[Federal Register Volume 66, Number 12 (Thursday, January 18, 2001)]
[Rules and Regulations]
[Pages 4674-4687]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-1388]
[[Page 4674]]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Health Care Financing Administration
42 CFR Parts 416, 482, and 485
[HCFA-3049-F]
RIN 0938-AK08
Medicare and Medicaid Programs; Hospital Conditions of
Participation: Anesthesia Services.
AGENCY: Health Care Financing Administration (HCFA), HHS.
ACTION: Final rule.
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SUMMARY: This final rule amends the Anesthesia Services Condition of
Participation (CoP) for hospitals, the Surgical Services Condition of
Participation for Critical Access Hospitals (CAH), and the Ambulatory
Surgical Center (ASC) Conditions of Coverage Surgical Services. This
final rule changes the physician supervision requirement for certified
registered nurse anesthetists furnishing anesthesia services in
hospitals, CAHs, and ASCs. Under this final rule, State laws will
determine which professionals are permitted to administer anesthetics
and the level of supervision required, recognizing a State's
traditional domain in establishing professional licensure and scope-of-
practice laws. States and hospitals are free to establish additional
standards for professional practice and oversight as they deem
necessary.
The hospital anesthesia services CoP, CAH surgical services CoP,
and the conforming change to the anesthesia Conditions of Coverage
apply to all Medicare and Medicaid participating hospitals, CAHs, and
ASCs.
EFFECTIVE DATE: These regulations are effective on March 19, 2001.
FOR FURTHER INFORMATION CONTACT:
Stephanie A. Dyson RN, BSN (410) 786-9226
Debbra M. Hattery RN, MS (410) 786-1855
SUPPLEMENTARY INFORMATION:
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I. Background
A. Legislation
Sections 1861(e)(1) through (e)(8) of the Social Security Act (the
Act) provide that a hospital participating in the Medicare program must
meet certain specified requirements. Section 1861(e)(9) of the Act
specifies that a hospital also must meet such other requirements as the
Secretary finds necessary in the interest of the health and safety of
the hospital's patients. Section 1820 of the Act contains criteria for
application for States establishing a Critical Access Hospital.
Sections 1832(a)(2)(F)(i) and 1833(i) provide coverage requirements for
ASCs. Section 1861(bb) of the Act, provides definitions for certified
registered nurse anesthetists (CRNAs) and their services.
B. General
On December 19, 1997, we published the proposed rule, ``Hospital
Conditions of Participation, Provider Agreements and Supplier
Approval,'' (62 FR 66726) in the Federal Register. This proposed rule
generated over 60,000 public comments and approximately one-third of
these comments addressed the proposed condition eliminating the Federal
requirement for physician supervision of a licensed independent
practitioner permitted by the State to administer anesthetics.
In 1997, when we proposed our changes to the current hospital
conditions of participation (CoPs), we stated our desire to move toward
standards that are patient-centered, evidence-based, and outcome
oriented. We also stated that a fundamental principle was to facilitate
flexibility in how a hospital meets our performance expectations, and
eliminate structure and process requirements unless there is evidence
that they are predictive of desired outcomes for patients. Where there
is agreement on a structure or process requirement predictive of
desired patient outcomes, we included that in our proposed rule. In
fact, comments on the standard for physician supervision of CRNAs
reflect a split between those who support flexibility in allowing
States and hospitals to make decisions about anesthesia services and
those who oppose the provision, supporting, instead, the structural
requirement for physician supervision. We have already finalized the
Organ Donation and Transplantation and Patients' Rights conditions,
which were contained in the December 19, 1997 proposed hospital rule.
We are now finalizing part of the anesthesia services standard
describing anesthesia administration. We continue to work to finalize
the other issues in the December 19, 1997 hospital conditions of
participation proposed rule.
C. Need for Amended Anesthesia Services CoP
The existing hospital CoPs require hospitals, CAHs, and ASCs to
provide quality care by adhering to our organizational and staffing
requirements. The current hospital CoPs are not written in a way that
promote or encourage a hospital, CAH, or ASC to assess the quality of
care and improve patient outcomes. One of the clear messages we
received from industry groups and professionals as we pursued this
change in regulatory approach is that the old way of focusing on
structure and process no longer represented current practice or the
best available method to foster delivery of quality health care
services.
Since publication of the December 19, 1997 proposed rule, we have
continued to receive input from representatives of individual industry
groups and have analyzed thousands of public comments from individual
providers, beneficiaries, hospitals, and professional and provider
organizations. We have given careful consideration to the scientific
literature cited by commenters. We have found no compelling scientific
evidence that an across-the-board Federal physician supervision
requirement for CRNAs leads to better outcomes, or that there will be
adverse outcomes by relying on State licensure laws instead.
We are also responding to considerable Congressional activity that
has occurred since the 1997 publication of the proposed rule. Interest
by Congress on both sides of the issue of physician supervision
resulted in Appropriations Conference committee language in the
Conference Report to the Balanced Budget Refinement Act (BBRA) of 1999
(H. Conf. Rep. No.106-
[[Page 4675]]
479, at 873 (November 18, 1999)) urging the Secretary to determine
whether there was sufficient information to move forward with a final
rule. The literature we reviewed (see appendix) indicated that the
anesthesia-related death rate is extremely low, and that the
administration of anesthesia in the United States is safe relative to
surgical risk.
There have been no studies published within the last 10 years
demonstrating any need for Federal intervention in State professional
practice laws governing CRNA practice. Currently, there is no reason to
require a Federal rule in these conditions of participation mandating
that physicians supervise the practice of another State-licensed health
professional where there is a statutory provision authorizing direct
Medicare payment for the services of that health professional. We
believe there is no reason to change our proposed approach, which gives
States and hospitals the flexibility to determine necessary oversight.
We believe the change, based on the available information,
appropriately reflects the important value of regulatory flexibility.
D. Recognizing State Laws and Professional Scope of Practice
Congress has specified which non-physician health professionals may
receive separate payment for their professional services (such as CRNAs
and nurse practitioners). In addition, Congress left the function of
licensing these health professionals to the States. Medicare recognizes
the scope of practice established by the States for these health
professionals. Prior to this final rule, Medicare's hospital CoPs did
not have Federal requirements for physicians to supervise the practice
of another State-licensed health professional where there is a
statutory provision authorizing direct Medicare payment for the
services of that health professional, with the sole exception of the
Federal requirement for physician supervision of CRNAs. We do not
believe that there is evidence to support maintaining a special Federal
requirement for physician supervision of CRNAs.
Eliminating the Federal requirement for physician supervision of
CRNAs is not a judgment on our part that one health professional is
better than another or that one type of care is superior. The change in
regulatory approach reflected in this final rule was discussed in the
preamble of the hospital CoPs proposed rule (62 FR 66740). This rule
establishes a shared commitment to quality care among us, the States,
and Medicare providers. Medicare providers are in the best position to
assess the evidence and consider data relevant to their own situations
(for example, physician access, hospital and patient characteristics
and needs of rural areas) about the best way to deliver anesthesia
care. Hospitals can always exercise stricter standards than required by
State law. We will monitor the effects on the quality of anesthesia
care furnished to Medicare beneficiaries resulting from the greater
flexibility provided to States and hospitals under this rule.
II. Analysis of and Responses to Public Comments
We received approximately 20,000 comments on the issue of physician
supervision of CRNA administration of anesthesia. Comments were largely
split among CRNAs, representatives of rural areas, and supporters of
State oversight who favor the proposal; and physicians who, in general,
opposed the proposal and argued that anesthesia administration is the
practice of medicine, requiring advanced medical education. A summary
of the major issues and our responses follow:
State Law and Professional Scopes of Practice
Comment: The majority of comments focused on whether States' scope-
of-practice laws are the proper level of regulatory oversight. Most
physicians maintained that anesthesia is the practice of medicine which
should only be practiced by a licensed physician, and opposed the
provision permitting State licensed independent practitioners to
administer anesthetics without physician supervision. These commenters
argued that, because of disparities among the various States, laws are
inconsistent and result in inequality of care across the country. As a
result, they stated that Medicare beneficiaries would lose an important
Federal guarantee for minimum standards of anesthesia care, and instead
would be subjected to a variety of State laws. Conversely, other
commenters argued that the Federal rule preempts State law, creating
barriers to practice and limiting opportunity for nurse anesthetists
licensed as independent practitioners. A physician supervision
requirement, they asserted, diminishes the role of local jurisdictions
and authorities that regulate and/or license other health professions
and aspects of health service delivery. Commenters also stated that the
current Federal requirement for physician supervision has been a
disincentive for employers to hire CRNAs, decreasing flexibility and
efficiency in anesthesia services, and limiting access in certain
areas. One commenter wrote that it is the State that best understands
its individual geographical, population, and financial needs and
resources and how these resources can best be utilized to deliver safe,
quality anesthesia services.
