[Federal Register Volume 71, Number 227 (Monday, November 27, 2006)]
[Rules and Regulations]
[Pages 68672-68695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E6-19957]



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Part II





Department of Health and Human Services





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Centers for Medicare & Medicaid Services



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42 CFR Part 482



Medicare and Medicaid Programs; Hospital Conditions of Participation; 
Final Rule

  Federal Register / Vol. 71 , No. 227 / Monday, November 27, 2006 / 
Rules and Regulations  

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Centers for Medicare & Medicaid Services

42 CFR Part 482

[CMS-3122-F]
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: Final rule.

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SUMMARY: In this rule, we finalize changes to four of the current 
requirements (or conditions of participation (CoPs)) that hospitals 
must meet to participate in the Medicare and Medicaid programs. 
Specifically, this final rule revises and updates our CoP requirements 
for: Completion of the 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. We 
also respond to timely public comments submitted on the proposed rule 
published in the March 25, 2005 Federal Register (70 FR 15266). The 
changes specified in this final rule are consistent with current 
medical practice and will reduce the regulatory burden on hospitals.

DATES: Effective Date: These regulations are effective on January 26, 
2007.

FOR FURTHER INFORMATION CONTACT: Patricia Chmielewski, (410) 786-6899, 
Monique Howard, (410) 786-3869, Jeannie Miller, (410) 786-3164.

SUPPLEMENTARY INFORMATION: Copies: You can view and photocopy this 
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.

Table of Contents

I. Legislative and Regulatory Background
    A. General
    B. Finalizing Provisions of the December 19, 1997 Proposed Rule 
(62 FR 66726)
    C. Changes as a Result of the Enactment of the Medicare 
Prescription Drug, Improvement, and Modernization Act of 2003 (MMA)
II. Provisions of the Proposed Regulations
    A. Completion of the Medical History and Physical Examination
    B. Authentication of Verbal Orders
    C. Securing Medications
    D. Completion of the Postanesthesia Evaluation
III. Analysis of and Responses to Public Comments and Final 
Decisions Made on the March 25, 2005 Proposed Rule
    A. Medical History and Physical Examination
    B. Authentication of Verbal Orders
    C. Securing Medications
    D. Completion of Postanesthesia Evaluation
IV. Provisions of the Final Regulations
V. Collection of Information Requirements
VI. Regulatory Impact Analysis
VII. Regulations Text

I. Legislative and Regulatory Background

A. General

    On March 25, 2005 we published a proposed rule in the Federal 
Register entitled ``Medicare and Medicaid Programs; Hospital Conditions 
of Participation: Requirements for History and Physical Examinations; 
Authentication of Verbal Orders; Securing Medications; and 
Postanesthesia Evaluations'' (70 FR 15266). In that document, we 
presented our proposals to: (1) Expand the timeframe for completion of 
the history and physical examination to 30 days and expand the number 
of permissible professional categories of individuals who may perform 
the history and physical examination; (2) require that all orders, 
including verbal orders, be dated, timed, and authenticated by a 
practitioner responsible for the care of the patient. In the absence of 
a State law specifying the timeframe for authentication of verbal 
orders, verbal orders would need to be authenticated within 48 hours; 
(3) require that all drugs and biologicals be kept in secure areas, and 
locked when appropriate; and, (4) permit the postanesthesia evaluation 
for inpatients to be completed and documented by any individual 
qualified to administer anesthesia. This action was initiated in 
response to broad criticism from the medical community that the current 
requirements governing these areas are burdensome and do not reflect 
current practice.
    Previously, we published a proposed rule in the December 19, 1997 
Federal Register (62 FR 66726), entitled ``Medicare and Medicaid 
Programs; Hospital Conditions of Participation (CoPs); Provider 
Agreements and Supplier Approval'' 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 Social Security Act 
(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 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 Sec.  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. All Medicare- and Medicaid-participating 
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 (62 FR 
66726)

    In the December 19, 1997 proposed rule (62 FR 66726), we proposed 
to revise all CoPs specified in Part 482. While our initial intention 
was to

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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 considered of 
particular urgency by providers was to finalize or ``carve-out'' 
specific CoPs as separate final rules. To date, we have published the 
following hospital CoPs: Organ, Tissue and Eye Procurement CoP (see the 
June 22, 1998 final rule (63 FR 33856); Patients' Rights (see the July 
2, 1999 interim final rule (64 FR 36069); Anesthesia Services-CRNA 
supervision (see the November 13, 2001 final rule (66 FR 56762); Fire 
Safety Requirements for Certain Health Care Facilities (see the January 
10, 2003 final rule (68 FR 1374); and, Quality Assessment Performance 
Improvement (see the January 24, 2003 final rule (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 in this final 
rule has evolved in large measure as a result of our continuing 
dialogue with the health care community. Through various CMS-sponsored 
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 the March 25, 2005 
proposed rule would have been stipulated in a final regulation. 
However, with the passage of section 902 of the MMA, we believe it was 
in the spirit of the legislation to publish a new proposed regulation 
and subsequent final rule.
    This final rule finalizes provisions set forth in the March 25, 
2005 proposed rule (70 FR 15266 through 15274). In addition, this final 
rule has been published in the Federal Register within the 3-year time 
limit imposed by section 902 of the MMA. Therefore, we believe that 
this final rule is in accordance with the Congress' intent to ensure 
timely publication of final regulations.

II. Provisions of the Proposed Regulations

    On March 25, 2005 we published a proposed rule (70 FR 15266) in the 
Federal Register entitled ``Medicare and Medicaid Programs; Hospital 
Conditions of Participation: Requirements for History and Physical 
Examinations; Authentication of Verbal Orders; Securing Medications; 
and Postanesthesia Evaluations.'' This proposed rule responded 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 burden, and ensure patient safety and quality care, we 
proposed revising aspects of the current medical staff, nursing 
services, medical record services, pharmaceutical services, and 
anesthesia services CoPs. Below we summarize and discuss our proposed 
changes to these conditions and requirements.
    As discussed in section I of the preamble to the proposed rule, we 
proposed the following changes:

A. Completion of the Medical History and Physical Examination

    These proposed revisions would expand the timeframe for completion 
of the history and physical (H&P) examination to 30 days and expand the 
number of permissible categories of individuals who may perform the 
H&P. They address ongoing concerns expressed by the American Medical 
Association (AMA) and the American Podiatric Medical Association, Inc. 
(APMA), related to the timeframe for completion, as well as who is 
permitted to complete the history and physical examination. We proposed 
to revise the current medical staff requirement at Sec.  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 proposed revising the current 
Medical Records CoP at Sec.  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 proposed revising Sec.  
482.22(c)(5) and Sec.  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.

B. Authentication of Verbal Orders

    These proposed revisions broaden the category of practitioners who 
may authenticate orders. It responds to health care community concerns, 
reduces regulatory burden, and provides flexibility for hospitals in 
meeting the

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requirements for authentication of verbal orders.
    We proposed to retain and revise the current requirement for 
authentication of medical record entries at Sec.  482.24(c)(1). This 
proposed provision stated that all patient 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. Additionally, we proposed retaining 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 Sec.  
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 proposed revising Sec.  482.23(c)(2)(ii) to require that all 
verbal orders must be authenticated based upon Federal and State law, 
and relocating it to Sec.  482.24(c)(1)(iii). We further proposed that 
if there is no State law that designates a specific timeframe for 
authentication of verbal orders, verbal orders must be authenticated 
within 48 hours. We also proposed to revise related nursing service 
requirements at Sec.  482.23(c)(2) that address documentation of orders 
for drugs and biologicals.
    We proposed 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 must be documented and signed by a 
practitioner who is authorized to write orders by hospital policy in 
accordance with State law, and who is responsible for the care of the 
patient as specified under Sec.  482.12(c).
    We proposed retaining the current requirements at Sec.  
482.23(c)(2)(iii) that state that when verbal orders are used, they are 
to be used infrequently. We also proposed retaining the current 
requirement at Sec.  482.23(c)(2)(i) 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.

C. Securing Medications

    The proposed revision addresses health care community concerns, 
provides flexibility for hospitals in determining control of 
nonscheduled drugs and biologicals, and would be more patient-focused 
and outcome-oriented than the current requirement. We proposed to 
revise the provision at Sec.  482.25(b)(2) to require that all drugs 
and biologicals be kept in a secure area, and locked when appropriate. 
We proposed 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 proposed that only 
authorized personnel may have access to locked areas.

D. Completion of the Postanesthesia Evaluation

    We proposed revising the requirement at Sec.  482.52(b)(3) to 
permit an individual qualified to administer anesthesia to complete and 
document the postanesthesia evaluation for inpatients.

III. Analysis of and Responses to Public Comments and Final Decisions 
Made on the March 25, 2005 Proposed Rule

    In response to the proposed rule published in the March 25, 2005 
Federal Register, we received a total of 609 timely comments from 
individuals, providers, national and regional health care professional 
associations and advocacy groups, State and local health organizations, 
labor unions, health care law firms, and others. Summaries of the 
public comments received and our responses to those comments are set 
forth below under the appropriate subject headings.
    We also received comments on issues outside the scope of this 
proposed rule. These comments will not be addressed in this final rule.

A. Medical History and Physical Examination

Condition of Participation: Medical Staff (Sec.  482.22)
    In response to the industry's concern that timeframes for 
completion of the medical history and physical examination (H&P) are 
too stringent, we proposed revisions that broaden the timeframe for 
completion of the patient's medical history and physical examination 
and entry into the patient's medical record, and broaden whom may 
perform such an examination. In the March 25, 2005 proposed regulation, 
we expanded the timeframe to state that the medical history and 
physical examination must be completed no more than 30 days before or 
24 hours after admission for each patient. We also proposed removing 
the reference to specific physicians who can perform the medical 
history and physical examination, and instead stated it must be 
performed 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. We also proposed that the 
medical history and physical examination must be placed in the 
patient's medical record within 24 hours after admission. We added that 
when the medical history and physical examination is completed within 
30 days before admission, we proposed that the hospital must ensure 
that an updated medical record entry documenting an examination for any 
changes in the patient's condition is completed. Finally, we stated 
that this updated examination must be completed and documented in the 
patient's medical record within 24 hours after admission.
    Comments and responses to these proposed changes are separated into 
four major categories: Medical staff, completion of the H&P, timeframes 
for completion of the H&P, and categories of providers permitted to 
perform the H&P.
Medical Staff
    Comment: A significant number of commenters identified the granting 
of privileges to conduct an H&P as problematic in both rural and urban 
areas. Commenters stated that the H&P is frequently conducted by the 
patient's primary care provider who may not be credentialed and 
privileged to complete an H&P by the admitting hospital.
    A commenter stated that the requirement for a pre-operative H&P to 
be completed only by a physician credentialed by the medical staff at a 
particular hospital is onerous and does not add value to the operative 
process for the patient. Instead, the commenter believes that a 
physician who is credentialed by a JCAHO-accredited hospital should be 
capable of performing this function.
    Response: We understand that it is often the patient's primary care 
provider who completes the patient's H&P before an elective admission 
or procedure in both urban and rural areas. We also understand that 
this provider may or may not be credentialed and privileged by the 
admitting hospital. Based on public comments, in this final rule we 
have deleted the requirement that the H&P be completed by a 
practitioner credentialed and privileged by the admitting hospital.

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    If a patient's H&P is completed before admission to the hospital, 
an updated examination must be completed and documented in the 
patient's medical record within 24 hours after admission, but before a 
surgical procedure. This update to the H&P would be completed after the 
patient is admitted to the hospital by a physician, oromaxillofacial 
surgeon or other qualified individual who has been granted these 
privileges by the medical staff in accordance with State law. 
Therefore, if the H&P was completed by the patient's primary care 
provider, the H&P would be reviewed, the patient would be examined, and 
the H&P would be updated by an individual who has been credentialed and 
privileged by the medical staff to conduct an H&P. If upon review, the 
H&P done before admission is found to be incomplete, inaccurate, or 
otherwise unacceptable, the practitioner reviewing the H&P, examining 
the patient, and completing the update may disregard the existing H&P, 
and conduct and document a new H&P within 24 hours after admission, but 
before a surgical procedure. The practitioner completing the update is 
responsible for ensuring that the H&P documented in the medical record 
is complete and accurate.
    Comment: A commenter requested that CMS clarify whether 
performance, documentation and authentication of the H&P can be split 
among qualified staff or must these functions be performed by a single 
individual. The commenter recommended that CMS clearly identify the 
individual who is ultimately responsible for the H&P documentation and 
integrity.
    Response: We believe it is standard practice to perform the H&P 
before a planned admission. Thus, if the H&P is done before admission, 
an update note will be needed which we expect would be done by a 
practitioner qualified to do the H&P. The hospital would be held 
responsible for ensuring a complete and accurate H&P is documented in 
the patient's medical record in accordance with the required 
timeframes.
    Additionally, more than one qualified practitioner can participate 
in performing, documenting, and authenticating the H&P for a single 
patient. However, we believe it is common practice that the 
practitioner who performs the H&P will proceed to document and 
authenticate the H&P as well. In those instances when performance, 
documentation, and authentication are split among qualified 
practitioners, the practitioner who authenticates the H&P, ultimately, 
will be responsible for the integrity of its contents.
    Comment: One commenter asked that CMS continue to allow delegation 
of all or part of the H&P to other practitioners. This commenter also 
recommended that CMS confirm that the completed H&P can be 
authenticated by another practitioner responsible for the care of the 
patient. The commenter further stated that this is especially important 
when the H&P is dictated, but the author cannot authenticate between 
the time the H&P is physically placed on the medical record and the end 
of the 24 hours following admission. The commenter stated that a 
dictated medical record entry usually indicates the time dictated, 
transcribed, and signed. The commenter further asked if a practitioner 
would be required to indicate the time the undersigned H&P was 
physically placed in the medical record or whether the signature of the 
responsible practitioner serves as the time stamp.
    Response: This requirement does not affect the physician's ability 
to delegate performance of the H&P to other qualified practitioners. 
The physician does not necessarily have to perform the H&P himself. 
However, the physician is responsible for ensuring that it is done, and 
complete. The completed H&P would be authenticated by the practitioner 
who conducted the H&P, and as applicable, the physician who delegated 
the performance of the H&P.
    If the H&P is performed when the patient arrives at the hospital 
and the H&P is not placed on the medical record immediately following 
completion, we expect the practitioner who conducts the H&P to document 
in the patient's medical record that the H&P was completed and dictated 
within 24 hours following admission. Authentication includes dating and 
timing of a medical record entry. Therefore, it is not necessary to 
document the time the H&P was physically placed in the medical record.
    Comment: One commenter requested that CMS align the physician and 
practitioner incentives to ensure timely and accurate completion of 
H&Ps. The commenter recommended that CMS address actions to be taken by 
the hospital staff if an H&P is not completed or received within the 
proposed standard timeframe. Additionally, the commenter stated that 
guidance to prohibit practitioners from billing for professional 
services rendered during an inpatient admission in the absence of a 
timely, accurate H&P would be helpful.
    Other commenters thought it would be very difficult to enforce a 
timeframe for updating the H&P. Instead, these commenters stated that 
they see no reason to require documentation in the form of an update 
note if there has been no change in the patient's condition. Instead, 
they believe CMS should align its regulations regarding the update note 
with the JCAHO requirements for an update just prior to beginning a 
procedure only if there have been changes to the patient's condition 
since the H&P was done. One commenter further stated that this would 
maintain the update when necessary, but not require additional 
processing when nothing more is required or of benefit.
    Another commenter stated that despite supporting the timeframe 
proposed for completion of the H&P, they were still concerned that 
hospitals are required to ensure that an updated medical record entry, 
documenting an examination for any changes in the patient's condition 
be completed within 24 hours after admission. The commenter asked how 
completely documented must a physical examination be in order to 
document a change in a patient's condition. The commenter also asked if 
a statement signed by the physician stating that ``no change'' has 
occurred in the patient's condition would be satisfactory. The 
commenter further stated that to provide safe patient care, but be less 
burdensome to those who perform H&Ps, it would be more appropriate to 
require a medical record entry documenting a re-examination of the 
patient and their condition.
    Response: Payment issues are out of the scope of this regulation. 
Thus, we will not specifically address this commenter's payment related 
concerns. However, hospitals have the flexibility to implement 
incentives or other systems and processes necessary to ensure timely 
completion and documentation of an H&P and update examination. The 
hospital is responsible for ensuring compliance with hospital policies, 
as well as, State and Federal regulations.
    We expect hospitals to evaluate the practitioner's performance 
regarding the requirements as well as hospital policies and procedures 
through mechanisms such as QAPI and peer review as part of the 
credentialing and privileging process. If a hospital is not in 
compliance with the H&P requirements, we expect the hospital to take 
the necessary corrective action to ensure compliance. Non-compliance 
could lead to termination from the Medicare & Medicaid programs.
    Regarding timely performance, documentation, and authentication of 
the H&P and update note, a physician, oromaxillofacial surgeon, or 
other qualified individual is expected to review the H&P that was 
completed

