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AN ACT relating to freestanding birthing centers. 1
Be it enacted by the General Assembly of the Commonwealth of Kentucky: 2
SECTION 1. A NEW SECTION OF KRS CHAPTER 216B IS CREATED TO 3
READ AS FOLLOWS: 4
(1) As used in this section, "freestanding birthing center" means any health facility, 5
place, or institution which is not a hospital, is not in a hospital or a private 6
residence, and is established to provide care for labor, delivery, the immediate 7
postpartum period, and the newborn immediately following delivery. 8
(2) The cabinet shall establish licensure standards for freestanding birthing centers 9
that: 10
(a) Require accreditation by the Commission for the Accreditation of Birth 11
Centers; 12
(b) Delineate requirements for medical malpractice insurance; 13
(c) Require location within thirty (30) miles of a hospital. If a hospital located 14
within thirty (30) miles of a freestanding birthing center ceases operations 15
after a freestanding birthing center has been established, the requirement of 16
this paragraph shall not apply to the affected freestanding birthing center; 17
(d) Do not prohibit a hospital from owning or operating a freestanding birthing 18
center that complies with the requirements of this section; and 19
(e) Include any other requirements deemed necessary by the cabinet that are 20
not inconsistent with the other requirements of this section. 21
(3) (a) A freestanding birthing center shall have a medical director who is a 22
licensed physician who has, at a minimum, the following functions: 23
1. Participation in approval of criteria that would exclude a client or 24
newborn from receiving care at the freestanding birthing center; and 25
2. Participation in the quality review functions of the freestanding 26
birthing center, including review of transfers and sentinel events. 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(b) The cabinet shall establish a timeline for a freestanding birthing center to 1
fill the position of medical director if the position becomes vacant. 2
(4) A freestanding birthing center shall obtain written informed consent for each 3
client receiving care. The written informed consent shall include: 4
(a) A description of the benefits, risks, and eligibility requirements for receiving 5
care at the freestanding birthing center; 6
(b) A description of the education and credentials of practitioners providing 7
clinical care at the freestanding birthing center; 8
(c) Instructions for obtaining a copy of the administrative regulations 9
promulgated pursuant to this section; 10
(d) Instructions for filing a complaint relating to the freestanding birthing 11
center with the cabinet; 12
(e) A summary of a written protocol for emergencies, including transfer to a 13
higher level of care; 14
(f) Disclosure of professional liability insurance held by health care providers 15
at the freestanding birthing center; and 16
(g) A summary of procedures established by the freestanding birthing center 17
for professional collaboration with other care providers. 18
(5) (a) A freestanding birthing center shall have a written patient transfer 19
agreement with a hospital that provides obstetric services. The cabinet shall 20
establish minimum requirements for the patient transfer agreement which 21
shall include: 22
1. Specifying the responsibilities that a freestanding birthing center and 23
a hospital assume in the transfer of a patient; and 24
2. Establishing the freestanding birthing center’s responsibility for: 25
a. Notifying the receiving hospital promptly of the impending 26
transfer of a patient; and 27 UNOFFICIAL COPY 25 RS SB 17/GA
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b. Arranging for appropriate and safe transportation. 1
(b) The cabinet shall establish a process and criteria by which the requirement 2
of paragraph (a) of this subsection may be waived if a freestanding birthing 3
center submits to the cabinet evidence of a failure by a hospital that 4
provides obstetric services to enter into a written patient transfer agreement 5
with the freestanding birthing center. 6
(6) (a) A freestanding birthing center shall have a written patient transfer 7
agreement with a licensed emergency medical transportation service. 8
(b) The cabinet shall establish a process and criteria by which the requirement 9
of paragraph (a) of this subsection may be waived if a freestanding birthing 10
center submits to the cabinet evidence of a failure by a licensed emergency 11
medical transportation service to enter into a written patient transfer 12
agreement with the freestanding birthing center. 13
(7) A certificate of need shall not be required to establish and license a freestanding 14
birthing center with no more than four (4) beds. 15
(8) (a) Nothing in this section is intended to expand or limit the liability of a health 16
care provider, health care facility, or freestanding birthing center. 17
(b) In the event of an action for injury or death due to any act or omission of a 18
health care provider rendering services at a freestanding birthing center 19
from which an injured patient is transferred to any other licensed health 20
care provider or licensed health care facility: 21
1. The liability of the subsequent licensed health care provider or 22
licensed health care facility shall be limited to their own negligent acts 23
and omissions that violate their standards of care according to existing 24
law, except as provided in subparagraph 2. of this paragraph; and 25
2. If the subsequent licensed health care provider or licensed health care 26
facility owns, operates, or provides care at the freestanding birthing 27 UNOFFICIAL COPY 25 RS SB 17/GA
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center from which the injured patient was transferred, then the 1
licensed health care provider or licensed health care facility shall be 2
liable for acts or omissions that violate their standards of care and that 3
occurred at the freestanding birthing center. 4
(9) In accordance with KRS 311.772, no person shall perform an abortion in a 5
freestanding birthing center. 6
Section 2. KRS 216B.015 is amended to read as follows: 7
Except as otherwise provided, for purposes of this chapter, the following definitions shall 8
apply: 9
