[Federal Register: November 27, 2006 (Volume 71, Number 227)]
[Rules and Regulations]
[Page 68671-68695]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr27no06-14]
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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
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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.[fxsp0]ashp.[fxsp0]org/bestpractices/MedMis/
MedMis--Gdl--Hosp.[fxsp0]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.
[fxsp0]ismp.[fxsp0]org/Newsletters/acutecare/articles/
20010124.[fxsp0]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.
[fxsp0]jcrinc.[fxsp0]com/subscribers/
patientsafety.[fxsp0]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.[fxsp0]nccmerp.[fxsp0]org/council/council2001-
02-20.[fxsp0]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.[fxsp0]ashp.[fxsp0]org/bestpractices/
MedMis/MedMis--Gdl--Hosp.[fxsp0]pdf;
ISMP, Medication Safety Alert! Acute Care: ``Reducing `at-
risk behaviors', October 7, 2004. http://www.[fxsp0]ismp.[fxsp0]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.[fxsp0]ismp.[fxsp0]org/
MSAarticles/VerbalOrders.[fxsp0]html; and,
NCC MERP, ``Recommendations to reduce medication errors
associated with verbal medication orders and prescriptions,'' February
20, 2001. (http://www.[fxsp0]nccmerp.[fxsp0]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.
[fxsp0]merriamwebster.[fxsp0]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.[fxsp0]ashp.[fxsp0]org/
bestpractices/drugdistribution/Distrib--TAB--Hosp.[fxsp0]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.[fxsp0]asahq.[fxsp0]org/clinical/
LockedCartPolicyFinalOct2003.[fxsp0]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.
[fxsp0]asahq.[fxsp0]org/publicationsAndServices/standards/
23.[fxsp0]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.[fxsp0]asahq.[fxsp0]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,
carolyn_lovett@omb.[fxsp0]eop.[fxsp0]gov. 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