15266 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 

procurement organizations (OPOs), 

including multiple new outcome and 

process performance measures based on 

donor potential and other related factors 

in each service area of qualified OPOs. 

The proposed rule includes 

comprehensive conditions for coverage 

for OPOs that would replace the OPO 

existing conditions for coverage. The 

proposed rule contains multiple new 

technical, structural, and performance 

requirements, including new procedures 

for re-certification of OPOs and new 

outcome performance measures based 

on organ donor potential. Due to the 

large number of proposed new 

requirements and the technical nature of 

the proposed outcome performance 

measures, we are extending the 

comment period to ensure sufficient 

time for the public to review and 

comment on the proposed requirements. 

Therefore, we are extending the public 

comment period for an additional 60 

days, until June 6, 2005.

Authority: Sections 1102, 1138, and 1871 

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

1320b–g, and 1395hh) and section 371 of the 

Public Health Service Act (42 U.S.C. 273).

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program; No. 93.773 Medicare—Hospital 

Insurance Program; and No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

Dated: March 14, 2005. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: March 18, 2005. 

Michael O. Leavitt, 

Secretary.

[FR Doc. 05–5917 Filed 3–24–05; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF HEALTH AND 

HUMAN SERVICES 

Centers for Medicare & Medicaid 

Services 

42 CFR Part 482

[CMS–3122–P] 

RIN 0938–AM88

Medicare and Medicaid Programs; 

Hospital Conditions of Participation: 

Requirements for History and Physical 

Examinations; Authentication of Verbal 

Orders; Securing Medications; and 

Postanesthesia Evaluations

AGENCY: Centers for Medicare & 

Medicaid Services (CMS), DHHS

ACTION: Proposed rule.

SUMMARY: In this proposed rule, we 

propose revisions to four of the current 

hospital conditions of participation 

(CoPs) for approval or continued 

participation in the Medicare and 

Medicaid programs. We are proposing 

changes to the CoP requirements related 

to: Completion of a history and physical 

examination in the medical staff and the 

medical record services CoPs; 

authentication of verbal orders in the 

nursing service and the medical record 

services CoPs; securing medications in 

the pharmaceutical services CoP; and 

completion of the postanesthesia 

evaluation in the anesthesia services 

CoP. These proposals respond to 

concerns within the medical community 

that the current Medicare hospital CoPs 

are contrary to current practice and are 

unduly burdensome. The changes 

specified in this proposed rule are 

consistent with current medical practice 

and will reduce the regulatory burden 

on hospitals.

DATES: To be assured consideration, 

comments must be received at one of 

the addresses provided below, no later 

than 5 p.m. on May 24, 2005.

ADDRESSES: In commenting, please refer 

to file code CMS–3122–P. Because of 

staff and resource limitations, we cannot 

accept comments by facsimile (FAX) 

transmission. 

You may submit comments in one of 

three ways (no duplicates, please): 

1. Electronically. You may submit 

electronic comments on specific issues 

in this regulation to http://

www.cms.hhs.gov/regulations/

ecomments. (Attachments should be in 

Microsoft Word, WordPerfect, or Excel; 

however, we prefer Microsoft Word.) 

2. By mail. You may mail written 

comments (one original and two copies) 

to the following address ONLY: Centers 

for Medicare & Medicaid Services, 

Department of Health and Human 

Services, Attention: CMS–3122–P, P.O. 

Box 8010, Baltimore, MD 21244–8010. 

Please allow sufficient time for mailed 

comments to be received before the 

close of the comment period. 

3. By hand or courier. If you prefer, 

you may deliver (by hand or courier) 

your written comments (one original 

and two copies) before the close of the 

comment period to one of the following 

addresses. If you intend to deliver your 

comments to the Baltimore address, 

please call telephone number (410) 786–

9994 in advance to schedule your 

arrival with one of our staff members.

Room 445–G, Hubert H. Humphrey 

Building, 200 Independence Avenue, 

SW., Washington, DC 20201; or 7500 

Security Boulevard, Baltimore, MD 

21244–1850.

(Because access to the interior of the 

HHH Building is not readily available to 

persons without Federal Government 

identification, commenters are 

encouraged to leave their comments in 

the CMS drop slots located in the main 

lobby of the building. A stamp-in clock 

is available for persons wishing to retain 

a proof of filing by stamping in and 

retaining an extra copy of the comments 

being filed.)

Comments mailed to the addresses 

indicated as appropriate for hand or 

courier delivery may be delayed and 

received after the comment period. 

Submission of comments on 

paperwork requirements. You may 

submit comments on this document’s 

paperwork requirements by mailing 

your comments to the addresses 

provided at the end of the ‘‘Collection 

of Information Requirements’’ section in 

this document. 

For information on viewing public 

comments, see the beginning of the 

SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT:

Patricia Chmielewski, (410) 786–6899. 

Jeannie Miller, (410) 786–3164.

SUPPLEMENTARY INFORMATION:

Submitting Comments: We welcome 

comments from the public on all issues 

set forth in this rule to assist us in fully 

considering issues and developing 

policies. You can assist us by 

referencing the file code CMS–3122-P 

and the specific ‘‘issue identifier’’ that 

precedes the section on which you 

choose to comment. 

Inspection of Public Comments: All 

comments received before the close of 

the comment period are available for 

viewing by the public, including any 

personally identifiable or confidential 

business information that is included in 

a comment. After the close of the 

comment period, CMS posts all 

electronic comments received before the 

close of the comment period on its 

public website. Comments received 

timely will be available for public 

inspection as they are received, 

generally beginning approximately 3 

weeks after publication of a document, 

at the headquarters of the Centers for 

Medicare & Medicaid Services, 7500 

Security Boulevard, Baltimore, 

Maryland 21244, Monday through 

Friday of each week from 8:30 a.m. to 

4 p.m. To schedule an appointment to 

view public comments, (410) 786–9994. 

Copies: To order copies of the Federal 

Register containing this document, send 

your request to: New Orders, 

Superintendent of Documents, P.O. Box 

371954, Pittsburgh, PA 15250–7954. 

Specify the date of the issue requested 

and enclose a check or money order 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 15267

payable to the Superintendent of 

Documents, or enclose your Visa or 

Master Card number and expiration 

date. Credit card orders can also be 

placed by calling the order desk at (202) 

512–1800 (or toll-free at 1–888–293–

6498) or by faxing to (202) 512–2250. 

The cost for each copy is $10. As an 

alternative, you can view and 

photocopy the Federal Register

document at most libraries designated 

as Federal Depository Libraries and at 

many other public and academic 

libraries throughout the country that 

receive the Federal Register. 

This Federal Register document is 

also available from the Federal Register

online database through GPO Access, a 

service of the U.S. Government Printing 

Office. The web site address is: http://

www.gpoaccess.gov/fr/index.html.

