[Federal Register Volume 66, Number 129 (Thursday, July 5, 2001)]
[Proposed Rules]
[Pages 35395-35399]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 01-16964]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Parts 416, 482, and 485

[HCFA-3070-P]

RIN 0938-AK95


Medicare and Medicaid Programs; Hospital Conditions of 
Participation: Anesthesia Services

AGENCY: Health Care Financing Administration (HCFA), HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

SUMMARY: This proposed rule would amend the physician supervision 
requirement for certified registered nurse anesthetists furnishing 
anesthesia services in hospitals, critical access hospitals, and 
ambulatory surgical centers that participate in the Medicare and 
Medicaid programs. Under this proposed rule, the current physician 
supervision requirement would be maintained, unless the Governor of a 
State, in consultation with the State's Boards of Medicine and Nursing, 
exercises the option of exemption from this requirement, consistent 
with State law.
    These proposed changes are an integral part of our efforts to 
improve the quality of care furnished through Federal programs, while 
at the same time recognizing a State's traditional domain in 
establishing professional licensure and scope-of-practice laws. It will 
give States the flexibility to improve access and address safety 
issues.

DATES: We will consider comments if we receive them at the appropriate 
address, as provided below, no later than 5 p.m. on September 4, 2001.

ADDRESSES: Mail written comments (1 original and 3 copies) to the 
following address only: Health Care Financing Administration, 
Department of Health and Human Services, Attention: HCFA-3070-P, P.O. 
Box 8013, Baltimore, MD 21207-8013.
    To ensure that mailed comments are received in time for us to 
consider them, please allow for possible delays in delivering them.
    If you prefer, you may deliver (by hand or courier) your written 
comments (1 original and 3 copies) to one of the

[[Page 35396]]

following addresses: Room 443-G, Hubert H. Humphrey Building, 200 
Independence Avenue, SW., Washington, DC 20201, or Room C5-14-03, 7500 
Security Boulevard, Baltimore, MD 21244.
    Comments mailed to the addresses indicated as appropriate for hand 
or courier delivery may be delayed and could be considered late.
    Because of staff and resource limitations, we cannot accept 
comments by facsimile (FAX) transmission. In commenting, please refer 
to file code HCFA-3070-P. For information on viewing public comments 
see the beginning of the SUPPLEMENTARY INFORMATION section.

FOR FURTHER INFORMATION CONTACT: Stephanie Dyson, RN (410) 786-9226. 
Jeannie Miller, RN (410) 786-3164.

SUPPLEMENTARY INFORMATION: Inspection of Public Comments: Comments 
received timely will be available for public inspection as they are 
received, generally beginning approximately 3 weeks after publication 
of a document, at 7500 Security Blvd, Baltimore, Maryland 21244, Monday 
through Friday of each week from 8:30 a.m. to 4 p.m. by calling (410) 
786-7197.
    To order copies of the Federal Register containing this document, 
send your request to: New Orders, Superintendent of Documents, P.O. Box 
371954, Pittsburgh, PA 15250-7954. Specify the date of the issue 
requested and enclose a check or money order payable to the 
Superintendent of Documents, or enclose your Visa or Master Card number 
and expiration date. Credit card orders can also be placed by calling 
the order desk at (202) 512-1800 or by faxing to (202) 512-2250. The 
cost for each copy is $9. As an alternative, you can view and photocopy 
the Federal Register document at most libraries designated as Federal 
Depository Libraries and at many other public and academic libraries 
throughout the country that receive the Federal Register.
    This Federal Register document is also available from the Federal 
Register online database through GPO Access, a service of the U.S. 
Government Printing Office. The Website address is: http://www.access.gpo.gov/nara/index.html.

I. Background

A. Statutory Provisions

    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 other requirements that we 
find necessary in the interest of the health and safety of the 
hospital's patients. Section 1820 of the Act contains criteria that a 
critical access hospital (CAH) must meet in order to be designated as a 
CAH by a State. Sections 1832(a)(2)(F)(i) and 1833(i) of the Act 
provide coverage requirements for ambulatory surgical centers (ASCs). 
Section 1861(bb) of the Act defines ``certified registered nurse 
anesthetists'' (CRNAs) and their services.

