HLS 19RS-840 REENGROSSED 2019 Regular Session HOUSE BILL NO. 536 BY REPRESENTATIVE HILFERTY Prefiled pursuant to Article III, Section 2(A)(4)(b)(i) of the Constitution of Louisiana. HEALTH CARE/FACILITIES: Provides relative to the licensing of free standing birth centers 1 AN ACT 2To enact R.S. 40:1203.1(3)(z), 2006(A)(2)(s), (B)(2)(j), and (E)(2)(x), and Part VI-G of 3 Chapter 11 of Title 40 of the Louisiana Revised Statutes of 1950, to be comprised 4 of R.S. 40:2180.21 through 2180.28, relative to free-standing birth centers; to 5 provide for definitions; to provide for licensing; to provide for rules and regulations; 6 to provide for licensing fees; and to provide for related matters. 7Be it enacted by the Legislature of Louisiana: 8 Section 1. R.S. 40:1203.1(3)(z), 2006(A)(2)(s), (B)(2)(j), and (E)(2)(x), and Part VI- 9G of Chapter 11 of Title 40 of the Louisiana Revised Statutes of 1950, comprised of R.S. 1040:2180.21 through 2180.28, are hereby enacted to read as follows: 11 §1203.1. Definitions 12 For the purposes of this Part: 13 * * * 14 (3) "Employer" means any of the following facilities, agencies, providers, 15 or programs: 16 * * * 17 (z) A free-standing birth center, as defined in R.S. 40:2180.23. 18 * * * 19 §2006. Fees; licenses; penalties 20 A. 21 * * * Page 1 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 (2) This Subsection shall apply to any licensed: 2 * * * 3 (s) Free-standing birth center. 4 B. 5 * * * 6 (2) This Subsection shall apply to any licensed: 7 * * * 8 (j) Free-standing birth center. 9 * * * 10 E. 11 * * * 12 (2) This Subsection shall apply to any licensed: 13 * * * 14 (x) Free-standing birth center. 15 * * * 16 PART VI-G. LICENSING OF FREE-STANDING BIRTH CENTERS 17 §2180.21. Short Title 18 This Part shall be known and may be cited as the "Free-Standing Birth Center 19 Licensing Law". 20 §2180.22. Purpose 21 The purpose of this Part is to authorize the Louisiana Department of Health 22 to promulgate and publish rules and regulations for the licensing of free-standing 23 birth centers; to provide for the health, safety, welfare, and well-being of persons 24 receiving services at free-standing birth centers; and to provide for the safe operation 25 and maintenance of free-standing birth centers. 26 §2180.23. Definitions 27 For the purposes of this Part, the following terms shall have the following 28 meanings: Page 2 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 (1) "Department" means the Louisiana Department of Health or any agency 2 or office thereof designated by the secretary to administer the provisions of this Part. 3 (2)(a) "Free-standing birth center" means a facility, place, center, agency, 4 person, institution, corporation, partnership, unincorporated association, group, or 5 other legal entity which provides free-standing birth center services and at which a 6 person is anticipated to give birth following a low-risk pregnancy. 7 (b) For the purposes of this Part, a free-standing birth center does not include 8 a hospital licensed pursuant to La. R.S. 40:2100 et seq., nor does it include the place 9 of residence of the person giving birth. 10 (3) "Free-standing birth center services" means peripartum care, including 11 prenatal, labor, delivery, and postpartum, and services for people with low-risk 12 pregnancies provided at free-standing birth centers. This includes any ancillary 13 ambulatory service provided to a person at low risk for pregnancy complications, if 14 such services are within the scope of practice of the individual providing the service. 15 (4) "License" means a license issued by the Louisiana Department of Health 16 to a free-standing birth center. 17 (5) "Low-risk pregnancy" means a normal, uncomplicated, singleton 18 pregnancy that has vertex presentation and is at low risk for development of 19 complications during labor and birth, as determined from an evaluation and 20 examination conducted by a physician or other practitioner or individual acting 21 within the scope of his or her practice. 22 (6) "Secretary" means the secretary of the Louisiana Department of Health 23 or his designee. 24 (7) "Standards" means policies, procedures, rules, guidelines, and standards 25 of current practice contained in this Part in addition to those rules and standards 26 promulgated by the Louisiana Department of Health for the licensing and operation 27 of free-standing birth centers. Page 3 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 §2180.24. Licensure of free-standing birth centers 2 A. All free-standing birth centers shall be licensed by the Louisiana 3 Department of Health. No facility, place, center, agency, person, institution, 4 corporation, partnership, unincorporated association, group, or other legal entity 5 providing free-standing birth center services shall be established or operated, or be 6 reimbursed under the Medicaid program, unless licensed as a free-standing birth 7 center by the department to perform such services. 