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before admission, see the patient, and conduct an assessment to 
determine if there have been any changes since the H&P was completed. 
If there are no changes to the H&P as written, the physician can simply 
document an update note stating that the H&P has been reviewed, that 
the patient has been examined, and that the physician concurs with the 
findings of the H&P completed on the specified date. If there are 
changes in the H&P examination, we would expect the changes to be 
documented in the patient's medical record as well. The update note 
could include language such as concurrence with the H&P conducted on 
the specified date ``with the following additions and/or exceptions.''
    Comment: One commenter recommended that instead of requiring that 
an update be conducted ``within a maximum of 24 hours after admission'' 
if the H&P was completed within 30 days before admission, that CMS 
modify the language to state, ``at time of admit'' since surgery or a 
procedure could be done before the 24 hour timeframe.
    Response: The current requirement at Sec.  482.51(b)(1) states, 
``There must be a complete history and physical work-up in the chart of 
every patient before surgery, except in emergencies. If this has been 
dictated, but not yet recorded in the patient's chart, there must be a 
statement to that effect and an admission note in the chart by the 
practitioner who admitted the patient.'' This current requirement has 
not changed and applies to all patients undergoing surgery or other 
procedures that require an H&P. We note that the update note could be 
done sooner than 24 hours after admission. We would expect hospital 
policies and procedures to address this issue.
    Comment: Numerous commenters support all proposed changes and 
believe the revised requirements for admission H&Ps would provide 
flexibility to better meet patient needs.
    Response: We thank them for their support.
Completion of the H&P
    Comment: One commenter stated we need to clarify that the proposed 
H&P revisions apply to inpatient admissions only. The commenter 
recommends eliminating wording that limits H&P requirements to just 
``patients admitted only for oromaxillofacial surgery'' and requests 
additional clarification explaining the extent to which the H&P applies 
to patient admissions regardless of the services or procedures 
performed. Additionally, the commenter recommended additional 
clarification regarding the term ``admission.'' Instead, the commenter 
suggests that CMS clarify in the final rule whether the requirement 
only applies to inpatient admissions, specific types of admissions, all 
admissions and/or outpatient surgery, and/or diagnostic and therapeutic 
procedures.
    Response: For the purposes of this requirement, the term 
``admission'' applies to any admission. An H&P is required for all 
admissions. An H&P is required prior to surgery as well as prior to 
other procedures that require an H&P based on current standards of 
practice and hospital policy regardless of whether care is being 
provided on an inpatient or outpatient basis.
    Comment: One commenter agreed with the completion of the H&P no 
more than 30 days before or 24 hours after admission. However, the 
commenter suggests modifying placement of the H&P in the medical record 
from 24 hours to ``as soon as possible'' due to the transcription turn 
around time of 24 hours. In agreement with this commenter, another 
commenter stated that requiring the H&P to be placed on the medical 
record within 24 hours after admission would force hospitals to staff 
transcription services 7 days a week which would be extremely difficult 
to do in small rural hospitals. The commenter believes this would 
result in increased cost with no increase in reimbursement for these 
small rural hospitals.
    Response: We expect that practitioners and hospitals will make 
every effort to meet this requirement through the timely performance of 
the H&P and by maintaining transcription services and other systems 
that support this effort. However, in current medical practice, it is 
fairly routine for an H&P to be performed prior to a planned admission 
or procedure. As a result, the number of dictated H&Ps should be small. 
However, when the H&P is performed and dictated within 24 hours after 
admission, we would expect an entry in the patient's medical record 
stating that the H&P was completed and dictated. Hospital policies and 
procedures should address the process and timeframes for transcription, 
authentication, and placement of a dictated H&P into the medical 
record. The hospital must ensure that these policies and procedures are 
being followed.
    The 24 hour timeframe establishes a clear and measurable guideline. 
Stating ``as soon as possible'' would allow too much flexibility and 
possibly lead to the H&P being placed in the chart well after 24 hours 
which could potentially impact patient care. These revised standards 
are consistent with the JCAHO's requirements that have been in place 
for several years.
    As the field of medical information technology advances to the 
common use of electronic medical records, it will be more probable that 
this reduced timeframe will become routine practice in hospital 
settings that may not be in compliance already. We believe there will 
be less need for transcription services replaced by more on-screen 
documentation.
    Comment: A commenter requested further clarification as to what 
point between 30 days and the patient's admission does it become 
necessary to update the medical record regarding the patient's 
condition. The commenter requested that we reword the regulation to 
indicate that anything greater than ``X'' days prior to admission must 
be updated. The commenter further asked if the H&P is conducted 24 
hours before admission, based on the proposed rule, would an update 
still be required.
    Response: An update note is required when the H&P is conducted 
prior to admission. This update can be brief as long as the update 
adequately addresses any changes in the patient's medical condition 
since the H&P was conducted. It would be adequate for the physician to 
make an entry in the patient's medical record stating that the H&P was 
reviewed, the patient was examined, and that ``no change'' has occurred 
in the patient's condition since the H&P was completed.
    Comment: An organization applauded CMS for proposing to codify the 
medical H&P requirements with guidance previously issued by CMS in a 
January 28, 2002 memorandum to the Associate Regional Administrators 
and the State Survey Agency Directors. The purpose of this memorandum 
was to clarify our policy with respect to the application of regulatory 
provisions for hospital admission and presurgical H&P requirements and 
guidance regarding the timing of the H&P for hospital admissions. They 
stated the proposed changes would also align the CoPs with standards 
used by the JCAHO, which, heretofore, has been an ongoing source of 
conflict for hospitals creating confusion, and needless additional 
work. However, the commenters seek clarification as to whether the 
requirement will remain a standard within the CoP at the proposed Sec.  
482.24(c) entitled ``Content of record.''
    Response: We appreciate the commenter's support. Yes, the proposed 
482.24(c) will continue to address the regulatory language regarding 
the requirements under the CoP: Medical record services.

[[Page 68677]]

Timeframe for Completion of H&P
    Comment: Many commenters expressed support for the proposed H&P 
timeframe revisions.
    Response: We appreciate this support.
    Comment: A commenter supports the use of timeframes; however, the 
commenter stated this would result in a disconnect between the CMS's 
requirements and the JCAHO's existing 24 hour requirement. The 
commenter further expressed the concern that if the H&P is done within 
30 days of admission and there is a need to update, this may lead to 
patient dissatisfaction due to the redundancy of the requirement for 
updating the H&P.
    Response: We recognize there may be redundancy in the information 
that was gathered at the time of the initial assessment and the 
completion of an updated assessment. However, we believe this timeframe 
is necessary for patient safety to ensure that a procedure or admission 
is still appropriate based on the patient's current condition.
    The JCAHO's standards must meet or exceed our requirements in 
accordance with section 1865(e)(9) of the Act. In this case, the JCAHO 
standards are more stringent than our requirements. JCAHO requires the 
H&P to be completed within no more than 24 hours of an inpatient 
admission. If the H&P was completed within 30 days before the patient 
was admitted or readmitted, updates on the patient's condition since 
the assessment(s) are recorded at the time of admission.
    Additionally, in the event of there being patient dissatisfaction 
with the redundancy of performing an update procedure, we believe 
educating the patient regarding the necessity and importance of 
performing this update for their safety should help to reduce 
dissatisfaction expressed by the occasionally dissatisfied patient.
    Comment: A commenter requested that CMS specifically address the 
updating requirements for obstetric H&Ps. The commenter requested CMS 
to define how and where this update should happen for obstetric H&Ps.
    Response: The update requirement for obstetric patients would be no 
different than the update requirements for other medical services. 
However, for women who have had prenatal care, an H&P would be 
conducted on the first prenatal visit. An update note would then be 
documented at each subsequent prenatal care visit. The next update note 
would be documented at the onset of labor. For women who have not had 
prenatal care before the onset of labor, the H&P must be completed 
within 24 hours of admission.
    Comment: A commenter opposed the proposed revisions stating the 
proposed requirements would create undue burden and expense for rural 
hospitals. The commenter stated that there is a shortage of physicians 
and other health care professionals in their rural state which 
challenges the providers in that area in delivering safe, quality 
patient care. The commenter further stated that many of the surgical 
patients are referred by their local family physician and come from 
more than sixty miles from the healthcare center. The commenter stated 
that many times the family physician provides an H&P that is done more 
than 24 hours in advance of the surgery. The commenter is concerned 
that, in those instances, when it is not possible to have a current H&P 
on the chart before surgery, the physician is responsible for 
performing an update to the H&P would charge additional costs to the 
patient and possibly ``resent'' that an update is requested.
    Response: The requirement at Sec.  482.22(c)(5) has been changed to 
remove reference to ``who has been granted these privileges by the 
medical staff.'' It is our desire that the expansion of who may perform 
the H&P would lessen the burden associated with meeting this 
requirement. Additionally, we would expect the hospital to address in 
its policies and procedures the practice of accepting the H&P completed 
by a practitioner who has not been granted these privileges by the 
hospital's medical staff.
    Regarding the issue of an additional physician seeking 
reimbursement for performing the H&P, we would expect that the 
performance of an H&P would be provided if necessary Reimbursement 
issues are beyond the scope of this regulation.
Categories of Providers Permitted To Perform the H&P
    The current medical history and physical examination requirements, 
including who is permitted to complete the history and physical 
examination, has continued to be a point of contention among various 
provider groups. Specifically, while podiatrists have expressed concern 
that doctors of podiatric medicine are currently not permitted to 
perform a history and physical examination, oromaxillofacial surgeons 
have been concerned that the lack of specific reference to 
oromaxillofacial surgeons in the regulation language could result in 
their loss of current privileges to perform the H&P.
    We received 342 comments regarding the proposed revision to adopt 
the definition of ``physician'' at section 1861(r) of the Act and the 
removal of the specific reference to oromaxillofacial surgeons. 
Commenters were evenly split. Nearly 48 percent of the commenters 
supported the proposed change, while over 52 percent of commenters 
opposed the proposed change.
    One group of commenters supported the definition of physician which 
includes doctors of medicine or osteopathy, doctors of dental surgery, 
or dental medicine, doctors of podiatric medicine, doctors of 
optometry, and chiropractors. These commenters believe that specific 
reference to these practitioners would result in increased access to 
care while protecting patient health and safety.
    The other group of commenters stated that in the specific context 
of eligibility to perform a complete H&P, which should be based on 
documented education, training, and current competence, they believe 
the use of this definition may be misinterpreted by hospital medical 
staffs and governing bodies. As a result, commenters believe the 
hospital medical staffs around the country may feel compelled to change 
the bylaws to grant such privileges only to those ``commonly known'' to 
have requisite training in history and physical exam (that is, MD and 
DO--allopathic and osteopathic) medical doctors. The commenters further 
stated that limitations or withdrawal of privileges for H&P exam for 
oromaxillofacial surgeons would limit access for many maxillofacial 
trauma, head and neck pathology, and reconstruction patients who need 
the services of an oral surgeon. Instead, the commenters believe that 
specific reference to oromaxillofacial surgeons must be retained in the 
final regulation to ensure that they continue to be recognized by the 
medical staff as qualified to perform the H&P.
    Many commenters who expressed opposition to the proposed revision 
stated the SSA definition might cause hospital medical staffs to 
exclude trained DMD or DDS. They suggest the definition be expanded to 
include other degreed professionals that are trained to perform H&Ps. 
Many commenters who opposed the revised language instead suggested the 
language read, ``a doctor of medicine or osteopathy, oral and 
maxillofacial surgeons, and those accredited to perform H&Ps''.
    Podiatrists were in support of being permitted by regulation to 
perform H&Ps, stating that podiatric physicians are, by education and 
training, capable of performing a comprehensive H&P for any of their 
patients. These commenters

[[Page 68678]]

referenced their 4 year educational requirements for podiatric students 
and the Council on Podiatric Medical Examination (CPME) publication 
120, Standards and Requirements for Accrediting Colleges of Podiatric 
Medicine (April 2000) and CPME publication 320, Standards (July 2003). 
Additionally, several commenters discussed how participation in the 
medicine and medical subspecialty training resources requires that 
podiatric residents perform a minimum number of comprehensive medical 
histories and physical examinations.
    Response: It is not our intent for this revised change to lead to a 
reduction in the pool of professionals who are qualified to perform the 
H&P. Instead, in an effort to reduce burden, we are increasing the pool 
of individuals who can perform the H&P by allowing other qualified 
individuals who have been granted privileges by the medical staff in 
accordance with State law to perform the H&P. For clarification in this 
final rule, the specific reference to oromaxillofacial surgeons has 
been retained. However, based on hospital policy and State law, the 
pool of ``other qualified individuals'' can be restricted.
    Comment: A commenter expressed concern stating that Sec.  482.22 
should read, ``nurse practitioners (NPs), licensed independent 
practitioners (LIPs), or other qualified individuals should be allowed 
to perform H&Ps independently of the MD.'' The commenter elaborated by 
stating that due to current work hour limitations on residents in acute 
hospitals, H&Ps are currently being performed by NPs. The commenter 
stated that H&Ps are frequently billed to Medicare under the ``shared 
care'' rules instead of under the NP's own Medicare provider number, 
thus, providing a great cost saving to Medicare. Instead, the commenter 
believes the proposed language is restrictive, in turn, creating 
barriers to care for Medicare beneficiaries and increased cost to 
Medicare.
    Another commenter voiced a lack of support over the expansion of 
the proposed rule to allow ``other qualified individuals who have been 
granted these privileges by medical staff in accordance with State 
law.'' The commenter references and supports the AMA's beliefs that the 
best interests of hospitalized patients are served when admission 
history and physical exams are performed by a physician, recognizing 
the ``portions'' of the histories and physical exams may be delegated 
by the physician to others whose credentials are accepted by the 
medical staff.
    Response: Again, it was not our intent to exclude practitioners who 
are believed to be appropriately trained and qualified to perform the 
H&P. We are aware that NPs, especially in rural settings have been an 
invaluable resource in performing H&Ps as a rule of practice. Thus, we 
want to provide the hospital the flexibility to determine if NPs are 
included in their lists of practitioners who are qualified to perform 
the H&P.

