of all 


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measures to ensure that there is as little 

administrative burden as possible, that 

the measures are compatible from entity 

to entity, and that the measures move 

the program in the same direction rather 

than splinter providers’ focus. 

Electronic Health Records (EHRs) 

Commenters suggested CMS consider 

how to incorporate EHRs into the CoPs 

and IGs. 

Payment 

Several commenters urged CMS to 

reevaluate payment. A few commenters 

stated they did not understand the 

rationale for CMS to impose stricter 

supervision regulations under the 

Outpatient Prospective Payment System 

(OPPS) rule, in that direct supervision is 

not a requirement for inpatient services 

when the patient is presumably more 

acutely ill, so to impose director 

supervision for outpatient therapeutic 

services is not clinically sensible. 

Future Rulemaking Affecting CoPs 

One commenter recommended that 

CMS provide guidance about how future 

rulemakings affecting CoPs or other 

programs will increasingly seek to 

incentivize evidence-based care 

processes that integrate patients and 

families into care decision-making and 

clinical workflow. 

Response: Thank you for the 

suggestions. These comments were 

outside the scope of this final rule, and 

we may consider these suggestions in 

future notice-and-comment rulemaking 

and/or through the IGs. 

Food and Dietetic Services 

Comment: One commenter suggested 

CMS consider revising the requirement 

for a paper-based therapeutic diet 

manual, in Food and dietetic services 

§ 482.28, and allow organizations a 

more contemporary approach for staying 

current with nutritional guidelines (for 

example, that facilities should be 

allowed the flexibility to utilize 

knowledge-based information in a 

variety of forms as a means of staying 

current, as opposed to utilizing a hardcopy manual, which does not allow 

organizations to keep up with rapid 

changes in the field.). 

Response: Currently, the CoP at 

§ 482.28(b)(3) does not specifically 

require a ‘‘paper-based’’ therapeutic diet 

manual. The current CoP at 

§ 482.28(b)(3) states, ‘‘A current 

therapeutic diet manual approved by 

the dietitian and medical staff must be 

readily available to all medical, nursing, 

and food service personnel.’’ We will 

take this comment into consideration for 

future rulemaking. 

III. Provisions of the Final Rule 

In this final rule, we are adopting the 

provisions of the October 24, 2011 

proposed rule (76 FR 65891) with the 

following revisions, which will apply to 

hospitals and CAHs, based on public 

comments: 

Governing Body (§ 482.12) 

• In response to public comments, we 

are revising the introductory text to add 

a requirement at § 482.12 that the 

governing body must include a member, 

or members, of the hospital’s medical 

staff. 

Patient’s Rights (§ 482.13) 

• We are revising paragraph (g)(2) to 

delete the phrase, ‘‘report to CMS,’’ and 

to clarify that for those deaths related 

only to soft, two-point wrist restraints 

the hospital staff must record the 

information regarding the patient’s 

death in an internal log or other system. 

• We are revising paragraph (g)(2) and 

(g)(4) to clarify that the log is internal to 

the hospital. 

• We are revising paragraph (g)(3) to 

specify that ‘‘The staff must document 

in the patient’s medical record the date 

and time the death was: (i) Reported to 

CMS for deaths described in paragraph 

(g)(1); or (ii) Recorded in the internal log 

or other system for deaths described in 

paragraph (g)(2).’’ 

• We are revising paragraph (g)(4)(ii) 

to specify that each entry must 

document the patient’s name, date of 

birth, date of death, ‘‘name of attending 

physician or other licensed independent 

practitioner who is responsible for the 

care of the patient as specified under 

§ 482.12(c),’’ medical record number, 

and primary diagnosis(es). 

Medical Staff (§ 482.22) 

• Remove proposed paragraph (a)(5). 

• Revising paragraph (a) to change the 

title of the standard from ‘‘Composition 

of medical staff’’ to ‘‘Eligibility and 

process for appointment to medical 

staff,’’ and require that the medical staff 

must include doctors of medicine or 

osteopathy, but may also include other 

categories of non-physician 

practitioners determined as eligible for 

appointment by the governing body in 

accordance with State law, including 

scope-of-practice laws. 

