4674 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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.

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–

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 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 nonphysician 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-ofpractice 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-ofpractice 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

4676 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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-theboard Federal requirement overly

burdensome. Differences between a

healthy young patient undergoing minor

surgery in a hospital outpatient

department and a medically

compromised, elderly patient

undergoing major surgery in a large

teaching facility are so great that a single

Federal requirement is not applicable in

every situation.

Comment: Several commenters

objected to our arguments that

eliminating CRNA supervision would,

‘‘allow greater flexibility to hospitals

and practitioners’’ and would ‘‘give

deference to State scope-of-practice

laws’’. These commenters believe that

our reasoning is weak, especially in the

absence of documentation that either of

these issues is a problem.

Response: We disagree with these

commenters. As previously noted, we

respect State control and oversight of

health care professionals by deference to

State licensing laws which regulate

professional practice. There is no reason

to consider physician supervision of

CRNAs a special case requiring a

national standard. Advances in

anesthesia and surgical techniques, the

availability and discovery of new drugs,

and the varying medical presentations

of patients make it less prudent to rely

on a single national standard requiring

physician supervision of CRNAs to be

applied in every situation. Doing so

risks losing the accountability of

practitioners, both to make clinical

decisions based on the needs of

patients, and to utilize resources

effectively. We believe States need

flexibility from Federal oversight of

those processes, such as professional

licensing, for which they are ultimately

accountable. In fact, it is at the State

level where much direct input by health

professionals into scope-of-practice and

licensing laws takes place.

Comment: One commenter asked

what rule would be operative in the

absence of any State law.

Response: The final rule allows only

a licensed practitioner permitted by the

State to administer anesthetics to do so.

Therefore, State health professional

practice laws, such as those covering

nurse and physician practice, as well as

hospital licensing requirements, would

be the basis for determining which

health care professionals can administer

anesthesia in any given State.

Safety and Quality of Care

Comment: Many of the commenters

who wrote expressing concern over

quality of anesthesia services referred to

published research to support their

point of view. For example, many

commenters who support the proposed

rule stated that evidence shows

anesthesia administered by CRNAs to be

as safe as that administered by

anesthesiologists. In contrast, we also

received comments from

anesthesiologists who noted positive

patient outcomes from anesthesia

administration to be related to the

presence of the anesthesiologist. The

articles most frequently cited by

commenters were three by Jeffrey Silber,

M.D. and colleagues (1992, 1995, 1997),

and another by J.P. Abenstein and M.A.

Warner (1996). Many commenters

claimed these studies concluded either

an anesthesiologist alone, or a CRNA in

‘‘collaboration’’ with an

anesthesiologist, had better patient

outcomes than a CRNA alone. Many

commenters contend, erroneously, the

recommendations from the Abenstein &

Warner article were adopted by the

Minnesota legislature (although it is not

clear to what recommendations the

commenters were referring). Many other

commenters urged us not to consider

the change made by this rule until there

is solid, scientifically defensible

outcome data to establish that

independent nurse anesthesia care is

just as safe as anesthesiologist care.

Response: The conclusions of the

commenters were not supported by

findings from the studies they cited, nor

do the studies conclude that States

provide inadequate oversight and that a

Federal standard is therefore necessary.

We reviewed available literature and

found the following major conclusions

(see appendix).

• All literature surveyed agreed that

the anesthesia-related death rate is

extremely low, and the administration

of anesthesia in the United States is safe

relative to surgical risk. In fact,

according to the 1999 Institute of

Medicine Report To Err Is Human,

‘‘anesthesia mortality rates are about

one death per 200,000–300,000

anesthetics administered, compared

with two deaths per 10,000 anesthetics

administered in the early 1980s,’’ a 40-

to 60-fold improvement.

• There are no studies published

within the last 10 years that are specific

to the issue of the final rule, namely

provision of anesthesia care by CRNAs

practicing without physician

supervision. All of the studies we

reviewed had significant limitations.