B. Authentication of Verbal Orders

Condition of Participation: Nursing Services (Sec.  482.23)
    We proposed revisions to strengthen the requirement regarding the 
infrequent use of verbal orders. We proposed 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 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 Sec.  
482.12(c). In addition, we proposed that if verbal orders are used, 
they are to be used infrequently and must only be accepted by persons 
who are authorized to do so by hospital policy and procedures 
consistent with Federal and State law.
    In the proposed rule, we stated that authentication requirements 
enhance patient safety and serve to protect practitioners carrying out 
verbal orders by preventing those giving the orders from later denying 
the order was given. We requested public comment on whether recurring 
problems exist with prescribing practitioners denying that they gave a 
verbal order after the verbal order was carried out. We also requested 
public comment on the perceived impact of this proposed rule on this 
potential issue.
    Comment: Several commenters stated that ordering practitioners only 
occasionally or rarely deny giving a verbal order. One commenter stated 
that there are anecdotal reports that this problem continues to occur, 
especially if an incorrect or incomplete order appears to contribute to 
patient morbidity or mortality, and stated that it is problematic for 
nurses when a practitioner does deny giving a verbal order. One 
commenter stated that their State health department and hospital 
association conducted a comprehensive study and found no examples of 
prescribing practitioners denying that they gave a verbal order after 
the verbal order was carried out when the order was repeated back to 
them.
    One commenter stated that these revisions address a recognized 
problem for RNs who frequently find that they are dealing with unsigned 
or denied verbal orders and clarifies when and how verbal orders are to 
be documented. The commenter stated that these revisions would support 
increased collaboration of the health care team and promote safe, 
effective patient care.
    Response: Denial of verbal orders does not appear to be a 
frequently occurring problem for the commenters. We agree, however, 
that it is problematic any time a prescribing practitioner denies 
giving a verbal order, particularly after the verbal order has been 
carried out. A denial jeopardizes the trust necessary in collaborative 
relationships among members of the health care team and may jeopardize 
patient safety and quality care as well. Therefore, it is necessary 
that this final rule clarifies when and how verbal orders are to be 
documented and authenticated.
    Comment: The majority of commenters supported the requirement that 
if verbal orders are used, they should be used infrequently. Commenters 
commended CMS for recognizing the critical importance of minimizing the 
use of verbal orders. One commenter stated that CMS should require 
hospitals and practitioners to take steps to limit the use of verbal 
orders, in the absence of electronic health record and computerized 
physician order entry technologies.
    A few commenters did not support this requirement. One commenter 
stated that the use of verbal orders is a common practice and certainly 
not infrequent. The commenter recommended that this requirement be 
tested with practicing physicians in both rural and urban hospitals. 
The commenter stated that verbal orders can comprise 100 percent of 
orders received at night in rural areas as well as other times when the 
patient's condition warrants and the physician is not physically 
available or capable of secure electronic communication.
    Another commenter stated that in order to provide more timely, 
appropriate, and patient-focused care, the use of verbal and/or 
telephone orders in the hospital has increased, and could be viewed as 
being used in circumstances that a regulatory agency may not consider 
``urgent or emergent.'' The commenter further stated that patient 
lengths of stay have declined dramatically over the past decade and, 
therefore,require more frequent changes

[[Page 68679]]

in orders and more immediate response to patient's expressed needs 
while hospitalized. This commenter recommended that CMS broaden its 
interpretation of ``emergent or urgent'' to recognize that verbal 
orders are needed to ensure the provision of timely, appropriate and 
patient-focused care and that verbal orders are often necessary from a 
service delivery perspective for patients and families. The commenter 
further stated that it is often necessary to secure verbal orders in 
order to change diet or activity orders, secure changes to therapy 
orders to better meet the needs of the patient, and obtain medication 
orders in response to patient response or non-response to ordered 
medication regimens, particularly with respect to pain management.
    Response: The use of verbal or telephone orders is cited as an 
error-prone process by the American Society of Health-System 
Pharmacists (ASHP) \1\, the Institute of Safe Medication Practices 
(ISMP) \2\, the Joint Commission on Accreditation of Healthcare 
Organizations (JCAHO) \3\, and the National Coordinating Council for 
Medication Error Reporting and Prevention (NCC MERP) \4\. These 
nationally recognized organizations recommend that the use of verbal 
orders be minimized as much as possible. In addition, minimizing the 
use of verbal or telephone orders was a key 2003 JCAHO National Patient 
Safety Goal.
---------------------------------------------------------------------------

    \1\ American Society of Hospital Pharmacists. ASHP guidelines on 
preventing medication errors in hospitals, Am J Hosp Pharm 1993; 
50:305-14. http://www.ashp.org/bestpractices/MedMis/MedMis_Gdl_Hosp.pdf.
    \2\ Smetzer J, Cohen MR. Instilling a measure of safety into 
those ``whispering down the lane'' verbal orders,'' ISMP Medication 
Safety Alert! Acute Care Edition, 2001; 6:1-2. http://www.ismp.org/Newsletters/acutecare/articles/20010124.asp.
    \3\ 2003 JCAHO National Patient Safety Goals: practical 
strategies and helpful solutions for meeting these goals. Joint 
Commission Perspectives on Patient Safety. 2003; 3:1-11. http://www.jcrinc.com/subscribers/patientsafety.asp?durki=3746#goal2.
    \4\ National Coordinating Council for Medication Error Reporting 
and Prevention. Recommendations to reduce medication errors 
associated with verbal medication orders and prescriptions. February 
20, 2001. http://www.nccmerp.org/council/council2001-02-20.html.
---------------------------------------------------------------------------

    The use of verbal orders poses an increased risk of 
miscommunication that could result in an adverse event, including a 
medication error, for the patient. The NCC MERP reports that confusion 
over the similarity of drug names accounts for approximately 25 percent 
of all medication errors.\5\ The ISMP described safety issues related 
to the use of verbal orders in the January 24, 2001 issue of Medication 
Safety Alert! \6\
---------------------------------------------------------------------------

    \5\ Ibid, National Coordinating Council for Medication Error 
Reporting and Prevention.
    \6\ Ibid, Smetzer J, Cohen MR.
---------------------------------------------------------------------------

    ''Verbal orders offer more room for error than orders that are 
written or sent electronically. The interpretation of what someone 
else says is inherently problematic because of different accents, 
dialects, and pronunciations. Background noise, interruptions, and 
unfamiliar terminology often compound the problem. Once received, 
verbal orders must be transcribed as a written order, which adds 
complexity and risk to the ordering process. The only real record of 
the verbal order is in the memories of those involved. When the 
recipient records a verbal order, the prescriber assumes that the 
recipient understood correctly. No one except the prescriber, 
however, can verify that the recipient heard the message correctly. 
If a nurse receives a verbal order and subsequently calls it to the 
pharmacy, there is even more room for error. The pharmacist must 
rely on the accuracy of the nurse's written transcription of the 
order and the pronunciation when it is read to the pharmacist.
    Sound-alike drug names also impact the accuracy of verbal 
orders. There are literally thousands of name pairs that can easily 
be misheard. For example, we have received scores of error reports 
where verbal orders for ``Celebrex 100 mg PO'' were misheard as 
``Cerebyx 100 mg PO.'' Drug names are not the only information prone 
to misinterpretation. Numbers are also easily misheard. For example, 
an emergency room physician verbally ordered ``morphine 2 mg IV,'' 
but the nurse heard ``morphine 10 mg IV'' and the patient received a 
10 mg injection and developed respiratory arrest. In another case, a 
physician called in an order for ``15 mg'' of hydralazine to be 
given IV every 2 hours. The nurse, thinking that he had said ``50 
mg,'' administered an overdose to the patient who developed 
tachycardia and had a significant drop in blood pressure.''

    If verbal orders are used, they must be used infrequently. This 
means that the use of verbal orders must not be a common practice. This 
is not a new requirement. The requirement for the infrequent use of 
verbal orders has been part of the hospital CoPs since 1986. We expect 
this requirement to be reflected in hospital policy as well as in 
actual practice. We expect hospitals to implement practices that 
minimize the use of verbal orders regardless of whether or not the 
hospital has implemented electronic health record and/or computerized 
physician order entry technologies. We do, however, strongly support 
the adoption and implementation of these technologies. If the use of 
verbal orders in a hospital is common practice, the hospital could be 
cited as being out of compliance with the Medicare hospital CoPs.
    We recognize that there are occasional situations in a hospital, 
regardless of a rural or urban setting, when the use of a verbal order 
is necessary. We also recognize that a practitioner responsible for the 
care of the patient may not necessarily be available on site during the 
night or always have access to electronic communication to issue a 
written order. However, every effort should be made to minimize the use 
of verbal orders given the risks to patient safety when verbal orders 
are used. The use of verbal orders should be limited to those 
situations in which it is impossible or impractical for the prescriber 
to write the order or enter it into a computer. Verbal orders are not 
to be used for the convenience of the ordering practitioner.
    We agree that ``timely, appropriate, and patient-focused care'' is 
important. We also recognize that patient length of stay has decreased 
and may necessitate more frequent order changes and more immediate 
response to patient needs. However, we do not agree that these factors 
necessarily translate into the need for the frequent use of verbal 
orders. We expect hospitals to have systems in place to enable staff to 
address patient needs on a timely basis without routinely resorting to 
the use of verbal orders. We do not specify in regulation that verbal 
orders must only be used in ``emergent or urgent'' situations. We 
require that if verbal orders are used, they must be used infrequently. 
We expect that hospital policy and practice would discourage the use of 
verbal orders as much as possible.
    Comment: The majority of commenters cited and endorsed the 2003 
JCAHO National Patient Safety Goal--``For verbal or telephone orders or 
for telephonic reporting of critical test results, verify the complete 
order or test result by having the person receiving the order or test 
result `read-back' the complete order or test result.'' Commenters also 
cited the related JCAHO requirement that hospitals ``implement a 
process for taking verbal or telephone orders or receiving critical 
test results that require a verification ``read-back'' of the complete 
order or test result by the person receiving the order or test result'' 
(IM 6.50, EP 4) and recommended that CMS consider including this 
requirement in the CoPs. One commenter stated that a regulatory 
requirement would further enhance the ability of nurses to clarify 
verbal orders without seeming to be personally confrontational to 
physician and practitioner colleagues who issue such orders to nurses. 
One commenter stated that their State law requires that a verbal order 
be repeated back to the prescribing practitioner and verified.

[[Page 68680]]

This commenter stated that this practice has reduced errors and has 
increased communication and patient safety.
    One commenter stated that verbal orders have generally been 
instituted well before authentication of the order can occur and stated 
that the possibility exists that harm could occur to the patient before 
it is recognized through an authentication procedure. The commenter 
strongly recommended that CMS consider including JCAHO's National 
Patient Safety Goal that requires the ``read-back'' of the verbal order 
to ensure that the order is heard correctly to reduce the likelihood of 
patient harm. The commenter states that this intervention is real-time 
and more likely to ensure the safety of patients as opposed to the 
authentication of the verbal order well after the verbal order has 
already been implemented.
    Response: We agree that the ``read-back'' verification process is a 
critical step in preventing medication errors and ensuring patient 
safety when verbal orders are used. We strongly support this practice 
as a national safety patient goal and expect hospitals to be actively 
working toward the achievement of this goal. However, ``read-back'' 
verification of a verbal order is just one critical measure designed to 
minimize errors and ensure patient safety. Authentication of verbal 
orders is another critical measure. Both of these important processes 
are supported by organizations such as the NCC MERP and ASHP. As part 
of a hospital's efforts to implement the JCAHO National Patient Safety 
Goals for Hospitals, as well as other nationally accepted guidelines 
and standards of practice, we would expect the hospital to implement a 
``read-back'' verification process when using verbal orders. We expect 
hospitals to comply with nationally accepted guidelines and standards 
of practice, such as the ``read-back'' verification process, to ensure 
patient safety and minimize medical errors regardless of whether they 
are contained in the regulatory text of the CoPs. Therefore, we have 
not included the ``read-back'' verification process in the final 
regulation text.
    Comment: One commenter stated that the proposed rule would benefit 
from adding the detail found in the ASHP ``Guidelines on Preventing 
Medication Errors in Hospitals''.
    Response: We expect hospitals to follow standards of practice and 
nationally accepted guidelines, such as those published by ASHP. 
However, given the number of standards of practice and practice 
guidelines that exist nationally, it would be impossible to include and 
maintain a complete, up-to-date set of standards and practices in the 
regulatory text. Clinical practice continuously evolves based on 
research findings, technology developments, and the needs of specific 
patient populations. Just because a practice standard or guideline is 
not contained in the regulation text does not mean that CMS does not 
support it.
    Several organizations, including ASHP, have published nationally 
accepted guidelines targeted at reducing medication errors and provide 
specific recommendations regarding the use of verbal orders. These 
guidelines serve as a strong foundation upon which hospitals can 
develop safe policies and practices. They include:
     ASHP, ``Guidelines on preventing medication errors in 
hospitals,'' 1993. http://www.ashp.org/bestpractices/MedMis/MedMis_Gdl_Hosp.pdf;
     ISMP, Medication Safety Alert! Acute Care: ``Reducing `at-
risk behaviors', October 7, 2004. http://www.ismp.org/Newsletters/acutecare/articles/20041007.asp?ptr=y
     ISMP, Medication Safety Alert! Acute Care, ``Instilling a 
measure of safety into those `whispering down the lane' verbal 
orders,'' January 24, 2001. http://www.ismp.org/MSAarticles/VerbalOrders.html; and,
     NCC MERP, ``Recommendations to reduce medication errors 
associated with verbal medication orders and prescriptions,'' February 
20, 2001. (http://www.nccmerp.org/council/council2001-02-20.html).
Authentication of Verbal Orders
    We proposed revisions that would broaden the category of 
practitioners who could authenticate orders. We proposed that all 
orders, including verbal orders, must be authenticated promptly by the 
prescribing practitioner or another practitioner who is responsible for 
the care of the patient as specified under Sec.  482.12(c) and 
authorized to write orders by hospital policy in accordance with State 
law for a period of 5 years following the effective date of this final 
rule.
    Comment: The vast majority of commenters voiced strong support for 
these proposed changes. Commenters welcomed the flexibility represented 
in these changes, and agreed that an authentication requirement is 
necessary to protect the health and safety of patients and to ensure 
quality, accountability and overall integrity of medical services 
rendered. One commenter stated that authentication of any type of 
orders in the hospital setting serves three distinct purposes that 
should be included in policy consideration: (1) Authentication is used 
to document and hold accountable the prescribing physician/practitioner 
for the medical necessity of the services ordered; (2) authentication 
is used to validate that hospital staff received, transcribed and 
performed orders appropriately, and (3) authentication is used to 
document that practitioners reviewed the patient medical record, 
findings and other relative documents when making medical decisions and 
interpretations.
    Another commenter stated strong agreement with CMS that this verbal 
order authentication requirement increases accountability for the 
service provided and verifies that the entry is complete and accurate. 
The commenter stated that the necessity for this requirement is 
evidenced by a JCAHO study indicating that most organizations (84 
percent) cited a breakdown in communication, most often (67 percent) 
with or between physicians, as one of multiple root causes leading to a 
sentinel event, defined by JCAHO as ``an unexpected occurrence 
involving death or serious physical or psychological injury, or risk 
thereof.'' The commenter stated that by the very nature of clinical 
practice in an Emergency Department, verbal orders are an essential 
component of emergency care, especially when a patient's condition 
rapidly deteriorates. The commenter stated that authentication of 
verbal orders enhances patient safety and minimizes the risk of medical 
errors by ensuring that the interdisciplinary communication that 
naturally occurs between practitioners in a busy Emergency Department 
environment is correct, complete, and implemented as intended to ensure 
positive patient outcomes. The commenter stated that such orders also 
enhance personal accountability of practitioners who issue and receive 
verbal orders and further augment provider performance by revealing 
potential discrepancies before inadvertent miscommunications can cause 
harm to patients.
    Commenters welcomed the proposed rule that would allow verbal 
orders to be dated, timed, and authenticated by the prescribing 
practitioner or another practitioner responsible for the care of the 
patient. One commenter stated that this approach reflects the needs of 
medical practice today and does not raise quality of care concerns. A 
commenter stated that the proposed changes at Sec.  482.23(c)(2) and 
Sec.  482.24 are both consistent with current hospital practices and 
help to clarify how hospitals and their staff must comply with the 
CoPs. The commenter further stated that in those cases when a 
practitioner gives an order, and then is