• Revise paragraph (a)(2) to require 

that the medical staff must examine the 

credentials of ‘‘all’’ eligible candidates 

and then make recommendations on 

medical staff membership to the 

governing body, and require that a 

candidate who has been recommended 

by the medical staff and appointed by 

the governing body be subject to all 

medical staff bylaws, rules, and 

regulations, in addition to the 

requirements contained in § 482.22. 

Nursing Services (§ 482.23) 

• Revise paragraph (c)(1)(i) to clarify 

that 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- ofpractice laws, ‘‘hospital policies, and 

medical staff bylaws, rules, and 

regulations.’’ 

• Revise paragraph (c)(3)(iii) to clarify 

that 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, 

including scope- of- practice laws, 

‘‘hospital policies, and medical staff 

bylaws, rules, and regulations.’’ 

• Revise paragraphs (c)(6)(i)(A) and 

(c)(6)(ii)(A) to change ‘‘assure’’ to 

‘‘ensure.’’ 

• Revise paragraphs (c)(6)(i)(D) and 

(c)(6)(ii)(D) to clarify that the hospital 

must have policies and procedures in 

place to ‘‘address’’ the security of the 

medication(s) for each patient and to 

document the administration of each 

medication. 

• Revise paragraphs (c)(6)(i)(E) and 

(c)(6)(ii)(E) to provide that the hospital 

must document the administration of 

medication ‘‘as reported by the patient 

(or the patient’s caregiver/support 

person where appropriate), in the 

patient’s medical record.’’ 

Medical Record Services (§ 482.24) 

• Revise paragraphs (c)(2) and 

(c)(3)(iv) to remove the reference to 

§ 482.12(c) and to clarify that all orders, 

including verbal orders and standing 

orders, must be dated, timed, and 

authenticated promptly by the ordering 

practitioner or by another practitioner 

who is responsible for the care of the 

patient ‘‘only if such a practitioner is 

acting in accordance with State law, 

including scope-of-practice laws, 

hospital policies, and medical staff 

bylaws, rules, and regulations.’’ 

• Revise paragraphs (c)(3)(i) and 

(c)(3)(iii) by removing proposed 

language ‘‘in consultation with.’’ 

CAHs 

• We have removed the definition for 

direct services at § 485.602, we have 

removed the reference to ‘‘direct 

services’’ at §§ 485.623(a) and 

485.635(a)(3)(i). 

• In § 485.604(a), we revised the 

definition to provide that a clinical 

nurse specialist is a registered nurse and 

is licensed to practice nursing in the 


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State in which the clinical nurse 

specialist services are performed, ‘‘in 

accordance with State nurse licensing 

laws and regulations;’’ and holds ‘‘a 

master’s or doctoral level’’ degree in a 

defined clinical area of nursing from an 

accredited educational institution. 

IV. 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). Responses to comments received 

for this section can be found below in 

the Regulatory Impacts section (V). 

According to CMS, there are about 

4,900 hospitals (not including CAHs) 

that are certified by Medicare. 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’’ (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 compensate for overhead and 

fringe benefits. 

A. ICRs Regarding Condition of 

Participation: Patient’s Rights (§ 482.13) 

Section 482.13(g) removes 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 includes 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 § 482.13(g)(2)(i) 

and (ii). We noted 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 rule 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)). Section 482.23(b)(4) 

allows 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 rule 

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 

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 this 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 


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current regulations and would adjust for 

any burden reductions resulting from 

this provision once the current rule 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)). In this 

final rule, we are eliminating 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 rule 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) 

In this final rule, we are removing 

§ 482.92(a) entirely. The elimination of 

this section removes 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 rule is 

finalized. For a more detailed 

discussion of estimated burden and cost 

savings, please see the Regulatory 

Impact Analysis section of this rule. 

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 final 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 final 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 conducted a 

retrospective review of the CoPs it 

imposes on hospitals to remove or 

revise obsolete, unnecessary, or 

burdensome provisions. The goal of the 

retrospective review was to identify 

opportunities to reduce system costs by 

removing obsolete or burdensome 

requirements while maintaining patient 

care and outcomes. 

CMS has not reviewed the entire set 

of CoPs for Hospitals in many years. 

These requirements have grown over 

time and, while often revised, have not 

been subject to a complete review. CMS 

staffs as well as CMS stakeholders, 

including TJC, the American Medical 

Association, the AHA, and many others, 

have identified problematic 

requirements over the years. 