(1) "Abortion facility" means any place in which an abortion is performed; 10
(2) "Administrative regulation" means a regulation adopted and promulgated pursuant 11
to the procedures in KRS Chapter 13A; 12
(3) "Affected persons" means the applicant; any person residing within the geographic 13
area served or to be served by the applicant; any person who regularly uses health 14
facilities within that geographic area; health facilities located in the health service 15
area in which the project is proposed to be located which provide services similar to 16
the services of the facility under review; health facilities which, prior to receipt by 17
the agency of the proposal being reviewed, have formally indicated an intention to 18
provide similar services in the future; and the cabinet and third-party payors who 19
reimburse health facilities for services in the health service area in which the project 20
is proposed to be located; 21
(4) (a) "Ambulatory surgical center" means a health facility: 22
1. Licensed pursuant to administrative regulations promulgated by the 23
cabinet; 24
2. That provides outpatient surgical services, excluding oral or dental 25
procedures; and 26
3. Seeking recognition and reimbursement as an ambulatory surgical center 27 UNOFFICIAL COPY 25 RS SB 17/GA
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from any federal, state, or third-party insurer from which payment is 1
sought. 2
(b) An ambulatory surgical center does not include the private offices of 3
physicians where in-office outpatient surgical procedures are performed as 4
long as the physician office does not seek licensure, certification, 5
reimbursement, or recognition as an ambulatory surgical center from a 6
federal, state, or third-party insurer. 7
(c) Nothing in this subsection shall preclude a physician from negotiating 8
enhanced payment for outpatient surgical procedures performed in the 9
physician's private office so long as the physician does not seek recognition or 10
reimbursement of his or her office as an ambulatory surgical center without 11
first obtaining a certificate of need or license required under KRS 216B.020 12
and 216B.061; 13
(5) "Applicant" means any physician's office requesting a major medical equipment 14
expenditure exceeding the capital expenditure minimum, or any person, health 15
facility, or health service requesting a certificate of need or license; 16
(6) "Cabinet" means the Cabinet for Health and Family Services; 17
(7) "Capital expenditure" means an expenditure made by or on behalf of a health 18
facility which: 19
(a) Under generally accepted accounting principles is not properly chargeable as 20
an expense of operation and maintenance or is not for investment purposes 21
only; or 22
(b) Is made to obtain by lease or comparable arrangement any facility or part 23
thereof or any equipment for a facility or part thereof; 24
(8) "Capital expenditure minimum" means the annually adjusted amount set by the 25
cabinet. In determining whether an expenditure exceeds the expenditure minimum, 26
the cost of any studies, surveys, designs, plans, working drawings, specifications, 27 UNOFFICIAL COPY 25 RS SB 17/GA
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and other activities essential to the improvement, expansion, or replacement of any 1
plant or any equipment with respect to which the expenditure is made shall be 2
included. Donations of equipment or facilities to a health facility which if acquired 3
directly by the facility would be subject to review under this chapter shall be 4
considered a capital expenditure, and a transfer of the equipment or facilities for 5
less than fair market value shall be considered a capital expenditure if a transfer of 6
the equipment or facilities at fair market value would be subject to review; 7
(9) "Certificate of need" means an authorization by the cabinet to acquire, to establish, 8
to offer, to substantially change the bed capacity, or to substantially change a health 9
service as covered by this chapter; 10
(10) "Certified surgical assistant" means a certified surgical assistant or certified first 11
assistant who is certified by the National Surgical Assistant Association on the 12
Certification of Surgical Assistants, the Liaison Council on Certification of Surgical 13
Technologists, or the American Board of Surgical Assistants. The certified surgical 14
assistant is an unlicensed health-care provider who is directly accountable to a 15
physician licensed under KRS Chapter 311 or, in the absence of a physician, to a 16
registered nurse licensed under KRS Chapter 314; 17
(11) "Continuing care retirement community" means a community that provides, on the 18
same campus, a continuum of residential living options and support services to 19
persons sixty (60) years of age or older under a written agreement. The residential 20
living options shall include independent living units, nursing home beds, and either 21
assisted living units or personal care beds; 22
(12) "Formal review process" means the ninety (90) day certificate-of-need review 23
conducted by the cabinet; 24
(13) "Health facility" means any institution, place, building, agency, or portion thereof, 25
public or private, whether organized for profit or not, used, operated, or designed to 26
provide medical diagnosis, treatment, nursing, rehabilitative, or preventive care and 27 UNOFFICIAL COPY 25 RS SB 17/GA
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includes alcohol abuse, drug abuse, and mental health services. This shall include 1
but shall not be limited to health facilities and health services commonly referred to 2
as hospitals, psychiatric hospitals, physical rehabilitation hospitals, chemical 3
dependency programs, nursing facilities, nursing homes, personal care homes, 4
intermediate care facilities, assisted living communities, family care homes, 5
outpatient clinics, ambulatory care facilities, ambulatory surgical centers, 6
emergency care centers and services, ambulance providers, hospices, community 7
mental health centers, home health agencies, kidney disease treatment centers and 8
freestanding hemodialysis units, freestanding birthing centers as defined in 9
Section 1 of this Act, and others providing similarly organized services regardless 10
of nomenclature; 11
(14) "Health services" means clinically related services provided within the 12