[[Page 68681]]

``off duty,'' it is appropriate that a practitioner other than the 
ordering practitioner be allowed to authenticate the order.
    Response: We appreciate the support. We agree that the 
authentication of verbal orders is critical to patient safety and 
quality care.
    Comment: One commenter did not agree that patient safety is 
compromised if a physician order is not authenticated and requested an 
example of such an occurrence. The commenter also asked how patient 
safety is enhanced by signing a verbal order the next day or the next 
week, and stated that the physician is responsible whether the verbal 
order is signed or not. Another commenter stated that he understands 
the perspective taken by CMS related to the importance of 
authentication of verbal orders from a provider accountability and 
hospital risk management standpoint; however, the commenter does not 
believe that authentication of verbal orders necessarily translates to 
improved patient safety and quality.
    Response: We agree that the practitioner giving a verbal order is 
responsible for the order whether it is authenticated or not. However, 
incomplete or incorrectly transcribed verbal orders present a risk to 
the patient's health and well being. If a verbal order for a onetime 
medication is not documented completely and accurately, patient harm 
can occur. Prompt correction of this verbal order can identify the 
error and ensure that appropriate patient follow up occurs as soon as 
possible. It can also be used to identify and correct related practice 
issues. Therefore, even though a verbal order may be authenticated 
after the order has already been implemented, authentication is 
important. If a verbal order for an ongoing medication is not 
documented completely and accurately, an ongoing medication error could 
occur and compromise the patient's health and well being. Prompt 
authentication of this verbal order could avoid ongoing medication 
errors. In addition to identifying and correcting the error, any 
necessary patient follow up as a result of the error can be implemented 
as soon as possible. Therefore, we believe that the authentication of 
verbal orders impacts patient safety and quality of care.
    Comment: One commenter stated that the proposed changes regarding 
verbal order authentication appears to place all the accountability and 
liability on the hospital personnel or facility-based professional who 
carry out the orders--including orders that the prescribing or ordering 
physician/practitioner may have issued unnecessarily or incorrectly. 
The commenter stated that he acknowledges that medical errors can occur 
due to documentation errors and has included in hospital bylaws 
safeguards requiring counter-signatures by the prescribing or ordering 
physician/practitioner within a defined time period. The commenter 
requested that CMS reconsider its position on eliminating the counter-
signature by the prescribing or ordering physician/practitioner on 
verbal orders and recommends that CMS maintain requirements for the 
prescribing or ordering physicians/practitioners to authenticate their 
verbal orders to ensure their accountability for ordered services (for 
example, attestation to medical necessity), but provide for greater 
flexibility by allowing other physician group members or physician 
employed non-physician practitioners to countersign on behalf of the 
prescribing physician. The commenter stated that this maintains the 
appropriate ``accountability'' for the service by the prescribing or 
ordering physician/practitioner.
    Response: This revised requirement does not, in any way, relieve 
the prescribing practitioner of his or her accountability and 
responsibility for the ordered service. The intent of the proposed 
revisions to the verbal order authentication requirements is to 
maximize the hospital's flexibility while maintaining patient safety 
and an appropriate level of accountability for both the hospital and 
prescribing practitioner for services rendered to the patient. We 
proposed that 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 Sec.  482.12(c) and authorized to write orders by 
hospital policy in accordance with State law. Under this proposed rule, 
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 write a specific order 
would be permitted to authenticate a verbal order, even if the order 
did not originate with him or her. This could include permitting other 
physician group members or non-physician practitioners to countersign 
on behalf of the prescribing physician based on hospital policy as 
recommended by the commenter. A hospital has the flexibility to limit 
who may authenticate a verbal order and could authorize only the 
prescribing practitioner to authenticate a verbal order.
    Comment: A commenter stated that many individuals are not 
comfortable signing another's orders and incurring the responsibility 
for the validity of the order. Another commenter expressed doubt that 
the proposed change to allow another provider caring for the patient to 
sign a verbal order for the prescribing provider would be held in high 
regard by the provider community. The commenter stated that they have 
multiple care providers with teaching services, and residents covering 
off-shifts, hence the utilization of telephone orders. The commenter 
stated that each provider may not necessarily see the patient in 
person. Finally, the commenter stated that the shorter length of stay 
also adds to the complexity of maintaining a signed hard-copy chart.
    Response: The proposed provision provides hospitals and 
practitioners the flexibility of permitting a verbal order to be 
authenticated promptly by the prescribing practitioner or another 
practitioner responsible for the care of the patient as specified under 
Sec.  482.12(c) and authorized to write orders by hospital policy in 
accordance with State law. However, this regulation does not require a 
practitioner responsible for the care of the patient to authenticate a 
verbal order that he or she did not give. Ultimately, the prescribing 
practitioner is responsible for authenticating the verbal order. A 
hospital has the flexibility to develop policies and practices to 
implement this regulation in a manner that makes sense for their 
hospital based on the needs of the patient population served. When a 
practitioner authenticates a verbal order that he or she did not give, 
the practitioner accepts responsibility for the order and is validating 
that the order is complete, accurate, and final based on the patient's 
condition. We expect a practitioner responsible for the care of the 
patient to have knowledge of the patient's hospital course, medical 
plan of care, condition and current status. A practitioner who does not 
possess this knowledge about a patient should not be authenticating 
verbal orders for this patient.
    When verbal orders are used, they must be used infrequently 
regardless of the patient's length of stay. When multiple practitioners 
are responsible for the care of a patient, there should be even fewer 
instances when verbal orders are necessary. Orders should be documented 
directly in the medical record by the prescribing practitioner either 
in writing or electronically. The use of verbal orders should be 
limited

[[Page 68682]]

to those situations in which it is impossible or impractical to write 
the order or enter it into the computer. Verbal orders are not to be 
used for the convenience of the ordering practitioner.
    Comment: One commenter stated that he does not support anyone other 
than the ordering practitioner authenticating verbal orders because it 
partially alleviates the ordering practitioner's accountability for the 
work he or she does. The commenter stated that only the ordering 
practitioner knows what their intentions were for a patient, not 
another practitioner.
    Response: We do not agree that the ordering practitioner's 
accountability for a verbal order is in any way decreased if another 
practitioner authenticates the order. When a practitioner authenticates 
a verbal order that he or she did not give, the practitioner accepts 
responsibility for the order and is validating that the order is 
complete, accurate, and final based on the patient's condition. We also 
do not agree that only the ordering practitioner knows what their 
intentions were for the patient when giving the verbal order. We expect 
a practitioner responsible for the care of the patient to have 
knowledge of the patient's hospital course, medical plan of care, 
condition and current status. We believe that a practitioner with this 
knowledge can safely evaluate the completeness and accuracy of a verbal 
order. If a practitioner does not possess this knowledge about a 
patient, the practitioner should not be authenticating a verbal order 
for the patient. If the practitioner has questions or concerns about 
the order, we would expect them not to authenticate the order and 
contact the prescribing practitioner to resolve any questions or 
concerns as soon as possible.
    Comment: One commenter requested clarification on what is meant by 
the requirement that verbal orders be legible, complete, dated and 
timed, and whether or not it is necessary for a physician to date and 
time the authentication of a verbal order.
    Response: This final regulation requires that all orders, including 
verbal orders, be legible, complete, dated, timed, and authenticated. 
Therefore, it would be necessary for a physician or other practitioner 
to date and time the authentication of a verbal order. The receiver 
should clearly record the order directly onto an order sheet in the 
patient's medical record or enter it directly into the computer. The 
receiver should date, time, ``read back,'' and sign the verbal order 
according to hospital policy. The prescriber or another practitioner 
responsible for the care of the patient must then verify, sign, date 
and time the order as soon as possible in accordance with hospital 
policy, and State and Federal requirements.
    Comment: One commenter requested clarification as to whether 
prescribing physicians/practitioners can use faxed or electronic 
signatures as a means to validate verbal orders.
    Response: Faxed or electronic signatures could be used to 
authenticate a verbal order. Authentication of a verbal order may occur 
in writing or electronically. The hospital must have a method to 
establish the identity of the practitioner who has authenticated a 
verbal order. This would include verification of the author of faxed 
verbal orders or computer entries. We would expect that hospital 
policies would address author verification processes for both written 
and electronic signatures.
    Comment: One commenter stated that discrepancies between the 
proposed rule and the current interpretive guidelines raise the 
question of whether hospitals which have recently effected policy and 
procedural changes to comply with the new interpretive guidelines would 
be required to make further changes in order to comply with new rules. 
The commenter also requested clarification regarding the temporary 5-
year exception to one aspect of the authentication requirements and 
whether hospitals would need to make still further changes upon 
termination of the exemption period.
    Response: Hospitals participating in the Medicare and Medicaid 
program are expected to comply with current CoPs. When a final rule is 
published, an effective date for the revised requirements is identified 
in the final rule. Upon the effective date, hospitals participating in 
the Medicare and Medicaid program are expected to comply with the new 
requirements. In addition, the interpretive guidelines will be revised 
based on the final rule.
    If CMS does not make the exemption permanent, then the individual 
ordering practitioner must authenticate his own verbal order. Hospitals 
are free, however, to maintain the more stringent requirement that 
verbal orders must be authenticated promptly by the prescribing 
practitioner and not permit another practitioner responsible for the 
care of the patient to authenticate verbal orders.
    Comment: One commenter stated that they are seeking to balance 
patient safety, ``common practice,'' and administrative problems 
associated with verbal orders. The commenter stated that from an 
administrative perspective, they appreciated the approach of allowing 
other qualified practitioners to sign an order and resolve some of the 
administrative barriers. However, the commenter stated concern that 
there are legal liabilities to such a practice that run contrary to the 
philosophy of patient safety, and that the proposed change may be 
illegal in some States. The commenter requested that if legality is not 
an issue that the requirement be modified to indicate that the 
qualified practitioners have some relationship to the patient's care, 
the medical service, or the medical practice. The commenter stated that 
to enhance patient safety, the practitioner should be more narrowly 
defined to ensure that he or she has the knowledge of the case, or 
service, to evaluate an order before signing it.
    Response: State laws may be more stringent than Federal 
requirements. If State law requires that the prescribing practitioner 
authenticate verbal orders, a practitioner other than the prescribing 
practitioner would not be permitted to authenticate verbal orders in 
that State. As proposed, this final rule requires that verbal orders be 
signed by the prescribing practitioner or another practitioner who is 
responsible for the care of the patient as specified under Sec.  
482.12(c) and authorized to write orders by hospital policy in 
accordance with State law. We expect a practitioner responsible for the 
patient's care to have knowledge of the patient's hospital course, 
medical plan of care, condition and current status.
    Comment: One commenter requested clarification as to whether a 
physician assistant or nurse practitioner who has prescriptive 
authority under State law is allowed to co-sign a physician's order.
    Response: A physician assistant or nurse practitioner may only 
authenticate verbal orders written by a physician or other licensed 
independent practitioner that they have authority to write themselves 
as determined by hospital policy in accordance with state law. For 
example, some hospitals limit who may give orders for certain types of 
drugs or therapies. If a physician assistant or nurse practitioner is 
not permitted by hospital policy to order a specific drug or therapy, 
he or she would not be permitted to authenticate a verbal order for 
such a drug or therapy. Hospitals have the flexibility to limit who may 
authenticate verbal orders.
    In addition, a physician assistant or nurse practitioner may only 
authenticate verbal orders for a patient for whom they have physician 
delegated responsibility. Like all practitioners responsible for the 
care of the patient, a physician assistant or nurse