Accordingly, we decided to conduct a 

retrospective review of the CoPs 

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. Based on our analysis, we 

decided to pursue those regulatory 

revisions that would reflect the 

substantial advances made in healthcare 

delivery and that would benefit 

hospitals and CAHs through cost 

savings. 

We received hundreds of substantive 

comments supporting our choice of 

provisions for reform, the specific 

reforms we proposed, and the general 

conclusions we had reached as to likely 

importance or magnitude of potential 

savings. Public comments and 

corresponding responses regarding the 

Collection of Information Requirements 

and the Regulatory Impacts section can 

be found below: 

Comment: We received numerous 

comments regarding the paperwork or 

information collection requirement 

(ICR) section and the regulatory impact 

section from health care institutions and 

their national organizations, health care 


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providers and their national 

organizations, health care advocacy 

organizations, as well as others. Most of 

these commenters were supportive of 

our efforts to reduce burden from the 

hospital CoPs, especially those that did 

not contribute to quality patient care, 

and our estimates of the resulting 

savings. Many commenters, especially 

health care providers stated that 

removing these burdensome provisions 

would actually contribute to quality of 

care for patients, allow them more time 

for direct patient care, and to better 

utilize their resources. 

Response: We would like to thank the 

commenters for their support of our 

efforts to reduce the burden from the 

hospital CoPs. 

Comment: We received a few 

comments that questioned our estimate 

of 882,000 occurrences of patients who 

died while either in, or within 24 hours 

of being removed from, soft, wrist only 

restraints. One commenter noted that 

we did not account for the time that 

would be required to perform the log 

entries. 

Response: We agree with the 

commenters. Since publication of the 

proposed rule, we have reviewed some 

new data and agree that the estimate of 

882,000 occurrences is likely overstated. 

We have revised our estimate below. We 

did not account for the time it would 

take to complete a log entry in the 

proposed rule. We believe that hospitals 

would likely choose the most efficient 

manner in which to keep this log. For 

example, they may have a nurse 

complete these entries as a group or 

develop a process for transferring the 

information electronically to a log. We 

continue to believe that removing the 

requirement to report these deaths to 

CMS would result in the savings we 

estimated in the proposed rule, of 

approximately 15 minutes for each 

entry. 

Comment: We received a few 

comments that questioned our estimate 

of $330 million in savings from the 

proposed revisions in § 482.22. 

Commenters indicated that they wanted 

further clarification, that they believed 

the estimate was in error, and 

questioned using the difference between 

a physician and non-physician’s salary. 

Response: We disagree with the 

commenters. In fact, we believe that the 

savings might be much greater. Our 

detailed estimate is located in the 

regulatory impact section (below). As 

we noted, we only estimated the savings 

for inpatient hospital stays. We did not 

estimate the savings for the 

approximately 620,000 annual 

outpatient visits. Therefore, we have not 

modified our estimate. 

Very few of these comments provided 

any criticism of, and no comments 

offered technical information to 

improve, our estimates of potential 

savings. Accordingly, we have not 

changed our estimates of potential and 

likely savings. We plan to evaluate cost 

savings and other potential impacts in 

the future, including changes that might 

increase or decrease patient safety or 

health, based on actual changes 

implemented by hospitals and CAHs. It 

is important to understand that our 

estimates are necessarily uncertain 

because they depend largely on changes 

that hospitals and their medical staffs 

could decide to adopt or not adopt on 

a case-by-case basis. Some estimates 

also depend upon the future decisions 

by States to change their laws and 

regulations covering the scope of 

practice of non-physician practitioners. 

Comment: A number of commenters 

noted that the ability of hospitals and 

CAHs to implement these reforms 

would depend upon our revising the 

current interpretative guidelines for the 

hospital and CAH CoPs. 

Response: As we have discussed 

elsewhere in this rule, we will be 

issuing guidance on how hospitals and 

CAHs can implement the changes in 

this final rule shortly. 

3. Summary of Impacts 

These reductions in process and 

procedure requirements detailed in this 

final rule may allow hospitals and CAHs 

to redirect staff resources to areas of 

higher priority that they view as 

producing greater benefit to patients. 

