[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

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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).
    <bullet> 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.
    <bullet> 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.
    <bullet> 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:
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.
    <bullet> 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.

References

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Chassin, Mark R. Is Health Care Ready for Six Sigma Quality? Milbank 
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Kohn, L.T., Corrigan, J., and Donaldson, M., To Err is Human. 
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Lagasse, R.S., Steinberg, E.S., Katz, R.I., & Saubermann, A.J. 
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Silber, J.H., Kennedy, S.K., Even-Shoahan, O., Chen, W., Koziol, 
L.F., Showan, A.M., & Longnecker, D.E. (2000). Do nurse anesthetists 
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152-163

[FR Doc. 01-1388 Filed 1-17-01; 8:45 am]
BILLING CODE 4120-01-P