8 B. A license issued to a free-standing birth center shall be valid for one 9 geographic location and issued to the entity or person and premises named in the 10 license application. 11 C. A license issued pursuant to this Part shall be valid for twelve months 12 unless revoked or otherwise suspended prior to that date, commencing with the 13 month of issuance. 14 D. Unless otherwise renewed or stated in the rules promulgated by the 15 department, a license issued pursuant to this Part shall expire on the last day of the 16 twelfth month after the date of issuance. 17 E. A license issued pursuant to this Part shall be on a form prescribed by the 18 department. 19 F. A license issued pursuant to this Part shall not be transferrable or 20 assignable. 21 G. A license issued to a free-standing birth center shall be posted in a 22 conspicuous place on the licensed premises. 23 §2180.25. Rules and regulations; licensing standards 24 A. The department shall prescribe, promulgate, and publish rules, 25 regulations, and licensing standards, in accordance with the Administrative 26 Procedure Act, and to provide for all of the following: 27 (1) The licensure of free-standing birth centers. 28 (2) The health, safety, welfare, and well-being of persons receiving services 29 at the free-standing birth centers. Page 4 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 (3) The safe operation and maintenance of free-standing birth centers. 2 B.(1) The rules, regulations, and licensing standards shall become effective 3 upon approval by the secretary of the department in accordance with the 4 Administrative Procedure Act. 5 (2) The rules, regulations, and licensing standards shall have the effect of 6 law and shall include, but not be limited to: 7 (a) Licensure application and renewal, including forms, procedures, and 8 requirements. 9 (b) Operational requirements. 10 (c) Practice standards to assure quality of care. 11 (d) Practice standards to assure the health, safety, welfare, well-being, and 12 comfort of persons receiving care and services. 13 (e) Confidentiality of clients' records. 14 (f) Criteria and protocols to assure uniform and quality assessment, 15 diagnosis, evaluation, and referral to appropriate level of care. 16 (g) Administration, personnel, and staffing requirements. 17 (h) Survey and complaint investigations, including investigations into 18 allegations that a provider is operating without a license. 19 (i) License types, including provisional licenses. 20 (j) Denial, revocation, suspension, and nonrenewal of licenses, and the 21 appeals therefrom. 22 (k) Planning, construction, and design of the center to ensure the health, 23 safety, welfare, well-being, and comfort of persons receiving care and services. 24 (l) The requirement that each free-standing birth center be located within a 25 ground-travel-time distance from a general acute care hospital providing obstetric 26 services which allows for an emergency cesarean delivery to begin within thirty 27 minutes of the decision that a cesarean delivery is necessary. Page 5 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 (m) Requirements for each free-standing birth center to have agreements or 2 written policies and procedures with other agencies, institutions, or individuals, for 3 services to clients including but not limited to: 4 (i) Laboratory and diagnostic services. 5 (ii) Obstetric consultation services. 6 (iii) Pediatric consultation services. 7 (iv) Transport services. 8 (v) Obstetric/newborn acute care in hospitals. 9 (n) Requirements for each free-standing birth center to have an established 10 consultation, collaboration, or referral system, in both emergency and 11 non-emergency circumstances, that falls outside the scope of birth center practice, 12 to meet the needs of a mother or baby. 13 (o) Requirements for transferring and transporting clients to hospitals; 14 protocols for the transfer of any patient to a licensed hospital; and arrangements with 15 a local ambulance for the transport of emergency patients to a licensed hospital. 16 (p) Requirements for documentation of adequate prenatal care during the 17 pregnancy. 