I. Legislative and Regulatory 

Background 

A. General 

In the December 19, 1997 Federal 

Register (62 FR 66726), we published a 

proposed rule entitled ‘‘Medicare and 

Medicaid Programs; Hospital Conditions 

of Participation (CoPs); Provider 

Agreements and Supplier Approval’’

(HCFA–3745–P) which specified our 

proposal to comprehensively revise the 

entire set of hospital CoPs. The CoPs are 

the requirements that hospitals must 

meet to participate in the Medicare and 

Medicaid programs. The CoPs are 

intended to protect patient health and 

safety and to ensure that high quality 

care is provided to all patients. 

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

of the Act define the term ‘‘hospital’’

and list the requirements that a hospital 

must meet to be eligible for Medicare 

participation. Section 1861(e)(9) of the 

Act specifies that a hospital must also 

meet such other requirements as the 

Secretary of Health and Human Services 

(the Secretary) finds necessary in the 

interest of the health and safety of the 

hospital’s patients. Under this authority, 

the Secretary has established in 

regulations, at Part 482, the 

requirements that a hospital must meet 

to participate in the Medicare program.

Compliance is determined by State 

survey agencies (SAs) or accreditation 

organizations. The SAs, in accordance 

with section 1864 of the Social Security 

Act (the Act), survey hospitals to assess 

compliance with the CoPs. The SAs 

conduct surveys using the State 

Operations Manual (SOM) (Centers for 

Medicare & Medicaid Services (CMS) 

Publication No. 7). The SOM contains 

the regulatory language of the CoPs as 

well as interpretive guidelines and 

survey procedures that give guidance on 

how to assess provider compliance. 

Under § 489.10(d), the SAs determine 

whether a hospital meets the CoPs and 

make corresponding recommendations 

to us about a hospital’s certification, 

(that is, whether a hospital has met the 

standards required to provide Medicare 

and Medicaid services and receive 

Federal and State reimbursement). 

Under section 1865 of the Act, 

hospitals that are accredited by the Joint 

Commission on the Accreditation of 

Healthcare Organizations (JCAHO), the 

American Osteopathic Association 

(AOA), and other national accreditation 

programs approved by us are deemed to 

meet the requirements in the CoPs. 

Therefore, accredited hospitals are not 

routinely surveyed by SAs for 

compliance with the CoPs but are 

deemed to meet most of the hospital 

CoPs based on their accreditation. (See 

42 CFR Part 488, ‘‘Survey Certification, 

and Enforcement Procedures’’). 

However, all Medicare- and Medicaidparticipating hospitals are required to be 

in compliance with our CoPs regardless 

of their accreditation status. 

B. Finalizing Provisions of the December 

19, 1997 Proposed Rule (HCFA–3745–P) 

In the December 19, 1997 proposed 

rule, we proposed to revise all CoPs 

specified in Part 482. While our initial 

intention was to finalize the December 

19, 1997 proposed rule in its entirety, 

delays within CMS, (then the Health 

Care Financing Administration (HCFA)) 

led us to re-evaluate this objective in 

light of concerns expressed by providers 

that we move forward with certain final 

rules in the interest of public health and 

safety. Our strategy to address CoPs 

deemed of particular urgency by 

providers was to finalize or ‘‘carve-out’’

specific CoPs as separate final rules. To 

date, we have finalized the following 

hospital CoPs: Organ, Tissue and Eye 

Procurement CoP (see the June 22, 1998 

Federal Register, 63 FR 33856); 

Patients’ Rights (see the July 2, 1999 

Federal Register, 64 FR 36069); 

Anesthesia Services—CRNA 

supervision (see the November 13, 2001 

Federal Register, 66 FR 56762); Fire 

Safety Requirements for Certain Health 

Care Facilities (see the January 10, 2003 

Federal Register, 68 FR 1374); and, 

Quality Assessment Performance 

Improvement (see the January 24, 2003 

Federal Register, 68 FR 3435). 

Beginning in 2003, we began to 

develop a final rule to address public 

comments provided on the December 

19, 1997 proposed rule for the following 

four requirements: (1) Completion of a 

history and physical examination in the 

medical staff and the medical record 

services CoPs; (2) authentication of 

verbal orders in the nursing service and 

the medical record services CoPs; (3) 

securing medications in the 

pharmaceutical services CoP; and (4) 

completion of the postanesthesia 

evaluation in the anesthesia services 

CoP. 

Our decision to carve out these four 

requirements has evolved in large 

measure as a result of our continuing 

dialogue with the health care 

community. Through various CMSsponsored provider forums such as the 

Physicians’ Regulatory Issues Team 

(PRIT) (a team of subject matter experts 

who work within the government to 

reduce the regulatory burden on 

Medicare participating physicians), our 

open door forums, and written 

correspondence by a variety of 

organizations and individuals, we were 

made aware that providers 

overwhelmingly believe that the 

existing regulations for these 

requirements no longer reflect current 

health care practice. In addition, public 

comments received on the December 19, 

1997 proposed rule strongly supported 

the revisions we proposed for these 

selected CoPs. 

C. Changes as a Result of the Enactment 

of the Medicare Prescription Drug, 

Improvement, and Modernization Act of 

2003 (MMA) 

On December 8, 2003, the Medicare 

Prescription Drug, Improvement, and 

Modernization Act of 2003 (MMA) was 

enacted. Section 902(a) of the MMA 

specifies that the Secretary, in 

consultation with the Director of the 

Office of Management and Budget 

(OMB), is required to establish and 

publish a regular timeline for the 

publication of final regulations based on 

the previous publication of a proposed 

regulation or an interim final regulation. 

Section 902 further provides that the 

timeline may vary among different 

regulations, but shall not be longer than 

3 years except under exceptional 

circumstances.

Although we do not believe that this 

law operates retroactively, out of an 

abundance of caution, we are applying 

the provisions of section 902(a) of the 

MMA to this rule since our publication 

of the December 19, 1997 rule was not 

finalized. Had section 902(a) of MMA 

not been enacted, the CoP provisions 

stipulated in this proposed rule would 

have been stipulated in a final 

regulation. However, with the passage of 

section 902 of the MMA, we believe it 

is in the spirit of the legislation to 

publish a new proposed regulation. 

15268 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 

II. Provisions of This Proposed Rule 

A. Overview 

In the interest of public health and 

safety, we propose changing the current 

requirements for completion of the 

initial inpatient medical history and 

physical examination, authentication of 

verbal orders, securing of medications, 

and completion of a postanesthesia 

evaluation within the hospital CoPs. 

This proposed rule responds to the 

health care community’s primary 

concern that the current regulations are 

contrary to current health care practice 

and unduly burdensome. In order to be 

consistent with current health care 

practice, reduce regulatory burdens, and 

ensure patient safety, we are proposing 

to revise aspects of the current medical 

staff, nursing services, medical record 

services, pharmaceutical services, and 

anesthesia services CoPs. 

