Medicare and Medicaid Programs; Hospital Conditions of Participation: Requirements for History and Physical Examinations; Authentication of Verbal Orders; Securing Medications; and Postanesthesia Evaluations, 68672-68695 [E6-19957]

Agencies

• Centers for Medicare & Medicaid Services
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

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



[[Page 68671]]

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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 https://
www.gpoaccess.gov/fr/.

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. https://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. https://
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. https://
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. https://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. https://www.ashp.org/bestpractices/
MedMis/MedMis_Gdl_Hosp.pdf;
     ISMP, Medication Safety Alert! Acute Care: ``Reducing `at-
risk behaviors', October 7, 2004. https://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.