Response: We respect the authority of States to meet regional/local
needs. Setting forth a final rule that allows States the ultimate
determination regarding which licensed independent practitioners may
administer anesthesia does not prohibit any State or hospital from
requiring physician supervision. It will effectively provide greater
discretion to State authorities that are experienced at regulating the
licensing, education, training, and skills of the professionals
practicing under their purview, without the burden associated with
duplicative regulatory oversight. There is no evidence that States are
less concerned with ensuring safety and quality than the Federal
government, especially where the health of their citizens is at stake.
We disagree that States are less capable or less committed to
protecting patients and ensuring quality anesthesia services than the
Federal government. The final rule removes the ``across the board''
Federal requirement for physician supervision in every case of
anesthesia administration. At the same time, it broadens overall
flexibility by permitting individuals and authorities closer to patient
care delivery to make decisions about the best way to deliver health
care services.
Comment: Some commenters were concerned that this change in
regulatory approach would grant the right to practice medicine to
individuals who were not properly prepared to do so. One commenter
pointed out that we were giving unsupervised privileges to prescribe
narcotics, paralytic agents, and cardiac drugs to people who have
neither a medical license nor the training and credentialing that is
associated with a medical license.
Response: States regulate professionals who may prescribe medicines
as well as which medical procedures may be performed under a
professional license through their professional practice laws. Our
regulations do not determine prescribing authority or grant medical
licenses, and this final rule does not change the traditional purview
under which these professional scope-of-practice issues have occurred
in the past. The final rule does not prohibit physicians from
practicing medicine, nor does it allow nurse anesthetists to practice
beyond the scope of their
[[Page 4676]]
practice or authority granted them by States.
Comment: We received several comments from both physicians and
nurse anesthetists in support of allowing physicians, hospitals, and
surgical centers more responsibility for the care they furnished. Some
commenters noted that the medical staffs within institutions should
determine guidelines for supervision of all health care personnel
contributing to the medical care of patients. Several commenters
recognized the value of allowing hospital boards and medical staffs to
set the standards of care. These commenters thought that relying on
greater accountability from doctors and hospitals instead of Federal
regulation would lead to better care for patients. Commenters noted
that this rule would allow hospitals to set standards different from
us, based on review and input from physicians and other health
professionals. The American Hospital Association (AHA) also supported
this rule change, stating ``This new policy ensures that only personnel
trained in administering anesthesia are allowed to do so. This
requirement balances accountability with flexibility.''
Response: We agree that providers have a shared responsibility,
with us and the States, to assure quality standards of practice. We are
pleased that the hospital industry recognizes the values of
accountability and flexibility in Federal regulation. Allowing States
to make determinations about health care professional standards of
practice, and hospitals to make decisions regarding the delivery of
care, assures that those closest to, and who know the most about, the
health care delivery system are accountable for the outcomes of that
care.
Comment: Several commenters stated that the administration of
anesthesia has never been exclusively the practice of medicine. These
commenters noted that anesthesia administration is within the scope of
practice of nurses, physicians, dentists, podiatrists, and other
professionals who have been properly educated and credentialed in the
field of anesthesia. Since more surgical procedures are moving out of
the hospital into clinic and office settings, an institution needs the
flexibility to utilize the anesthesia professional of its choice which
best matches the needs of the patient.
Response: Although this final rule governs anesthesia
administration in hospital, CAH, and ASC settings only, we agree with
the need for flexibility in other settings, especially as surgical
techniques, methods for administering anesthesia and the availability
of drugs is improved.
We believe that the range of patient types, surgical procedures,
new technologies, and provider settings (for example, hospital
outpatient departments, intensive care units, and teaching hospitals)
makes an across-the-board Federal requirement overly burdensome.
Differences between a healthy young patient undergoing minor surgery in
a hospital outpatient department and a medically compromised, elderly
patient undergoing major surgery in a large teaching facility are so
great that a single Federal requirement is not applicable in every
situation.
Comment: Several commenters objected to our arguments that
eliminating CRNA supervision would, ``allow greater flexibility to
hospitals and practitioners'' and would ``give deference to State
scope-of-practice laws''. These commenters believe that our reasoning
is weak, especially in the absence of documentation that either of
these issues is a problem.
Response: We disagree with these commenters. As previously noted,
we respect State control and oversight of health care professionals by
deference to State licensing laws which regulate professional practice.
There is no reason to consider physician supervision of CRNAs a special
case requiring a national standard. Advances in anesthesia and surgical
techniques, the availability and discovery of new drugs, and the
varying medical presentations of patients make it less prudent to rely
on a single national standard requiring physician supervision of CRNAs
to be applied in every situation. Doing so risks losing the
accountability of practitioners, both to make clinical decisions based
on the needs of patients, and to utilize resources effectively. We
believe States need flexibility from Federal oversight of those
processes, such as professional licensing, for which they are
ultimately accountable. In fact, it is at the State level where much
direct input by health professionals into scope-of-practice and
licensing laws takes place.
Comment: One commenter asked what rule would be operative in the
absence of any State law.
Response: The final rule allows only a licensed practitioner
permitted by the State to administer anesthetics to do so. Therefore,
State health professional practice laws, such as those covering nurse
and physician practice, as well as hospital licensing requirements,
would be the basis for determining which health care professionals can
administer anesthesia in any given State.
Safety and Quality of Care
Comment: Many of the commenters who wrote expressing concern over
quality of anesthesia services referred to published research to
support their point of view. For example, many commenters who support
the proposed rule stated that evidence shows anesthesia administered by
CRNAs to be as safe as that administered by anesthesiologists. In
contrast, we also received comments from anesthesiologists who noted
positive patient outcomes from anesthesia administration to be related
to the presence of the anesthesiologist. The articles most frequently
cited by commenters were three by Jeffrey Silber, M.D. and colleagues
(1992, 1995, 1997), and another by J.P. Abenstein and M.A. Warner
(1996). Many commenters claimed these studies concluded either an
anesthesiologist alone, or a CRNA in ``collaboration'' with an
anesthesiologist, had better patient outcomes than a CRNA alone. Many
commenters contend, erroneously, the recommendations from the Abenstein
& Warner article were adopted by the Minnesota legislature (although it
is not clear to what recommendations the commenters were referring).
Many other commenters urged us not to consider the change made by this
rule until there is solid, scientifically defensible outcome data to
establish that independent nurse anesthesia care is just as safe as
anesthesiologist care.
Response: The conclusions of the commenters were not supported by
findings from the studies they cited, nor do the studies conclude that
States provide inadequate oversight and that a Federal standard is
therefore necessary. We reviewed available literature and found the
following major conclusions (see appendix).
All literature surveyed agreed that the anesthesia-related
death rate is extremely low, and the administration of anesthesia in
the United States is safe relative to surgical risk. In fact, according
to the 1999 Institute of Medicine Report To Err Is Human, ``anesthesia
mortality rates are about one death per 200,000-300,000 anesthetics
administered, compared with two deaths per 10,000 anesthetics
administered in the early 1980s,'' a 40- to 60-fold improvement.
There are no studies published within the last 10 years
that are specific to the issue of the final rule, namely provision of
anesthesia care by CRNAs practicing without physician supervision. All
of the studies we reviewed had significant limitations. Conclusions are
limited by these
[[Page 4677]]
studies' failure to control adequately for possible correlations among
variables such as higher risk patients and hospital characteristics
(for example, size and sophistication of medical technology) as they
would affect deaths attributable to anesthesia.
There is no evidence that there would be adverse outcomes
by relying on States and hospitals to regulate the appropriate
supervision and scope of practice of health professionals administering
anesthesia. Nor has there been any evidence that States do a poor job
in regulating and overseeing health care professional practice or that
States are not capable of making decisions regarding requirements for
supervision of one State-licensed independent practitioner by another.
In the Silber studies, the authors did not conclude that CRNAs may
be providing poor care that might more likely lead to negative
outcomes. The 1992 study did not address whether there is an
association between patient outcomes and the type of professional who
furnished anesthesia. The anesthesia variable used in the study was not
specific to the patient, rather it was a variable at the hospital level
(for example, percent of anesthesiologists who are board-certified).
The anesthesia variable might be a proxy indicator of quality of the
hospital: Thus, there would be lower mortality in the higher quality
hospitals and if a complication occurred the patient would more likely
be rescued.
Silber urges ``that the limitations of the project be recognized.''