We have developed this proposed rule 

taking into consideration comments 

received in response to the December 

19, 1997 proposed rule as well as 

ongoing concerns expressed by the 

health care community since 1998 via 

the following public forums: Physicians’

Regulatory Issues Team, (PRIT), our 

open door forums, written 

correspondence, and general questions. 

It is our intent to finalize this proposed 

rule within the 3-year publication 

timeframe specified in the MMA. 

1. Completion of the Medical History 

and Physical Examination 

The current medical history and 

physical examination requirement has 

been an ongoing focus and point of 

contention for the American Medical 

Association (AMA) and the American 

Podiatric Medical Association, Inc. 

(APMA). The current regulatory 

requirement states that a physical 

examination and medical history be 

done no more than 7 days before or 48 

hours after an admission for each 

patient by a doctor of medicine or 

osteopathy, or, for patients admitted 

only for oromaxillofacial surgery, by an 

oromaxillofacial surgeon who has been 

granted such privileges by the medical 

staff in accordance with State law. 

These professional groups continue to 

challenge the timeframe for completion 

of the medical history and physical 

examination, as well as who is 

permitted to complete the history and 

physical examination. Questions have 

intensified as a result of the JCAHO’s 

revised standard that states a history 

and physical examination performed 

within 30 days before admission may be 

used in the patient’s medical record, 

provided any changes in the patient’s 

condition are documented in the 

medical record at the time of admission. 

We believe that expanding the current 

requirement for completion of a medical 

history and physical examination from 

no more than 7 days before admission 

to within 30 days before admission 

supports safe patient care as long as the 

hospital ensures documentation of the 

patient’s current condition in the 

medical record within 24 hours after 

admission. 

On January 28, 2002, our Survey and 

Certification Group issued a 

memorandum (referenced as S&C–02–

15) to the Associate Regional 

Administrators and State Survey 

Agency Directors addressing our 

position on hospital admission and 

presurgical history and physical 

examination requirements and the 

timing of the history and physical 

examination for hospital admissions. (A 

copy of the memorandum can be found 

on our Web site at http://

www.cms.hhs.gov/medicaid/surveycert/012802.asp). This proposed rule 

would codify the guidance provided in 

the January 28, 2002 memorandum, and 

published in the June 2003 issue of the 

Open Door Forum Newsletter. 

In addition, we have received 

communications from the President of 

APMA and other podiatrists regarding 

their concerns that doctors of podiatric 

medicine are currently not permitted to 

perform a history and physical 

examination. This proposed rule 

addresses this concern as well. 

We propose to revise the current 

medical staff requirement at 

§ 482.22(c)(5) to specify that a medical 

history and physical examination must 

be completed no more than 30 days 

before or 24 hours after admission for 

each patient by a physician (as defined 

in section 1861(r) of the Act) or other 

qualified individual who has been 

granted these privileges by the medical 

staff in accordance with State law, and 

that the medical history and physical 

examination must be placed in the 

medical record within 24 hours after 

admission. We also propose revising the 

current Medical Records CoP at 

§ 482.24(c)(2)(i) to reflect that a medical 

history and physical examination must 

be completed no more than 30 days 

before or 24 hours after admission, and 

placed in the patient’s medical record 

within 24 hours after admission. We 

also propose revising § 482.22(c)(5) and 

§ 482.24(c)(2)(i) to require that when a 

medical history and physical 

examination is completed within the 30 

days before admission, the hospital 

must ensure that an updated medical 

record entry documenting an 

examination for any changes in the 

patient’s current condition is 

completed. This updated examination 

must be completed and documented in 

the patient’s medical record within 24 

hours after admission. 

2. Authentication of Verbal Orders 

In the December 19, 1997 proposed 

rule, we solicited comments on 

authentication of medical record entries. 

Many in the hospital industry supported 

modifying and even eliminating the 

requirement. Many commenters 

believed that authentication does not 

add value to the quality of the medical 

record, especially after the service has 

been delivered or after the patient has 

been discharged. Other commenters 

believed that the absence of 

authentication leads to questions of 

accountability. In a related issue, we 

also solicited comments on the issue of 

whether a timeframe should be 

specified for signing verbal orders. 

Current requirements at 

§ 482.23(c)(2)(ii) state that verbal orders 

for the administration of drugs or 

biologicals must be signed or initialed 

by the prescribing practitioner as soon 

as possible.

A key CMS goal is to protect the 

health and safety of patients. We believe 

that an authentication requirement is 

necessary to protect the health and 

safety of patients. Unless all medical 

record entries are authenticated, patient 

safety, quality of care, accountability 

and integrity of the patient medical 

record are comprised. 

When a medical record entry is 

authenticated, the person authenticating 

the entry is assuming accountability for 

a service provided and verifying that the 

entry is complete and accurate. The 

authentication requirements decrease 

the risk of errors that could jeopardize 

a patient’s health and safety by ensuring 

that all medical record entries, 

including verbal orders, are 

communicated and documented 

completely and accurately. The current 

regulations use the terms ‘‘telephone 

orders’’ and ‘‘oral orders.’’ For the 

purposes of this proposed rule, the term 

‘‘verbal orders’’ is used to encompass 

both telephone and oral orders. 

Authentication requirements enhance 

the accountability of a practitioner for 

verbal orders. Accountability means that 

the person who signed the entry is 

responsible for the care of the patient, 

and has verified that the order has been 

recorded completely and accurately. It 

does not mean that the person who 

authenticates a verbal order is 

necessarily the person who gave it. 

Authentication requirements also 

protect practitioners carrying out verbal 

orders by preventing those giving the 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 15269

orders from later denying that the order 

was made. 

Hospitals and practitioners perceive 

our current requirement that the 

prescribing practitioner must 

authenticate verbal orders as soon as 

possible as unnecessarily burdensome. 

We continue to receive questions from 

hospitals about authentication of verbal 

orders when the prescribing practitioner 

is not available (for example, the 

prescribing practitioner gives a verbal 

order, and then is ‘‘off duty’’ for a 

weekend or an extended period of time). 

The current regulation does not address 

the ability of a covering practitioner to 

authenticate a verbal order for the 

prescribing practitioner. 

Based on discussions with the health 

care community concerning 

authentication and verbal orders, we are 

proposing a temporary exception to the 

authentication requirement, which will 

provide hospitals with flexibility while 

still maintaining an appropriate level of 

accountability. 

We propose to retain and revise the 

current requirement for authentication 

of medical record entries at 

§ 482.24(c)(1). This proposed provision 

states that all patient record entries 

must be legible, complete, dated, timed 

and authenticated in written or 

electronic form by whomever is 

responsible for providing or evaluating 

a service provided. Additionally, we 

would retain the current requirement 

that all orders, including verbal orders, 

must be dated, timed, and authenticated 

promptly by the prescribing 

practitioner, with the exception being 

that from the effective date of the final 

rule, to 5 years following the effective 

date of the final rule, all orders, 

including verbal orders, must be dated, 

timed, and authenticated promptly by 

the prescribing 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, even if the order did not 

originate with him or her. 