Commonwealth to two (2) or more persons, including but not limited to diagnostic, 13
treatment, or rehabilitative services, and includes alcohol, drug abuse, and mental 14
health services; 15
(15) "Independent living" means the provision of living units and supportive services, 16
including but not limited to laundry, housekeeping, maintenance, activity direction, 17
security, dining options, and transportation; 18
(16) "Intraoperative surgical care" includes the practice of surgical assisting in which the 19
certified surgical assistant or physician assistant is working under the direction of 20
the operating physician as a first or second assist, and which may include the 21
following procedures: 22
(a) Positioning the patient; 23
(b) Preparing and draping the patient for the operative procedure; 24
(c) Observing the operative site during the operative procedure; 25
(d) Providing the best possible exposure of the anatomy incident to the operative 26
procedure; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(e) Assisting in closure of incisions and wound dressings; and 1
(f) Performing any task, within the role of an unlicensed assistive person, or if 2
the assistant is a physician assistant, performing any task within the role of a 3
physician assistant, as required by the operating physician incident to the 4
particular procedure being performed; 5
(17) "Major medical equipment" means equipment which is used for the provision of 6
medical and other health services and which costs in excess of the medical 7
equipment expenditure minimum. In determining whether medical equipment has a 8
value in excess of the medical equipment expenditure minimum, the value of 9
studies, surveys, designs, plans, working drawings, specifications, and other 10
activities essential to the acquisition of the equipment shall be included; 11
(18) "Nonsubstantive review" means an expedited review conducted by the cabinet of an 12
application for a certificate of need as authorized under KRS 216B.095; 13
(19) "Nonclinically related expenditures" means expenditures for: 14
(a) Repairs, renovations, alterations, and improvements to the physical plant of a 15
health facility which do not result in a substantial change in beds, a substantial 16
change in a health service, or the addition of major medical equipment, and do 17
not constitute the replacement or relocation of a health facility; or 18
(b) Projects which do not involve the provision of direct clinical patient care, 19
including but not limited to the following: 20
1. Parking facilities; 21
2. Telecommunications or telephone systems; 22
3. Management information systems; 23
4. Ventilation systems; 24
5. Heating or air conditioning, or both; 25
6. Energy conservation; or 26
7. Administrative offices; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(20) "Party to the proceedings" means the applicant for a certificate of need and any 1
affected person who appears at a hearing on the matter under consideration and 2
enters an appearance of record; 3
(21) "Perioperative nursing" means a practice of nursing in which the nurse provides 4
preoperative, intraoperative, and postoperative nursing care to surgical patients; 5
(22) "Person" means an individual, a trust or estate, a partnership, a corporation, an 6
association, a group, state, or political subdivision or instrumentality including a 7
municipal corporation of a state; 8
(23) "Physician assistant" means the same as the definition provided in KRS 311.550; 9
(24) "Record" means, as applicable in a particular proceeding: 10
(a) The application and any information provided by the applicant at the request 11
of the cabinet; 12
(b) Any information provided by a holder of a certificate of need or license in 13
response to a notice of revocation of a certificate of need or license; 14
(c) Any memoranda or documents prepared by or for the cabinet regarding the 15
matter under review which were introduced at any hearing; 16
(d) Any staff reports or recommendations prepared by or for the cabinet; 17
(e) Any recommendation or decision of the cabinet; 18
(f) Any testimony or documentary evidence adduced at a hearing; 19
(g) The findings of fact and opinions of the cabinet or the findings of fact and 20
recommendation of the hearing officer; and 21
(h) Any other items required by administrative regulations promulgated by the 22
cabinet; 23
(25) "Registered nurse first assistant" means one who: 24
(a) Holds a current active registered nurse licensure; 25
(b) Is certified in perioperative nursing; and 26
(c) Has successfully completed and holds a degree or certificate from a 27 UNOFFICIAL COPY 25 RS SB 17/GA
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recognized program, which shall consist of: 1
1. The Association of Operating Room Nurses, Inc., Core Curriculum for 2
the registered nurse first assistant; and 3
2. One (1) year of postbasic nursing study, which shall include at least 4
forty-five (45) hours of didactic instruction and one hundred twenty 5
(120) hours of clinical internship or its equivalent of two (2) college 6
semesters. 7
A registered nurse who was certified prior to 1995 by the Certification Board of 8
Perioperative Nursing shall not be required to fulfill the requirements of paragraph 9
(c) of this subsection; 10
(26) "Secretary" means the secretary of the Cabinet for Health and Family Services; 11
(27) "Sexual assault examination facility" means a licensed health facility, emergency 12
medical facility, primary care center, or a children's advocacy center or rape crisis 13
center that is regulated by the Cabinet for Health and Family Services, and that 14
provides sexual assault examinations under KRS 216B.400; 15
(28) "State health plan" means the document prepared triennially, updated annually, and 16
approved by the Governor; 17
(29) "Substantial change in a health service" means: 18
(a) The addition of a health service for which there are review criteria and 19
standards in the state health plan; or 20
(b) The addition of a health service subject to licensure under this chapter; 21
(30) "Substantial change in bed capacity" means the addition or reduction of beds by 22
licensure classification within a health facility; 23
(31) "Substantial change in a project" means a change made to a pending or approved 24
project which results in: 25