The limitations include: There were relatively few deaths, adverse
outcomes and failures, and relatively few patients per hospital so the
rates could only be compared for groups of hospitals, not specific
facilities.
In a subsequent article to the one summarized above, Silber and
colleagues (1995) found that ``most of the predictable variation in
outcome rates among hospitals appears to be predicted by differing
patient characteristics rather than by differing hospital
characteristics, that is, by who is treated rather than by the
resources available for treatment.'' The authors found higher
proportions of board-certified anesthesiologists to be associated with
lower death and failure rates, but also with higher adverse occurrence
rates. The study did not address the relationship between the patient
outcomes and the type of professional who furnished the anesthesia
care. The study did not address the issue of provision of anesthesia
care by CRNAs supervised and not supervised by physicians. The article
presents no information that States are not capable of making decisions
regarding requirements for supervision of one State-licensed
independent practitioner by another. Silber and his colleagues (1997)
have also conducted methodological studies that compare the usefulness
of three outcome measures, mortality, complication and failure-to-
rescue rates. They concluded that for the general surgical procedures
studied, the complication rate is poorly correlated with the death and
failure rate. The authors suggest that great caution be taken when
using complication rates and that they should not be used in isolation
when assessing hospital quality of care. The study did not address the
relationship between the patient outcomes and the type of professional
who furnished the anesthesia care. Nor did the study address the issue
of provision of anesthesia care by CRNAs supervised and not supervised
by physicians, the issue in the rule. The article presents no
information that States are not capable of making decisions regarding
requirements for supervision of one State-licensed independent
practitioner by another.
We have also reviewed a more recently published article by Dr.
Silber (July 2000) and colleagues from the University of Pennsylvania.
This article also is not relevant to the policy determination at hand
because it did not study CRNA practice with and without physician
supervision, again the issue of this rule. Moreover, it does not
present evidence of any inadequacy of State oversight of health
professional practice laws, and does not provide sound and compelling
evidence to maintain the current Federal preemption of State law.
Even on its own terms, the study has the following methodological
shortcomings:
The study used a non-experimental research design and only
examined claims data, instead of reviewing medical records or observing
actual care. Even though the researchers statistically controlled for
106 proxy indicators of care, without a stronger research design, they
can only make a weak conclusion about an ``association'' between a
variable and an outcome.
The study did not control for the cause of death. Cases
where a patient died from an anesthesia related cause, the surgery
itself, an unrelated medical error, or an unknown medical condition are
all considered, regardless of the cause of death. Not having data on
deaths actually attributed to anesthesia is problematic since the
mortality data used covers any death occurring within 30 days of a
hospital admission. Events occurring 30 days from admission cannot be
attributed to the anesthesia care alone. While the researchers argue
that ``delayed'' death (that is, within 30 days of admission) is the
appropriate measure of mortality for anesthesia care, the study does
not produce causal evidence for such a theory. At a minimum, the
researchers could have presented results for mortality measured for
shorter periods of time such as within 72 hours of admission which may
or may not have shown different outcomes for short-term and delayed
deaths.
Both the study and comparison groups included cases where
physicians supervised CRNAs and personally furnished anesthesia. (The
study group also included cases where anesthesiologists medically
directed residents). The purpose of the study was to examine
differences when an anesthesiologist versus a non-anesthesiologist
physician is involved in the case. One cannot use this analysis to make
conclusions about CRNA performance with or without physician
supervision.
The study used data where anesthesia was furnished by
unknown suppliers (incorrectly referred to in the article as ``unknown
providers'') either personally providing care or supervising CRNAs.
Because a supplier is not a physician there are likely to be data
coding errors which could contaminate and bias the results.
Even if the methodological shortcomings were fixed, because the
study did not address the issue in the final rule, it is inappropriate
to impute results from this study to the issue in this final rule, the
provision of care by CRNAs supervised and not supervised by physicians.
Even if the recent Silber study did not have methodological
problems, we disagree with its apparent policy conclusion that an
anesthesiologist should be involved in every case, either personally
performing anesthesia or providing medical direction of CRNAs. Such a
policy is much more restrictive than current Medicare policy because it
would prohibit non-anesthesiologist physicians to supervise CRNAs. This
would make it difficult to perform surgeries in many small and rural
hospitals because anesthesiologists generally do not practice in these
hospitals.
Finally, even if we were to consider that the Silber article should
guide our policy, we note, that due to the difference between relative
risk and absolute risk, the reported size-effect is too small to cause
us to change our
[[Page 4678]]
decision. The Silber article reported an odds ratio for death of 1.08
corresponding to 2.5 excess deaths per 1000 cases (relative risk).
However, due to the lack of medical record review in this study these
excess deaths cannot be solely attributed to anesthesia care and thus
is not the absolute risk. For example, if we accept the IOM review of
the literature of 33.3-50 anesthesia related deaths per 10 million
(i.e., one per 200,000-300,000) then the absolute risk of excess deaths
would be in the range of 2.7-4.0 per 10 million (.08 times range of
33.3-50). This size of absolute risk must be balanced against the risk
of death due to lack of timely access to anesthesia services because of
a federal imposition of a supervision requirement. At a minimum States
are certainly capable of balancing the risks of lack of supervision
versus the shortage of anesthesiologists given the supply of
anesthesiologists in each of their respective States.
The Abenstein & Warner (1996) paper describes a number of aspects
of anesthesia care and reviews studies in several areas. The paper
notes that there has been a dramatic improvement in anesthetic deaths
in the last 15 years: ``Since 1979, five studies have documented a
remarkably abrupt decrease in anesthetic-related death rates,
morbidity, and risk of perioperative deaths.'' The paper concludes
that: For many patients, it is now as safe to be anesthetized as to be
a passenger in an automobile.''
The paper notes that ``identifying the cause for the improvement in
anesthetic outcome is as problematic as determining the cause of
perioperative death.'' The paper indicates that ``huge numbers of
surgical patients (that is, >1,000,000) must be enrolled in studies to
provide the statistical power needed to determine whether there are
associations between perioperative disability or death and various
anesthetic techniques, technologies, and practice models.'' The paper
notes that studies of this size are expensive. None of the studies
reviewed meet this standard.
The paper reviewed two studies that compared mortality for
anesthesia care furnished by anesthesiologists, and anesthesia care
team and nurse anesthetist supervised by a physician. Neither meets the
criteria for an adequate study identified in the paper. As the authors
note, the first study did not provide statistical analysis of the data.
The second study used data now 25 years old and found no statistically
significant difference between the groups. Neither study examined the
provision of anesthesia furnished independently by CRNAs, the issue of
this rule.
The paper suggested a number of reasons for improved anesthesia
care including ``new and improved patient monitoring techniques.'' The
paper also notes that the ``decline in adverse outcomes occurred at the
same time that the number of American trained physicians entering and
graduating from anesthesiology residency programs more than doubled
(1975-1985).'' The paper suggests that ``the increase in the number of
physicians engaged in the practice of anesthesiology is primarily
responsible for the dramatic improvement in perioperative outcomes.''
However, the paper also notes that during roughly the same period of
time, 1970-1985, the number of active nurse anesthetists doubled.
On the basis of studies which are flawed methodologically, which do
not prove causality, and which do not meet the authors' own criteria
for rigorous study, the authors nevertheless conclude that ``the
presence of board-certified anesthesiologists has been associated with
the decline in death and disability commonly attributed to adverse
perioperative events.'' The authors' conclusion is not substantiated by
their own review and analysis of the literature. Finally, the paper
presents no information regarding the issue in the rule or that States
are not capable of making decisions regarding requirements for
supervision of one State-licensed independent practitioner by another.
As part of the decision to finalize the rule, we considered the
feasibility of conducting a study comparing the mortality and adverse
outcomes of Medicare patients for anesthesia care furnished by CRNAs
with and without physician supervision. However, we concluded that it
was not feasible to conduct such a retrospective study. Not only would
the low overall anesthesia mortality make it difficult to develop a
sufficient sample, but because of the current Medicare rule, there are
no cases where CRNAs practice without supervision and thus there would
be no data for the key comparison. We also considered the feasibility
of conducting a study using data from non-Medicare patients. However,
because Medicare's current hospital conditions of participation apply
to all patients, here too there would be no data for the key
comparison. Finally, we do not believe that it would be wise to conduct
a prospective demonstration which would waive State law and
prospectively randomly assign patients to study and control groups
because it would remove patient choice of anesthesia professional.
Comment: Several commenters felt strongly that anesthesia should be
considered a high-risk procedure where mistakes are measured in terms
of death and injury. These commenters believe that millions of patients
will be at a higher risk for injury without the supervision of board
certified anesthesiologists. One commenter noted that without the
requirement, no trained physician would be available to respond to any
emergency during a case where a CRNA was practicing independently.
