Medicaid Program: Nurse-Midwife Services

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