They could also enhance hospitals’ 

ability to flexibly deploy resources and 

reengineer internal processes. We 

present a summary of these costreducing changes in Table 2. 

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

[2012 Dollars; entries rounded to nearest $100K if under $50M and to nearest $10M if higher] 

Regulatory area Section Annual 

savings ($K) 

Five year 

savings 

($K) 

Patient’s Rights—Death Notice Soft Restraints ........................................................................ 482 .13 $5,100 $25,500 

Medical Staff .............................................................................................................................. 482 .22 330,000 1,650,000 

Nursing Services—Care Plan .................................................................................................... 482 .23 110,000 550,000 

Medical Record Services—Authentication ................................................................................ 482 .24 80,000 400,000 

Medical Record Services—Standing Orders ............................................................................. 482 .24 90,000 450,000 

Infection Control—eliminate log ................................................................................................. 482 .42 6,600 33,000 

Outpatient Services ................................................................................................................... 482 .54 300,000 1,500,000 

Transplant Organ Recovery ...................................................................................................... 482 .92 200 1,000 

CAH Provision of Services ........................................................................................................ 485 .635 15,800 79,000 

Total .................................................................................................................................... .......................... 937,700 4,688,500 

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 are modifying or deleting, we 


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are not aware of any information 

suggesting that these changes would 

create consequential risks for patients. 

In other words, we do not believe that 

any eliminated requirement in this final 

rule has saved lives in recent decades. 

In public comments, several 

commenters raised important questions 

regarding patient safety. We reviewed 

all of those comments with great care; 

however, in our review of these 

comments we could not identity a single 

comment that provided any empirical or 

scientific evidence, or even plausible 

arguments, that any proposed reform 

threatened patient safety. The mere 

possibility of harm, unsupported by 

evidence, does not justify retention of 

regulatory provisions that are based on 

mere supposition or hypothetical 

arguments. Under the standards of EO 

12866 and EO 13563, a regulatory 

requirement must be justified by a 

showing of need. No comments we 

received demonstrated any need to 

retain the particular provisions we 

proposed to eliminate or reform. 

4. Anticipated Impacts 

There are about 4,900 hospitals and 

1,200 CAHs that are certified by 

Medicare. According to CASPER 

(February 1, 2012), there are 6,180 

hospitals. However, that number 

includes religious non-medical health 

care institutions (RNHCIs), which are 

not included in this rule, and critical 

access hospitals (CAHs), which are not 

included in the hospital provisions. In 

addition, according to CMS, there are 

about 107 CAHs with distinct part units 

(DPUs) that must comply with the 

hospital CoPs. Therefore, we have 

analyzed the hospital provision for 

4,900 hospitals (6,180 total hospitals— 

18 RNHCIs—1,330 CAHs + 107 CAHs 

with DPUs = 4,939 or about 4,900 

hospitals). For the CAHs, we analyzed 

the burden for 1,200 CAHs (1,330 CAHs 

–107 CAHs with DPUs that are analyzed 

with the hospitals = 1,223 or about 

1,200 CAHs). Thus, in the final rule, we 

used these figures to estimate the 

potential impacts of this rule. In 

addition, we used 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/). We 

received no comments suggesting a 

change in these hourly wage 

assumptions. 

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 normally necessary 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) 

In this final rule, we are removing 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 for patients who died 

within 24 hours of having been removed 

from these types of restraints is also 

removed. 

In the proposed rule, we estimated 

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. In 

addition, we also received comments 

questioning the estimate of 882,000 

occurrences. We conducted further 

research and have decided that our 

estimate in the proposed rule was 

overstated. Therefore, we have revised 

our savings estimate below. 

In addition, the assumption in the 

2006 final rule was that administrative 

support personnel would carry out these 

functions. 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. 

According to the United States 

Agency for Healthcare Research and 

Quality (AHRQ), there were 757,841, or 

about 758,000, in-hospital deaths in 

2009 (http://hcupnet.ahrq.gov/ 

HCUpnet.jsp accessed February 10, 

2010). There are many reasons for a 

patient to be physically restrained. 