(a) A substantial change in a health service, except a reduction or termination of a 26
health service; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(b) A substantial change in bed capacity, except for reductions; 1
(c) A change of location; or 2
(d) An increase in costs greater than the allowable amount as prescribed by 3
regulation; 4
(32) "To acquire" means to obtain from another by purchase, transfer, lease, or other 5
comparable arrangement of the controlling interest of a capital asset or capital 6
stock, or voting rights of a corporation. An acquisition shall be deemed to occur 7
when more than fifty percent (50%) of an existing capital asset or capital stock or 8
voting rights of a corporation is purchased, transferred, leased, or acquired by 9
comparable arrangement by one (1) person from another person; 10
(33) "To batch" means to review in the same review cycle and, if applicable, give 11
comparative consideration to all filed applications pertaining to similar types of 12
services, facilities, or equipment affecting the same health service area; 13
(34) "To establish" means to construct, develop, or initiate a health facility; 14
(35) "To obligate" means to enter any enforceable contract for the construction, 15
acquisition, lease, or financing of a capital asset. A contract shall be considered 16
enforceable when all contingencies and conditions in the contract have been met. 17
An option to purchase or lease which is not binding shall not be considered an 18
enforceable contract; and 19
(36) "To offer" means, when used in connection with health services, to hold a health 20
facility out as capable of providing, or as having the means of providing, specified 21
health services. 22
Section 3. KRS 216B.020 is amended to read as follows: 23
(1) The provisions of this chapter that relate to the issuance of a certificate of need shall 24
not apply to abortion facilities as defined in KRS 216B.015; any hospital which 25
does not charge its patients for hospital services and does not seek or accept 26
Medicare, Medicaid, or other financial support from the federal government or any 27 UNOFFICIAL COPY 25 RS SB 17/GA
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state government; assisted living residences; family care homes; state veterans' 1
nursing homes; services provided on a contractual basis in a rural primary-care 2
hospital as provided under KRS 216.380; community mental health centers for 3
services as defined in KRS Chapter 210; primary care centers; rural health clinics; 4
private duty nursing services operating as health care services agencies as defined 5
in KRS 216.718; group homes; licensed residential crisis stabilization units; 6
licensed free-standing residential substance use disorder treatment programs with 7
sixteen (16) or fewer beds, but not including Levels I and II psychiatric residential 8
treatment facilities or licensed psychiatric inpatient beds; outpatient behavioral 9
health treatment, but not including partial hospitalization programs; end stage renal 10
disease dialysis facilities, freestanding or hospital based; swing beds; special 11
clinics, including but not limited to wellness, weight loss, family planning, 12
disability determination, speech and hearing, counseling, pulmonary care, and other 13
clinics which only provide diagnostic services with equipment not exceeding the 14
major medical equipment cost threshold and for which there are no review criteria 15
in the state health plan; nonclinically related expenditures; nursing home beds that 16
shall be exclusively limited to on-campus residents of a certified continuing care 17
retirement community; home health services provided by a continuing care 18
retirement community to its on-campus residents; the relocation of hospital 19
administrative or outpatient services into medical office buildings which are on or 20
contiguous to the premises of the hospital; the relocation of acute care beds which 21
occur among acute care hospitals under common ownership and which are located 22
in the same area development district so long as there is no substantial change in 23
services and the relocation does not result in the establishment of a new service at 24
the receiving hospital for which a certificate of need is required; the redistribution 25
of beds by licensure classification within an acute care hospital so long as the 26
redistribution does not increase the total licensed bed capacity of the hospital; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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residential hospice facilities established by licensed hospice programs; freestanding 1
birthing centers as defined in Section 1 of this Act; the following health services 2
provided on site in an existing health facility when the cost is less than six hundred 3
thousand dollars ($600,000) and the services are in place by December 30, 1991: 4
psychiatric care where chemical dependency services are provided, level one (1) 5
and level two (2) of neonatal care, cardiac catheterization, and open heart surgery 6
where cardiac catheterization services are in place as of July 15, 1990; or 7
ambulance services operating in accordance with subsection (6), (7), or (8) of this 8
section. These listed facilities or services shall be subject to licensure, when 9
applicable. 10
(2) Nothing in this chapter shall be construed to authorize the licensure, supervision, 11
regulation, or control in any manner of: 12
(a) Private offices and clinics of physicians, dentists, and other practitioners of 13
the healing arts, except any physician's office that meets the criteria set forth 14
in KRS 216B.015(5) or that meets the definition of an ambulatory surgical 15
center as set out in KRS 216B.015; 16
(b) Office buildings built by or on behalf of a health facility for the exclusive use 17
of physicians, dentists, and other practitioners of the healing arts; unless the 18
physician's office meets the criteria set forth in KRS 216B.015(5), or unless 19
the physician's office is also an abortion facility as defined in KRS 216B.015, 20
except no capital expenditure or expenses relating to any such building shall 21
be chargeable to or reimbursable as a cost for providing inpatient services 22
offered by a health facility; 23
(c) Outpatient health facilities or health services that: 24