B. General

    On December 19, 1997, we published a proposed rule entitled, 
``Hospital Conditions of Participation, Provider Agreements and 
Supplier Approval'', (62 FR 66726) in the Federal Register.
    The final rule was published January 18, 2001 (66 FR 4674) and was 
to have been effective March 19, 2001. This rule eliminated the federal 
physician supervision requirement for CRNAs furnishing anesthesia 
services in participating hospitals, ASCs, and CAHs. Instead, under the 
January 2001 rule, the level of supervision of CRNAs in participating 
Medicare facilities would be determined according to state law. On 
March 19, 2001, the effective date was delayed 60 days in accordance 
with the memorandum to the President from the Chief of Staff, dated 
January 20, 2001, and published in the Federal Register (see 66 FR 
15352). On May 18, the rule was further delayed for 180 days in order 
to explore alternatives for implementation (see 66 FR 27598). Upon 
review of the January 2001 final rule, we identified two important 
questions that were not raised and thus not addressed previously.
     One question concerned the States' reliance on Medicare 
physician supervision requirements in establishing State scope-of-
practice laws and monitoring practices. In some cases, State laws and 
regulations may have been written with the assumption that Medicare 
would continue its longstanding policy requiring physician supervision 
of the anesthesia care provided by CRNAs. Eliminating the federal CRNA 
supervision requirements for participating Medicare facilities could 
mean that some States would change their supervision practices without 
considering its potential safety impact. In the absence of federal 
regulations, we were concerned that States might have promulgated 
different laws or different monitoring practices.
     The second question was whether a prospective study or 
monitoring should be undertaken to assess the impact in those States 
where CRNAs practice without physician supervision, or where physicians 
practice without the assistance of CRNAs. To date, no study has 
definitively addressed these issues, although the literature we 
reviewed 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. However, in the absence of clear 
research evidence it is impossible to definitively document outcomes 
related to these practices.
    We have concluded that we must resolve these implementation 
questions before we will consider eliminating entirely the federal CRNA 
supervision requirement. At the same time, however, we wish to give 
States the flexibility they need to ensure that their citizens have 
appropriate access to quality anesthesia services. Accordingly, we 
again have delayed the effective date of the final rule and are 
proposing an alternative method in lieu of proposing an immediate 
removal of the federal supervision requirement. Our alternative 
proposed method would be to--
    (1) Establish an exemption from the physician supervision 
requirement by recognizing a Governor's written request to us attesting 
that, after consultation with the State's Boards of Medicine and 
Nursing on issues related to access to and the quality of anesthesia 
services, and consistent with state law, he or she is aware of the 
State's right to an exemption from the requirement and has determined 
that it is in the best interests of the State's citizens to exercise 
this exemption, and
    (2) Have the Agency for Health Research and Quality (AHRQ), with 
input from HCFA and that of other stakeholders, including 
anesthesiologists and CRNAs, design and conduct a prospective study or 
monitoring effort to assess outcomes of care issues relating to CRNA 
practice and involvement. One approach that we are seeking comment on 
would be to create a voluntary registry that could prospectively 
monitor these practices. We are interested in comments on other 
approaches, as well.
    The Secretary is specifically seeking comments on both aspects of 
our alternative implementation approach.

II. Provisions of the Proposed Regulations

A. Overview

    Under the proposal, we would continue to require CRNA supervision 
by a physician in hospitals, CAHs, and ASCs that participate in the 
Medicare program. However, we would add a new standard, entitled 
``State Exemptions.''

[[Page 35397]]

This new standard would allow State Governors, following consultation 
with the State's Boards of Medicine and Nursing on issues related to 
access to and the quality of anesthesia services, and consistent with 
state law, to exercise their option of exemption from the physician 
supervision requirement in anesthesia administration through a letter 
of attestation. The Governor seeking such an exemption would be 
required to submit a letter to us, attesting that it is in the best 
interests of the State's citizens to opt-out of the requirement of 
physician supervision, and that such an opt-out is consistent with 
State law. We are developing a model letter of attestation that a 
Governor may send to the HCFA Administrator to signify that the State 
is exempt from the physician supervision requirement. The request to 
opt-out, and any withdrawal of a request to opt-out, would both be 
automatic and effective upon submission to HCFA. As with the current 
conditions of participation, the exemption would apply to all patients 
receiving anesthesia services in Medicare participating hospitals, 
CAHs, and ASCs, assuring that Medicare patients would not receive a 
different level of care from non-Medicare patients.

B. Discussion

    We continue to believe that States are best positioned to regulate 
practitioners' scope-of-practice and that our proposal will allow 
Governors, in consultation with the State's Boards of Medicine and 
Nursing, to make important safety-related determinations when electing 
to exercise authority over anesthesia services. It will effectively 
provide greater discretion to State authorities that are experienced at 
regulating the licensing, education, training, and performance of the 
professionals practicing under their purview, without the burden 
associated with duplicative regulatory oversight. Allowing States to 
make determinations about health care professional standards of 
practice, and hospitals, CAHs, and ASCs 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. Since the January 2001 rule is not yet effective, the 
regulatory changes we are proposing here are drafted as revisions to 
the 2000 CFR.