According to Evans and FitzGerald, two 

of the most often cited reasons for 

restraining patients were treatmentrelated and for safety reasons (Evans, D. 

and FitzGerald, M, Reasons for 

physically restraining patient and 

residents: a systematic review and 

content analysis, International Journal 

of Nursing Studies 39 (2002), pp. 735– 

743). The treatment-related reasons 

include preventing patients from 

disturbing medical devices, such as 

endotracheal tubes, intravenous lines 

(IVs), nasogastric or feeding tubes, 

urinary catheters, wounds, dressings, 

and sutures (Evans and FitzGerald, p. 

738). Patients might also be restrained 

for their own safety, such as when 

patients have impaired judgment or 

might harm themselves. We believe that 

many of the patients who die in the 

hospital are those who were seriously ill 

or injured and whose treatment likely 

involved medically necessary devices 

(such as endotracheal tubes and 

respirators due to post-operative 

respiratory failure) or those who may 

have suffered from impaired cognition 

and judgment due to their conditions. 

Thus, we believe that many of these 

patients may have been restrained at the 

time of, or within 24 hours of, their 

deaths so that medically necessary 

treatments could be carried out in the 

most safe and effective manner. Thus, 

we estimate that 60 percent of the 

758,000 in-hospital deaths, or 454,800 

deaths, would have been reported to 

CMS. 

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. 

We are also basing this timesaving 

estimate on our experiences with 

hospitals as well as feedback from 

stakeholders that indicated that this 

estimate was reasonable. Therefore, we 

estimate that this reduction in burden 

would reduce each hospital’s burden 

hours by about 23 hours (454,800 

occurrences × .25 hours ÷ 4,900 = 23.20 

or about 23 hours) each year valued at 

$45 for each hour for an average annual 

savings of $1,035 (23 hours × $45 hourly 

wage for a nurse = $1,035). Thus, we 

estimate that for all 4,900 hospitals this 

would result in a savings of about 

$5,116,500 (454,800 occurrences × $45 × 

.25 hours = $5,116,500 estimated 

savings). 

Medical Staff (§ 482.22) 

Our changes and clarifications 

regarding medical staff and privileging 

allow hospitals to substitute and 

rearrange actual delivery of care. In 

particular, use of Advanced Practice 

Nurse Practitioners (APRNs) and 


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Physician Assistants (PAs) in lieu of 

higher-paid physicians could provide 

immediate savings to hospitals. While 

we have no precise basis for calculating 

potential savings, we feel confident that 

our estimates reflect a reasonable 

approach to hospital cost savings. 

However, much will depend on the 

future staffing and management 

decisions that individual hospitals 

make. For example, the savings that we 

believe that hospitals will realize from 

the changes to the Medical staff CoP 

will depend on the extent to which 

hospitals take advantage of the 

regulatory flexibility that the new 

requirements afford. Those hospitals 

that view these changes as a means to 

be more inclusive of non-physician 

practitioners on their medical staffs 

would most likely reap the most 

benefits. 

With that said, we also believe that an 

interdisciplinary team approach to 

patient care is the best model for 

hospital patients. Within this model, 

non-physician practitioners have proven 

themselves capable of handling many 

common patient complaints, initial 

patient work-up and follow-up, patient 

education and counseling, and the 

specific aspects of patient care for 

which they have been educated and 

trained. Physicians, as leaders of these 

teams due to their more extensive 

training and expertise, are then able to 

more fully turn their attention to more 

complicated patient problems. In this 

way, non-physician medical staff 

members allow physicians to more 

efficiently and effectively manage their 

time so that these physician leaders can 

focus on more medically complex 

patients. It is within this context of 

efficient and effective care delivery by 

physicians and non-physician 

practitioners working collaboratively 

that we have based our estimates. For 

purposes of this analysis, we have 

reached an estimate of $330 million in 

savings using the following 

assumptions, which are based on our 

experience with hospitals: 

• 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 structure their 

medical staffs in this manner; 

• 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 non-physician 

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/non-physician 

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 these 

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 received several comments 

criticizing this lack of precision in these 

estimates. One of these suggested 

additional consultation with 

stakeholders. We agree with those 

commenters that better estimates would 

be desirable. However, no commenters 

provided any information showing that 

there would be costs not accounted for 

in these estimates (for example, 

reductions in patient safety), or 

provided any information showing that 

these estimates were either too low or 

too high. Since these estimates depend 

overwhelmingly on future State 

decisions regarding non-physician 

practitioner practice limitations, and on 

the independent decisions of hospital 

governing boards and medical staffs, we 

have no basis for a revision in this final 

rule. We point out, however, that our 

initial savings estimates were quite 

conservative when viewed against the 

potential ability of medical staffs to 

economize by delegation to nonphysician practitioners acting within 

the scope of the licenses already granted 

by many States. 