1. Do not provide services or hold patients in the facility after midnight; 25
and 26
2. Are exempt from certificate of need and licensure under subsection (3) 27 UNOFFICIAL COPY 25 RS SB 17/GA
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of this section; 1
(d) Dispensaries and first-aid stations located within business or industrial 2
establishments maintained solely for the use of employees, if the facility does 3
not contain inpatient or resident beds for patients or employees who generally 4
remain in the facility for more than twenty-four (24) hours; 5
(e) Establishments, such as motels, hotels, and boarding houses, which provide 6
domiciliary and auxiliary commercial services, but do not provide any health 7
related services and boarding houses which are operated by persons 8
contracting with the United States Department of Veterans Affairs for 9
boarding services; 10
(f) The remedial care or treatment of residents or patients in any home or 11
institution conducted only for those who rely solely upon treatment by prayer 12
or spiritual means in accordance with the creed or tenets of any recognized 13
church or religious denomination and recognized by that church or 14
denomination; and 15
(g) On-duty police and fire department personnel assisting in emergency 16
situations by providing first aid or transportation when regular emergency 17
units licensed to provide first aid or transportation are unable to arrive at the 18
scene of an emergency situation within a reasonable time. 19
(3) The following outpatient categories of care shall be exempt from certificate of need 20
and licensure on July 14, 2018: 21
(a) Primary care centers; 22
(b) Special health clinics, unless the clinic provides pain management services 23
and is located off the campus of the hospital that has majority ownership 24
interest; 25
(c) Specialized medical technology services, unless providing a State Health Plan 26
service; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(d) Retail-based health clinics and ambulatory care clinics that provide 1
nonemergency, noninvasive treatment of patients; 2
(e) Ambulatory care clinics treating minor illnesses and injuries; 3
(f) Mobile health services, unless providing a service in the State Health Plan; 4
(g) Rehabilitation agencies; 5
(h) Rural health clinics; and 6
(i) Off-campus, hospital-acquired physician practices. 7
(4) The exemptions established by subsections (2) and (3) of this section shall not 8
apply to the following categories of care: 9
(a) An ambulatory surgical center as defined by KRS 216B.015(4); 10
(b) A health facility or health service that provides one (1) of the following types 11
of services: 12
1. Cardiac catheterization; 13
2. Megavoltage radiation therapy; 14
3. Adult day health care; 15
4. Behavioral health services; 16
5. Chronic renal dialysis;[ 17
6. Birthing services;] or 18
6.[7.] Emergency services above the level of treatment for minor illnesses or 19
injuries; 20
(c) A pain management facility as defined by KRS 218A.175(1); 21
(d) An abortion facility that requires licensure pursuant to KRS 216B.0431; or 22
(e) A health facility or health service that requests an expenditure that exceeds the 23
major medical expenditure minimum. 24
(5) An existing facility licensed as an intermediate care or nursing home shall notify 25
the cabinet of its intent to change to a nursing facility as defined in Public Law 100-26
203. A certificate of need shall not be required for conversion of an intermediate 27 UNOFFICIAL COPY 25 RS SB 17/GA
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care or nursing home to the nursing facility licensure category. 1
(6) Ambulance services owned and operated by a city government, which propose to 2
provide services in coterminous cities outside of the ambulance service's designated 3
geographic service area, shall not be required to obtain a certificate of need if the 4
governing body of the city in which the ambulance services are to be provided 5
enters into an agreement with the ambulance service to provide services in the city. 6
(7) Ambulance services owned by a hospital shall not be required to obtain a certificate 7
of need for the sole purpose of providing non-emergency and emergency transport 8
services originating from its hospital. 9
(8) (a) As used in this subsection, "emergency ambulance transport services" means 10
the transportation of an individual that has an emergency medical condition 11
with acute symptoms of sufficient severity that the absence of immediate 12
medical attention could reasonably be expected to place the individual's health 13
in serious jeopardy or result in the serious impairment or dysfunction of the 14
individual's bodily organs. 15
(b) A city or county government that has conducted a public hearing for the 16
purposes of demonstrating that an imperative need exists in the city or county 17
to provide emergency ambulance transport services within its jurisdictional 18
boundaries shall not be required to obtain a certificate of need for the city or 19
county to: 20
1. Directly provide emergency ambulance transport services as defined in 21
this subsection within the city's or county's jurisdictional boundaries; or 22
2. Enter into a contract with a hospital or hospitals within its jurisdiction, 23
or within an adjoining county if there are no hospitals located within the 24
county, for the provision of emergency ambulance transport services as 25
defined in this subsection within the city's or county's jurisdictional 26
boundaries. 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(c) Any license obtained under KRS Chapter 311A by a city or county for the 1
provision of ambulance services operating under a certificate of need 2
exclusion pursuant to this subsection shall be held exclusively by the city or 3
county government and shall not be transferrable to any other entity. 4
(d) Prior to obtaining the written agreement of a city, an ambulance service 5
operating under a county government certificate of need exclusion pursuant to 6
this subsection shall not provide emergency ambulance transport services 7
within the boundaries of any city that: 8
1. Possesses a certificate of need to provide emergency ambulance 9
services; 10
2. Has an agency or department thereof that holds a certificate of need to 11
provide emergency ambulance services; or 12