We believe this temporary revision to 

the authentication requirement will 

maintain an appropriate level of 

accountability while providing hospitals 

with flexibility until the advancement of 

health information technology is 

sufficient to allow the originating 

physician to authenticate his or her own 

orders in an efficient manner. Prior to 

the conclusion of the 5-year period, we 

will reevaluate this requirement, taking 

into account the advancement of health 

information technology.

We frequently receive questions about 

the timeframe for authentication of 

verbal orders and how we define ‘‘as 

soon as possible.’’ Some States have 

laws requiring authentication of verbal 

orders within 24 to 48 hours. Other 

State laws, however, do not address 

timeframes for authentication of verbal 

orders at all, and they defer to hospital 

policy. There is no consistency on this 

issue in the absence of a Federal 

requirement. Therefore, we propose 

revising § 482.24(c)(1)(iii) to require that 

all verbal orders must be authenticated 

based upon Federal and State law. We 

further propose that if there is no State 

law that designates a specific timeframe 

for authentication of verbal orders, then 

verbal orders must be authenticated 

within 48 hours. We invite public 

comment on this proposed approach to 

the timeframe for authentication of 

verbal orders. Hospitals would no 

longer be burdened by the requirement 

that verbal orders must be signed by the 

practitioner who gave the order. Any 

practitioner responsible for the care of 

the patient who is authorized by 

hospital policy and permitted by State 

law to independently write a specific 

order would be permitted to 

authenticate a verbal order, even if the 

order did not originate with him or her. 

In the interest of public health and 

safety, the proposed requirement would 

also establish a consistent timeframe for 

the authentication of verbal orders when 

State law does not specify a timeframe 

for such orders. 

We also propose to revise related 

nursing service requirements at 

§ 482.23(c)(2) that address 

documentation of orders for drugs and 

biologicals. We propose that 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 be 

documented and signed by a 

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. This proposed 

requirement would provide hospitals, in 

conjunction with their medical staff, the 

ability to determine who may 

authenticate verbal orders for whom, as 

well as identify and implement systems 

and processes that meet the safety needs 

of their patient population. 

As stated earlier, authentication 

requirements serve to protect 

practitioners carrying out verbal orders 

by preventing those giving the orders 

from later denying that the order was 

made. However, we are requesting 

comments on whether there are 

recurring problems with prescribing 

practitioners denying that they gave a 

verbal order after the verbal order was 

carried out. We are also requesting 

public comment on the perceived 

impact of this proposed rule on this 

potential issue. We expect that a 

hospital’s governing body and 

administration would address any 

issues through the hospital’s Quality 

Assessment and Performance 

Improvement Program and credentialing 

process. 

We propose retaining the current 

requirements at § 482.23(c)(2)(iii) that 

state that verbal orders are to be used 

infrequently. The use of verbal orders 

should not be a common practice. 

Verbal orders should be used only to 

meet the urgent care needs of the patient 

when it is not feasible for the ordering 

practitioner to immediately 

communicate the order in written or 

electronic form. Verbal orders are not to 

be used for the convenience of the 

ordering practitioner. We also propose 

retaining the current requirement that 

when verbal orders are used, they must 

only be accepted by persons that are 

authorized to do so by hospital policies 

and procedures, consistent with State 

and Federal law. 

3. Securing Medications 

We have had ongoing dialogue with 

the American Society of 

Anesthesiologists (ASA) and the JCAHO 

regarding the current requirement that 

all drugs and biologicals be kept in a 

locked storage area. The dialogue has 

centered on locked anesthesia carts in 

the operative suite. Anesthesiologists 

take issue with the fact that anesthesia 

carts containing non-controlled drugs 

must be kept locked or under constant 

observation inside a secure operative 

suite. Anesthesiologists contend that it 

is standard practice for the 

anesthesiologist to set up an anesthesia 

cart in advance preparation for use in 

the operative suite. They contend that 

the same is true for epidural carts in a 

labor and delivery suite. This practice is 

supported by the ASA. (See the ASA 

Position Statement approved by the 

ASA Executive Committee, October 

2003, entitled ‘‘Security of Medications 

in the Operating Room.’’)

We have also had ongoing dialogue 

with the JCAHO and have received 

numerous questions from the healthcare 

community regarding patient selfadministration of medications. It is 

current practice for hospitals to give 

patients access to urgently needed 

drugs, such as nitroglycerine tablets and 

inhalers, at the bedside. It is also current 

practice to place selected 

nonprescription medications at the 

bedside for the patient’s use (for 

example, lotions and creams, rewetting 

15270 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 

eye drops.) Hospitals have also 

developed formalized patient 

medication self-administration 

programs for select populations of 

patients in collaboration with the 

medical staff, nursing, and pharmacy 

that include the development of the 

necessary hospital policies and 

procedures to ensure patient safety and 

security of medications. The current 

hospital CoPs do not contemplate 

medications at the patient’s bedside as 

the current requirement mandates that 

all medications be in locked storage. 

Therefore, we propose to revise the 

provision at § 482.25(b)(2) to require 

that all drugs and biologicals be kept in 

a secure area, and locked when 

appropriate. We propose that drugs 

listed in Schedules II, III, IV, and V of 

the Comprehensive Drug Abuse 

Prevention and Control Act of 1970 

must be kept locked within a secure 

area. We further propose that only 

authorized personnel may have access 

to locked areas. We believe this 

addresses the identified issues, affords 

hospitals flexibility in implementation, 

and is more patient-focused and 

outcome oriented than the current 

requirements. 

We do not expect the proposed 

revision to alter the appropriate safety 

mechanisms that hospitals use to 

control medications and ensure the 

health and safety of its patients. All 

controlled substances need to be 

securely locked. These drugs must be 

tightly controlled and accounted for as 

required by Federal law and regulations. 

Non-controlled drugs, however, do not 

necessarily need to be locked. They may 

be secured, and locked when 

appropriate, to prevent diversion or 

tampering with the medications. A 

medication is considered secure if 

unauthorized persons are prevented 

from obtaining access. Medications 

should not be stored in areas that are 

readily accessible to unauthorized 

persons. For example, medications left 

in an unlocked drawer in a patient 

waiting area or patient examination 

room would not be considered secure. 

However, if medications are kept in a 

private office, or other area where 

patients and visitors are not allowed 

without the supervision or presence of 

a health care professional (for example, 

procedure room), they are considered 

secure, even if not locked. Areas 

restricted to authorized personnel only 

would generally be considered ‘‘secure’’

areas. If medication security becomes a 

problem, the hospital is expected to 

evaluate its current medication control 

policies and procedures, and implement 

the necessary systems and processes to 

ensure that the problem is corrected and 

that patient health and safety are 

maintained. 