[[Page 68683]]

practitioner would be expected to have knowledge of the patient's 
hospital course, medical plan of care, condition and current status. 
With this knowledge, a practitioner can safely evaluate the 
completeness and accuracy of a verbal order.
    Comment: A commenter requested that in the proposed Sec.  
482.24(c)(1)(i) and Sec.  482.24(c)(1)(ii), CMS replace the term 
``prescribing'' practitioner with the term ``ordering'' practitioner in 
keeping with Federal and State laws on prescriptive authority, current 
hospital practice and CMS objectives.
    Response: We agree. In this final rule, we are replacing the term 
``prescribing'' with the term ``ordering'' at Sec.  482.24(c)(i) and 
Sec.  482.24(c)(1)(ii).
Sunset Provision
    We proposed limiting the length of time that a practitioner other 
than the prescribing practitioner would be permitted to authenticate an 
order. We proposed that for the 5-year period 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 Sec.  482.12(c) and authorized to write 
orders by hospital policy in accordance with State law.
    Comment: Several commenters supported the 5-year sunset provision. 
One commenter stated that the 5-year timeframe is reasonable and should 
allow adequate time for evaluation. A few commenters stated that it 
will provide greater flexibility while health information technology 
continues to evolve to the point where the originating physician may 
authenticate his or her own orders in an efficient manner. Another 
commenter stated that the 5-year temporary provision provides hospitals 
with flexibility while maintaining an appropriate level of 
accountability. One commenter stated that the American Health 
Information Management Association is actively working with healthcare 
systems, vendors and others to promote the adoption of a standard 
electronic health record and the capability for all orders to be 
immediately authenticated, as they are dictated or written, 
electronically.
    Response: We appreciate the support of these commenters and the 
work being done to promote the use of electronic medical record 
systems.
    Comment: Several other commenters did not support the 5-year sunset 
provision. One commenter expressed concern that the proposed 5-year 
exception would expire prior to the technology actually being widely 
available and used. The commenter recommended replacing the 5-year 
sunset language with ``until such time as health information technology 
is sufficient to allow the originating physician to authenticate his or 
her own orders in an efficient and non cost-prohibitive manner.''
    Another commenter shared the current administration's interest in 
implementing electronic medical records. However, the commenter stated 
that it is highly unlikely that all hospitals in any given State would 
be able to afford to implement health information technology fully 
within the next 5 years. This commenter strongly urged CMS to authorize 
the authentication of verbal orders by practitioners who meet the 
specified criteria without any time limitation. The commenter stated 
that CMS can then assess after 5 years whether the implementation of 
health information technology has occurred and revise regulations at 
that time if necessary. The commenter stated that, otherwise, hospitals 
unable to implement health information technology would experience 
undue administrative burden in 5 years.
    A few commenters expressed concern about a potential gap between 
the expiration of the exception and the publication of new regulations. 
One commenter recommended revising the provision as follows: 
``exception is 5 years from the effective date following the date of 
the final rule, or the publication of new requirements, whichever comes 
later.'' Another commenter emphasized the need to re-evaluate the 5-
year ``temporary exception'' period in a systematic and timely manner. 
The commenter recommended that CMS begin planning this evaluation at 
least 12 months before the end of the 5-year period to allow for 
adequate time to assess the availability and capability of electronic 
health records and hospital information systems.
    Response: We appreciate the health care community's support of 
health information technology. We understand that the implementation of 
this technology requires an investment of hospital resources and that 
the rate of health information technology adoption and full 
implementation in hospitals varies across the country. We agree that 
this provision may need to be revised in 5 years based on the level of 
health information technology adoption and implementation at that time. 
We also agree that a policy decision must be made within a timeframe 
that avoids a gap between the expiration of the exception and the 
publication of a new regulation, if necessary.
Timeframe for Authentication of Verbal Orders
    We proposed revisions that would clarify the timeframe for 
authentication of verbal orders. We proposed that 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.
    Comment: Many commenters supported the proposed rule as written. 
Other commenters stated that they support the proposed change that all 
verbal orders must be authenticated based upon Federal and State law, 
but did not support the proposed 48 hour timeframe for authentication 
of verbal orders in the absence of a State law that designates a 
specific timeframe for the authentication of verbal orders. One 
commenter stated that he was unable to identify any study to support 
the theory that the 48-hour rule has any significant impact on 
preventing patient harm. Another commenter stated that while they would 
still prefer to allow ``hospitals and their medical staffs to establish 
their own policies on authentication of verbal orders,'' they supported 
the application of the 48-hour timeframe only to those States that do 
not currently have a timeframe in place for the verification of such 
orders.
    Another commenter stated that a timeframe for the authentication of 
verbal orders adds no value because if an order is issued and carried 
out promptly, as it should be, signing the order after the fact does 
nothing to reverse any misadventure that may have occurred due to an 
unsigned order. Several commenters stated that the 48-hour timeframe is 
burdensome for physicians, nurses and medical records staff.
    Response: We appreciate the support we received from commenters. 
Although there is little in the literature regarding an appropriate 
timeframe for authentication of verbal orders, the use of verbal orders 
is cited as an error-prone process by the JCAHO, ISMP, NCC MERP and 
ASHP. Authentication of a verbal order is an opportunity to identify a 
transcription error and minimize risk to patient safety. The goal is to 
intercept an error as soon as possible. Prompt authentication of a 
verbal order enables early identification and correction of an error. 
Early identification and correction of an error enables the 
practitioners to minimize or eliminate the risk to patient safety posed

[[Page 68684]]

by incomplete or incorrectly transcribed verbal orders.
    As discussed previously, verbal orders can be given for a variety 
of patient interventions, including medications and biologicals that 
direct staff to provide both onetime and ongoing patient care and 
treatments. If a verbal order for a onetime medication is not 
documented completely and accurately, patient harm can occur. 
Authentication of this onetime verbal order can identify the error and 
ensure that appropriate patient follow up occurs as soon as possible. 
Therefore, even though a verbal order may be authenticated after the 
order has already been implemented, authentication is important. If a 
verbal order for an ongoing medication is not documented completely and 
accurately, an ongoing medication error could occur and compromise the 
patient's safety and well being. Authentication of this verbal order 
could avert ongoing medication errors. In addition to identifying and 
correcting the error, any necessary patient follow up as a result of 
the error can be implemented as soon as possible. Therefore, we believe 
that the authentication of verbal orders impacts patient safety and 
quality of care.
    We do not agree that the 48-hour timeframe is unnecessarily 
burdensome. If verbal orders are used, they must be used infrequently. 
Therefore, practitioners and other hospital staff should not need to 
expend a great deal of time and energy ensuring that verbal orders are 
authenticated within 48 hours. However, if a hospital is not in 
compliance with this requirement and the use of verbal orders is 
routine or commonplace, compliance with this 48-hour requirement could 
seem daunting.
    We have also broadened the current requirement that states that 
verbal orders must be authenticated by the prescribing practitioner. 
This final rule provides hospitals flexibility by allowing a verbal 
order to be authenticated by the prescribing practitioner or another 
practitioner who is responsible for the care of the patient as 
specified under Sec.  482.12(c) and authorized to write orders by 
hospital policy in accordance with State law for a period of 5 years. 
The next time the prescribing practitioner or another practitioner 
responsible for the care of the patient assesses the patient or 
documents information in the patient's medical record, a verbal order 
should be authenticated. In an acute care setting, opportunities exist 
throughout the course of 48 hours for a verbal order to be 
authenticated by one of these practitioners.
    Comment: Many commenters stated that the ``repeat and verify'' 
process for verbal orders enhances patient safety more effectively than 
a timeframe for authentication of verbal orders after the service has 
been provided once or many times. Other commenters stated that if a 
verbal order is repeated and verified and considered acceptable by the 
ordering practitioner, the order need not be authenticated until the 
medical record is closed. Commenters further stated that if a verbal 
order is not repeated and verified, it should be authenticated within 
48 hours. Several commenters stated that their State law permits verbal 
orders that follow the ``repeat and verify'' process to be signed 
within 30 days of discharge; if the ``repeat and verify'' process is 
not implemented, verbal orders must be authenticated within 48 hours. 
One commenter stated that their State law requires repetition and 
verification of verbal orders if a physician does not want to 
authenticate within 48 hours.
    Response: We agree that the ``repeat and verify'' process for 
verbal orders enhances patient safety. We expect hospital policies and 
practices to implement this practice when verbal orders are used 
regardless of whether the physician wants to authenticate the order 
within 48 hours. Implementation of this nationally recognized safe 
practice should not be hampered by practitioner convenience or 
preference. However, the ``repeat and verify'' process is just one 
critical measure designed to minimize errors and ensure patient safety 
when verbal orders are used. Authentication of verbal orders is another 
critical measure. Both of these important processes are supported by 
organizations such as the NCC MERP and the AHSP. Implementation of the 
``repeat and verify'' process does not negate the need for prompt 
authentication of verbal orders. Neither of these practices alone can 
ensure patient safety as effectively as both can when used together.
    Comment: One commenter stated that their State law, which permits a 
30-day timeframe for authentication of verbal orders if the ``repeat 
and verify'' process is followed, is acceptable and does not jeopardize 
patient care. A commenter requested clarification regarding whether a 
State law providing for a 30-day timeframe for the authentication of 
verbal orders if the order is ``repeated and verified'' is acceptable. 
A few commenters requested clarification of what is meant by the word 
``promptly.''
    Response: We are not aware of any data that would support the 
commenter's statement that a 30-day timeframe for authentication of 
verbal orders is acceptable and does not jeopardize patient care. We 
are also not aware of any data that define a specific timeframe for the 
authentication of verbal orders. Although authentication of verbal 
orders is supported by national organizations such as NCC MERP and 
ASHP, neither of these organizations specifies a timeframe for 
authentication of verbal orders.
    The prompt authentication of all medical record entries, including 
verbal orders, has been a requirement for hospitals since 1986 (Sec.  
482.24(c)(1)). The Merriam-Webster online dictionary \7\ defines 
``prompt'' as performed readily or immediately. A 30-day timeframe for 
authentication of verbal orders would not be consistent with this 
requirement. Authentication of a verbal order represents an opportunity 
to identify a transcription error and potential risk to patient safety. 
Prompt authentication of a verbal order enables early identification 
and correction of an error. Early identification and correction of an 
error enables the practitioners to minimize or eliminate the potential 
risk to patient safety. A 30-day timeframe for authentication is not 
consistent with the intent to intercept an error as soon as possible.
---------------------------------------------------------------------------

    \7\ The Merriam-Webster Online Dictionary. http://www.merriamwebster.com/dictionary/promptly.
---------------------------------------------------------------------------

    It is possible that some States misinterpreted the intent of the 
Medical Records CoP at Sec.  482.24(c)(2)(viii). This provision 
requires final diagnosis with completion of medical records within 30 
days following discharge. It was not our intent for this requirement to 
support authentication of verbal orders 30 days following the patient's 
discharge. This requirement addresses a specific issue and does not 
negate the requirement for prompt authentication of all medical record 
entries, including verbal orders, at Sec.  482.24(c)(1) or other 
specific timeframe requirements found in other CoPs. For example, the 
H&P examination must be placed in the patient's medical record within 
24 hours after admission. A hospital would be noncompliant if the H&P 
examination was not placed in the medical record until 30 days 
following discharge. Likewise, if the postanesthesia evaluation was not 
completed and documented within 48 hours of surgery, a hospital would 
be found noncompliant.
    However, given the lack of data supporting a specific timeframe for 
authentication of verbal orders, the lack of consensus on a timeframe 
for authentication of verbal orders (as evidenced by the wide 
variability of timeframes specified in State law from

[[Page 68685]]

24- to 48-hours up to 30 days after discharge), and many public 
comments stating support for deferring to State law on this issue, we 
have finalized this provision as proposed. We will continue to defer to 
State law on this issue. In the absence of a State law, verbal orders 
must be authenticated within 48 hours. As hospitals continue to adopt 
health information technologies, the prompt authentication of all 
medical record entries, including verbal orders, will become less 
burdensome for hospitals.
    Comment: A few commenters stated that they support the current 
requirement that verbal orders for the administration of drugs or 
biologicals must be signed or initiated by the prescribing practitioner 
as soon as possible. Another commenter stated that current 
authentication requirements for prescribing practitioners may appear to 
be burdensome. However, the commenter stated that they do not believe 
the requirements are burdensome in their nature, but rather, are 
burdensome because the current requirement language, ``as soon as 
possible'' sets an arbitrary standard that cannot be operationalized or 
enforced. The commenter recommended that CMS define a ``reasonable'' 
timeframe for verbal orders to be documented, authenticated, and 
counter-signed in the patient medical record that is enforceable and 
can be incorporated into hospital policy and procedure. The commenter 
stated that since CMS is considering an H&P to be evident in the 
medical record within 24-48 hours, he recommended that CMS apply the 
same time standard for verbal orders.
    Response: We appreciate the support for authentication of verbal 
orders as soon as possible. We agree that 48 hours is a reasonable and 
enforceable timeframe for authentication of verbal orders. It clarifies 
the current expectation of ``as soon as possible'' and supports patient 
safety. Therefore, we have finalized this provision as proposed. All 
verbal orders must be authenticated based upon Federal and State law. 
In the absence of a State law that designates a specific timeframe for 
the authentication of verbal orders, verbal orders must be 
authenticated within 48 hours.
    We agree that current requirements are not necessarily burdensome. 
Hospital burden related to verbal order authentication can be 
minimized. Hospitals must evaluate current practices and policies, and 
implement measures that minimize the use of verbal orders. If a 
hospital permits the routine, frequent use of verbal orders, not only 
is the hospital out of compliance with the CoPs, but the hospital has 
created a tremendous authentication burden. The use of verbal orders 
should be limited to those situations in which it is impossible or 
impractical for the prescribing practitioner to write the order either 
manually or electronically. These situations should become even less 
frequent as hospitals implement electronic medical record and 
computerized physician order entry systems. As hospitals minimize the 
use of verbal orders, they will also minimize the burden associated 
with their authentication. In addition, when it is necessary to use a 
verbal order, this final rule gives hospitals more flexibility in terms 
of who may authenticate the verbal order.
    Comment: A commenter stated that establishing a 48-hour requirement 
would not change the fact that some verbal orders would continue to be 
unsigned at discharge and health information management staff will 
continue to expend resources chasing physicians to sign orders. 
Instead, the commenter recommended that no verbal orders be allowed if 
CMS wants to put teeth in its rules. The commenter stated that patient 
safety would be improved by the physician actually writing the order, 
typing it into an email, faxing an order, or using a computerized order 
entry system.
    Response: We acknowledge the fact that establishing a 48-hour 
requirement may not eliminate unsigned verbal orders. However, the use 
of verbal orders must not be commonplace. We agree that the use of 
technology such as computerized physician order entry, fax and email 
should be used to minimize the use of verbal orders whenever possible. 
However, we do not believe it is in the best interest of patient safety 
to disallow the use of verbal orders. Even when 100 percent of 
hospitals in the nation have completely implemented a computerized 
medical record and computerized physician order entry, there would 
still be those situations in which it is impossible or impractical for 
the prescriber to write the order or enter it in the computer (for 
example, in medical emergencies, or when the practitioner is scrubbed 
in the operating room). Thus, the need for verbal orders would continue 
to exist.
    Comment: In contrast, another commenter recommended that CMS add 
further provisions that waive or delay the ``time'' element on verbal 
orders during a ``medical emergency'' when staff are not able to stop 
and document orders without jeopardizing the patient's health. A 
possible solution would be to allow for an independent scribe to 
document verbal orders in those instances and then have the physician/
practitioners sign, date, and time once the patient is stabilized.
    Response: We agree the use of verbal orders is often necessary 
during a medical emergency. We would expect the hospital to have 
policies and procedures that ensure that the necessary emergency care 
is provided to the patient without delay and appropriate documentation 
of emergency care. In an emergency situation, it is standard practice 
for verbal orders to be documented, dated and timed by someone other 
than the ordering practitioner, and then authenticated, dated and timed 
by the ordering practitioner once the patient has been stabilized. It 
is also standard practice in an emergency situation for the 
practitioner administering a medication to repeat the verbal order back 
to the ordering practitioner.
    Comment: One commenter stated disagreement with the 48-hour 
authentication requirement due to the additional burden on physicians 
in residential facilities located in a psychiatric hospital. Current 
regulations require a patient to be seen by their attending physician 
as required by the condition of the patient. The medical staff is only 
expected to see their patients once or twice weekly. The requirement to 
sign verbal orders within 48 hours would negate the once to twice 
weekly expectation these physicians have scheduled themselves to for 
many years. The commenter stated that many residential facilities must 
be compliant with the CMS hospital regulations.
    Response: Psychiatric hospitals participating in the Medicare and 
Medicaid programs must comply with the hospital CoPs. If a residential 
unit is considered a unit of a hospital, the unit must comply with the 
hospital CoPs. If verbal orders are used, they must be used 
infrequently. The final rule permits verbal orders to be authenticated 
by the prescribing practitioner or another practitioner who is 
responsible for the care of the patient.
    The current regulation text cited by the commenter is contained in 
the specialty requirements for psychiatric hospitals at Sec.  482.61. 
Section 482.61(d) states:

    ``Progress notes must be recorded by the doctor of medicine or 
osteopathy responsible for the care of the patient as specified in 
Sec.  482.12(c), nurse, social worker and, when appropriate, others 
significantly involved in active treatment modalities. The frequency 
of progress notes is determined by the condition of the patient but 
must be recorded at least weekly for the first 2 months and at least 
once a month thereafter and must contain recommendations for 
revisions in the

[[Page 68686]]

treatment plan as indicated as well as precise assessment of the 
patient's progress in accordance with the original or revised 
treatment plan.''

