[Federal Register Volume 60, Number 230 (Thursday, November 30, 1995)]
[Rules and Regulations]
[Pages 61483-61487]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 95-29194]



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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Health Care Financing Administration

42 CFR Part 440

[MB-085-F]
RIN 0938-AG73


Medicaid Program: Nurse-Midwife Services

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

ACTION: Final rule.

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SUMMARY: In accordance with section 13605 of the Omnibus Budget 
Reconciliation Act of 1993, this final rule expands coverage of nurse-
midwife services under the Medicaid program by including coverage for 
those services that nurse-midwives perform outside the maternity cycle 
as allowed by State law and regulation. In addition, this rule includes 
several clarifying revisions to the Medicaid regulations.

EFFECTIVE DATE: January 2, 1996.

FOR FURTHER INFORMATION CONTACT: Linda Sizelove, (410) 786-4626.

SUPPLEMENTARY INFORMATION:

I. Background

A. Scope of Covered Services

    Title XIX of the Social Security Act (the Act) authorizes States to 
establish Medicaid programs to provide medical assistance to needy 
individuals. Section 1902(a)(10) of the Act describes the two broad 
classifications of most individuals to whom medical assistance may be 
provided: the categorically needy (section 1902(a)(10)(A)) and the 
medically needy (section 1902(a)(10)(C)). Section 1905 of the Act 
defines medical assistance as payment of part or all of the costs of 
specified services to eligible individuals.
    Section 1905(a)(17) of the Act includes, as a service for which 
medical assistance may be available, nurse-midwife services which the 
nurse-midwife is authorized to provide under 

[[Page 61484]]
State law or regulation. Nurse-midwife services are mandatory for the 
categorically needy under section 1902(a)(10)(A) of the Act. At the 
State's option, a State may also provide these services to the 
medically needy.
    Before October 1, 1993, section 1905(a)(17) of the Act (through a 
cross-reference to section 1861(gg) of the Act) and implementing 
regulations at 42 CFR 440.165 required that a nurse-midwife must be a 
registered nurse who (1) is either certified as a nurse-midwife by an 
organization recognized by the Secretary or has completed a program of 
study and clinical experience that has been approved by the Secretary 
and (2) performs services in the care of mothers and babies throughout 
the maternity cycle. Section 1905(a)(17) (again, through a cross-
reference to section 1861(gg) of the Act) also specifies that the 
services that a nurse-midwife is legally authorized to perform under 
State law and regulations must be covered regardless of whether the 
nurse-midwife is under the supervision of, or associated with, a 
physician or other health care provider.
    Section 13605 of the Omnibus Budget Reconciliation Act of 1993 
(OBRA '93), Pub. L. 103-66, amended section 1905(a)(17) of the Act to 
remove the limitation that a nurse-midwife can provide services only 
during the maternity cycle.

B. Current Regulatory Provisions

    There are four existing sections of Medicaid regulations that are 
affected by this final rule. Section 440.165 defines nurse-midwife 
services as a distinct service category and lists the requirements for 
coverage of services under that category. Three other sections, 
Secs. 440.10, 440.20, and 440.90, contain cross-references to 
Sec. 440.165 to indicate that nurse-midwife services may be performed 
in specified settings. Sections 440.10 and 440.20 provide that nurse-
midwife services may be performed in inpatient and outpatient hospital 
settings. Section 440.90 provides that nurse-midwife services may be 
performed in clinic settings.

II. Provisions of the Proposed Regulations

    On July 18, 1994, we published a proposed rule that set forth 
changes to the Medicaid regulations based on the provisions of OBRA '93 
and our reexamination of existing regulations (59 FR 36419). 
Specifically, we proposed the following revisions:
     To amend Sec. 440.165 by removing paragraphs (a)(1) and 
(c) to delete the definition of, and all other references to, the 
maternity cycle in accordance with the OBRA '93 amendment that provides 
for the coverage of nurse-midwife services regardless of whether the 
services are performed in the management of care of mothers and babies 
throughout the maternity cycle. Removal of this limitation will allow 
nurse-midwives to perform any service that is allowed under State law 
or regulation.
     To remove the exception cross-references to Sec. 440.165 
contained in Secs. 440.10, 440.20, and 440.90. Because nurse-midwife 
services are defined as a distinct service category under Sec. 440.165, 
we have determined that the inclusion of cross-references to the 
description of covered nurse-midwife services within the descriptions 
of other covered Medicaid services is more confusing than clarifying.