4. Completion of the Postanesthesia 

Evaluation

The medical community has 

repeatedly requested that we modify the 

current hospital anesthesia regulation 

that requires the individual who 

administers the anesthesia to write the 

follow up report. The medical 

community requested that CMS allow 

the postanesthesia report to be written 

by an individual qualified to administer 

anesthesia. This issue has been 

identified as particularly important by 

the PRIT, open door forums participants 

and through general questions 

submitted to CMS. Discussions with the 

health care community continue to 

indicate that the current postanesthesia 

evaluation requirement at § 482.52(b)(3) 

is: (1) Not consistent with the current 

preanesthesia evaluation requirement; 

(2) not reflective of current practice; and 

(3) an unnecessary burden for hospitals 

and practitioners that provide 

anesthesia. This requirement has also 

been a priority issue for the American 

Medical Association (AMA). These 

ongoing discussions have served as the 

impetus for us to propose revisions to 

this requirement in the current 

anesthesia services CoP. The proposed 

revision of this regulation would be 

consistent with the current regulation at 

§ 482.52(b)(1) addressing preanesthesia 

reports. This requirement states, ‘‘A 

preanesthesia evaluation by an 

individual qualified to administer 

anesthesia under paragraph (a) of this 

section performed within 48 hours prior 

to surgery.’’ Implementation of the 

proposed change allowing the 

postanesthesia evaluation report to be 

written by an individual qualified to 

administer anesthesia would give 

hospitals greater flexibility in meeting 

the needs of patients and impose less 

burden than the current requirement. 

B. Summary of the Proposed Rule 

Condition of Participation: Medical Staff 

(§ 482.22) 

Section 482.22(c)(5) 

This proposed requirement would 

expand the timeframe for completion of 

the patient’s medical history and 

physical examination and would 

expand the number of permissible 

professional categories of individuals 

who may perform the medical history 

and physical examination. It would 

require that each patient receive a 

medical history and physical 

examination, to be completed no more 

than 30 days before or 24 hours after 

admission, and placed in the patient’s 

medical record within 24 hours after 

admission. A physician (as defined in 

section 1861(r) of the Act), or other 

qualified individual who has been 

granted these privileges by the medical 

staff in accordance with State law, could 

complete the medical history and 

physical examination. In addition, when 

a medical history and physical 

examination is completed within the 30 

days before admission, the hospital 

would be required to ensure that an 

updated medical record entry 

documenting an examination for any 

changes in the patient’s current 

condition is completed. This updated 

examination would be completed and 

documented in the patient’s medical 

record within 24 hours after admission. 

Condition of Participation: Nursing 

Services (§ 482.23) 

Section 482.23(c)(2) 

This proposed requirement would 

clarify that 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 would be documented and 

signed by a practitioner who is 

responsible for the care of the patient as 

specified under § 482.12(c) and 

authorized to write these orders by 

hospital policy in accordance with State 

law. 

Section 482.23(c)(2)(i) and (c)(2)(ii) 

This proposed requirement would 

reinforce the current regulations that 

verbal orders are to be used 

infrequently, and, when used, be 

accepted only by persons authorized by 

hospital policy and procedures 

consistent with Federal and State law.

Condition of Participation: Medical 

Record Services (§ 482.24) 

Section 482.24(c)(1)

This proposed requirement would 

maintain and reinforce the current 

regulation for authentication of all 

medical record entries. It would require 

that all patient medical record entries be 

legible, complete, dated, timed, and 

authenticated in written or electronic 

form by the person responsible for 

providing or evaluating a service 

provided. 

Section 482.24(c)(1)(i) 

This proposed provision would 

require that all orders, including verbal 

orders, be dated, timed, and 

authenticated promptly by the 

prescribing practitioner, except as noted 

in subsection (ii). 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 15271

Section 482.24(c)(1)(ii) 

This proposed provision would 

permit a temporary exception to the 

requirement that all orders, including 

verbal orders, be dated, timed, and 

authenticated promptly by the 

prescribing practitioner. For a period of 

5 years beginning with the effective date 

of the final rule, verbal orders would not 

need to be signed by the prescribing 

practitioner but could be authenticated 

by another practitioner responsible for 

the care of the patient. We believe this 

requirement would reduce burden and 

provide flexibility and clarity for 

hospitals in meeting the requirements 

for authentication of verbal orders. 

Section 482.24(c)(1)(iii) 

This proposed provision would 

specify that all verbal orders be 

authenticated based on Federal and 

State law. If there were no State law that 

designates a specific timeframe for the 

authentication of verbal orders, then 

verbal orders would need to be 

authenticated within 48 hours. 

In addition, a consistent timeframe for 

authentication of verbal orders would be 

established to ensure patient health and 

safety when State law does not 

designate a specific timeframe for the 

authentication of verbal orders and 

defers to hospital policy. 

Section 482.24(c)(2)(i) and (c)(2)(ii) 

The proposed requirements would be 

revised to be consistent with the 

changes in the Medical staff CoP. These 

regulations specify documentation 

requirements for medical history and 

physical examinations. The two 

proposed provisions would require 

evidence of the following: (1) A medical 

history and physical examination 

completed no more than 30 days before 

or 24 hours after admission. The 

medical history and physical must be 

placed in the patient’s medical record 

within 24 hours after admission; (2) an 

updated medical record entry 

documenting an examination for any 

changes in the patient’s condition when 

the medical history and physical 

examination was completed within 30 

days before admission. This updated 

examination would need to be 

completed and documented in the 

patient’s medical record within 24 

hours after admission. 

Condition of Participation: 

Pharmaceutical Services (§ 482.25) 

Section 482.25(b)(2)(i) 

This proposed provision would 

specify that all drugs and biologicals be 

kept in secure areas, and locked when 

appropriate. 

Section 482.25(b)(2)(ii) 

This proposed provision would 

require that scheduled drugs (II, III, IV, 

and V), as outlined in the 

Comprehensive Drug Abuse Prevention 

and Control Act of 1970, must be locked 

within a secure area. 

Section 482.25(b)(2)(iii) 

This proposed requirement states that 

only authorized personnel would have 

access to locked areas. 

Condition of Participation: Anesthesia 

Services (§ 482.52) 

Section 482.52(b)(3) 

This proposed requirement would 

permit the postanesthesia evaluation for 

inpatients to be completed and 

documented by any individual qualified 

to administer anesthesia. 

Implementation of this standard would 

give hospitals greater flexibility in 

meeting the needs of patients and 

decrease hospital and practitioner 

burden. 

III. Collection of Information 

Requirements 

Under the Paperwork Reduction Act 

(PRA) 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 PRA 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.

Therefore, we are soliciting public 

comments on each of these issues for 

the information collection requirements 

discussed below. 

The following information collection 

requirements and associated burdens 

are subject to the PRA. 

Condition of Participation: Medical 

Staff (§ 482.22) 

Paragraph (c) requires that a hospital 

have bylaws that include specified 

information. This proposed rule would 

revise some of the contents required in 

the bylaws. 