    This standard addresses the frequency of progress notes. It does 
not address the frequency of physician visits. Even if the attending 
physician does not see the patient on a daily basis, we would expect 
another practitioner responsible for the care of the patient to be in 
attendance in a hospital setting. How often the medical staff is 
required to see a patient is determined by the patient's condition and 
hospital policy. In the situation described by the commenter, hospital 
policy may need to be revised to ensure compliance with the CoPs and 
State law.
    Comment: One commenter recommended that we consider specifying a 
calendar day timeframe for verbal order authentication instead of in 
hours.
    Response: The revised regulations now include timing of verbal 
order authentication. This supports a requirement for a verbal order 
authentication timeframe in 48 hours versus two calendar days. A 
timeframe stated in calendar days could be ambiguous and unclear, and 
could vary from situation to situation and hospital to hospital. For 
example, a verbal order is documented on a Wednesday at 12 noon. A 48-
hour timeframe for authentication would clearly require that the verbal 
order be authenticated by 12 noon on Friday. Conversely, calendar days 
are less clear. In the previous example, it would be less clear when 
the verbal order must be authenticated. The outside timeframe for two 
calendar days could be interpreted as 12 noon Friday, or as 12 midnight 
Friday. Our intent is to ensure consistency in the timeframe for 
authentication of verbal orders. Therefore, we have retained the 48-
hour timeframe for authentication of verbal orders in the final rule.
    Comment: A few commenters asserted that the 48 hour authentication 
requirement for verbal orders would place undue burden on the hospital 
and physician in both urban and rural areas. One commenter stated that 
members of the medical staff asserted that the 48 hour authentication 
requirement for verbal orders would cause significant ``bottle-
necking'' at time of discharge and would increase length of stay. The 
commenter stated concern that any order not signed within 48 hours 
might become invalid and cause problems with insurance fraud. The 
commenter also stated that this would eliminate their ability to 
electronically complete this portion of the medical record. The 
commenter stated that a major concern is with the non-compliance with 
regard to ``verbal orders'' (telephone and verbal) today as measured 
using the expectation of 30 days. The commenter stated that compliance 
with the 48-hour limit would be extremely difficult, adding to their 
already high non-compliance rate. The commenter also stated that 
shorter lengths of stay add to the complexity of maintaining a signed 
hard-copy chart. Another commenter stated that while they understand 
the value of authentication of orders, the 48-hour time frame for 
authentication of verbal orders would be very difficult to meet in 
rural areas as they were working with limited resources and have a very 
small medical staff.
    A few commenters stated that the 48-hour requirement would be 
burdensome in outpatient hospital physical therapy settings where there 
is less contact with and less supervision from the attending physician, 
and treatment is often begun with a verbal order. These commenters 
requested that this proposed requirement be limited to inpatient 
settings or that the current language requiring prompt authentication 
of verbal orders be maintained.
    Response: The fundamental issue raised by these commenters is the 
apparent routine use of verbal orders. We agree that the routine use of 
verbal orders and their subsequent authentication could create a 
tremendous burden for both the hospital and practitioners regardless of 
an urban or rural setting. However, this is a costly burden created by 
the hospital and practitioners who tolerate the routine use of verbal 
orders in their daily practice and the resulting risk to patient 
safety.
    The use of verbal orders is nationally recognized as an error prone 
process that poses an increased risk of miscommunication that could 
result in adverse effects, including medication errors, for patients. 
If verbal orders are used, they must be used infrequently. This means 
that the use of verbal orders must not be a common practice. This is 
not a new requirement. The requirement for the infrequent use of verbal 
orders has been part of the hospital CoPs since 1986. We expect that 
this requirement be reflected in hospital policy as well as in actual 
practice. If the use of verbal orders is common practice, the hospital 
is out of compliance with the CoPs. Current ordering practices in the 
hospital should be evaluated and measures implemented to minimize the 
use of verbal orders.
    We recognize the challenges that a decreased patient length of stay 
presents and that more frequent order changes and more immediate 
response to patient needs may be necessary. However, we do not agree 
that these factors necessarily translate into the need for the frequent 
use of verbal orders. We expect hospitals to have systems in place to 
enable staff to address patient needs on a timely basis without 
routinely resorting to the use of verbal orders. A hospital's concern 
about potential insurance fraud issues is another reason for hospitals 
to minimize the use of verbal orders. We recognize that there are times 
when verbal orders are necessary, but their use must be infrequent. The 
use of verbal orders should be limited to those situations in which it 
is impossible or impractical for the prescriber to write the order or 
enter it into the computer. Verbal orders are not to be used for the 
convenience of the ordering practitioner. Hospital policy and practice 
should discourage the use of verbal orders as much as possible. When it 
is necessary to use a verbal order, this final rule gives hospitals 
more flexibility in terms of who may authenticate the verbal order.
    We do not see why this requirement would eliminate a hospital's 
ability to complete this portion of the medical record electronically. 
In fact, this requirement could serve as an impetus for a hospital to 
adopt and implement information technology such as electronic medical 
record and computerized physician order entry systems.
    Finally, the hospital CoPs apply to both inpatient and outpatient 
settings. It would not be in the best interest of patient health and 
safety to exempt any particular provider or patient care setting in a 
hospital from this requirement. Everyone providing patient care is 
accountable for safe care.
    Comment: A few commenters stated that in the absence of State law, 
hospital policy should prevail, and recommended that CMS delete a 
specific time frame as to when hospitals must ensure authentication of 
verbal orders. One commenter stated that CMS should also require that 
hospital policies and procedures identify which types of orders, such 
as orders for high-alert medications, may warrant more timely 
authentication than orders that do not carry the same risk of patient 
harm.
    Response: All verbal orders need to be authenticated to support 
continuity of care and patient safety. It is not logical to require 
authentication for only select ``high-alert'' medications. What is high 
risk for one patient may not be high risk for another patient. In 
addition, errors can be made in the documentation of a verbal order. A 
verbal order that is incorrectly documented may result in

[[Page 68687]]

the wrong medication being administered or the correct medication being 
administered via the wrong route or at the wrong dose. These errors 
pose a risk to a patient regardless of whether or not the medication is 
considered to be a ``high-alert'' medication.
    Hospitals do, however, have the flexibility to develop policies 
that are more stringent. A hospital may decide that verbal orders 
cannot be given or accepted for certain types of high risk drugs. For 
example, many hospitals do not permit verbal orders for 
chemotherapeutic agents. Additionally, many hospitals already require 
that verbal orders be authenticated within 24 hours.
    Comment: One commenter stated that in some States in which the law 
does not provide a specific timeframe, the law would have to be amended 
through a statutory or regulatory amendment process which takes time. 
In the meantime, hospitals would have to make changes to comply with 
the new 48-hour rule, and then change again to the timeframe designated 
in their new State rule. The constant changing of procedures is 
confusing to staff, and presents an unnecessarily burdensome challenge 
to hospitals.
    Response: Whether or not a hospital needs to implement changes in 
policy and procedure as a result of this final rule will vary from 
hospital to hospital. It is not uncommon for current hospital policies 
to be more stringent and require that verbal orders be authenticated 
within 24 hours. In addition, individual States may or may not choose 
to amend their laws based on this final rule. If a State chooses to 
adopt a timeframe for the authentication of verbal orders that is 
longer than 48 hours, a hospital can choose to maintain a more 
stringent timeframe in their policy. Conversely, if a State chooses to 
adopt a more stringent timeframe, hospital policy may not be more 
lenient and policy changes would be necessary. Hospitals are expected 
to maintain compliance with State and Federal regulations as well as 
their own policies at all times.
    Comment: One commenter stated that the language proposed under 
Sec.  482.24(c)(1)(iii) should be corrected to read: ``All verbal 
orders must be authenticated based upon Federal or (not `and') State 
law.'' The commenter stated that as currently written, it is not 
possible for hospitals to comply with both Federal and State law if 
State law is different than 48 hours.
    Response: As a general rule, when Federal and State law are 
different, we expect a hospital to comply with the more stringent 
requirement. However, in this provision, the Federal requirement of 48 
hours is only applicable in the absence of a State law that designates 
a specific timeframe for the authentication of verbal orders. 
Therefore, we have finalized the provision as proposed.
    Comment: One commenter stated concern about current interpretive 
guidelines and urged CMS to cease implementation of the new 
interpretive guidelines related to the authentication of verbal orders.
    Response: Current interpretive guideline revisions are beyond the 
scope of this rule. However, when these final regulations are 
effective, the interpretive guidelines will be revised accordingly to 
reflect the final regulations.
Section 482.24 Condition of Participation: Medical Record Services
    We proposed adding ``timed'' to the existing medical records 
documentation requirements. We proposed that 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.
    Comment: A few commenters objected to the requirement that all 
medical record entries be timed and requested that this requirement be 
deleted. Some commenters acknowledged that timing of all entries in the 
patient record is good practice, but not the current standard of 
practice for such things as progress notes by professionals other than 
nursing. One commenter stated that this requirement would be difficult 
for hospitals to comply with unless the medical record is computerized. 
A commenter who strongly objected to timing all medical record entries 
stated that currently, health care providers time only those medical 
record entries that require timing for clinical reasons, that is, blood 
draws. This commenter stated that there is no clinical need to time 
basic progress notes and that this requirement would also create an 
issue for nursing flow sheets with check boxes that are not timed. This 
commenter asserted that this requirement significantly increases 
administrative burden. Another commenter requested clarification of the 
preamble language in the March 25, 2005 proposed rule (71 FR 15270) 
regarding Sec.  482.24(c)(1)(i). The commenter indicated that this 
proposed provision would require that all orders, including verbal 
orders, be dated, timed, and authenticated promptly by the prescribing 
practitioner, with few exceptions, and recommended that the word 
``timed'' be deleted from the final rule or that it be clarified to 
state that the requirements to time the entry applies only to the 
authentication of verbal orders.
    Response: The timing of medical record entries is crucial for 
patient safety and quality of care. Timing applies to all medical 
record entries, not just to the authentication of verbal orders. This 
would include orders, progress notes, procedure notes, patient 
assessments, H&Ps, etc. Timing establishes when an order was given, 
when an activity, intervention, treatment, or procedure occurred, or 
when an activity, intervention, treatment or procedure is to take 
place. Timing and dating of entries establishes a baseline for future 
actions or assessments and establishes a timeline of events. Many 
patient interventions or assessments are based on time intervals or 
time lines of various signs, symptoms, or events.
Authentication of Medical Record Entries
    We proposed minor revisions that would clarify that all patient 
medical record entries must be legible, complete, dated, timed, and 
authenticated in written or electronic form.
    Comment: One commenter requested that CMS move away from requiring 
that all entries be authenticated due to the burden it would impose. 
The commenter stated that the JCAHO requires authentication, at a 
minimum, for H&Ps, operative reports, consults, discharge summaries and 
other entries in accordance with law or regulation and hospital policy. 
The commenter stated that if CMS requires authentication for all 
entries, they support the 5-year exception to accommodate advancements 
in health information technology and the plan to re-evaluate these 
advances prior to the end of the 5-year period.
    Response: The requirement that all medical record entries be 
authenticated is not a new requirement. This requirement has been in 
place since 1986. The proposed requirement that all medical record 
entries be timed is the only substantive proposed change to this 
particular provision. We do not believe that retaining this requirement 
adds additional burden as hospitals have been subject to this 
requirement for a significant period of time. Hospitals have 
incorporated the authentication of all medical record entries as part 
of standard operating procedures. As discussed throughout this 
preamble, authentication is a critical measure that supports patient 
safety. We expect authentication

[[Page 68688]]

requirements to become less of an issue as hospitals continue to 
implement health information technologies, including an electronic 
medical record.
    We recognize that JCAHO authentication requirements differ from CMS 
standards. However, Medicare participating hospitals must comply with 
the Medicare hospital CoPs. JCAHO standard IM.6.10, element of 
performance number 4 does, in fact, refer to our regulations by stating 
that ``medical record entries are dated, the author identified and, 
when necessary, according to law, regulation or hospital policy, 
authenticated, either by written signature, electronic signature, or 
computer key or rubber stamp.''