Conclusions are limited by these

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 4677

studies’ failure to control adequately for

possible correlations among variables

such as higher risk patients and hospital

characteristics (for example, size and

sophistication of medical technology) as

they would affect deaths attributable to

anesthesia.

• There is no evidence that there

would be adverse outcomes by relying

on States and hospitals to regulate the

appropriate supervision and scope of

practice of health professionals

administering anesthesia. Nor has there

been any evidence that States do a poor

job in regulating and overseeing health

care professional practice or that States

are not capable of making decisions

regarding requirements for supervision

of one State-licensed independent

practitioner by another.

In the Silber studies, the authors did

not conclude that CRNAs may be

providing poor care that might more

likely lead to negative outcomes. The

1992 study did not address whether

there is an association between patient

outcomes and the type of professional

who furnished anesthesia. The

anesthesia variable used in the study

was not specific to the patient, rather it

was a variable at the hospital level (for

example, percent of anesthesiologists

who are board-certified). The anesthesia

variable might be a proxy indicator of

quality of the hospital: Thus, there

would be lower mortality in the higher

quality hospitals and if a complication

occurred the patient would more likely

be rescued.

Silber urges ‘‘that the limitations of

the project be recognized.’’ The

limitations include: There were

relatively few deaths, adverse outcomes

and failures, and relatively few patients

per hospital so the rates could only be

compared for groups of hospitals, not

specific facilities.

In a subsequent article to the one

summarized above, Silber and

colleagues (1995) found that ‘‘most of

the predictable variation in outcome

rates among hospitals appears to be

predicted by differing patient

characteristics rather than by differing

hospital characteristics, that is, by who

is treated rather than by the resources

available for treatment.’’ The authors

found higher proportions of boardcertified anesthesiologists to be

associated with lower death and failure

rates, but also with higher adverse

occurrence rates. The study did not

address the relationship between the

patient outcomes and the type of

professional who furnished the

anesthesia care. The study did not

address the issue of provision of

anesthesia care by CRNAs supervised

and not supervised by physicians. The

article presents no information that

States are not capable of making

decisions regarding requirements for

supervision of one State-licensed

independent practitioner by another.

Silber and his colleagues (1997) have

also conducted methodological studies

that compare the usefulness of three

outcome measures, mortality,

complication and failure-to-rescue rates.

They concluded that for the general

surgical procedures studied, the

complication rate is poorly correlated

with the death and failure rate. The

authors suggest that great caution be

taken when using complication rates

and that they should not be used in

isolation when assessing hospital

quality of care. The study did not

address the relationship between the

patient outcomes and the type of

professional who furnished the

anesthesia care. Nor did the study

address the issue of provision of

anesthesia care by CRNAs supervised

and not supervised by physicians, the

issue in the rule. The article presents no

information that States are not capable

of making decisions regarding

requirements for supervision of one

State-licensed independent practitioner

by another.

We have also reviewed a more

recently published article by Dr. Silber

(July 2000) and colleagues from the

University of Pennsylvania. This article

also is not relevant to the policy

determination at hand because it did not

study CRNA practice with and without

physician supervision, again the issue of

this rule. Moreover, it does not present

evidence of any inadequacy of State

oversight of health professional practice

laws, and does not provide sound and

compelling evidence to maintain the

current Federal preemption of State law.

Even on its own terms, the study has

the following methodological

shortcomings:

• The study used a non-experimental

research design and only examined

claims data, instead of reviewing

medical records or observing actual

care. Even though the researchers

statistically controlled for 106 proxy

indicators of care, without a stronger

research design, they can only make a

weak conclusion about an ‘‘association’’

between a variable and an outcome.