Response: If we were to require board certification for
anesthesiologists as a hospital CoP it would be a stricter requirement
than currently exists for the practice of any other medical specialty
subject to our CoPs. Hospitals have been providing anesthesia care
without a Federal requirement for board certified anesthesiologists
since the inception of the Medicare program. This rule does not change
the requirement that hospitals must have physicians available at all
times and that all Medicare patients are under the care of a physician
as defined in section 1861(r) of the Act. Therefore, the patient's
medical and/or surgical care continues to be the responsibility of his
or her assigned physician.
Comment: Several commenters wanted to know what had changed since a
1992 HCFA comment that, ``In view of the lack of definitive clinical
studies on this issue, and in consideration of the risks associated
with anesthesia procedures, we believe it would not be appropriate to
allow anesthesia administration by a nonphysician anesthetist unless
under supervision by either an anesthesiologist or the operating
practitioner.''
Response: As discussed above, there are no definitive studies one
way or the other which address this question. The studies we discussed
in our 1992 final rule on fee schedules for CRNAs (57 FR 33878, July
31, 1992) have limitations, as does the literature since 1992.
Moreover, there is no evidence that an across-the-board physician
supervision requirement for CRNAs leads to better outcomes or that
there will be adverse outcomes by relying on State licensure laws
instead. What has changed since 1992 is our view that it is unnecessary
to continue a special Federal preemption of State licensing laws
regulating professional practice for CRNAs.
The 1999 IOM Report cites a drop in anesthesia mortality rates from
two deaths per 10,000 anesthetics administered in the early 1980's to
[[Page 4679]]
about one death per 200,000 to 300,000 anesthetics administered today.
Chassin (1998) identifies several studies which note this improvement
is a result of ``a variety of mechanisms, including improved monitoring
techniques, the development and widespread adoption of practice
guidelines and other systematic approaches to reducing error.'' This is
an impressive improvement and confirms the soundness of the approach
taken in this final hospital CoP, which broadens the flexibility for
States and providers, who are much closer to the realities of patient
care, to make decisions about the best way to improve standards and
implement best practices.
Comment: Several commenters stated that quality of care should be
an important consideration in determining the need for physician
supervision. Some commenters noted an association between improved
anesthesia outcomes and increased numbers of anesthesiologists
practicing. Many commenters noted that some CRNAs could function
independently, but that others lack the judgement and knowledge to
safely provide anesthesia without supervision. Further, commenters
point out that CRNAs are more than capable of administering anesthesia
on a healthy adult; however, when a patient's health is poor, an
anesthesiologist should be involved in the care. Some nurse
anesthetists report concern with their ability to deal with anesthetic
complications without the availability of an anesthesiologist.
Response: Our decision to change the Federal requirement for
supervision of CRNAs applicable in all situations is because, as stated
in the preamble of the proposed rule, we are committed to changing
current regulations that focus largely on procedural requirements, such
as the Federal regulation mandating physician supervision of CRNAs.
These comments make clear there are a range of factors to be considered
(for example, patient types, surgical procedures, technology, and
provider settings). Differences between a healthy young patient
undergoing minor surgery in a hospital outpatient department and a
medically compromised, elderly patient undergoing major surgery in a
large teaching facility are so great that a single Federal requirement
applicable in every situation is not sensible.
Comment: One commenter noted that the practice of anesthesiology
extends beyond the operating room to the Intensive Care Unit (ICU),
pain management, and other medical consultation. The commenter believes
that the removal of the medical supervision requirement risks removing
the anesthesiologist from the practice of anesthesia.
Response: The change in the physician supervision requirement for
CRNAs does not affect the anesthesiologist's ability to provide
services outside the operating room.
Comment: A few commenters told us they believed it was the Federal
government's responsibility to set safety standards for the nation and
this rule evades that responsibility. One commenter agreed that CRNAs
have a good safety record, but emphasized that they have been under the
direct supervision of the anesthesiologist. He believed that
eliminating the supervision requirement would cause these positive
patient outcomes to occur less frequently. Other commenters agreed that
physicians absolutely need to be involved for the practice of medicine
to be safe, and this regulation change is in direct violation of this
principle. Some commenters noted that the practice of safe anesthesia
administration is largely due to better monitoring techniques,
technology, improved drugs, and not to greater supervision by a
physician. One commenter stated that in combination with improved drugs
and techniques, CRNAs will bring greater access to anesthesia services
in situations and areas where they are currently limited in their
practice because of the physician supervision requirement, thus
allowing such delivery of medical services that improve patient health
and safety, and provide services to a greater number of people.
Response: We are acutely aware that ensuring patient safety and
high quality patient outcomes are the principal considerations in
regulating providers. There is no indication that physician supervision
of a CRNA affects such outcomes. It is for this reason that we are
moving away from a focus on physician supervision, where there is no
evidence or data linking this structural requirement to patient
outcomes. As previously noted, changing the supervision requirement
does not obviate the requirement that every Medicare patient admitted
to the hospital be under the care of a physician or doctor of
osteopathy. This requirement remains an important component in the
hospital CoPs. Even under the current regulation CRNAs are not required
to be under the supervision of an anesthesiologist; the operating
physician can meet the rule's supervision requirement. This rule does
not prohibit anesthesiologist supervision or administration; it simply
leaves the decision up to State law or hospital policy.
This rule recognizes the significant improvement in the safety of
anesthesia administration made by improved technology and
implementation of practice guidelines. As in other areas of health
care, new drugs and pharmaceuticals have contributed to improved
patient outcomes as well. This underscores the findings in our review
of the literature that multiple variables, some interacting in
combination with each other, contribute to anesthesia-related patient
outcomes.
Comment: We received several comments from beneficiaries who had
received anesthesia care from a CRNA and felt comfortable with the
service that was provided. They describe their anesthesia experiences
as compassionate and thorough, including quality service and attention
from these professionals. Many felt their care was excellent. Another
commenter noted nurse anesthetists take time to be compassionate and
attentive to fears, approaching anesthesia care holistically.
We also received comments from beneficiaries who felt that their
care was being compromised for economic reasons by not requiring a
doctor to be in charge of their anesthesia. Many reported increased
fears during a time when they are most vulnerable, without the
guarantee that a doctor will be in charge of their anesthesia care.
Many reported that, as senior citizens, they faced more complicated
medical and surgical procedures than younger patients and therefore
that hospitals should be required to have a doctor in charge of
administering their anesthesia.
Response: Patient experiences can be influenced not only by the
anesthetist, but the surgeon, the type of procedure, the emergency
nature of the procedure, and other factors. We also believe that many
Medicare beneficiaries have been receiving anesthesia from CRNAs
without being specifically aware of the credentials of the
administering professional. We agree that a patient's perception of the
safety and concern demonstrated by medical personnel is important but
there is no evidence linking safety or better patient outcomes to the
Federal requirement for physician supervision.
The change made by this rule is not specific to the patient's
status as a Medicare beneficiary but to the participation of the
provider in the Medicare program. The increased flexibility gained by
this rule will allow hospitals and doctors to make decisions, pursuant
to State law, about what is best for patients, reinforcing the primacy
of the doctor-patient relationship.
[[Page 4680]]
Professional Education and Training
Comment: Several commenters noted the differences in training and
education between a CRNA and an anesthesiologist. These differences
were considered significant by anesthesiologists, who believe that
anesthesia administration is the practice of medicine and should only
be performed by physicians. Physician commenters pointed out that
anesthesiologists receive in-depth training in physiology,
pharmacology, diagnosis, treatment and independent management of
patient care. In addition, because they are physicians and have
received medical training, anesthesiologists assess a patient's medical
condition, as well as plan and administer the anesthetic. One physician
stated ``nurse anesthetists are trained to assist anesthesiologists;
they are not physicians and are not trained in medical diagnosis and
therapy. The lack of medical background prevents the CRNA from being
able to diagnose and treat the unexpected, and often serious, reactions
that can accompany anesthesia in even the simplest of cases. CRNAs
should be considered valued extenders of care but not as substitutes
for the expertise of an anesthesiologist.'' Other commenters stated
that nurses are trained to follow orders and medical protocols, and are
not trained to diagnose and treat. Several anesthesiologists, who had
been nurse anesthetists, wrote describing that not until they had
medical school training did they understand the full impact of the
differences between the education preparing them as nurse anesthetists
versus their preparation to practice as anesthesiologists. One
commenter stated he believed the regulation should be based on
demonstrated formal education. Another physician commenter stated he
believed CRNAs were well educated and trained and had good records of
performance, but that this was due to their collaboration with doctors,
and not their independent management of medical situations.