The most obvious example of this 

potential ability to economize by 

delegation would be the surgeon who 

uses the services of available hospital 

APRNs and PAs to see and provide postoperative care and management of his or 

her patients, freeing the surgeon to focus 

on procedures and surgeries in the 

operating room. The surgeon still leads 

the team, but this model allows for both 

the surgeon and the APRN or PA to 

practice to the full extent of their 

training and experience and to 

effectively manage their time regarding 

patient care, ultimately benefitting each 

patient in the process. Some hospitals 

have already realized that having a 

dedicated APRN/PA service available to 

physicians can reduce overall costs by 

allowing for the more effective 

management and care of most patients 

during their hospital stay, from 

admission through discharge. In 

listening to stakeholders, we realized 

that the revisions to the Medical staff 

CoP that we have finalized here are 

necessary to ensure that all hospitals 

have the opportunities for potential 

savings and improved patient care that 

we believe are likely. With some 

significant exceptions discussed earlier 

in this preamble, mainly focused on 

anesthesiology or on medical 

governance received from physicians, 

we received overwhelming support for 

these proposals. All major nonphysician stakeholder groups supported 

our reforms and the likely magnitude of 

savings. 

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. In this final 

rule, we are allowing 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 


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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, this would result in a 

reduction of 2,400,000 burden hours 

valued at $45 per hour for a savings of 

$108,000,000. The comments we 

received by nursing groups and other 

expert reviewers strongly supported our 

policy change and these overall 

estimates, though without providing any 

empirical support for the precise 

savings we estimated. 

Medical Record Services— 

Authentication and Standing Orders 

(§ 482.24) 

In this final rule, we are revising 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 also are making 

permanent the temporary provision (5- 

year sunset provision which expired in 

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 adding new provisions to 

allow hospitals to use pre-printed 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 

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. As discussed in the 

Information Collection section, 

comments overwhelmingly supported 

this reform and did not suggest specific 

changes in our estimates. 

Outpatient Services (§ 482.54) 

Allowing one or more individuals to 

be responsible for the supervision of 

outpatient services would permit large 

savings in this final rule. Under the 

existing CoP, 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 that potential. Based upon 

our experience with hospitals, we 

estimate 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 regardless of how 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. We 

received very few comments on this 

reform, but all of these supported the 

reform and agreed it would produce 

substantial savings. 

Transplant Organ Recovery (§ 482.92) 

We are removing the current blood 

typing requirement entirely. The 

elimination of this section removes 

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 are deleting 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 this finalized 

requirement, the OPO performs a 

verification before organ recovery and 

the transplant center surgeon performs a 

verification before the organ is 

transplanted. We are eliminating 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. Eliminating 


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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). 

Surgeons working for their own 

transplant centers conduct most organ 

recoveries for heart and lung 

transplants. 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. Based on 

our experience with transplant centers, 

we estimate that surgeons who are 

working for the transplant centers 

conduct 25 percent of kidney, liver and 

pancreas organ recoveries. 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. 

Several commenters pointed out that 

we would need to change our IG to 

surveyors to assure these savings. We 

agree, and will make the necessary 

changes. 

Infection Control Log (§ 484.42) 

We are eliminating a requirement for 

keeping a dedicated log of incidents 

related to infections and communicable 

diseases, and instead allowing hospitals 

flexibility in their approach to the 

tracking and surveillance of infections. 

We believe the changes we are finalizing 

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 

(that is., 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. Again, 

we received no comments suggesting 

that these savings could not be realized. 

CAH Provision of Services (§ 485.635) 

Our 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. This is an area where 

our savings may well be 

underestimated, based on the tenor of 

the comments we received. We did not, 

however, obtain suggestions for specific 

changes. 

5. Alternatives Considered 

From within the entire body of CoPs, 

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 final 

rule. 

For each requirement that we have 

deleted or modified, there were a 

number of possible options, including 

making no change, making the change 

we proposed, and in some but not all 

cases making some in-between change. 