III. Collection of Information Requirements

    This document does not impose information collection and 
recordkeeping requirements. Consequently, it need not be reviewed by 
the Office of Management and Budget under the authority of the 
Paperwork Reduction Act of 1995.

IV. Response to Comments

    Because of the large number of items of correspondence we normally 
receive on Federal Register documents published for comment, we are not 
able to acknowledge or respond to them individually. We will consider 
all comments we receive by the date and time specified in the DATES 
section of this preamble, and, if we proceed with a subsequent 
document, we will respond to the major comments in the preamble to that 
document.

V. Regulatory Impact Analysis

A. Overall Impact

    We have examined the impacts of this rule as required by Executive 
Order 12866 and the Regulatory Flexibility Act (RFA) (Pub. L. 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, CAHs, 
and ASCs to initiate new processes of care, reporting, or to increase 
the amount of time spent on providing or documenting patient care 
services. This proposed rule would provide hospitals, CAHs, and ASCs 
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 entities. 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 $25 
million to $25 million or less annually (65 FR 69432). For purposes of 
the RFA, all non-profit hospitals, CAHs, and other hospitals with 
revenues of $25 million or less annually are considered to be small 
entities. Ambulatory surgical centers with revenues of $7.5 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 603 of the RFA. For 
purposes of section 1102(b) of the Act, we define a small rural 
hospital as a hospital that is located outside of a Metropolitan 
Statistical Area and has fewer than 100 beds.
    We 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.
    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, that exceeds the inflation-adjusted threshold of $110 
million. This rule places no additional costs for implementation on the 
governments mentioned. It will allow the Governor through a letter to 
us, to opt-out of the physician supervision requirement for CRNAs and 
allow the CRNAs to practice independently where State law permits. This 
change is consistent with our policy of respecting State control and 
oversight of health care professions by deferring to State 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. We have examined this proposed rule and have determined 
that this rule will not have a negative impact on the rights, rules, 
and responsibilities of State, local, or tribal governments.
    In accordance with the provisions of Executive Order 12866, this 
proposed rule was reviewed by the Office of Management and Budget.

List of Subjects

42 CFR Part 416

    Health facilities, Kidney diseases, Medicare, Reporting and 
recordkeeping requirements.

[[Page 35398]]

42 CFR Part 482

    Grant programs-health, Health facilities, 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, the Health Care 
Financing Administration proposes to amend 42 CFR chapter IV as 
follows:

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).

    2. In Sec. 416.42, revise paragraph (b), and add a new paragraph 
(d) to read as follows:


Sec. 416.42  Condition for coverage--Surgical services.

* * * * *
    (b) Standard: Administration of anesthesia. Anesthetics must be 
administered by only--
    (1) A qualified anesthesiologist; or
    (2) A physician qualified to administer anesthesia, a certified 
registered nurse anesthetist (CRNA) or an anesthesiologist's assistant 
as defined in Sec. 410.68(b) of this chapter, or a supervised trainee 
in an approved educational program. In those cases in which a non-
physician administers the anesthesia, unless exempted in accordance 
with paragraph (d) of this section, the anesthetist must be under the 
supervision of the operating physician, and in the case of an 
anesthesiologist's assistant, under the supervision of an 
anesthesiologist.
* * * * *
    (d) Standard: State exemption. (1) An ASC may be exempted from the 
requirement for physician supervision of CRNAs as described in 
paragraph (b)(2) of this section, if the State in which the ASC is 
located submits a letter to HCFA signed by the Governor, following 
consultation with the State's Boards of Medicine and Nursing, 
requesting exemption from physician supervision of CRNAs. The letter 
from the Governor must attest that he or she has consulted with State 
Boards of Medicine and Nursing about issues related to access to and 
the quality of anesthesia services in the State and has concluded that 
it is in the best interests of the State's citizens to opt-out of the 
current physician supervision requirement, and that the opt-out is 
consistent with State law.
    (2) The request for exemption and recognition of State laws, and 
the withdrawal of the request may be submitted at any time, and are 
effective upon submission.

PART 482--CONDITIONS OF PARTICIPATION FOR HOSPITALS

    1. 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.