The burden associated with these 

proposed requirements is the time spent 

by the hospital to revise their bylaws. 

We believe that this proposed 

requirement reflects customary and 

usual business practice. Thus, the 

burden is not subject to the PRA in 

accordance with section 1320.3(b)(2). In 

addition, we estimate that there are 

fewer than 10 new hospitals per year 

that would have to comply, on a onetime basis, with this requirement. 

Information collection requirements 

affecting fewer that 10 entities are 

exempt from the PRA. 

Condition of Participation: Nursing 

Services (§ 482.23) 

Proposed paragraph (c) of this section 

would require 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 be documented and signed 

by a practitioner who is responsible for 

the care of the patient and authorized to 

write orders by hospital policy in 

accordance with State law. 

The burden associated with these 

proposed requirements is the time spent 

by the practitioner in documenting and 

signing orders. We believe that these 

proposed requirements reflect 

customary and usual business and 

medical practice. Thus, the burden is 

not subject to the PRA in accordance 

with section 1320.3(b)(2). 

Condition of Participation: Medical 

Record Services (§ 482.24) 

Proposed paragraph (c) of this section 

would require that all patient medical 

record entries be legible, complete, 

dated, timed and authenticated in 

written or electronic form by the person 

responsible for providing or evaluating 

the service provided. 

All orders, including verbal orders, 

would have to be dated, timed, and 

authenticated promptly by the 

prescribing practitioner, except for a 5-

year period of time beginning with the 

effective date of the final rule. During 

this 5-year time period, all orders, 

including verbal orders must be dated, 

timed and authenticated promptly by a 

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. This exception is time 

limited in anticipation that the 

advancement of health information 

technology will facilitate a prescribing 

practitioner authenticating his or her 

own orders.

15272 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 

Verbal orders would be required to be 

authenticated based upon Federal and 

State law. If there were no State law that 

designated a specific timeframe for the 

authentication of verbal orders, then 

verbal orders would need to be 

authenticated within 48 hours. Records 

must include evidence of a medical 

history and physical examination 

completed no more than 30 days before 

or 24 hours after admission, and placed 

in the patient’s medical record within 

24 hours after admission. When the 

medical history and physical 

examination are completed within 30 

days before admission, the hospital 

must ensure that documentation of an 

examination of the patient’s current 

condition is placed in the medical 

record within 24 hours after admission. 

The burden associated with these 

proposed requirements would be the 

time spent in signing and dating 

medical record entries and in placing 

evidence of a history and physical 

examination in the patient’s records. We 

believe that these requirements reflect 

customary and usual business and 

medical practice. Thus, the burden is 

not subject to the PRA in accordance 

with section 1320.3(b)(2). 

Condition of Participation: Anesthesia 

Services (§ 482.52) 

Under proposed paragraph (b)(3) of 

this section, with respect to inpatients, 

a postanesthesia evaluation is to be 

completed and documented by an 

individual qualified to administer 

anesthesia within 48 hours after surgery. 

The burden associated with these 

proposed requirements would be the 

time spent in documenting the 

evaluation. We believe that these 

requirements reflect customary and 

usual medical practice. Thus, the 

burden is not subject to the PRA in 

accordance with section 1320.3(b)(2). 

We have submitted a copy of this 

proposed rule to OMB for its review of 

the proposed information collection 

requirements described above. These 

requirements are not effective until they 

have been approved by OMB. 

If you comment on any of these 

information collection and record 

keeping requirements, please mail 

copies directly to the following:

Centers for Medicare & Medicaid 

Services, Office of Strategic 

Operations and Regulatory Affairs, 

Regulations Development and 

Issuances Group, Attn: Jim Wickliffe, 

CMS–3122–P Room C5–14–03, 7500 

Security Boulevard, Baltimore, MD 

21244–1850; and 

Office of Information and Regulatory 

Affairs, Office of Management and 

Budget, Room 10235, New Executive 

Office Building, Washington, DC 

20503, Attn: Christopher Martin, CMS 

Desk Officer, CMS–3122–P, 

Christopher_Martin@omb.eop.gov Fax 

(202) 395–6974. 

IV. Response to Comments 

Based on the large number of public 

comments we normally receive on 

Federal Register documents, we are not 

able to acknowledge or respond to them 

individually. We will consider all 

comments we receive by the date and 

time specified in the DATES section of 

this preamble, and, when we proceed 

with a subsequent document, we will 

respond to the comments in the 

preamble to that document. 

V. Regulatory Impact Statement 

We have examined the impact of this 

proposed rule as required by Executive 

Order 12866 (September 1993, 

Regulatory Planning and Review), the 

Regulatory Flexibility Act (RFA) 

(September 19, 1980, Pub. L. 96–354), 

section 1102(b) of the Social Security 

Act, the Unfunded Mandates Reform 

Act of 1995 (Pub. L. 104–4), and 

Executive Order 13132.

Executive Order 12866 directs 

agencies to assess all costs and benefits 

of available regulatory alternatives and, 

if regulation is necessary, to select 

regulatory approaches that maximize 

net benefits (including potential 

economic, environmental, public health 

and safety effects, distributive impacts, 

and equity). A regulatory impact 

analysis (RIA) must be prepared for 

major rules with economically 

significant effects ($100 million or more 

in costs/savings any one year). This 

proposed rule would impose minimal 

additional costs on hospitals. In fact, 

hospitals may realize some minimal cost 

savings. We believe the cost of 

implementing these provisions borne by 

hospitals would be limited to a one time 

cost associated with completing minor 

revisions to portions of the medical staff 

bylaws, and policies and procedures 

related to the requirements for history 

and physical examinations, 

authentication of verbal orders, securing 

medications, and postanesthesia 

evaluations, as well as communicating 

these changes to affected staff. The 

changes contained within this proposed 

rule are consistent with current practice, 

would decrease existing burden, and 

would provide hospitals with more 

flexibility in meeting CoP requirements. 

Although we believe that 

implementation of this proposed rule 

will result in greater efficiencies for 

hospitals, we do not believe that the 

proposed changes will result in 

significant savings near the $100 million 

threshold. We believe these benefits will 

offset the implementation costs that a 

hospital would incur, and, therefore, be 

budget neutral. Therefore, we have 

determined that it is not considered a 

major rule and no RIA is required. There 

are no proposed requirements for 

hospitals to initiate new processes of 

care, reporting, or increases in the 

amount of time spent providing or 

documenting patient care services. 

However, we lack data to quantify the 

effects of this proposed rule. We invite 

public comment on the impact on 

hospitals and practitioners. The RFA 

requires agencies to analyze options for 

regulatory relief of small entities. For 

purposes of the RFA, small entities 

include small businesses, nonprofit 

organizations, and government 

jurisdictions. Most hospitals and most 

other providers and suppliers are small 

entities, either by nonprofit status or by 

having receipts of $6 million to $29 

million or less annually (65 FR 69432). 