3. Is providing emergency ambulance transport services within its 13
jurisdictional boundaries pursuant to this subsection. 14
(9) (a) Except where a certificate of need is not required pursuant to subsection (6), 15
(7), or (8) of this section, the cabinet shall grant nonsubstantive review for a 16
certificate of need proposal to establish an ambulance service that is owned by 17
a: 18
1. City government; 19
2. County government; or 20
3. Hospital, in accordance with paragraph (b) of this subsection. 21
(b) A notice shall be sent by the cabinet to all cities and counties that a certificate 22
of need proposal to establish an ambulance service has been submitted by a 23
hospital. The legislative bodies of the cities and counties affected by the 24
hospital's certificate of need proposal shall provide a response to the cabinet 25
within thirty (30) days of receiving the notice. The failure of a city or county 26
legislative body to respond to the notice shall be deemed to be support for the 27 UNOFFICIAL COPY 25 RS SB 17/GA
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proposal. 1
(c) An ambulance service established under this subsection shall not be 2
transferred to another entity that does not meet the requirements of paragraph 3
(a) of this subsection without first obtaining a substantive certificate of need. 4
(10) Notwithstanding any other provision of law, a continuing care retirement 5
community's nursing home beds shall not be certified as Medicaid eligible unless a 6
certificate of need has been issued authorizing applications for Medicaid 7
certification. The provisions of subsection (5) of this section notwithstanding, a 8
continuing care retirement community shall not change the level of care licensure 9
status of its beds without first obtaining a certificate of need. 10
(11) An ambulance service established under subsection (9) of this section shall not be 11
transferred to an entity that does not qualify under subsection (9) of this section 12
without first obtaining a substantive certificate of need. 13
(12) (a) The provisions of subsections (7), (8), and (9) of this section shall expire on 14
July 1, 2026. 15
(b) All actions taken by cities, counties, and hospitals, exemptions from obtaining 16
a certificate of need, and any certificate of need granted under subsections (7), 17
(8), and (9) of this section prior to July 1, 2026, shall remain in effect on and 18
after July 1, 2026. 19
Section 4. KRS 196.173 is amended to read as follows: 20
(1) Except as provided in subsection (2) of this section, an inmate housed in a jail, 21
penitentiary, or local or state correctional or detention facility, residential center, or 22
reentry center who is known to be pregnant shall be restrained solely with 23
handcuffs in front of her body unless further restraint is required to protect herself 24
or others. 25
(2) (a) Except in an extraordinary circumstance, no inmate who is known to be 26
pregnant shall be restrained during labor, during transport to a medical facility 27 UNOFFICIAL COPY 25 RS SB 17/GA
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or freestanding birthing center for delivery, or during postpartum recovery. 1
(b) As used in this subsection, "extraordinary circumstance" means that 2
reasonable grounds exist to believe the inmate presents an immediate and 3
credible: 4
1. Serious threat of hurting herself, staff, or others; or 5
2. Risk of escape that cannot be reasonably minimized through any method 6
other than restraints. 7
Section 5. KRS 211.122 is amended to read as follows: 8
(1) The Cabinet for Health and Family Services shall, in cooperation with maternal and 9
infant health and mental health professional societies: 10
(a) Develop written information on perinatal mental health disorders and make it 11
available on its website for access by freestanding birthing centers, hospitals 12
that provide labor and delivery services, and the public; and 13
(b) Provide access on its website to one (1) or more evidence-based clinical 14
assessment tools designed to detect the symptoms of perinatal mental health 15
disorders for use by health care providers providing perinatal care and health 16
care providers providing pediatric infant care. 17
(2) The Cabinet for Health and Family Services shall establish the Kentucky Maternal 18
and Infant Health Collaborative. The collaborative shall be composed of the 19
following members appointed by the secretary of the Cabinet for Health and Family 20
Services: 21
(a) Four (4) representatives of health care facilities that provide obstetrical, 22
newborn, maternal, and infant health care, one (1) of whom shall be a member 23
of the Kentucky Chapter of the American College of Obstetricians and 24
Gynecologists; 25
(b) Two (2) providers of maternal mental health care; 26
(c) Two (2) representatives of university mental health training programs; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(d) Two (2) maternal health advocates; 1
(e) Three (3) women, each of whom shall have experience living with at least one 2
(1) of the following: 3
1. Perinatal mental health disorders; 4
2. Substance use disorder; and 5
3. Intimate partner violence; 6
(f) One (1) public health director of a local health department in the 7
Commonwealth; and 8
(g) The commissioner of the Department for Public Health or his or her designee. 9
(3) The purposes of the collaborative shall be: 10
(a) Improving the quality of prevention and treatment of perinatal mental health 11
disorders; 12
(b) Promoting the implementation of evidence-based bundles of care to improve 13
patient safety; 14
(c) Identifying unaddressed gaps in service related to perinatal mental health 15
disorders that are linked to geographic, racial, and ethnic inequalities; lack of 16
screenings; and insufficient access to treatments, professionals, or support 17
groups; and 18
(d) Exploring grant and other funding opportunities and making 19
recommendations for funding allocations to address the need for services and 20
supports for perinatal mental health disorders. 21
(4) The collaborative shall annually review the operations of the Kentucky Maternal 22
Psychiatry Access Program established in KRS 211.123. 23
(5) The objectives set forth in subsection (3) of this section may be achieved by 24
incorporating the collaborative's findings and recommendations into other programs 25