Some commenters stated, inaccurately, that the postgraduate
training of nurse anesthetists is unique in that, after a minimum of a
bachelors degree in nursing, the nurse anesthetist student is required
to have at least two years of practical experience in a critical care
setting before advanced formal education in anesthetic administration.
They stated that this advanced training prepares the nurse anesthetist
to provide the full range of anesthesia services, independently.
Several commenters noted that nurse anesthetists must be board
certified by successfully completing the National Certification
Examination. Other commenters felt that the knowledge and expertise in
nurse anesthesia care is equivalent to the preparation provided
physicians. Some commenters reminded us that the Federal supervision
requirement has been the only obstacle to independent practice, and
that otherwise nurse anesthetists are licensed and trained to practice
independently. One CRNA stated he did not agree with the contention
that educational differences between CRNAs and anesthesiologists are
sufficient reasons to place practice restrictions on CRNAs.
Response: Education and training requirements for CRNAs vary among
the States. Decisions about appropriate and necessary education and
training for health professionals are made by States and educational
institutions in compliance with education accreditation standards.
Professional schools, both medical and nursing, are accredited by
educational organizations with specific standards for curriculum
content. Evidence of graduation from an accredited school is part of a
State's licensing and certification requirements, independent of
Federal regulation. Anesthesia administration by nurse anesthetists has
a long history in this country, including a level of independent
practice in Department of Defense hospitals. We cannot agree that
anesthesia administration is the practice of medicine and therefore can
only be done after medical school training. Moreover, the rule does not
allow any provider to practice outside the parameters of his or her
professional license.
We also believe that this rule is consistent with both sides of
this argument as reflected in the comments. The added flexibility and
shared responsibility allows each health professional to practice
within his/her licensed scope of practice without an across-the-board
Federal requirement limiting any collaborative, team or independent
practice.
Comment: Additional commenters claimed significant variation among
program requirements in nurse anesthetist training. Some of these
commenters cited an article from the June 1996 Journal of the American
Association of Nurse Anesthetists, identifying that more than one-third
(37 percent) of nurse anesthetists do not have bachelor's degrees, less
than a quarter (22 percent) have a master's degree, and less than 1
percent have a Ph.D. In comparison, the writers note, all
anesthesiologists have an undergraduate degree, 4 years of medical
school and specialty training in anesthesiology.
Response: We recognize that education and training requirements
vary among the States. As previously noted, States are well skilled at
deciding requirements related to health care professional licensing.
Our change in the hospital rule deferring to State oversight is not an
endorsement of one health professional over another. It is not a rule
that defines medical or nursing standards of practice or educational
preparation. The rule merely allows the authority (that is, States)
whose traditional role it is to make such determinations (for example,
which health care professional is trained to provide which health care
services) to do so in the case of anesthesia administration.
Comment: There was some concern expressed that eliminating the
Federal requirement for supervision would result in decreased physician
involvement in the training of CRNAs. One commenter speculated that
this provision would reduce the incentive for a physician to specialize
in anesthesiology and physician-administered anesthesia would soon
vanish.
Response: We disagree that eliminating the Federal supervision
requirement will necessarily lead to physicians making decisions about
practice specialties, other than anesthesiology. This rule change is
not a judgment about the value or contribution of one health
professional or another. We believe that with greater staffing
flexibility, opportunities for collaboration between physicians and
nurse anesthetists will increase based on individual patient needs,
hospital characteristics, and an increasing ability to implement best
practice protocols.
Comment: A few commenters thought that eliminating supervision by
the anesthesiologist will limit the choice of anesthesia modalities and
deprive patients of an appropriate anesthesia plan. These commenters
stated that CRNAs are not trained in various types of nerve blocks and/
or the use of certain devices. These additional skills are necessary to
care for critically ill patients.
Response: This change in regulatory approach does not permit any
licensed independent health care provider to practice beyond his or her
licensed scope of practice. While we acknowledge there will continue to
be medical interventions or treatments that fall under the practice
authority of a medical licensee, these determinations are not, and
never have been, made by Federal regulation, but by States, with
[[Page 4681]]
input from, and consultation with, licensed health professionals.
Typically these decisions on practice issues fall to provider
credentialing, licensing or certification authorities. All areas of
health care are constantly faced with implementing new technologies,
procedures, drugs, biologicals, or devices. As these new techniques
become available we believe it is the responsibility of States,
hospitals, and professional organizations to implement standards for
training and assuring practice competency. In addition, we have no
evidence to indicate that eliminating the Federal supervision
requirement for CRNAs will limit the choice of anesthetic modalities or
deprive patients of appropriate anesthesia plans.
Comment: There were a few comments stating that the evolution of
non-physician practitioners is expanding through the use of well-
trained and very capable professionals. Advanced practice nurses
represent part of the movement to broaden access, increase efficiency
and maintain health care quality. One commenter applauded our efforts
to eliminate restrictions preventing full utilization of these highly
trained and qualified health professionals.
Others wrote in with concerns that this rule was opening the door
to allowing other independent health professionals to engage in
unsupervised practice in hospitals and through other providers
regulated by us. Some of these commenters pointed to increasing
activity at the State level to expand scope-of-practice laws for
nonphysicians. Examples, such as psychologists seeking prescribing
authority and complementary and alternative medicine practitioners
lobbying to expand their professional practice rights, have been used
to argue that lesser-trained professionals are attempting to practice
medicine without the appropriate training or supervision. They point
out that these are more examples of loosening regulatory safeguards
over the practice of medicine and patient care.
Response: States have an excellent track record of protecting
patient health through their own regulations. We respect State control
and oversight of health professionals by deferring to State licensing
laws to regulate professional practice. We have determined that there
is no need for continuing Federal preemption of State laws by
maintaining a requirement for physician supervision of CRNAs as a
special case. There is no evidence that States are any less concerned
with ensuring safety and quality than the Federal government,
especially when it comes to the health and safety of their citizens. In
fact, our evidence-based, outcome-oriented standards establish a shared
commitment between us, the States, and Medicare providers to ensure
safe, quality anesthesia administration. States have a good track
record in determining best practices. In fact, it is at the State level
where most direct input by health professionals into scope-of-practice
licensing laws takes place.
Additionally, we believe that independently licensed health
professionals have served a valuable role in expanding access to, and
maintaining quality in, many health services. The change in the Federal
requirement for physician supervision is not an endorsement of any
health profession, model of care delivery, or promotion of a specific
standard of care. It is a change in approach to regulatory oversight
that recognizes the worth of State control in meeting regional/local
needs.
Operating Surgeon Providing Physician Oversight
Previous regulation required physician supervision by either an
anesthesiologist or the operating surgeon. We received many comments
from surgeons asking about the surgeon's liability as well as questions
about who would be considered in charge of the patient's care.
Comment: One surgeon noted that he is dependent on the
anesthesiologist as a consultant to provide care and recommendations
concerning his patient. Other surgeons did not want responsibility for
the anesthesia care of their patients when they were not trained in
anesthesia. One commenter stated ``surgical residency programs have
intensified training in surgical technical skills, and decreased
emphasis on anesthesiology training, leaving such matters to the
consultant in Anesthesiology. As a result, [the surgeon's] ability to
supervise the CRNA has declined.'' This commenter asserted this should
encourage us to require CRNA supervision by an anesthesiologist only.
One anesthesiologist asked whether he would be responsible for
anesthesia management done prior to his consultation.
Response: This final rule does not require supervision, direction,
or oversight of any independently licensed practitioner administering
anesthesia by the operating surgeon. The surgeon would still be able to
involve an anesthesiologist as a consultant or in any other capacity.
This rule does nothing to restrict that relationship. CRNAs, as well as
anesthesiologists, are accountable for their own practices, the care
they deliver, patient outcomes, as well as insurance liability
coverage.
Comment: A few commenters stated there will be increasing pressure
on surgeons, from hospitals, CAHs, and ASCs, to eliminate the
anesthesiologist. Another commenter wrote that he believes if we
allowed this change, it would not be long before private insurers would
refuse to pay physicians no matter how sick the patient or complex the
procedure.
Response: This rule governs participation requirements for
hospitals, CAH, and ASCs participating in the Medicare program. It does
not eliminate, restrict, or in any way limit the practice of any
practitioner. In addition, an insurance company cannot establish health
professional practice rules that are in conflict with State licensing
laws.