C. Securing Medications

    We proposed revisions to provide hospitals with greater flexibility 
in terms of storage of non-controlled substances. These proposed 
revisions are in response to concerns expressed by the medical 
community related to carts containing medications as well as 
medications kept at the patient's bedside. We proposed that all drugs 
and biologicals must be kept in a secure area, and locked when 
appropriate. We proposed 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, and that only authorized 
personnel may have access to locked areas.
    Comment: Anesthesia professionals as well as other commenters 
overwhelmingly supported these proposed revisions, particularly as it 
relates to anesthesia carts in the operating room and labor and 
delivery. Commenters stated that the proposed changes address concerns 
of the medical community, provides flexibility for hospitals in 
determining control of nonscheduled drugs and biologicals, and is more 
patient-focused and outcome-oriented than the current requirements. 
Commenters stated the proposed language would help to ameliorate 
patient safety and practical anesthesia practice concerns as well as 
help to ensure that medications are not accessible to those persons who 
might tamper with, abuse and/or distribute these medications. A 
commenter stated that this revision is consistent with the ``ASHP 
Technical Assistance Bulletin on Hospital Drug Distribution and 
Control'' \8\ document which states, ``Storage is an important aspect 
of the total drug control system * * * Storage areas must be secure: 
Fixtures and equipment used to store drugs should be constructed so 
that drugs are accessible only to designated and authorized 
personnel.'' Commenters stated that the proposed changes will provide 
hospitals flexibility in determining which non-controlled drugs and 
biologicals need to be stored in locked areas versus which can be 
stored in secured and monitored areas that are only accessible to 
authorized hospital personnel.
---------------------------------------------------------------------------

    \8\ American Society of Hospital Pharmacists. ASHP technical 
assistance bulletin on hospital drug distribution and control. Am J 
Hosp Pharm. 1980;37:1097-103. http://www.ashp.org/bestpractices/drugdistribution/Distrib_TAB_Hosp.pdf.
---------------------------------------------------------------------------

    Several commenters stated that the current regulation is too 
restrictive and has led to unnecessary and redundant security 
requirements for anesthesia personnel resulting in delays in care. 
Several commenters stated that there has never been any question that 
controlled drugs must be locked. However, the commenters stated that 
locking non-controlled medication on top of or in anesthesia carts 
between cases in a busy operating room is a threat to patient safety. 
Commenters stated that emergency carts and anesthesia carts need to be 
readily available in order to treat patients in imminent danger. The 
commenter stated that emergency carts should be sealed, for example, 
tamper-evident, but never locked. Commenters stated that delayed access 
to needed medications could be lethal. Commenters listed broken locks, 
lost keys, and forgotten combinations or security codes among the 
shortcomings of equipment used to lock anesthesia medications. One 
commenter stated that there is an inherent conflict between 
accessibility and security. One commenter stated that he supported the 
proposed revision in light of technology advances such as omnicells and 
pixus.
    Response: We appreciate the strong support of commenters on these 
proposed revisions. We acknowledge that there can be a conflict between 
accessibility and security. We agree that it is critical for 
resuscitation drugs to be readily accessible and available when needed 
for patient care. We also recognize the need to set up anesthesia and 
other carts in advance preparation for use in the operative or labor 
and delivery suites. 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,'' 
http://www.asahq.org/clinical/LockedCartPolicyFinalOct2003.pdf.
    The intent of these revisions is to enhance patient safety and 
minimize delays in care. However, patient safety can also be at risk 
when drugs or biologicals are missing or not readily available for 
patient care. The security of drugs and biologicals is essential to 
patient safety. All controlled substances must be kept locked. 
Therefore, we expect hospitals to implement and maintain appropriate 
safety mechanisms to control drugs and biologicals to ensure the health 
and safety of its patients. We agree that technology, such as Omnicells 
and Pixus medication storage units, assists hospitals in controlling 
drugs and biologicals.
    Comment: Several commenters requested clarification of the 
definition of ``authorized personnel.'' Commenters stated that the 
definition of ``authorized personnel'' needs to include ancillary 
support personnel such as engineering, housekeeping staff, orderlies 
and security when needed to perform their assigned duties. One 
commenter stated that hospitals should have the latitude to determine 
who authorized persons are based on State law and local conditions.
    Response: This final rule provides hospitals with the flexibility 
to define which personnel have access to locked areas based on their 
own needs as well as State and local law. The definition of 
``authorized personnel'' should be addressed in hospital policies and 
procedures. Hospitals may or may not choose to include the categories 
of staff mentioned by commenters in their definition of ``authorized 
personnel.''
    Comment: Several commenters requested clarification of ``secure 
area.'' Commenters stated that they considered the operating room, 
delivery room, or similar critical care area to be secure locations 
when in use. One commenter agreed that areas restricted to authorized 
personnel would generally be considered ``secure'' under the proposed 
revisions. This commenter recommended that the regulations require that 
access to operating room suites be strictly limited to authorized 
persons. Another commenter supported the statement in the preamble of 
the proposed rule that secure areas would be those areas where 
``patients and visitors are not allowed without the supervision or 
presence of a healthcare professional.''
    Response: The goal of this provision is to provide hospitals 
flexibility in the storage of non-controlled drugs and biologicals when 
delivering patient care, and the safe guarding of drugs and biologicals 
to prevent tampering or diversion. An area in which staff are actively 
providing patient care or preparing to receive patients, that is, 
setting up for procedures before the arrival of a patient, would 
generally be considered a ``secure area.'' For example, the operating 
room suite

[[Page 68689]]

would be considered secure when the suite is staffed and staff are 
actively providing patient care. When the entire suite is not 
operational or otherwise not in use, for example, weekends, holidays, 
and after hours, the suite would not be considered secure. When the 
suite is closed or otherwise not in use, we would expect all drugs and 
biologicals to be locked. A hospital may choose to lock the entire 
suite, lock non-mobile carts containing drugs and biologicals, lock 
mobile carts containing drugs and biologicals within a locked room, or 
otherwise lock drugs and biologicals within a secure area. When 
individual operating rooms are closed or otherwise not in use, we would 
expect a hospital to lock non-mobile carts containing drugs and 
biologicals and lock mobile carts containing drugs and biologicals 
within a locked room. Generally, labor and delivery suites and critical 
care units are staffed and actively providing patient care around the 
clock, and would be considered secure areas. In addition, we expect 
hospital policies and procedures to ensure that these areas are secure 
with entry and exit limited to appropriate staff, patients, and 
visitors. All controlled substances would need to be locked within a 
secure area regardless of whether a patient care area is staffed or 
actively providing patient care.
    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, 
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, ambulatory 
infusion), they are considered secure. 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.
    Comment: One commenter cited the current interpretive guidelines 
that if an anesthesia cart, nursing or other ``cart containing drugs or 
biologicals is in use and unlocked, someone with legal access to the 
drugs and biologicals in the cart must be close by and directly 
monitoring the cart.'' The commenter requested that CMS clearly state 
that the final rule does not require direct monitoring of an unlocked 
anesthesia cart in an operating suite that is in use. Another commenter 
stated that medication carts should remain locked or in line of sight 
of a licensed practitioner, but should not require additional security.
    Response: This final rule does not address interpretive guidelines. 
The interpretive guidelines will be revised once this rule is 
finalized. This final rule requires that all drugs and biologicals be 
secure, and locked when appropriate. We expect hospital policies and 
procedures to address the security and monitoring of any carts, locked 
or unlocked, containing drugs and biologicals in all patient care areas 
to ensure their safe storage and to ensure patient safety.
    Comment: Commenters agreed that a hospital must monitor issues 
related to medication security, and reassess and modify its systems and 
process as needed.
    Response: We appreciate the support. We would expect hospitals to 
reevaluate their policies, procedures, systems and processes related to 
the safe storage of all drugs and biologicals periodically, regardless 
of whether there is evidence of tampering or diversion.
    Comment: One commenter requested that CMS give more guidance as to 
what ``locked when appropriate'' means.
    Response: All controlled substances must be locked. We expect all 
non-controlled substances to be locked when a patient care area is not 
staffed. Hospitals have the flexibility to determine the most effective 
way to safeguard non-controlled drugs and biologicals when they are not 
locked. We expect hospitals to develop, implement and evaluate 
policies, procedures and practices to keep medications and biologicals 
secure and to minimize the risk of tampering and diversion as much as 
possible. Hospitals may choose to keep all non-controlled drugs and 
biologicals locked at all times. Hospitals may choose to keep non-
controlled drugs and biologicals secure when a patient care area is 
staffed. We expect that hospitals would tighten their security measures 
when there is evidence of tampering or diversion of any drugs or 
biologicals. We realize that the security of drugs and biologicals 
cannot be guaranteed. However, for the safety of patients and quality 
of care, hospitals need flexibility regarding the security of non-
controlled substances.
    Comment: Commenters strongly supported the proposed provision 
related to patient self-administration of medication at the bedside 
citing standard medical practice that allows urgently needed 
medications to be available at the patient's bedside. Commenters stated 
that the current requirements are burdensome and potentially harmful to 
patients when medications, such as nitroglycerine and inhalers cannot 
be accessed in a timely and effective manner. One commenter requested 
clarification of whether patients are considered ``authorized'' to keep 
non-controlled medications at the bedside.
    One commenter stated that JCAHO defines self-administration as 
including instances when a patient independently uses a medication. The 
commenter stated that the JCAHO standards on self-administration 
outline the safe and accurate administration of medication including 
patient education on dosage, frequency, route of administration and 
monitoring of potential side effects. The commenter recommended that 
CMS revise the CoP to specifically address the acceptability of patient 
self-administration of drugs and biologicals.
    Response: This final rule gives hospitals the flexibility to 
integrate patient self-administration of drugs and biologicals into 
their practice as appropriate. This final rule is consistent with the 
current practice of giving patients access to urgently needed 
medications, such as nitroglycerine tablets and inhalers, at the 
patient's bedside. It supports the current practice of placing selected 
nonprescription medications at the bedside for the patient's use, such 
as lotions and creams and rewetting eye drops. Finally, this final rule 
supports hospitals in the development of formal 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.
    We would expect hospital policies and procedures to address patient 
self-administration of medications. When a hospital allows a patient to 
self-administer medication, the hospital authorizes the patient to have 
access to these medications. We expect hospitals to implement measures 
to secure bedside medications. We agree that self-administration 
includes those instances where a patient independently uses a 
medication. Hospital policies and procedures should address competence 
of the patient to self-administer medications, patient education 
regarding self-administration of medications including elements 
outlined by JCAHO standards, as well as measures to secure medications 
at the bedside.

[[Page 68690]]

    Comment: One commenter requested that sodium chloride solution in 
the form of saline flush and respiratory saline be exempt from the 
standards. The commenter stated that these items are completely 
innocuous, and are excipients, rather than medications.
    Response: It is not in the best interest of patient safety to 
exempt any drug or biological from this requirement. Although a saline 
flush or respiratory saline may have an extremely low risk of 
diversion, the possibility of tampering exists. It may not be necessary 
to lock these items but they must be secured. We also acknowledge that 
it may be common practice for clinicians to carry items such as these 
on their person. Therefore, we would expect hospital policy to address 
the security of these items as well.
    In summary, no changes were made to the proposed regulations based 
on public comment. The regulations have been finalized as proposed.

D. Completion of the Postanesthesia Evaluation

    We proposed that, with respect to inpatients, a postanesthesia 
evaluation must be completed and documented by an individual qualified 
to administer anesthesia within 48 hours after surgery.
    Comment: Anesthesia professionals as well as other commenters 
overwhelmingly supported this proposed revision. Commenters stated that 
implementation of the proposed change would give hospitals greater 
flexibility in meeting the needs of patients, ensure high quality 
patient care, and impose less burden than the current requirement. One 
commenter stated that this is a change that the ASA has been seeking 
for some time. Another commenter stated that this proposed revision 
``gives hospitals and anesthesiology departments much needed 
flexibility to deploy anesthesiologist, anesthesiologist assistants and 
nurse anesthetists so as to ensure the highest quality and timeliness 
of postoperative anesthesia care.'' One commenter stated that the 48-
hour timeframe is reasonable and allows hospitals to determine which 
patients need to be evaluated sooner due to risk factors such as age, 
co-morbid medical conditions, anticipated post-procedure length of 
stay, and the patient experience during the surgical or interventional 
procedure and immediately post-procedure.
    Response: We appreciate the support of commenters. We agree that 
this change provides more flexibility and decreases burden for 
hospitals and anesthesia professionals while maintaining patient 
safety. The 48 hour timeframe for completion and documentation of the 
postanesthesia evaluation is an outside parameter. As commenters 
stated, individual patient risk factors may dictate that the 
postanesthesia evaluation be completed and documented sooner than 48 
hours. This should be addressed by hospital policies and procedures.
    Comment: One commenter recommended that the CoP be modified to 
state, ``within 48 hours or before discharge, whichever comes first.'' 
The commenter also recommended that consideration be given to determine 
if any non-surgical procedures may require a postanesthesia assessment.
    Response: A postanesthesia evaluation is required any time general, 
regional or monitored (this would include deep sedation/analgesia) 
anesthesia has been administered to the patient. ASA guidelines define 
monitored anesthesia care as ``a specific anesthesia service for a 
diagnostic or therapeutic procedure. Indications for monitored 
anesthesia care include the nature of the procedure, the patient's 
clinical condition, and/or the potential need to convert to a general 
or regional anesthetic.'' \9\ The type of procedure, surgical or non-
surgical, is not necessarily the determining factor.
---------------------------------------------------------------------------

    \9\ American Society of Anesthesiologists. Position on monitored 
anesthesia care. (Approved by the House of Delegates on October 21, 
1986, and last amended on October 25, 2005) http://www.asahq.org/publicationsAndServices/standards/23.pdf.
---------------------------------------------------------------------------

    If the patient is discharged less than 48 hours after the 
procedure, completion and documentation of the postanesthesia 
evaluation is still required. This is the case regardless of whether 
the procedure is performed on an inpatient or outpatient basis or when 
the patient is discharged. There are many factors that may require that 
the postanesthesia evaluation be done in less than 24 hours post-
procedure, such as an outpatient procedure, the patient's condition and 
length of stay. Obviously, the postanesthesia evaluation must be done 
before the patient is discharged. Hospital policies and procedures 
approved by the medical staff should address the completion and 
documentation of the postanesthesia evaluation. This is consistent with 
the current anesthesia services CoP at Sec.  482.52(b)(4) which states 
``with respect to outpatients, a postanesthesia evaluation for proper 
anesthesia recovery performed in accordance with policies and 
procedures approved by the medical staff'' must be provided for each 
patient.
    Comment: One commenter stated that many patient-related anesthesia 
issues can best be handled by a pharmacist. The commenter recommended 
that CMS consider a pharmacist qualified to assist in completing 
postanesthesia evaluations.
    Response: This standard requires that the postanesthesia evaluation 
be completed by an individual qualified to administer anesthesia as 
specified in Sec.  482.52(a). A pharmacist is not generally qualified 
to administer anesthesia. However, if a patient experiences a problem 
with a medication, a pharmacist can be consulted. We expect individuals 
administering anesthesia to use the pharmacist as a clinical resource. 
We expect pharmacists to participate in the care of patients and assist 
in evaluating patients post-procedure as needed. However, a 
pharmacist's evaluation would not meet this requirement.
    Comment: One commenter stated that he did not support anyone other 
than the professional who administered the anesthesia to complete the 
postanesthesia evaluation. The commenter stated that the anesthesiology 
professional who administered the anesthesia is most familiar with the 
patient and should be held accountable.
    Response: We agree that the professional who administered 
anesthesia is most familiar with the patient. However, other 
practitioners qualified to administer anesthesia can safely perform a 
postanesthesia evaluation and determine the patient's response to and 
recovery from anesthesia. In addition to the practitioner's own 
anesthesia knowledge base and expertise, the practitioner also has 
access to all of the patient's medical records for information 
regarding the patient's pre-, intra-, and post-operative status.
    Comment: One commenter supports the proposed change, but stated 
concern that it may create unnecessary confusion when applied to 
procedures requiring conscious sedation.
    Response: A postanesthesia evaluation is required anytime general, 
regional or monitored (this would include deep sedation/analgesia 
anesthesia has been administered to the patient). ASA guidelines do not 
define moderate or conscious sedation as anesthesia.\10\ The 
practitioner administering the conscious sedation may or may not be 
trained to administer