administered by the Cabinet for Health and Family Services that are intended to 26
improve maternal health care quality and safety. 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(6) On or before November 1 of each year, the collaborative shall submit a report to the 1
Interim Joint Committee on Families and Children, the Interim Joint Committee on 2
Health Services, and the Advisory Council for Medical Assistance describing the 3
collaborative's work and any recommendations to address identified gaps in 4
services and supports for perinatal mental health disorders. 5
Section 6. KRS 211.647 is amended to read as follows: 6
(1) The office, on receipt of an auditory screening report of an infant from a hospital or 7
freestanding[alternative] birthing center in accordance with KRS 216.2970 shall 8
review each auditory screening report that indicates a potential hearing loss. The 9
office shall contact the parents to schedule follow-up evaluations or make a referral 10
for evaluations within three (3) business days. 11
(2) The office shall secure information missing from birth certificates or hospital 12
referral reports which is relevant to identifying infants with a hearing loss. 13
(3) The office shall establish standards for infant audiological assessment and 14
diagnostic centers based on accepted national standards, including but not limited to 15
the "Guidelines for the Audiologic Assessment of Children From Birth to 5 Years 16
of Age" as published by the American Speech-Language-Hearing Association 17
(ASHA) and the "Year 2007 Position Statement: Principles and Guidelines for 18
Early Hearing Detection and Intervention Programs" as published by the Joint 19
Committee on Infant Hearing (JCIH). The office may promulgate administrative 20
regulations in accordance with KRS Chapter 13A to establish the standards for the 21
centers. 22
(4) The office shall maintain a list of approved infant audiological assessment and 23
diagnostic centers that meet the standards established by the office. An audiological 24
assessment and diagnostic center included on the list shall meet the standards 25
established by the office. An approved center may voluntarily choose not to be 26
included on the list. 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(5) An approved audiology assessment and diagnostic center shall agree to provide 1
requested data to the office for each infant evaluated and on any newly identified 2
children ages birth to three (3) years with a permanent childhood hearing loss 3
within forty-eight (48) hours and make a referral to the Kentucky Early Intervention 4
System point of entry in the service area of the child's residence for services under 5
KRS 200.664. A center shall submit documentation to the office of a referral made 6
to the Kentucky Early Intervention System. A referral received by the Kentucky 7
Early Intervention System from a center shall be considered a referral from the 8
office. 9
(6) If the audiological evaluation performed by the office contains evidence of a 10
hearing loss, within forty-eight (48) hours the office shall: 11
(a) Contact the attending physician and parents and provide information to the 12
parents in an accessible format as supplied by the Kentucky Commission on 13
the Deaf and Hard of Hearing; and 14
(b) Make a referral to the Kentucky Early Intervention System point of entry in 15
the service area of the child's residence for services under KRS 200.664. 16
(7) The office shall forward a report of an audiological evaluation that indicates a 17
hearing loss, with no information that personally identifies the child, to: 18
(a) The Kentucky Commission on the Deaf and Hard of Hearing for census 19
purposes; and 20
(b) The Kentucky Birth Surveillance Registry for information purposes. 21
(8) Cumulative demographic data of identified infants with a hearing loss shall be made 22
available to agencies and organizations including but not limited to the Cabinet for 23
Health and Family Services and the Early Childhood Advisory Council, requesting 24
the information for planning purposes. 25
Section 7. KRS 211.660 is amended to read as follows: 26
(1) The Department for Public Health shall establish and maintain a Kentucky birth 27 UNOFFICIAL COPY 25 RS SB 17/GA
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surveillance registry that will provide a system for the collection of information 1
concerning birth defects, stillbirths, and high-risk conditions. The system may cover 2
all or part of the Commonwealth. 3
(2) In establishing the system, the department may review vital statistics records, and 4
shall also consider expanding the current list of congenital anomalies and high-risk 5
conditions as reported on birth certificates. 6
(3) (a) The department may require general acute-care hospitals licensed under KRS 7
Chapter 216B to maintain a list of all inpatients and voluntarily to maintain a 8
list of all outpatients up to the age of five (5) years with a primary diagnosis 9
of a congenital anomaly or high-risk condition as defined by the department 10
upon the recommendation of the appointed advisory committee. Hospital 11
participation regarding its outpatients shall be voluntary and subject to the 12
discretion of each hospital. 13
(b) The department may require medical laboratories licensed under KRS Chapter 14
333 to maintain medical records for all persons up to the age of five (5) years 15
with a primary diagnosis of or a laboratory test result indicating congenital 16
anomaly or high-risk condition as defined by the department upon the 17
recommendation of the appointed advisory committee. 18
(4) Each licensed freestanding[free-standing] birthing center, general acute-care 19
hospital licensed under KRS Chapter 216B, and medical laboratory licensed under 20
KRS Chapter 333 shall grant, if required or otherwise participating voluntarily 21
under the provisions of subsection (3) of this section, to any Kentucky Birth 22
Surveillance Registry personnel or his or her designee, upon presentation of proper 23
identification, access to the medical records of any patient meeting the criteria in 24
subsection (3) of this section. If the department's agent determines that copying of 25
the medical records is necessary, associated costs shall be borne by the Department 26