Comment: We received several comments asserting the physician
supervision requirement was responsible for surgeons choosing not to
practice in some settings because they do not want the liability
associated with the supervision responsibility. One commenter noted
that one possible result of lifting the Federal supervision requirement
is that more surgeons may be willing to practice in geographical areas
they previously would have avoided partially because they did not want
to be responsible for supervising the CRNA. Some believed the rule
change will alleviate fears of surgeons who were concerned about taking
on increased legal liability. Others noted that removing the
supervision requirement afforded greater flexibility for surgeons and
hospitals to choose their anesthesia providers without fear of
increased liability.
Response: The rule makes no legal change in the scope of
malpractice liability, traditionally a State issue. Our rule,
permitting any State licensed health professional permitted by the
State to administer anesthesia would not definitively affect any
provider or professional the same way in all States. Because both
scope-of-practice and malpractice liability differs from state to
state, as a general matter, any professional who has contact with the
patient could conceivably be held liable for personal injury, depending
on the facts and circumstances of the case and on the State's laws.
This issue is not the subject of this rulemaking.
Rural Issues
Comment: We had many comments on this provision relative to the
practice of nurse anesthetists in rural areas. Even
[[Page 4682]]
many physicians supported the changed supervision requirement in rural
areas where access to anesthesiologists is limited. Some comments from
surgeons practicing in small communities noted they have worked solely
with CRNAs for all procedures, and they never felt they had a need for
any additional supervision, regardless of the medical situation. They
further point out that without nurse anesthetists willing to practice
in medically underserved areas, no one would be available to administer
anesthesia.
However, other physician commenters noted that under current
regulation, even without a supervising anesthesiologist, the operating
surgeon provides supervision to the nurse anesthetist. One commenter
noted, ``the administration of anesthetics by nurse anesthetists in
rural communities of this country is a condition of necessity, not
design, since these areas are generally underserved by physicians.''
The commenter disagrees with proposing a national standard based on
these criteria.
Response: The intent of this rule is not to limit or prohibit any
anesthesia care model. We are changing a thirty year old policy to more
accurately reflect demands of current practice, variations in hospital,
CAH or ASC, patient characteristics, resource management, technology,
and ever-increasing medical knowledge. We concur with the experience of
the commenters who state that nurse anesthetists have increased access
to anesthesia care, and thereby, access to medical and surgical
procedures that would likely be unavailable if not for a practitioner
qualified to administer anesthesia. We disagree, however, that the new
rule, by itself, will guarantee an adequate supply of CRNAs in rural
settings. A patient population's medical or surgical needs; hospital,
CAH, or ASC characteristics; State practice laws, etc. are all factors
contributing to decisions of CRNAs about where to practice. These
variables exist in rural as well as other geographic areas.
Comment: A few commenters believed we were erroneous in our
assumption that allowing independent practice of CRNAs would increase
access to needed medical procedures in rural areas. One commenter
asserted we were wrong in our assumption that there is a problem of
access to care in rural areas. CRNA commenters noted that CRNAs
administer anesthesia unsupervised by an anesthesiologist in
approximately 70 percent of rural hospitals within the United States,
providing a full range of anesthetic services (for example, surgical,
obstetrical, and trauma stabilization).
Response: Without CRNA availability in certain areas there would be
limits on the types of surgical interventions or procedures that could
be performed in those areas, because no anesthesia professionals other
than CRNAs would be available.
Comment: Several people asked that we create a rural carve-out for
CRNA independent practice. Some of these commenters agreed with keeping
the requirement for operating physician supervision, while others
supported full independent practice. Still others, even though in
agreement with a rural carve-out, wanted us to create a requirement for
supervision by an anesthesiologist wherever there were no shortages of
this physician specialty. Additionally, these commenters wanted
assurance that patient care outcomes would continue to be monitored so
that all patients would be receiving the care they deserve.
Response: The purpose of the change in the requirement is not
simply to respond to the needs of physician shortage areas. We gave
full consideration to this option but decided that the importance of
increased flexibility, decreased burden, and broadened implementation
of best practice protocols were important for hospitals in all
geographic settings. We believe there is no reason for an across-the-
board Federal requirement that could potentially limit development of
new practice models of anesthesia delivery, or interfere with progress
in promoting practices that improve patient outcomes.
There are additional mechanisms in place to support monitoring of
patient outcomes. There are other hospital standards and oversight
activities that address how care is delivered and identify mechanisms
hospitals must have in place to assure patients receive safe, quality
care.
Comment: One commenter stated that by expanding CRNA independent
practice outside of rural areas, increased competition would occur with
anesthesiologists for jobs in better served areas and would result in
CRNAs choosing not to locate in less desirable and under-served areas.
This commenter supported a rural carve-out for fear that without such a
carve-out, these underserved areas would again experience access
problems. Another commenter mistakenly believed that requiring
physician supervision would result in CRNAs working without payment,
leading small community operating rooms to close.
Response: CRNAs are paid under the CRNA fee schedule. The CRNA may
furnish the service under the ``medical direction'' of a physician,
usually the anesthesiologist, or the CRNA may furnish the entire
anesthesia service without medical direction, while still under the
supervision of the operating surgeon. Payment rules for CRNAs, as well
as for physician anesthesiologists, do not change as a result of this
rule.
This issue of health professional shortage has always been present
but there is no way to predict that this will be a definite outcome of
the rule change. The Congress, the Department of Health and Human
Services, and the States continue to address the issue of health
professional shortages through a variety of mechanisms, including
increasing educational grants and loans for those who choose to
practice in designated critical shortage areas.
Pre- and Post-Anesthesia Evaluations
Comment: Several writers cited the importance of the pre-anesthesia
evaluation as critical to prevention of complication during and after a
procedure. Many of these commenters felt that only a physician with
detailed knowledge of medicine has the ability to make a reasoned,
informed judgment about the medical state of a patient. Other
commenters noted that in addition to the pre-anesthetic evaluation, all
peri-operative assessment and care requires physician oversight. One
commenter pointed out that anesthesia complications might be a result
of several factors, including inadequate pre-anesthetic preparation,
severity of concurrent disease, inappropriate monitoring and lack of
post-anesthetic follow-up care. Another commenter stated this process
is more accurately described as ``pre-procedure assessment'',
indicating the importance of thorough consideration of the patient's
medical needs.
Response: We agree with commenters that a variety of factors and
contributing variables influence surgical and anesthesia outcomes. Our
literature review and analyses of comments confirms our conclusion that
interactions among and between these variables are difficult to isolate
in terms of their individual effects on outcomes. Education and
training programs for CRNAs include pre- and post-anesthesia care. Pre-
and post-anesthesia assessment and monitoring are scope-of-practice
issues determined by each State as it considers education and training
requirements for professional licensing.
We are sensitive to the debate between physician anesthesiologists
and nurse anesthetists regarding what
[[Page 4683]]
constitutes the practice of medicine with regard to anesthesia
administration. States have handled these issues through laws and
health professional practice acts. Questions of who is properly trained
to do a pre-anesthesia evaluation, care for a patient in recovery,
order pain medication, or perform a procedure that results in conscious
sedation of a patient, have all faced States when they adopted
professional licensing laws. This rule change does not prohibit
collaboration between medical professionals including surgeons, nurse
anesthetists, and/or anesthesiologists in the total care and treatment
of any patient in the hospital. As expanded scope-of-practice issues
are debated at the State level, we expect continued involvement by
medical and health professionals to ensure best practices and protocols
are incorporated in final decisions about which professionals meet the
required training and education to perform any particular service.
Collaboration and Anesthesia Team Approach
Comment: Several commenters explained that this rule would not
significantly change the manner in which CRNAs currently work. One
commenter noted that ``anesthesia always has been and always will be
given only as an adjunct to a surgical or diagnostic procedure.
Collaboration must occur with the primary physician no matter if the
anesthesia is provided by a physician anesthesiologist or a nurse
anesthetist.'' Other commenters reaffirmed this by pointing out that
collaboration is intrinsic to the practice of anesthesia
administration, and therefore an explicit requirement of supervision is
at best unnecessary. Others brought to our attention that State laws
that require supervision vary in their definitions and in many cases
define supervision as collaboration rather than direction.
Several anesthesiologists commented in support of the
collaborative, team approach to anesthesia delivery. Commenters
stressed the valuable and knowledgeable assets CRNAs are to the
anesthesia team. These commenters expressed some concern that the rule
will destroy the longstanding concept of the anesthesia care team,
making it less likely hospitals will take advantage of the skills of
the nurse anesthetist and the medical training of the anesthesiologist.
Response: As we have said, this rule makes no judgment in support
of one model of care over another. In addition, the rule does not
prohibit collaboration or teamwork during anesthesia administration. We
believe the rule will promote best practices and encourage professional
collaboration, in an effort to improve anesthesia care delivery and
patient outcomes. We are pleased with the comments in recognition of
the valuable contribution made by both professionals to the care of
patients during anesthesia administration.