18 (q) Requirements for documentation and evidence that the delivery is 19 expected to be low risk, singleton birth, and vertex presentation. 20 (r) Requirements for meeting specific national standards for birth centers 21 published or established by the American Association of Birth Centers, as well as 22 requirements for accreditation by the Commission for Accreditation of Birth Centers. 23 (s) Other regulations or standards that will ensure proper care and treatment 24 of persons receiving care and services at the free-standing birth center, that may be 25 deemed necessary by the department for an effective administration of this Part. 26 C.(1) No free-standing birth center shall be required to obtain a license 27 pursuant to this Part until the initial rules, regulations, and licensing standards are 28 promulgated by the Louisiana Department of Health pursuant to the Administrative 29 Procedure Act. Page 6 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 (2) Each entity that meets the definition of free-standing birth center as 2 defined in this Part shall submit an initial licensing application and fee to the 3 department within ninety days of the promulgation of the initial rules, regulations, 4 and licensing standards. If the entity is not licensed within one hundred twenty days 5 after submission of its initial licensing application and fee, the entity shall cease 6 operations until such time as it is licensed as a free-standing birth center by the 7 department. 8 §2180.26. License issuance; application; fees; onsite inspections 9 A. Each application for licensure as a free-standing birth center shall be 10 submitted to the department on forms prescribed by the department and shall contain 11 such information as the department may require. Additional information required by 12 the department shall be provided by the applicant as requested. 13 B. Each application for licensure and each license renewal application shall 14 be accompanied by a nonrefundable license fee in the amount required pursuant to 15 R.S. 40:2006. 16 C. Following receipt of the completed initial licensing application and fee, 17 the department shall perform an onsite survey and inspection. If, after the onsite 18 survey and inspection, the Louisiana Department of Health finds that the 19 free-standing birth center meets the requirements of this Part and the licensing 20 standards adopted pursuant to this Part, a license shall be issued. 21 D. As a condition for renewal of license, the licensee shall submit to the 22 department a completed annual renewal application on the forms prescribed by the 23 department, which shall contain all information required by the department. 24 Additionally, the annual renewal licensing fee shall be submitted with the annual 25 renewal application. Upon receipt of the completed annual renewal application and 26 the annual renewal fee, the department shall determine if the free-standing birth 27 center continues to meet the requirements established pursuant to this Part and the 28 licensing standards adopted pursuant to this Part. The department may perform an 29 onsite survey and inspection upon annual renewal. If the provider continues to meet Page 7 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 the requirements established pursuant to this Part and the licensing standards adopted 2 pursuant to this Part, a license shall be issued which shall be valid for up to one year, 3 unless otherwise revoked or suspended. 4 E. The department may perform an onsite survey or inspection at reasonable 5 times as necessary to ensure compliance with this Part and the licensing standards 6 adopted pursuant to this Part. 7 §2180.27. Operation without license; penalty 8 A. A free-standing birth center shall not operate without a license issued by 9 the department. Any center or facility operating without a license in violation of 10 these provisions shall be charged with a misdemeanor. Upon conviction, that center 11 shall be fined no less than two hundred fifty dollars and no more than one thousand 12 dollars. Each day of violation shall constitute a separate offense. It shall be the 13 responsibility of the department to inform the appropriate district attorney of the 14 alleged violation to ensure enforcement. 15 B. If a free-standing birth center is operating without a license issued by the 16 department, the department shall have the authority to issue an immediate cease and 17 desist order to the center. Any center receiving a cease and desist order from the 18 department shall immediately cease operations until such time as that provider is 19 issued a license by the department. 