There was 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 highperforming 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. 

Throughout the preamble to this final 

rule, we have identified ways to 

improve, avoid problems, or clarify the 

proposed reforms. Many of these 

improvements arose directly from 

public comments. While some of those 

changes are vital to realizing the reforms 

we proposed, most of the final rule 

changes required no substantial changes 

to our estimates of the potential 

reductions in regulatory burden. 

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 eliminated 

requirement contributed in any 

consequential way to patient safety. 

Thus, we are confident that the final 

rule yields net benefits. In this analysis, 

we provided some illustrative estimates 

to suggest the potential savings these 

reforms could achieve under certain 

assumptions. We appreciate that those 

assumptions are simplified, and that 

actual results could be substantially 

higher or lower. We have no basis for 

estimating the range of uncertainty with 

any precision. Moreover, in the set of 

calculations for each reform one 

assumption might be too high and 

another too low, with these offsetting 

effects leading to a similar overall 

saving even though each component of 

the calculation could be substantially 

higher or lower. Therefore, no one set of 

range estimates could capture the many 

uncertainties involved. We plan to 

evaluate these reforms over time, and 

welcome independent external 

evaluations of their effects by 

professional societies, individual 

hospitals, hospital associations, 

academics, and others. We are 

particularly interested in evidence as to 

actual savings in time and effort realized 

as hospitals implement the increased 

flexibility provided by 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. 


srobinson on DSK4SPTVN1PROD with RULES4
Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 29073 

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: 

Annualized Monetized reductions in Costs .............................................. ¥$940 

¥$940 

2012 

2012 

7% 

3% 

2012–16 

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. In addition, 

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 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 CoPs. 

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 final rule 

would not have a significant economic 

impact on a substantial number of small 

entities, and that a Final 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 

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 

$139 million. This final 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 final rule 

would not significantly affect the rights, 

roles, or responsibilities of the States. 

This final 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 received several 

comments on the Federalism analysis in 

the proposed rule and respond as 

follows. The problem facing States 

considering reforms in scope of practice 

and other laws was that our previous 

rules would in many areas have 

rendered useless State reforms, since we 

dictated stringent limits on nonphysician roles. By removing these 

unnecessary limits, we are enabling 

States to consider such reforms without 

Federal constraints that, while not 

legally preemptive, in practical effect 

would have nullified potential State 

reforms. We believe that some States are 

therefore likely to legislate reforms that 

would take advantage of this increased 

flexibility to reduce health care costs by 

allowing non-physician practitioners to 

utilize the full scope of their training 

and expertise. We support this 

increased flexibility for States to make 

reforms that they determine are 

professionally appropriate and reduce 

health care costs while protecting or 

improving patient care. 


srobinson on DSK4SPTVN1PROD with RULES4
29074 Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 

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 amends 42 CFR 

chapter IV as set forth below: 

PART 482—CONDITIONS OF 

PARTICIPATION FOR HOSPITALS 

■ 1. The authority citation for part 482 

continues to read as follows: 

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. The 

governing body (or the persons legally 

responsible for the conduct of the 

hospital and carrying out the functions 

specified in this part that pertain to the 

governing body) must include a 

member, or members, of the hospital’s 

medical staff. 

* * * * * 

■ 3. Section 482.13 is amended by — 

■ a. Revising paragraphs (g)(1) through 

(3). 

■ b. Adding paragraph (g)(4). 

The revisions and addition 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 record in an internal log or other 

system, the following information: 

(i) Any death that occurs while a 

patient is in such restraints. 

(ii) Any death that occurs within 24 

hours after a patient has been removed 

from such restraints. 

(3) The staff must document in the 

patient’s medical record the date and 

time the death was: 

(i) Reported to CMS for deaths 

described in paragraph (g)(1) of this 

section; or 

(ii) Recorded in the internal log or 

other system for deaths described in 

paragraph (g)(2) of this section. 

(4) For deaths described in paragraph 

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

internal 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, name of attending physician or 

other licensed independent practitioner 

who is responsible for the care of the 

patient as specified under § 482.12(c), 

medical record number, and primary 

diagnosis(es). 

(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 

revising paragraphs (a) introductory 

text, (a)(2), and (b)(3) to read as follows: 

§ 482.22 Condition of participation: 

Medical staff. 