For purposes of the RFA, all hospitals 

are considered to be small entities. 

However, the nature of this proposed 

rule is such that no additional 

regulatory burden will be placed upon 

hospitals. Instead, burden would be 

decreased for hospitals by this proposed 

regulation. Therefore, no regulatory 

relief options are considered. 

In addition, section 1102(b) of the Act 

requires us to prepare a regulatory 

impact analysis if a rule may have a 

significant impact on the operations of 

a substantial number of small rural 

hospitals. This analysis must conform to 

the provisions of section 603 of the 

RFA. For purposes of section 1102(b) of 

the Act, we define a small rural hospital 

as a hospital that is located outside of 

a Metropolitan Statistical Area and has 

fewer than 100 beds. We do not 

anticipate that the operations of a 

substantial number of small rural 

hospitals will be significantly impacted. 

We are not preparing analyses for 

either the RFA or section 1102(b) of the 

Act because we have determined that 

this proposed rule would not have a 

significant economic impact on a 

substantial number of small entities or 

a significant impact on the operations of 

a substantial number of small rural 

hospitals. However, we lack data to 

quantify the effects of this proposed rule 

on small entities or small rural 

hospitals. We invite public comment on 

the impact of this proposed rule on 

small entities and small rural hospitals. 

Section 202 of the Unfunded Mandates 

Reform Act of 1995 also requires that 

agencies assess anticipated costs and 

benefits before issuing any rule that may 

result in an expenditure in any 1 year 

by State, local, or tribal governments, in 

Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 15273

the aggregate, or by the private sector, 

that exceeds the inflation adjusted 

threshold of $110 million. This 

proposed rule would place no 

additional burden for implementation 

on State, local, or tribal governments or 

on the private sector. 

Executive Order 13132 establishes 

certain requirements that an agency 

must meet when it promulgates a 

proposed rule (and subsequent final 

rule) that imposes substantial direct 

requirement costs on State and local 

governments, preempts State law, or 

otherwise has Federalism implications. 

We have examined this proposed rule 

and have determined that it would not 

have a negative impact on the rights, 

rules, and responsibilities of State, local 

or tribal governments. 

In accordance with the provisions of 

Executive Order 12866, the Office of 

Management and Budget reviewed this 

proposed rule.

List of Subjects in 42 CFR Part 482

Grant programs—health, Hospitals, 

Medicaid, Medicare, Reporting and 

recordkeeping requirements.

For the reasons set forth in the 

preamble, the Centers for Medicare & 

Medicaid Services proposes to amend 

42 CFR chapter IV, part 482 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 and 1871 of the 

Social Security Act, unless otherwise noted 

(42 U.S.C. 1302 and 1395hh).

2. Section 482.22 is amended by 

revising paragraph (c)(5) to read as 

follows:

§ 482.22 Condition of participation: 

Medical staff.

* * * * *

(c) * * *

(5) Include a requirement that a 

medical history and physical 

examination be completed no more than 

30 days before or 24 hours after 

admission for each patient by a 

physician (as defined in section 1861(r) 

of the Act), or other qualified individual 

who has been granted these privileges 

by the medical staff in accordance with 

State law. The medical history and 

physical examination must be placed in 

the patient’s medical record within 24 

hours after admission. When the 

medical history and physical 

examination are completed within 30 

days before admission, the hospital 

must ensure that an updated medical 

record entry documenting an 

examination for any changes in the 

patient’s condition is completed. This 

updated examination must be 

completed and documented in the 

patient’s medical record within 24 

hours after admission.

* * * * *

3. Section 482.23 is amended by 

revising paragraph (c)(2) to read as 

follows:

§ 482.23 Condition of participation: 

Nursing services.

* * * * *

(c) * * *

(2) 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 by hospital policy and in 

accordance with State law, 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.

* * * * *

4. Section 482.24 is amended by—

A. Revising paragraph (c)(1). 

B. Revising paragraph (c)(2)(i). 

The revisions read as follows:

§ 482.24 Condition of participation: 

Medical record services.

* * * * *

(c) * * *

(1) All patient medical record entries 

must be legible, complete, dated, timed, 

and authenticated in written or 

electronic form by the person 

responsible for providing or evaluating 

the service provided, consistent with 

hospital policies and procedures. 

(i) All orders, including verbal orders, 

must be dated, timed, and authenticated 

promptly by the prescribing 

practitioner, except as noted in 

paragraph (c)(1)(ii) of this section. 

(ii) For the period from the effective 

date of the final rule, to 5 years 

following the effective date of the final 

rule, all orders, including verbal orders, 

must be dated, timed, and authenticated 

by the prescribing 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. 

(iii) All verbal orders must be 

authenticated based upon Federal and 

State law. If there is no State law that 

designates a specific timeframe for the 

authentication of verbal orders, then 

verbal orders must be authenticated 

within 48 hours. 

(2) * * *

(i) Evidence of—

(A) A medical history and physical 

examination completed no more than 30 

days before or 24 hours after admission. 

The medical history and physical 

examination must be placed in the 

patient’s medical record within 24 

hours after admission. 

(B) An updated medical record entry 

documenting an examination for any 

changes in the patient’s condition when 

the medical history and physical 

examination are completed within 30 

days before admission. This updated 

examination must be completed and 

documented in the patient’s medical 

record within 24 hours after admission.

* * * * *

5. Section 482.25 is amended by 

revising paragraph (b)(2) to read as 

follows:

§ 482.25 Condition of participation: 

Pharmaceutical services.

* * * * *

(b) * * *

(2)(i) All drugs and biologicals must 

be kept in a secure area, and locked 

when appropriate. 

(ii) Drugs listed in Schedules II, III, 

IV, and V of the Comprehensive Drug 

Abuse Prevention and Control Act of 

1970 must be kept locked within a 

secure area. 

(iii) Only authorized personnel may 

have access to locked areas.

* * * * *

6. Section 482.52 is amended by 

revising paragraph (b)(3) to read as 

follows:

§ 482.52 Condition of participation: 

Anesthesia services.

* * * * *

(b) * * *

(3) With respect to inpatients, a 

postanesthesia evaluation must be 

completed and documented by an 

individual qualified to administer 

anesthesia as specified in paragraph (a) 

of this section within 48 hours after 

surgery.

* * * * *

(Catalog of Federal Domestic Assistance 

Program No. 93.778, Medical Assistance 

Program) 

(Catalog of Federal Domestic Assistance 

Program No. 93.773, Medicare—Hospital 

Insurance; and Program No. 93.774, 

Medicare—Supplementary Medical 

Insurance Program)

15274 Federal Register / Vol. 70, No. 57 / Friday, March 25, 2005 / Proposed Rules 

Dated: September 1, 2004. 

Mark B. McClellan, 

Administrator, Centers for Medicare & 

Medicaid Services. 

Approved: December 2, 2004. 

Tommy G. Thompson, 

Secretary.