    2. In Sec. 482.52, revise paragraph (a), and add a new paragraph 
(c) to read as follows:


Sec. 482.52  Condition of participation: Anesthesia services

* * * * *
    (a) Standard: Organization and staffing. The organization of 
anesthesia services must be appropriate to the scope of the services 
offered. Anesthesia must be administered only by--
    (1) A qualified anesthesiologist;
    (2) A doctor of medicine or osteopathy (other than an 
anesthesiologist);
    (3) A dentist, oral surgeon, or podiatrist who is qualified to 
administer anesthesia under State law;
    (4) A certified registered nurse anesthetist (CRNA), as defined in 
Sec. 410.69(b) of this chapter, who, unless exempted in accordance with 
paragraph (c) of this section, is under the supervision of the 
operating practitioner or of an anesthesiologist who is immediately 
available if needed; or
    (5) An anesthesiologist's assistant, as defined in Sec. 410.69(b) 
of this chapter, who is under the supervision of an anesthesiologist 
who is immediately available if needed.
* * * * *
    (c) Standard: State exemption. (1) A hospital may be exempted from 
the requirement for physician supervision of CRNAs as described in 
paragraph (a)(4) of this section, if the State in which the hospital is 
located submits a letter to HCFA signed by the Governor, following 
consultation with the State's Boards of Medicine and Nursing, 
requesting exemption from physician supervision of CRNAs. The letter 
from the Governor must attest that he or she has consulted with State 
Boards of Medicine and Nursing about issues related to access to and 
the quality of anesthesia services in the State and has concluded that 
it is in the best interests of the State's citizens to opt-out of the 
current physician supervision requirement, and that the opt-out is 
consistent with State law.
    (2) The request for exemption and recognition of State laws, and 
the withdrawal of the request may be submitted at any time, and are 
effective upon submission.

PART 485--CONDITIONS OF PARTICIPATION: SPECIALIZED PROVIDERS

    1. 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)).

    2. In Sec. 485.639, paragraph (c) is revised and new paragraph (e) 
is added to read as follows:


Sec. 485.639  Condition of participation: Surgical services.

* * * * *
    (c) Administration of anesthesia. The CAH designates the person who 
is allowed to administer anesthesia to CAH patients in accordance with 
its approved policies and procedures and with State scope-of-practice 
laws.
    (1) Anesthesia must be administered by only--
    (i) A qualified anesthesiologist;
    (ii) A doctor of medicine or osteopathy other than an 
anesthesiologist; including an osteopathic practitioner recognized 
under section 1101(a)(7) of the Act;
    (iii) A doctor of dental surgery or dental medicine;
    (iv) A doctor of podiatric medicine;
    (v) A certified registered nurse anesthetist (CRNA), as defined in 
Sec. 410.69(b) of this chapter;
    (vi) An anesthesiologist's assistant, as defined in Sec. 410.69(b) 
of this chapter; or
    (vii) A supervised trainee in an approved educational program, as 
described in Secs. 413.85 or 413.86 of this chapter.
    (2) In those cases in which a CRNA administers the anesthesia, the 
anesthetist must be under the supervision of the operating practitioner 
except as provided in paragraph (e) of this section. An 
anesthesiologist's assistant who administers anesthesia must be under 
the supervision of an anesthesiologist.
* * * * *
    (e) Standard: State exemption. (1) A CAH may be exempted from the 
requirement for physician supervision of CRNAs as described in 
paragraph (c)(2) of this section, if the State in which the CAH is 
located submits a letter to HCFA signed by the Governor, following 
consultation with the State's

[[Page 35399]]

Boards of Medicine and Nursing, requesting exemption from physician 
supervision for CRNAs. The letter from the Governor must attest that he 
or she has consulted with State Boards of Medicine and Nursing about 
issues related to access to and the quality of anesthesia services in 
the State and has concluded that it is in the best interests of the 
State's citizens to opt-out of the current physician supervision 
requirement, and that the opt-out is consistent with State law.
    (2) The request for exemption and recognition of State laws and the 
withdrawal of the request may be submitted at any time, and are 
effective upon submission.

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)
(Catalog of Federal Domestic Assistance Program No. 93.773, 
Medicare--Hospital Insurance; and Program No. 93.774, Medicare--
Supplementary Medical Insurance Program)
    Dated: June 6, 2001.
Thomas A. Scully,
Administrator, Health Care Financing Administration.
    Approved: July 2, 2001.
Tommy G. Thompson,
Secretary.
[FR Doc. 01-16964 Filed 7-3-01; 8:45 am]
BILLING CODE 4210-01-P