20 C. The department shall seek an injunction in the Nineteenth Judicial District 21 Court against any provider or center who receives a cease and desist order from the 22 department, as provided in Subsection B of this Section, and who does not 23 immediately cease operations. Any provider or center against whom an injunction 24 is granted shall be liable to the department for attorney fees, costs, and damages. 25 §2180.28. Right of inspection; records; reports 26 A. Each free-standing birth center that has applied for a license or that is 27 licensed pursuant to this Part shall be open at reasonable times for inspection by the 28 department, the state fire marshal, and any other authorized governmental entity. Page 8 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 1 B. Every applicant or licensee shall keep all records and make all reports as 2 the department shall prescribe, and all necessary records shall be available for 3 inspection by the department or other authorized governmental entity. 4 Section 3. This Act shall become effective upon signature by the governor or, if not 5signed by the governor, upon expiration of the time for bills to become law without signature 6by the governor, as provided by Article III, Section 18 of the Constitution of Louisiana. If 7vetoed by the governor and subsequently approved by the legislature, this Act shall become 8effective on the day following such approval. DIGEST The digest printed below was prepared by House Legislative Services. It constitutes no part of the legislative instrument. The keyword, one-liner, abstract, and digest do not constitute part of the law or proof or indicia of legislative intent. [R.S. 1:13(B) and 24:177(E)] HB 536 Reengrossed 2019 Regular Session Hilferty Abstract: Provides for the licensing of free-standing birth centers and authorizes the Louisiana Department of Health to publish rules and regulations for licensing standards. Present law provides for criminal history checks on nonlicensed and licensed persons and licensed ambulance personnel. Proposed law adds free-standing birth centers to the list of enumerated employers. Present law provides for the fees, licensing, and penalties of any legal entity currently operating or planning to operate any of the facilities listed within the present law. Proposed law adds "free-standing birth centers" to present law. Proposed law authorizes the Louisiana Department of Health (LDH) to promulgate and publish rules and regulations for the licensing of free-standing birth centers. Proposed law defines "free standing birth center", "free-standing birth center services", "low- risk pregnancy", and "standards". Proposed law provides that free-standing birth centers shall be licensed by LDH and that no such center shall be established, operated, or reimbursed under the Medicaid program unless licensed to provide such services as a free-standing birth center by LDH. Proposed law provides for specific requirements of licenses of free-standing birth centers such as: specific geographic location, the term and expiration date, the form of such license, and the location of posting such license. Proposed law provides that the rules and regulations promulgated by LDH shall be in accordance with the Administrative Procedure Act; provides that such rules shall be in the interest of the health, safety, welfare, and well being of persons receiving services from free standing birthing centers; and that such rules are effective upon approval by the secretary of LDH and shall have the effect of law. Page 9 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions. HLS 19RS-840 REENGROSSED HB NO. 536 Proposed law provides for the process an applicant must follow to apply to be licensed as a free-standing birth center by LDH. Proposed law provides for the penalties of any entity operating as a free-standing birth center without a license from LDH. Proposed law provides that any licensed free-standing birth center is subject to inspection of records and reports by LDH. Effective upon signature of governor or lapse of time for gubernatorial action. (Adds R.S. 40:1203.1(3)(z), 2006(A)(2)(s), (B)(2)(j), and (E)(2)(x), and 2180.21-2180.28). Summary of Amendments Adopted by House The Committee Amendments Proposed by House Committee on Health and Welfare to the original bill: 1. Make technical changes. The House Floor Amendments to the engrossed bill: 1. Make technical changes. Page 10 of 10 CODING: Words in struck through type are deletions from existing law; words underscored are additions.