III. Discussion of Public Comments

    In response to the July 18, 1994 proposed rule, we received 30 
timely items of correspondence. We have summarized the comments and 
present them below with our responses.
    Comment: Several commenters requested that we revise the 
regulations to clarify that nurse-midwife services may be provided in a 
variety of settings. The commenters suggested that we explain in the 
regulations that a nurse-midwife can order home health visits, can be 
reimbursed for services provided in freestanding birth centers and 
clinics, and can be reimbursed for patient services provided in the 
home without regard to whether the services were provided under the 
direction of a physician or other health care provider. One commenter 
suggested that we revise Sec. 440.70 to clarify that nurse-midwife 
services may be provided in the home and that these services are not 
subject to the requirement that home health services must be on the 
order of the recipient's physician. Another commenter requested that we 
revise Sec. 440.165 to specify the settings where nurse-midwife 
services may be performed.
    Additionally, while several commenters supported our proposed 
revisions to Secs. 440.10, 440.20, and 440.90, other commenters were 
concerned that our proposal to remove the cross references to nurse-
midwife services in these sections may lead parties to mistakenly 
believe that the supervision of a physician is required for nurse-
midwife services furnished in inpatient or outpatient hospital settings 
or clinic settings. The majority of the comments we received focused on 
the issues described above.
    Response: To help clarify our position on the settings where nurse-
midwife services may be provided and the restrictions imposed on 
services furnished in those settings, we will provide some general 
information on how Medicaid services are paid. We will follow this with 
specific information on nurse-midwife services.

A. General Principles

    Generally, Medicaid services are classified by three types of 
categories. Each separate category may have specific Federal 
requirements relating to supervision or location of services. First, 
services are described in terms of the setting in which they are 
provided. Some services included in this category are inpatient or 
outpatient hospital services and clinic services. Second, services are 
described by the type of services being furnished, such as 
rehabilitation or physical therapy services. Finally, services are 
described in terms of the individual providing the service such as 
physician, nurse practitioner, and nurse-midwife services. Each 
category is separate and has a distinct set of regulatory requirements.
    While we view each category of service as separate and distinct, 
the categories are not mutually exclusive. Some services, including 
nurse-midwife services, can be classified in more than one category. It 
is also possible that a service provided may meet the requirements 
under one category and not another even though, as a general rule, the 
service could be classified under either category. The specific 
circumstances under which a service is provided and how the provider 
bills for the service determines how the service is categorized and 
which regulatory requirements apply.

B. Nurse-Midwife Services

    The general principles of Medicaid coverage discussed above apply 
to nurse-midwife services. There are no Federal restrictions on 
settings where nurse-midwife services may be furnished. Nurse-midwife 
services are limited only through State licensure or scope of practice 
laws. Additionally, the Act does not dictate that a nurse-midwife who 
practices in a hospital or clinic must receive payment through that 
facility. Nurse-midwife services are similar to physician services in 
that they may be billed in their own distinct category or alternatively 
may be billed under other categories such as hospital or clinic 
services. If nurse-midwife services are provided under the 
classification of inpatient or outpatient hospital services or clinic 
services, and billed as such, then the requirements outlined in 
Secs. 440.10, 440.20, or 440.90 

