[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