[FR Doc. 05–5916 Filed 3–24–05; 8:45 am] 

BILLING CODE 4120–01–P

DEPARTMENT OF TRANSPORTATION

Federal Railroad Administration 

49 CFR Parts 222 and 229

[Docket No. FRA–1999–6439, Notice No. 15] 

RIN 2130–AA71

Use of Locomotive Horns at HighwayRail Grade Crossings

AGENCY: Federal Railroad 

Administration (FRA), Department of 

Transportation (DOT).

ACTION: Notice of public conference.

SUMMARY: FRA is issuing notice of a 

public conference that will be held in 

Fort Lauderdale, FL to discuss the 

appropriate excess risk estimate that 

should be applied to highway-rail grade 

crossings that are currently subject to 

FRA Emergency Order 15 (‘‘E.O. 15’’). 

The public conference will provide an 

opportunity for interested parties to 

provide information to FRA on the 

effect of silencing the locomotive horn 

at highway-rail grade crossings that are 

currently subject to E.O. 15.

DATES: Public Conference: The public 

conference will be held on Friday, April 

15, 2005, beginning at 9 a.m.

ADDRESSES: The public conference will 

be held at the Holiday Inn Fort 

Lauderdale Beach, 999 Fort Lauderdale 

Beach Blvd., Fort Lauderdale, Florida 

33304.

FOR FURTHER INFORMATION CONTACT:

Ivornette Lynch, FRA Docket Clerk, 

Office of Chief Counsel, 1120 Vermont 

Avenue, NW., Washington, DC 20590 

(telephone: 202–493–6030); Ron Ries, 

Office of Safety, FRA, 1120 Vermont 

Avenue, NW., Washington, DC 20590 

(telephone: 202–493–6299); or Kathy 

Shelton, Office of Chief Counsel, FRA, 

1120 Vermont Avenue, NW., 

Washington, DC 20590 (telephone: 202–

493–6038).

SUPPLEMENTARY INFORMATION: Any 

person who would like to provide an 

oral statement at the public conference 

should notify the FRA Docket Clerk at 

least 10 calendar days prior to the date 

of the public conference and provide 

either a telephone number or e-mail 

address at which the person may be 

contacted. (Please refer to the FOR

FURTHER INFORMATION CONTACT section 

for contact information for the FRA 

Docket Clerk.) Any speaker who will be 

speaking on behalf of an organization 

should also provide the name of the 

organization that he/she will be 

representing. 

FRA will attempt to accommodate all 

persons who wish to provide an oral 

statement. However, depending on the 

number of conference participants, FRA 

may find it necessary to limit the length 

of oral statements, in order to 

accommodate as many people as 

possible. Conference participants may 

choose to submit complete written 

statements for inclusion in the record, 

while providing an oral summary of 

their written statements at the 

conference. 

Please note that anyone is able to 

search the electronic form of all 

comments received into any of our 

dockets by the name of the individual 

submitting the comment (or signing the 

comment), if submitted on behalf of an 

association, business, labor union, etc. 

You may review DOT’s complete 

Privacy Act Statement in the Federal 

Register published on April 11, 2000 

(volume 65, number 70, pages 19477–

78) or you may visit http://dms.dot.gov.

Background 

Effective July 1, 1984, a Florida 

statute authorized counties and 

municipalities to restrict the nighttime 

sounding of the locomotive horn by 

intrastate railroads at highway-rail grade 

crossings equipped with flashing lights, 

bells, crossing gates, and advance 

warning signs indicating that the 

locomotive horn would not be sounded 

at night. However, FRA noted an 

alarming increase in the number of 

accidents at highway-rail grade 

crossings subject to these nighttime 

whistle bans. Therefore, FRA issued 

Emergency Order 15 (‘‘E.O. 15’’) on July 

26, 1991, which required the Florida 

East Coast Railway Company (an 

intrastate railroad) to sound the 

locomotive horn when approaching and 

entering public highway-rail grade 

crossings. E.O. 15 was later amended to 

allow communities to establish quiet 

zones, provided FRA approval was 

obtained prior to the implementation of 

sufficient safety measures at every 

highway-rail grade crossing within the 

proposed quiet zone to alleviate excess 

risk resulting from the absence of the 

warning provided by the locomotive 

horn. 

On November 2, 1994, Congress 

passed Public Law 103–440 (‘‘Act’’), 

which added § 20153 to title 49 of the 

United States Code. This Act required 

FRA to issue regulations that would 

require railroads to sound the 

locomotive horn at public grade 

crossings, but gave FRA the authority to 

make reasonable exceptions. After 

issuing a Notice of Proposed 

Rulemaking on January 13, 2000 (65 FR 

2230), FRA published an Interim Final 

Rule on the Use of Locomotive Horns at 

Highway-Rail Grade Crossings on 

December 18, 2003 (68 FR 70586). 

Under the Interim Final Rule, public 

authorities are authorized to create quiet 

zones by implementing supplementary 

safety measures and alternative safety 

measures to offset the excess risk that 

results from prohibiting routine use of 

the locomotive horn at highway-rail 

grade crossings within the proposed 

quiet zone. However, the Interim Final 

Rule provides greater flexibility in the 

types of safety improvements that can 

be employed within a proposed quiet 

zone than E.O. 15. Therefore, FRA 

stated in the Interim Final Rule that it 

would re-examine the effect of silencing 

the locomotive horn at E.O. 15 grade 

crossings. 

The upcoming public conference will 

provide an opportunity for interested 

parties to provide information to FRA 

on the effect of silencing the locomotive 

horn at highway-rail grade crossings 

that are currently subject to E.O. 15. In 

particular, FRA is soliciting comments 

on whether the national excess risk 

estimate on the effect of silencing the 

locomotive horn at highway-rail grade 

crossings equipped with flashing lights 

and gates (i.e., 66.8% increase in risk) 

should be applied to E.O. 15 grade 

crossings. In that regard, participants are 

requested to address FRA’s findings in 

the report titled, ‘‘Florida’s Train 

Whistle Ban’’, that accident frequency 

increased by 195% when train horns 

were banned at nighttime at crossings 

later subject to E.O. 15. In the 

alternative, should a regional excess risk 

estimate be applied to E.O. 15 grade 

crossings? Or, would a nighttimespecific excess risk estimate be more 

appropriate? 

Conference participants are asked to 

review the following documents 

available in the electronic docket of this 

rulemaking at http://dms.dot.gov prior 

to the conference: Document no. FRA–

1999–6439–16 (‘‘Florida’s Train Whistle 

Ban’’); Document no. FRA–1999–6439–

2391 (‘‘Analysis of the Safety Impact of 

Train Horn Bans at Highway-Rail Grade 

Crossings: An Update Using 1997–2001 

Data’’); and Document no. FRA–1999–

6439–2392 (‘‘Interim Final Rule on the 

Use of Locomotive Horns at HighwayRail Grade Crossings’’).