[[Page 61485]]
must be met. For example, nurse-midwife services performed in a 
hospital setting could be billed as either nurse-midwife services or 
hospital services. If the hospital bills Medicaid for the nurse-midwife 
services, the services will be categorized as inpatient hospital 
services (or outpatient hospital services as the case may be) and all 
Federal requirements relating to inpatient (or outpatient) hospital 
services must be met. That is, in accordance with Sec. 440.10, the 
hospital services provided by the nurse-midwife must be provided under 
the overall direction of a physician. If a nurse-midwife bills for the 
services as nurse-midwife services (which happen to be furnished in a 
hospital setting), all Federal regulatory requirements relating to 
nurse-midwife services must be met. Thus, under Sec. 440.165, the 
services may be performed without regard to whether the nurse-midwife 
is under the supervision of, or associated with, a physician or other 
health care provider.
    This same rationale applies to nurse-midwife services furnished in 
the home. As long as the services are billed as nurse-midwife services, 
the nurse-midwife may provide services in the home and receive payment 
for such services without regard to whether the services were ordered 
by the recipient's physician. However, if the services are billed 
through a home health agency, the Federal requirements set forth in 
Sec. 440.70 for home health services must be met.
    Similarly, if nurse-midwife services provided in freestanding birth 
centers are billed as clinic services, then the Federal requirements 
outlined in Sec. 440.90 for clinic services must be met in order to 
receive payment. Therefore, the services would have to be performed 
under the direction of a physician. If the nurse-midwife bills for the 
services performed in the clinic as nurse-midwife services, regulations 
at Sec. 440.165 must be followed. That is, nurse-midwife services which 
happen to be provided in the clinic setting may be furnished without 
regard to whether the nurse-midwife is under the direction of a 
physician.
    Thus, there are no restrictions on settings where a nurse-midwife 
may furnish services. Whether supervision by a physician or other 
health care provider is necessary depends on how the services are 
classified when they are billed. Therefore, we do not believe that the 
revisions suggested by the commenter are necessary since the proposed 
regulations already provide for nurse-midwife services in a variety of 
settings. We note that this regulation does not implement any new 
requirements. We removed the cross references to Sec. 440.165 in 
Secs. 440.10, 440.20, and 440.90 for the sake of clarity. These 
revisions do not impose new supervision requirements.
    Comment: Several commenters noted that the regulations did not 
include any reference to out-of-hospital birth centers. One commenter 
stated that Sec. 440.90(c), which defines ``clinic services,'' clearly 
includes services furnished in freestanding birth centers. The 
commenter expressed concern that removal of the cross reference to 
Sec. 440.165 in this section could be interpreted to mean that nurse-
midwife services furnished in freestanding birth centers are not 
covered under Medicaid. Commenters suggested that we revise Sec. 440.90 
to indicate that nurse-midwife services furnished in a freestanding 
birth center are covered under Medicaid. Other commenters recommended 
that specific reference to birth centers should be inserted in 
Sec. 440.165(a)(1).
    Response: Nurse-midwife services are practitioner services that are 
ordinarily furnished on an outpatient basis, except that nurse-midwife 
services may be furnished to patients in an inpatient setting 
reimbursable under section 1905(a) of the Act, such as a hospital or 
nursing facility. We do not believe that the specific inclusion of 
``freestanding birth center'' or ``out-of-hospital birth center'' in 
Sec. 440.165(a)(1) or the addition of such terms to the definition of 
clinic services found at Sec. 440.90 is necessary. The current 
definition of clinic services as those services that are ``preventive, 
diagnostic, therapeutic, rehabilitative, or palliative services that 
are furnished by a facility that is not part of a hospital but is 
organized and operated to provide medical care to outpatients'' clearly 
includes the services of a freestanding or out-of-hospital birth center 
that meets the other conditions of clinic services. Nurse-midwife 
services furnished at a birth center would be claimed as outpatient 
care, either under the category of nurse-midwife services or as clinic 
services, unless the birth center met the definition of a hospital or 
nursing facility.
    Comment: Two commenters believe that we should require nurse-
midwives to have a predetermined arrangement with a physician to assure 
the orderly availability of physician care for purposes of 
consultations and referrals beyond the scope of the nurse-midwife's 
practice and to aid in emergency and other situations a nurse-midwife 
may encounter in the course of providing care.
    Response: Section 1905(a)(17) of the Act provides in part for 
services furnished by a nurse-midwife that the nurse-midwife is legally 
authorized to perform under State law, regardless of whether the nurse-
midwife is under the supervision of, or associated with, a physician or 
other health care provider. We do not have statutory authority to amend 
the regulations to require that a nurse-midwife have a predetermined 
arrangement with a physician. Such an arrangement would be an 
``association'' with a physician within the meaning of section 
1905(a)(17) of the Act. Congress intended State law, or the appropriate 
State regulatory mechanism, to define a nurse-midwife's scope of 
practice, including any physician supervision or association 
requirements.
    Comment: One commenter stated that our proposal to remove reference 
to ``maternity cycle'' in Sec. 440.165 is consistent with section 
1905(a)(17) of the Act. The commenter noted, however, that it is 
important that the regulations not be interpreted to preempt State law 
or regulations setting scope of practice. The elimination of the ``only 
during the maternity cycle'' limitation should not be considered as the 
authority for nurse-midwives to receive payment for any service they 
may perform. The commenter gave the example that while a nurse-midwife 
may provide some child care services for a newborn in the course of 
care for a woman during her maternity cycle, this does not mean the 
nurse-midwife has the training necessary to provide pediatric care 
services.
    Response: As discussed above, the Act specifies that a nurse-
midwife's scope of practice is defined by State law or State regulatory 
mechanisms. Federal regulations cannot dictate the extent of services a 
nurse-midwife may furnish. If State law allows a nurse-midwife to 
provide pediatric care services, then such services are covered under 
Medicaid. As long as the service is categorized as nurse-midwife 
services and the nurse-midwife meets the requirements set in State and 
Federal regulations, the nurse-midwife may provide the service and 
receive payment for such services as nurse-midwife services.
    Comment: One commenter stated that certified nurse-midwives should 
be covered as surgical, or first assistants.
    Response: As stated above, certified nurse-midwife services are 
limited in scope of practice only by State law or State regulatory 
mechanisms. The State determines the services a nurse-midwife can 
legally perform. If the State laws and regulations provide that a 
nurse-midwife can perform surgical assistant 