* * * * * 

(a) Standard: Eligibility and process 

for appointment to medical staff. The 

medical staff must include doctors of 

medicine or osteopathy. In accordance 

with State law, including scope-ofpractice laws, the medical staff may also 

include other categories of nonphysician practitioners determined as 

eligible for appointment by the 

governing body. 

* * * * * 

(2) The medical staff must examine 

the credentials of all eligible candidates 

for medical staff membership and make 

recommendations to the governing body 

on the appointment of these candidates 

in accordance with State law, including 

scope-of-practice laws, and the medical 

staff bylaws, rules, and regulations. A 

candidate who has been recommended 

by the medical staff and who has been 

appointed by the governing body is 

subject to all medical staff bylaws, rules, 

and regulations, in addition to the 

requirements contained in this section. 

* * * * * 

(b) * * * 

(3) The responsibility for organization 

and conduct of the medical staff must be 

assigned only to one of the following: 

(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. 

(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 

revising paragraphs (b)(4) and (c) to 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 


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Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 29075 

orders of other practitioners not 

specified under § 482.12(c) only if such 

practitioners are acting in accordance 

with State law, including scope-ofpractice laws, hospital policies, and 

medical staff bylaws, rules, and 

regulations. 

(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, 

including scope-of-practice laws, 

hospital policies, and medical staff 

bylaws, rules, and regulations. 

(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) Ensure 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) Address the security of the 

medication(s) for each patient. 

(E) Document the administration of 

each medication, as reported by the 

patient (or the patient’s caregiver/ 

support person where appropriate), 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) Ensure 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) Address the security of the 

medication(s) for each patient. 

(E) Document the administration of 

each medication, as reported by the 

patient (or the patient’s caregiver/ 

support person where appropriate), in 

the patient’s medical record. 

■ 6. Section 482.24 is amended by— 

■ a. Removing paragraphs (c)(1)(i) 

through (iii). 

■ b. Redesignating (c)(2) as (c)(4). 

■ c. Adding a new paragraphs (c)(2) and 

(3). 

The 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 

by another practitioner who is 

responsible for the care of the patient 

only if such a practitioner is acting in 

accordance with State law, including 

scope-of-practice laws, hospital policies, 

and medical staff bylaws, rules, and 

regulations. 

(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 and 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 and the hospital’s 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 by another practitioner 

responsible for the care of the patient 

only if such a practitioner is acting in 

accordance with State law, including 

scope-of-practice laws, hospital policies, 

and medical staff bylaws, rules, and 

regulations. 

* * * * * 

■ 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 paragraphs (a) introductory text 

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, 


srobinson on DSK4SPTVN1PROD with RULES4
29076 Federal Register / Vol. 77, No. 95 / Wednesday, May 16, 2012 / Rules and Regulations 

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. In § 485.604, paragraph (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 in accordance 

with State nurse licensing laws and 

regulations; and 

(2) Holds a master’s or doctoral level 

degree in a defined clinical area of 

nursing from an accredited educational 

institution. 

* * * * * 

■ 14. In § 485.623, paragraph (a) is 

revised to read as follows: 

§ 485.623 Condition of participation: 

Physical plant and environment. 

(a) Standard: Construction. The CAH 

is constructed, arranged, and 

maintained to ensure access to and 

safety of patients, and provides 

adequate space for the provision of 

services. 

* * * * * 

■ 15. In § 485.635, paragraphs (a)(3)(i) 

and (b) are revised to read as follows: 

§ 485.635 Condition of participation: 

Provision of services. 

(a) * * * 

(3) * * * 

(i) A description of the services the 

CAH furnishes, including those 

furnished through agreement or 

arrangement. 

* * * * * 

(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 the 

following: 

(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. 

(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. 

* * * * * 

■ 16. 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: March 19, 2012. 

Marilyn Tavenner, 

Acting Administrator, Centers for Medicare 

& Medicaid Services. 

Approved: April 2, 2012. 

Kathleen Sebelius, 

Secretary, Department of Health and Human 

Services. 

[FR Doc. 2012–11548 Filed 5–10–12; 9:15 am] 

BILLING CODE 4120–01–P 


srobinson on DSK4SPTVN1PROD with RULES4