Comment: One commenter wrote that in most settings patient care is
a team effort, and the current supervision requirement encourages
polarization rather than collaboration. This commenter noted that when
CRNAs have problems or questions about patient care they seek
consultation with colleagues. Other commenters stated that the removal
of the requirement provides surgeons, medical physicians, and others
who perform diagnostic or surgical procedures freedom to collaborate or
choose the anesthesia provider best suited to the procedure and the
patient's needs. Additionally, many who supported the change in the
rule believe that only a few CRNAs in certain circumstances would want
to practice without supervision. They felt that both nurses and
anesthesiologists preferred a team model of practice.
Two commenters stated that dentists, some physicians, and
podiatrists work in settings where collaboration with an independent
nurse anesthetist better suits the needs of the patient. They
particularly noted the practice by nurse anesthetists of staying with
patients for the entire duration of the procedure and through discharge
from surgery as being helpful.
Similarly, we had several physicians state that the average healthy
person can be safely managed by a CRNA. However, they contend a person
with multiple medical problems or those undergoing complex or high-risk
surgery should have a physician evaluation and medical direction during
his or her care. The commenters believed that with this type of
distinction in care, both parties would work together to deliver high
quality anesthesia.
Response: One of the limits to requiring an overarching, across the
board Federal requirement for supervision is the problem it creates for
providers to tailor care to the needs of patients. These comments
reaffirm what we have previously noted about the wide variability in
patient presentations (for example, medical factors, type and nature of
procedure, age, health, etc.) and how these variables influence
clinical decisions about anesthesia administration. This rule change
removes these unnecessary restrictions.
Cost to the Medicare Program
Comment: We received many comments on the financial motivations of
various types of professionals for taking a position on one side of
this issue or another. Many of the 20,000 comments accused one
professional group or another of lacking concern for safety or adding
additional burden to the health care delivery system for the sole
purpose of financial gain or practice monopoly. We also received
comments asserting that our motivation was to save money payable
through the Medicare and Medicaid programs at the cost of quality
anesthesia services. Those who support the change note that it removes
a financial disincentive to use nurse anesthetists by no longer
requiring payment to two professionals. They feel nurse anesthetist
will be more efficient and expand a hospital's ability to provide
services to more patients.
Many nurse anesthetists report having full responsibility for
administering an anesthetic and caring for a patient while the
anesthesiologist is somewhere else in the surgical area having no
interaction with the patient. They note CRNAs are able to provide the
same quality service at a lower cost, without the additional fee to an
anesthesiologist for providing supervision. One commenter expressed
support for the change as one that will greatly facilitate the use of
cost-effective, outcome-based providers, noting ``Unnecessarily
mandated layers of supervision ultimately add cost to care, and yet
have never documented any benefits.'' Many commenters wrote us with
specific examples of how Medicare charges and costs would decrease as a
result of the rule.
There was a common misunderstanding among many commenters that this
change meant that Medicare patients would be forced to receive a lesser
level of care because the rule changed the reimbursement for Medicare
patients. One commenter asked, ``Why would HCFA institute payment
procedures that decrease the level of care provided to Medicare and
Medicaid patients in the name of flexibility?'' Another stated this
rule proposes a double standard in that Medicare and Medicaid patients
would not have the benefit of a physician's expertise to ensure their
safety during critical peri-operative time.
Response: This rule does not change the payment policies for
anesthesia services. Medicare payment rules remain the same. CFR
section 415.110(a) requires that the anesthesiologist perform specific
activities for each patient in order to be paid for providing
[[Page 4684]]
``medical direction.'' It must be emphasized that the ``medical
direction'' rules are rules for payment of the physician's service
under the physician fee schedule. The physician fee schedule payment
per service is related to the amount of physician work associated with
the service. Thus, the medical direction requirement must establish
some level of physician work that is reasonable in relation to the
allowance recognized for the service. The ``supervision'' of the CRNA
by a physician, usually the operating surgeon, is not a separately
payable service for the surgeon. The payment for this service is
considered a part of the global surgical fee paid to the surgeon.
Because this rule does not affect payment , the determination about
supervision is not specific to a Medicare beneficiary. These rules
apply to all patients receiving anesthesia services in Medicare
participating hospitals, CAHs, and ASCs, thus Medicare patients would
not receive a different level of care from non-Medicare patients and
therefore, does not mean different care for Medicare or Medicaid
patients. The rule is specific to the provision of anesthesia services
in a Medicare participating hospital, CAH, or ASC, and applies to all
patients.
Comment: Several commenters who opposed this provision warned that
costs to the Medicare program will increase as a result of this rule.
Many believed that, although there will be no immediate effect since
payment remains the same, costs would increase in the long term because
of resulting anesthetic complications and malpractice. Others told us
they believe anesthesiologist consultations will increase because some
of these services are included in the anesthesia administration fee but
as consultants, anesthesiologists would have to charge separately for
these services.
Response: Neither costs to the Medicare program nor payment to
different professionals was part of the decision to change the hospital
CoP for anesthesia services. The fears of long term negative outcomes,
increasing medical complications and higher malpractice insurance
premiums, related to professional type, are unwarranted, based on our
review of the literature. This rule will not prohibit consultation,
physician supervision, or anesthesiologist administration of anesthesia
where State and/or hospital by-laws require it. Whether payment can be
made for consultations will be determined by the usual physician
coverage and payment rules.
General
Comment: We received many anecdotal comments from beneficiaries,
describing both positive and negative experiences during anesthesia,
such as, the importance of a caring, well-trained professional who
gives the needed patient attention, and answers the patient's
questions. Rarely did the comments identify the professional by
credentials.
Response: These reports are important in that they confirm our
commitment to patient-centered, outcome-oriented approaches to
regulating Medicare participating providers.
Comment: Several certified anesthesiology assistants (AAs)
expressed concerns about how the rule might affect their practice.
Since the rule allows anesthesia to be administered only by a person
licensed by the State to do so, they question whether this requirement
would prohibit their practice. Some of the AAs recommended that we omit
the term licensed and allow States to determine whether licensure is
required at all to practice anesthesia.
Response: We do not agree with the comments that no State licensure
should be required for anesthesia health professional practice. As
noted, this rule defers to State scope-of-practice laws which identify
health professionals that are allowed to administer anesthesia. Under
this rule, AA s would be allowed to practice within their scope-of-
practice specified by State law.
Comment: One commenter recommended that we require a CRNA to
disclose that a nurse, not a doctor, would be providing anesthesia care
and that if the patient desired to choose another provider his or her
request would be honored. Other commenters stated that this rule is
being promulgated without adequate input from patient advocate groups
and without regard to how it might affect patient care. They believe
that this rule serves special interests and that patient interests have
not been adequately considered.
Response: The request for an anesthesia provider is usually made by
the surgeon or physician in charge of the patient's care. We believe
the flexibility allowed through this rule change will enable physicians
to make the best and most suitable choice for their patient's
characteristics, medical and anesthesia needs. Patients are always free
to ask about the qualifications of any practitioner providing care,
including doctors, nurses, therapists, surgeons, or anesthetists.
We received comments regarding this proposal from patient advocates
and individual Medicare and Medicaid beneficiaries as well as providers
on both sides of the issue. We agree that safety and quality patient
outcomes should be the principal consideration in regulating providers.
It is exactly this focus which has led to the regulatory change in
supervision of CRNAs.
Comment: Several commenters pointed to other ways in which the
Federal government supported nurse anesthetists, citing, as examples,
Federal funds under Title VIII of the Public Health Service Act and
Medicare Education Funds. One commenter wrote that nurse anesthetists
received approximately $2.7 million dollars per year for student
trainees, faculty fellowships, and new program startup money.
Response: As previously noted, this rule is not intended to endorse
one health care professional over another. It is intended to recognize
the value in flexibility for providers when making decisions about how
to best manage resources to ensure access to quality health services.
Comment: We received a few comments from nurse anesthetists who
believed that implementation of this rule would be easy in those parts
of the country where CRNAs have practiced and are treated with respect.
Some of these commenters identified difficulty in achieving
professional courtesy and referrals from doctors who did not recognize
their skills and abilities.
Response: To the extent that this rule provides opportunity for
greater flexibility for providers and increased access to quality
health care for patients, we hope that this will occur. It is not our
goal in this rule to prescribe, or to limit, which health care
professionals may collaborate, supervise or work independently. We do,
however, hope to decrease barriers to access, increase efficiency, and
encourage improved models of safe anesthesia delivery. We believe that
is best accomplished by sharing the responsibility with States and
providers.
