[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] ======================================================================= ----------------------------------------------------------------------- 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. ----------------------------------------------------------------------- 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