[[Page 61486]]
or first assistant duties, these services will be covered under 
Medicaid.
    Comment: One commenter stated that additional amendments to 
Sec. 440.165(b)(4) are necessary to reflect actual statutes and 
regulations relating to licensure in the various States. Specifically, 
the commenter proposed that Sec. 440.165(b)(4) (i) and (ii) be revised 
to indicate current certification of nurse-midwives by the American 
College of Nurse-Midwives (ACNM) Certification Council, Inc. Since 
1991, the certification function has been conducted by the ACNM 
Certification Council (ACC), a corporation separate from the ACNM which 
was created to handle certification functions separately from the 
membership structure and other functions of the ACNM.
    Response: We agree with the commenter and will revise section 
440.165(b)(4) (i) and (ii) by adding ``or by the ACNM Certification 
Council, Inc. (ACC).'' This revision will recognize the current 
certification of nurse-midwives by the ACC.
    Comment: One commenter suggested that if for any reason the 
definition of ``maternity cycle'' must be retained, it should be 
amended to reflect the generally recognized postpartum period as 6 
weeks rather than 60 days.
    Response: The definition of maternity cycle at Sec. 440.165(c), 
which included the statutory Medicaid definition of the postpartum 
period, is not retained in this regulation because OBRA '93 deleted the 
maternity cycle definition from section 1905(a)(17) of the Act. Nurse-
midwife services are no longer limited by the ``during the maternity 
cycle'' requirement.

IV. Provisions of the Final Rule

    In this final rule we are adopting the provisions as proposed with 
one addition. Specifically, in response to a public comment, we are 
revising Sec. 440.165(b)(4) (i) and (ii) to include the American 
College of Nurse-Midwives Certification Council as an organization that 
may certify nurse-midwives.

V. Impact Statement

    We generally prepare an initial regulatory flexibility analysis 
that is consistent with the Regulatory Flexibility Act (RFA) (5 U.S.C. 
601 through 612) unless the Secretary certifies that a final rule will 
not have a significant economic impact on a substantial number of small 
entities. For purposes of the RFA, we consider all providers and 
suppliers of health care and services for Medicaid recipients to be 
small entities. Individuals and States are not included in the 
definition of a small entity.
    Also, section 1102(b) of the Act requires the Secretary to prepare 
a regulatory impact analysis for any final rule that may have a 
significant impact on the operations of a substantial number of small 
rural hospitals. Such an 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 a 
Metropolitan Statistical Area and has fewer than 50 beds.
    We have determined, and the Secretary certifies, that these final 
regulations will not have a significant impact on a substantial number 
of small entities and will not have a significant impact on the 
operation of a substantial number of small rural hospitals. Therefore 
we have not prepared a regulatory flexibility analysis or an analysis 
of the effect on small rural hospitals.
    Cost savings will occur regardless of the promulgation of these 
regulations. The provisions of this rule merely conform the regulations 
to the legislative provisions of OBRA '93. In accordance with the 
provisions of Executive Order 12866, this final rule was not reviewed 
by the Office of Management and Budget.