[[Page 68691]]

anesthesia. Certainly, current practice dictates that the patient 
receiving conscious sedation be monitored and evaluated before, during 
and after the procedure by trained practitioners. However, a 
postanesthesia evaluation would not be required when the administration 
of conscious sedation does not require a practitioner qualified to 
administer anesthesia.
---------------------------------------------------------------------------

    \10\ American Society of Anesthesiologists. ``Continuum of depth 
of sedation, definition of general anesthesia and levels of 
sedation/analgesia,'' ASA Standards, Guidelines and Statements 
(Approved by ASA House of Delegates on October 13, 1999, and amended 
on October 27, 2004), http://www.asahq.org/
publicationsAndServices/standards/20.[fxps0]pdf.
---------------------------------------------------------------------------

    Comment: One commenter stated that he supports broadening the 
standard for who can perform the postanesthesia evaluation but believes 
the proposed language does not go far enough. The commenter recommended 
that the language be broadened to allow physician delegation to a 
qualified provider to the extent permitted by State law. The commenter 
stated that this would allow anesthesiologists to delegate the 
postanesthesia evaluation and report to qualified physician assistants 
whom they supervised. The commenter stated that the proposed language 
and the parallel language regarding preanesthesia reports unnecessarily 
limit the ability of physicians to delegate to qualified physician 
assistants. The commenter cited the broad delegation authority afforded 
medical doctors and doctors of osteopathy at Sec.  482.12(c)(1)(i):

    ``Every Medicare patient is under the care of: A doctor of 
medicine or osteopathy (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.);''

    The commenter stated that when rules confer both a broad authority 
as found at Sec.  482.12(c)(1)(i), and a more narrowly defined 
authority at Sec.  482.52, it is often not clear which provision is 
meant to prevail.
    Response: The commenter is correct in that the requirement at Sec.  
482.12(c)(1)(i) applies to all CoPs. However, individual CoPs often 
provide qualifiers that limit this authority, as is the case in this 
situation. The revision at Sec.  482.52 states that the postanesthesia 
evaluation must be completed and documented by an individual qualified 
to administer anesthesia as specified in paragraph (a) of this section. 
A physician assistant is not specified in paragraph (a) as an 
individual qualified to administer anesthesia. A physician assistant 
does not have the required education, training and experience to 
administer anesthesia or to conduct a comprehensive evaluation of a 
patient recovering from anesthesia. Therefore, a physician is not 
permitted to delegate the completion and documentation of the 
postanesthesia evaluation to a physician assistant or any other 
individual not qualified to administer anesthesia.

IV. Provisions of the Final Regulations

    This final rule responds to the health care community's primary 
concern that current regulations related to completion of the history 
and physical examination, authentication of verbal orders, storage of 
medications, and completion of the postanesthesia evaluation are 
contrary to current medical practice and unduly burdensome. In order to 
be consistent with current medical practice, reduce burden, and ensure 
patient safety, we are revising the current Medical staff, Nursing 
services, Medical record services, Pharmaceutical services, and 
Anesthesia services CoPs. These changes are made with respect to 
completion of the history and physical examination, authentication of 
verbal orders, securing medications, and completion of the 
postanesthesia evaluation. We believe that these issues are 
particularly burdensome to hospitals and it is in the best interest of 
patients and quality care for us to move forward with these changes.
    For these reasons, we are codifying these changes within the 
current hospital CoPs at 42 CFR part 482. Any changes that have been 
made to clarify or strengthen the provisions that appeared in the March 
25, 2005 proposed rule (70 FR 15266) are noted in the following 
description of the provisions.

Section 482.22 Condition of Participation: Medical Staff

Section 482.22(c)(5)
    This requirement expands the timeframe for completion of the 
history and physical examination and broadens who may perform the 
history and physical examination. It requires that each patient receive 
a history and physical examination completed no more than 30 days 
before or 24 hours after admission and documentation be placed in the 
patient's medical record within 24 hours of admission. A physician (as 
defined in section 1861(r) of the Act), oromaxillofacial surgeon, or 
other qualified individual could complete the history and physical 
examination in accordance with State law and hospital policy. In 
addition, when a history and physical examination is recorded 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 condition is completed and documented in the patient's 
medical record within 24 hours after admission.
    Several revisions were made to this standard in this final rule. 
Based on public comments, the following changes were made at Sec.  
482.22(c)(5): (1) We retained the specific reference to 
oromaxillofacial surgeons; (2) we deleted the requirement that 
practitioners must be granted the privilege to conduct a medical 
history and physical examination by the medical staff; and, (3) in its 
place we added the language, ``in accordance with State law and 
hospital policy.'' The remainder of the standard is being finalized as 
proposed.

Section 482.23 Condition of Participation: Nursing Services

Section 482.23(c)(2)
    This requirement clarifies 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 must be documented 
and signed by a practitioner who is responsible for the care of the 
patient as specified under Sec.  482.12(c) and authorized to write 
orders by hospital policy and in accordance with State law. This 
standard has not been revised and, therefore, is being finalized 
without change.
Section 482.23(c)(2)(i) and Section 482.23(c)(2)(ii)
    These provisions reinforce current requirements that when verbal 
orders are used, they are to be used infrequently, and be accepted only 
by persons authorized by hospital policy and procedures consistent with 
Federal and State law. This standard has not been revised; and, 
therefore is being finalized without change.

Section 482.24 Condition of Participation: Medical Record Services

Section 482.24(c)(1)
    This requirement maintains and reinforces the current regulation 
for authentication of all medical record entries. It requires that all 
patient medical record entries be legible, dated, timed, and 
authenticated in written or electronic form by the person responsible 
for providing or evaluating a service provided. This standard has not 
been revised and, therefore, is being finalized without change.
Section 482.24(c)(1)(i)
    This provision requires that all orders, including verbal orders, 
be dated, timed,

[[Page 68692]]

and authenticated promptly by the ordering practitioner, except as 
noted in subsection (ii). One minor revision has been made in the final 
rule based on public comment. The word ``ordering'' has replaced the 
word ``prescribing.'' Otherwise, the standard is being finalized as 
proposed.
Section 482.24(c)(1)(ii)
    This provision permits a temporary exception to the requirement 
that all orders, including verbal orders be dated, timed, and 
authenticated by the ordering practitioner. For a period of 5 years 
beginning with the effective date of this final rule, verbal orders 
will not need to be signed by the ordering practitioner, but could be 
authenticated by another practitioner responsible for the care of the 
patient. One minor revision has been made in this final rule based on 
public comment. The word ``ordering'' has replaced the word 
``prescribing.'' Otherwise, the standard is being finalized as 
proposed.
Section 482.24(c)(1)(iii)
    This provision specifies that 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. This standard has not been revised and, therefore, is being 
finalized without change.
Section 482.24(c)(2)(i) and Section 482.24(c)(2)(ii)
    These requirements have been revised to be consistent with the 
changes in the Medical staff CoP. These regulations specify 
documentation requirements for history and physical examinations. The 
two provisions require evidence of either: (1) A medical history and 
physical examination completed within 30 days before or 24 hours after 
admission, and 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 conditions when the 
medical history and physical examination was completed within 30 days 
before admission. This updated examination will need to be completed 
and documented in the patient's medical record within 24 hours of 
admission. These standards have not been revised and, therefore, are 
being finalized without change.

Section 482.25 Condition of Participation: Pharmaceutical Services

Section 482.25(b)(2)(i)
    This provision specifies that all drugs and biologicals be kept in 
secure areas, and locked when appropriate. This standard has not been 
revised and, therefore, is being finalized without change.
Section 482.25(b)(2)(ii)
    This provision requires 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. This standard has not 
been revised and, therefore, is being finalized without change.
Section 482.25(b)(2)(iii)
    This requirement states that only authorized personnel may have 
access to locked areas. This standard has not been revised and, 
therefore, is being finalized without change.

Section 482.52 Condition of Participation: Anesthesia Services

Section 482.52(b)(3)
    This requirement permits the postanesthesia evaluation for 
inpatients to be completed and documented by any individual qualified 
to administer anesthesia. This standard has not been revised and, 
therefore, is being finalized without change.

V. Collection of Information Requirements

    Under the Paperwork Reduction Act of 1995, we are required to 
provide 30-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 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.
    Therefore, we are soliciting public comment on each of these issues 
for the following sections of this document that contain information 
collection requirements:

Section 482.22 Condition of Participation: Medical Staff

    Paragraph (c) requires that a hospital have bylaws that include 
specified information. This rule revises some of the contents required 
in the bylaws.
    The burden associated with these requirements is the time spent in 
drafting the bylaws regarding performance of the H&P, the update 
examination, and documentation of both. We believe that this 
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 one-time basis, with 
this requirement; information collection requirements affecting fewer 
that 10 entities are exempt from the PRA.

Section 482.23 Condition of Participation: Nursing Services

    Paragraph (c) of this section requires that with the exception of 
influenza and pneumococcal polysaccharide vaccines, which can 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 authorized to write orders by 
hospital policy in accordance with State law, and who is responsible 
for the care of the patient as specified under Sec.  482.23(c).
    The burden associated with these requirements is the time spent by 
the practitioner in documenting and signing orders. 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 
Sec.  1320.3(b)(2).

Section 482.24 Condition of Participation: Medical Record Services

    Paragraph (c) of this section requires that 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. All orders, including verbal orders, 
must be dated, timed and authenticated promptly by the ordering 
practitioner or another practitioner who is responsible for the care of 
the patient as specified under Sec.  482.12(c) and authorized to write 
orders by hospital policy in accordance with State law. All verbal 
orders must be authenticated based

[[Page 68693]]

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. 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 of admission.
    The burden associated with these requirements is 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 Sec.  1320.3(b)(2).

Section 482.52 Condition of Participation: Anesthesia Services

    Under paragraph (b)(3) of this section, with respect to inpatients, 
a postanesthesia evaluation must be completed and documented by an 
individual qualified to administer anesthesia within 48 hours after 
surgery.
    The burden associated with these requirements is 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 Sec.  1320.3(b)(2).
    As required by section 3504(h) of the Paperwork Reduction Act of 
1995, we have submitted a copy of this document to the Office of 
Management and Budget (OMB) for its review of these information 
collection requirements.
    If you would like to comment on these information collection and 
recordkeeping 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: Melissa Musotto, CMS-3122-F 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: 
Carolyn Lovett, CMS Desk Officer, CMS-3122-F, [email protected]. Fax (202) 395-6974.

VI. Regulatory Impact

    We have examined the impact of this final 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 final 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 final 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 final rule will 
result in greater efficiencies for hospitals, we do not believe that 
the final 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 final 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 
final rule. We invited public comment on the impact on hospitals and 
practitioners. However, we did not receive any comments.
    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 final rule is such that no additional regulatory 
burden will be placed upon hospitals. Instead, burden would be 
decreased for hospitals by this final 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 final 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 final rule on small entities or small rural hospitals. 
We invited public comment on the impact of the proposed rule on small 
entities and small rural hospitals. We did not receive any comments on 
the impacts presented, thus, we have finalized this rule as proposed. 
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 aggregate, or by the private sector, that 
exceeds the inflation adjusted threshold of $110 million. This final 
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 final rule and have determined that it would 
not have a negative impact on the rights, rules, and responsibilities 
of State, local or tribal governments. Since this regulation does not 
impose any costs on State or local governments, the requirements of 
E.O. 13132 are not applicable.

[[Page 68694]]

    In accordance with the provisions of Executive Order 12866, the 
Office of Management and Budget reviewed this final rule.

List of Subjects in 42 CFR Part 482

    Grant programs--health, Hospitals, Medicaid, Medicare, Reporting 
and recordkeeping requirements.

0
For the reasons set forth in the preamble, the Centers for Medicare & 
Medicaid Services amends 42 CFR chapter IV, part 482 as set forth 
below:

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

0
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).

0
2. Section 482.22 is amended by--
0
A. Republishing paragraph (c) introductory text.
0
B. Revising paragraph (c)(5) to read as follows:


Sec.  482.22  Condition of participation: Medical staff.

* * * * *
    (c) Standard: Medical staff bylaws. The medical staff must adopt 
and enforce bylaws to carry out its responsibilities. The bylaws must:
* * * * *
    (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), an oromaxillofacial surgeon, or other qualified 
individual in accordance with State law and hospital policy. 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.
* * * * *

0
3. Section 482.23 is amended by--
0
A. Republishing paragraph (c) introductory text.
0
B. Revising paragraph (c)(2) to read as follows:


Sec.  482.23  Condition of participation: Nursing services.

* * * * *
    (c) Standard: Preparation and administration of drugs. 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 Sec.  482.12(c), 
and accepted standards of practice.
* * * * *
    (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 Sec.  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.
* * * * *

0
4. Section 482.24 is amended by--
0
A. Republishing paragraph (c) introductory text.
0
B. Revising paragraph (c)(1).
0
C. Republishing paragraph (c)(2) introductory text.
0
D. Revising paragraph (c)(2)(i).
    The revisions read as follows:


Sec.  482.24  Condition of participation: Medical record services.

* * * * *
    (c) Standard: Content of record. The medical record must contain 
information to justify admission and continued hospitalization, support 
the diagnosis, and describe the patient's progress and response to 
medications and services.
    (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 ordering practitioner, except as noted in 
paragraph (c)(1)(ii) of this section.
    (ii) For the 5 year period following January 26, 2007, all orders, 
including verbal orders, must be dated, timed, and authenticated by the 
ordering practitioner or another practitioner who is responsible for 
the care of the patient as specified under Sec.  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, verbal orders must 
be authenticated within 48 hours.
    (2) All records must document the following, as appropriate:
    (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.
* * * * *

0
5. Section 482.25 is amended by--
0
A. Republishing paragraph (b) introductory text.
0
B. Revising paragraph (b)(2) to read as follows:


Sec.  482.25  Condition of participation: Pharmaceutical services.

* * * * *
    (b) Standard: Delivery of services. In order to provide patient 
safety, drugs and biologicals must be controlled and distributed in 
accordance with applicable standards of practice, consistent with 
Federal and State law.
* * * * *
    (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.
* * * * *
0
6. Section 482.52 is amended by--
0
A. Republishing paragraph (b) introductory text.
0
B. Revising paragraph (b)(3) to read as follows:


Sec.  482.52  Condition of participation: Anesthesia services.

* * * * *

[[Page 68695]]

    (b) Standard: Delivery of services. Anesthesia services must be 
consistent with needs and resources. Policies on anesthesia procedures 
must include the delineation of preanesthesia and postanesthesia 
responsibilities. The policies must ensure that the following are 
provided for each patient:
* * * * *
    (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)

    Dated: June 27, 2006.
Mark B. McClellan,
Administrator, Centers for Medicare & Medicaid Services.
    Approved: August 11, 2006.
Michael O. Leavitt,
Secretary.
 [FR Doc. E6-19957 Filed 11-24-06; 8:45 am]
BILLING CODE 4120-01-P