• The study did not control for the

cause of death. Cases where a patient

died from an anesthesia related cause,

the surgery itself, an unrelated medical

error, or an unknown medical condition

are all considered, regardless of the

cause of death. Not having data on

deaths actually attributed to anesthesia

is problematic since the mortality data

used covers any death occurring within

30 days of a hospital admission. Events

occurring 30 days from admission

cannot be attributed to the anesthesia

care alone. While the researchers argue

that ‘‘delayed’’ death (that is, within 30

days of admission) is the appropriate

measure of mortality for anesthesia care,

the study does not produce causal

evidence for such a theory. At a

minimum, the researchers could have

presented results for mortality measured

for shorter periods of time such as

within 72 hours of admission which

may or may not have shown different

outcomes for short-term and delayed

deaths.

• Both the study and comparison

groups included cases where physicians

supervised CRNAs and personally

furnished anesthesia. (The study group

also included cases where

anesthesiologists medically directed

residents). The purpose of the study was

to examine differences when an

anesthesiologist versus a nonanesthesiologist physician is involved

in the case. One cannot use this analysis

to make conclusions about CRNA

performance with or without physician

supervision.

• The study used data where

anesthesia was furnished by unknown

suppliers (incorrectly referred to in the

article as ‘‘unknown providers’’) either

personally providing care or supervising

CRNAs. Because a supplier is not a

physician there are likely to be data

coding errors which could contaminate

and bias the results.

Even if the methodological

shortcomings were fixed, because the

study did not address the issue in the

final rule, it is inappropriate to impute

results from this study to the issue in

this final rule, the provision of care by

CRNAs supervised and not supervised

by physicians.

Even if the recent Silber study did not

have methodological problems, we

disagree with its apparent policy

conclusion that an anesthesiologist

should be involved in every case, either

personally performing anesthesia or

providing medical direction of CRNAs.

Such a policy is much more restrictive

than current Medicare policy because it

would prohibit non-anesthesiologist

physicians to supervise CRNAs. This

would make it difficult to perform

surgeries in many small and rural

hospitals because anesthesiologists

generally do not practice in these

hospitals.

Finally, even if we were to consider

that the Silber article should guide our

policy, we note, that due to the

difference between relative risk and

absolute risk, the reported size-effect is

too small to cause us to change our

4678 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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 boardcertified 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

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 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.

4680 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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 physicianadministered 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

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 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 welltrained 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

4682 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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 everincreasing 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 carveout, 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 acrossthe-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-ofpractice 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

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 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 preanesthesia 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

4684 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

‘‘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-ofpractice 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 § 482.52(a)(4) of the

current hospital CoPs and

§ 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

§ 416.42(b)(2). This final regulation

eliminates a Federal requirement for

physician supervision and defers to

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 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 bestpractice 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 acrossthe-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

4686 Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations

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:

§ 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:

§ 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.

* * * * *

Federal Register / Vol. 66, No. 12 / Thursday, January 18, 2001 / Rules and Regulations 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:

§ 485.639 Condition of participationsurgical 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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Anesthesia providers, patient outcomes,

and costs. Anesth. Analg. 62. 1273–1283.

Chassin, Mark R. Is Health Care Ready for Six

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Kohn, L.T., Corrigan, J., and Donaldson, M.,

To Err is Human. Institute of Medicine.

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Lagasse, R.S., Steinberg, E.S., Katz, R.I., &

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Silber, J.H., Rosenbaum, P.R., Williams, S.V.,

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Silber, J.H., Kennedy, S.K., Koziol, L.F.,

Showan, A.M., & Longnecker, D.E.

(1998). Do nurse anesthetists need

medical direction by anesthesiologists?

Anesthesiology, 89: A1184

Silber, J.H., Kennedy, S.K., Even-Shoahan,

O., Chen, W., Koziol, L.F., Showan,

A.M., & Longnecker, D.E. (2000). Do

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Anesthesiology, 93 (1): 152–163

[FR Doc. 01–1388 Filed 1–17–01; 8:45 am]

BILLING CODE 4120–01–P