VI. 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 1980 (44 U.S.C. 3501 et seq.).

List of Subjects in 42 CFR Part 440

    Grant programs--health, Medicaid.

    42 CFR part 440 would be amended as set forth below:

PART 440--SERVICES: GENERAL PROVISIONS

    1. The authority citation for part 440 continues to read as 
follows:

    Authority: Sec. 1102 of the Social Security Act (42 U.S.C. 
1302).

    2. In Sec. 440.10 the introductory text of paragraph (a) is 
republished, paragraph (a)(2) is revised, the introductory text of 
paragraph (a)(3) is republished, and paragraph (a)(3)(iii) is revised 
to read as follows:


Sec. 440.10  Inpatient hospital services, other than services in an 
institution for mental diseases.

    (a) Inpatient hospital services means services that--
* * * * *
    (2) Are furnished under the direction of a physician or dentist; 
and
* * * * *
    (3) Are furnished in an institution that--
* * * * *
    (iii) Meets the requirements for participation in Medicare as a 
hospital; and
* * * * *
    3. In Sec. 440.20 the introductory text to paragraph (a) is 
republished, paragraph (a)(2) is revised, the introductory text of 
paragraph (a)(3) is republished and paragraph (a)(3)(ii) is revised to 
read as follows:


Sec. 440.20  Outpatient hospital services and rural health clinic 
services.

    (a) Outpatient hospital services means preventive, diagnostic, 
therapeutic, rehabilitative, or palliative services that--
* * * * *
    (2) Are furnished by or under the direction of a physician or 
dentist; and
* * * * *
    (3) Are furnished by an institution that--
* * * * *
    (ii) Meets the requirements for participation in Medicare as a 
hospital; and
* * * * *
    4. Section 440.90 is amended by removing paragraph (c).
    5. In Sec. 440.165, the introductory text of paragraph (a) is 
republished, paragraph (a)(1) is removed, paragraphs (a)(2) and (a)(3) 
are redesignated paragraphs (a)(1) and (a)(2) respectively and 
republished, the introductory text of paragraph (b) is republished, 
paragraphs (b)(4)(i) and (b)(4)(ii) are revised and paragraph (c) is 
removed. The revisions are to read as follows:


Sec. 440.165  Nurse-midwife services.

    (a) Nurse-midwife services means services that--
    (1) Are furnished by a nurse-midwife within the scope of practice 
authorized by State law or regulation, and in the case of inpatient or 
outpatient hospital services or clinic services, are furnished by or 
under the direction of a nurse-midwife to the extent permitted by the 
facility; and
    (2) Unless required by State law or regulation or a facility, are 
paid without regard to whether the nurse-midwife is under the 
supervision of, or associated 

[[Page 61487]]
with a physician or other health care provider. (See Sec. 441.21 of 
this chapter for provisions on independent provider agreements for 
nurse-midwives.)
* * * * *
    (b) Nurse-midwife means a registered professional nurse who meets 
the following requirements:
* * * * *
    (4) * * *
    (i) Is currently certified as a nurse-midwife by the American 
College of Nurse-Midwives (ACNM or by the ACNM Certification Council, 
Inc. (ACC).
    (ii) Has satisfactorily completed a formal education program (of at 
least one academic year) that, upon completion qualifies the nurse to 
take the certification examination offered by the American College of 
Nurse-Midwives (ACNM) or by the ACNM Certification Council, Inc. (ACC).

(Catalog of Federal Domestic Assistance Program No. 93.778, Medical 
Assistance Program)

    Dated: October 25, 1995.
Bruce C. Vladeck,
Administrator, Health Care Financing Administration.
[FR Doc. 95-29194 Filed 11-29-95; 8:45 am]
BILLING CODE 4120-03-P