III. Provisions of the Final Regulations
We are amending Sec. 482.52(a)(4) of the current hospital CoPs and
Sec. 485.639(c)(1)(v) of the current critical access hospitals CoPs, to
codify requirements for who may administer anesthesia under Subpart D--
Standard: Anesthesia Services. This change is also reflected in a
conforming amendment to the ASC Conditions of coverage at
Sec. 416.42(b)(2). This final regulation eliminates a Federal
requirement for physician supervision and defers to
[[Page 4685]]
States the determination of which licensed practitioners are allowed to
administer anesthesia.
IV. Collection of Information Requirements
This document does not impose information collection and record
keeping requirements. Consequently, it need not be reviewed by the
Office of Management and Budget under the authority of the Paperwork
Reduction Act of 1995.
V. Regulatory Impact Statement
A. Overall Impact
We have examined the impacts of this rule as required by Executive
Order 12866 and the Regulatory Flexibility Act (RFA) (Public Law 96-
354). 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 annually). This rule is not
considered to have a significant economic impact on hospitals and,
therefore, is not considered a major rule. There are no requirements
for hospitals to initiate new processes of care, reporting, or to
increase the amount of time spent on providing or documenting patient
care services. This final rule will provide hospitals with more
flexibility in how they provide quality anesthesia services, and
encourage implementation of the best practice protocols.
The RFA requires agencies to analyze options for regulatory relief
of small businesses. For purposes of the RFA, small entities include
small businesses, nonprofit organizations and government agencies. Most
hospitals and most other providers and suppliers are small entities,
either by nonprofit status or by having revenues of $5 million or less
annually. For purposes of the RFA, all non-profit hospitals, and other
hospitals with revenues of $5 million or less annually are considered
to be small entities. Some critical access hospitals and some ASCs with
revenues of $5 million or less annually are also considered to be small
entities. Individuals and States are not included in the definition of
small entities.
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 604 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 50 beds.
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 one year by
State, local, or tribal governments, in the aggregate, or by the
private sector, of $100 million. This rule places no additional cost
requirements for implementation on the governments mentioned. It will
allow CRNAs to practice without physician supervision where State law
permits or to be supervised by a physician where such oversight is
required by State law. This change is consistent with our policy of
respecting State control and oversight of health care professions by
deferring to State licensing laws to regulate professional practice.
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 compliance costs on State and
local governments, preempts State law, or otherwise has Federalism
implications. This final rule imposes no direct compliance costs on
State or local governments.
B. Anticipated Effects
1. Medicare and Medicaid participating hospitals, CAHs, and
Ambulatory Surgical Centers will defer to State licensing laws in
determining which health professionals are permitted to administer
anesthesia. In addition, these facilities are free to exercise stricter
standards than required by State law.
2. First, it must be noted that this final rule does not change the
Medicare payment policies for anesthesia services. There is an
important payment distinction between the medical ``direction''
requirements and the physician ``supervision'' requirement. Payment
made by Medicare on a fee schedule basis is not payment for
``supervision'' but rather payment for ``direction'' and the payment
per service is related to the amount of physician work associated with
the service.
Second, economic effects on individual health professionals as a
result of this rule change will be influenced by other factors. Because
the final rule defers to State licensing laws, the impact on either
physician or CRNA income from billed services will be determined by
each States' laws. State laws vary widely in both the definition and
degree of physician supervision and oversight required of CRNAs. In
addition, some State laws leave the determination up to individual
hospital, CAH, or ASC medical staff by-laws, resulting in a financial
impact that is different depending on where the physician or CRNA
provides the services. In any of these situations the potential impact
might include an increase or decrease in billed services by CRNAs
practicing alone, in billed services by physicians practicing alone, in
billed services by physicians providing medical direction in
collaboration with CRNAs, as well as the possibility of no change in
billed services by either provider. In some of these cases, where there
is decreased physician billing, there may be increased savings to third
party payers.
Finally, the flexibility resulting from the rule change could
provide increased access to services in some areas, and broaden
opportunity for providers to implement professional standards of
practice that improve quality and promote more efficacious models of
care delivery.
3. This rule increases flexibility in the provision of anesthesia
services for Medicare and Medicaid hospitals, CAHs, and ASCs. It
removes the burden of implementing a Federal requirement for physician
supervision of CRNAs in all cases. The rule change will allow
hospitals, CAHs, and ASCs the flexibility, within the authority of
State licensing laws, to implement best-practice protocols in providing
anesthesia services most associated with positive patient outcomes.
Moreover, hospitals are free to exercise stricter practice standards.
As discussed in the preamble of the December 19, 1997 proposed rule,
this provision does not lend itself to a quantitative impact estimate,
and we do not anticipate a substantial economic impact either in costs
or savings.
C. Conclusion
We are changing the current across-the-board Federal requirement
for physician supervision of CRNAs to allow State control and oversight
through professional licensing laws. This change applies to all
Medicare and Medicaid participating hospitals, CAHs, and ASCs. Our
decision to change the Federal requirement for supervision of CRNAs
applicable in all situations is, in part, the result of our review of
the scientific literature which shows no overarching need for a Federal
regulation mandating any model of anesthesia practice, or limiting the
[[Page 4686]]
practice of any licensed professional. The clinical evidence indicates
anesthesia outcomes have improved substantially in recent years such
that anesthesia is a relatively safe procedure. Both our literature
review and comment analysis made clear that there is such a range of
variables and influences to be considered (for example, patient types,
surgical procedure, and/or availability of technology) that a single
Federal requirement applicable in all situations is unnecessary and may
actually interfere with factors that promote quality patient outcomes.
For these reasons, we are not preparing analyses for either the RFA
or section 1102(b) of the Act because we have determined, and we
certify, that this rule will 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.
In accordance with the provisions of Executive Order 12866, this
regulation was reviewed by the Office of Management and Budget.
VI. Federalism
We have reviewed this final rule under the threshold criteria of
Executive Order 13132, Federalism. We have determined that it does
significantly affect the rights, roles, and responsibilities of States.
This final rule removes the Federal guideline that requires CRNAs to be
supervised by a physician and allows the laws of the States to
determine which practitioners are permitted to administer anesthetics
and the level of supervision required.
List of Subjects
42 CFR Part 416
Health facilities, Kidney diseases, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 482
Grant programs-health, Hospitals, Medicaid, Medicare, Reporting and
recordkeeping requirements.
42 CFR Part 485
Grant programs-health, Health facilities, Medicaid, Medicare,
Reporting and recordkeeping requirements.
For the reasons set forth in the preamble, 42 CFR Chapter IV is
amended as set forth below:
PART 416--AMBULATORY SURGICAL SERVICES
1. The authority citation for Part 416 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh).
Subpart C--Specific Conditions for Coverage
2. Section 416.42 is amended by revising paragraph (b) to read as
follows:
Sec. 416.42 Condition for coverage--surgical services.
* * * * *
(b) Standard: Administration of anesthesia. Anesthesia must be
administered by a licensed practitioner permitted by the State to
administer anesthetics.
* * * * *
PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS
3. The authority citation for part 482 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395hh), unless otherwise noted.
Subpart D--Optional Hospital Services
4. Section 482.52 is amended by revising paragraph (a) to read as
follows:
Sec. 482.52 Condition of participation: anesthesia services.
* * * * *
(a) Standard: Staffing. The organization of anesthesia services
must be appropriate to the scope of the services offered. Anesthesia
must be administered by only a licensed practitioner permitted by the
State to administer anesthetics.
* * * * *
[[Page 4687]]
PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS
5. The authority citation for Part 485 continues to read as
follows:
Authority: Secs. 1102 and 1871 of the Social Security Act (42
U.S.C. 1302 and 1395 (hh)).
Subpart F--Critical Access Hospitals (CAHs)
6. Section 485.639 is amended by revising paragraph (c) to read as
follows:
Sec. 485.639 Condition of participation-surgical services.
* * * * *
(c) Administration of anesthesia. The CAH designates the person who
is allowed to administer anesthesia to CAH patients in accordance with
its approved policies and procedures and with State scope of practice
laws. Anesthesia is administered only by a licensed practitioner
permitted by the State to administer anesthetics.
* * * * *
(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: January 5, 2001.
Robert A. Berenson,
Administrator, Health Care Financing Administration.
Approved: January 10, 2001.
Donna E. Shalala,
Secretary.
Note: This list of references will not appear in the Code of
Federal Regulations.
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[FR Doc. 01-1388 Filed 1-17-01; 8:45 am]
BILLING CODE 4120-01-P