for Public Health at the rate pursuant to KRS 422.317. 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(5) No liability of any kind, character, damages, or other relief shall arise or be 1
enforced against any licensed freestanding[free-standing] birthing center, general 2
acute-care hospital, or medical laboratory by reason of having provided the 3
information or material to the Kentucky Birth Surveillance Registry. 4
(6) The Department for Public Health may implement the provisions of KRS 211.651 5
to 211.670 through the promulgation of administrative regulations in accordance 6
with the provisions of KRS Chapter 13A. 7
Section 8. KRS 213.046 is amended to read as follows: 8
(1) A certificate of birth for each live birth which occurs in the Commonwealth shall be 9
filed with the state registrar within five (5) working days after such birth and shall 10
be registered if it has been completed and filed in accordance with this section and 11
applicable administrative regulations. No certificate shall be held to be complete 12
and correct that does not supply all items of information called for in this section 13
and in KRS 213.051, or satisfactorily account for their omission except as provided 14
in KRS 199.570(3). If a certificate of birth is incomplete, the state registrar shall 15
immediately notify the responsible person and require that person to supply the 16
missing items, if that information can be obtained. 17
(2) When a birth occurs in a health facility[an institution] or en route thereto, the 18
person in charge of the health facility[institution] or that person's designated 19
representative, shall obtain the personal data, prepare the certificate, secure the 20
signatures required, and file the certificate as directed in subsection (1) of this 21
section or as otherwise directed by the state registrar within the required five (5) 22
working days. The physician, midwife, or other person in attendance shall provide 23
the medical information required for the certificate and certify to the fact of birth 24
within five (5) working days after the birth. If the physician, midwife, or other 25
person in attendance does not certify to the fact of birth within the five (5) working 26
day period, the person in charge of the health facility[institution] shall complete 27 UNOFFICIAL COPY 25 RS SB 17/GA
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and sign the certificate. 1
(3) When a birth occurs in a health facility[hospital] or en route thereto to a woman 2
who is unmarried, the person in charge of the health facility[hospital] or that 3
person's designated representative shall immediately before or after the birth of a 4
child, except when the mother or the alleged father is a minor: 5
(a) Meet with the mother prior to the release from the health facility[hospital]; 6
(b) Attempt to ascertain whether the father of the child is available in the health 7
facility[hospital], and, if so, to meet with him, if possible; 8
(c) Provide written materials and oral, audio, or video materials about paternity; 9
(d) Provide the unmarried mother, and, if possible, the father, with the voluntary 10
paternity form necessary to voluntarily establish paternity; 11
(e) Provide a written and an oral, audio, or video description of the rights and 12
responsibilities, the alternatives to, and the legal consequences of 13
acknowledging paternity; 14
(f) Provide written materials and information concerning genetic paternity 15
testing; 16
(g) Provide an opportunity to speak by telephone or in person with staff who are 17
trained to clarify information and answer questions about paternity 18
establishment; 19
(h) If the parents wish to acknowledge paternity, require the voluntary 20
acknowledgment of paternity obtained through the health facility-21
based[hospital-based] program be signed by both parents and be authenticated 22
by a notary public; 23
(i) Upon both the mother's and father's request, help the mother and father in 24
completing the affidavit of paternity form; 25
(j) Upon both the mother's and father's request, transmit the affidavit of paternity 26
to the state registrar; and 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(k) In the event that the mother or the alleged father is a minor, information set 1
forth in this section shall be provided in accordance with Civil Rule 17.03 of 2
the Kentucky Rules of Civil Procedure. 3
If the mother or the alleged father is a minor, the paternity determination shall be 4
conducted pursuant to KRS Chapter 406. 5
(4) The voluntary acknowledgment of paternity and declaration of paternity forms 6
designated by the Vital Statistics Branch shall be the only documents having the 7
same weight and authority as a judgment of paternity. 8
(5) The Cabinet for Health and Family Services shall: 9
(a) Provide to all public and private health facilities offering obstetric or 10
midwifery services[birthing hospitals] in the state written materials in 11
accessible formats and audio or video materials concerning paternity 12
establishment forms necessary to voluntarily acknowledge paternity; 13
(b) Provide copies of a written description in accessible formats and an audio or 14
video description of the rights and responsibilities of acknowledging 15
paternity; and 16
(c) Provide staff training, guidance, and written instructions regarding voluntary 17
acknowledgment of paternity as necessary to operate the health services-18
based[hospital-based] program. 19
(6) When a birth occurs outside a health facility[an institution], verification of the birth 20
shall be in accordance with the requirements of the state registrar and a birth 21
certificate shall be prepared and filed by one (1) of the following in the indicated 22
order of priority: 23
(a) The health care provider[physician] in attendance at or immediately after the 24
birth; or, in the absence of such a person, 25
(b) A midwife or any other person in attendance at or immediately after the birth; 26
or, in the absence of such a person, 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(c) The father, the mother, or in the absence of the father and the inability of the 1
mother, the person in charge of the premises where the birth occurred or of 2
the health facility[institution] to which the child was admitted following the 3
birth. 4
(7) No physician, midwife, or other attendant shall refuse to sign or delay the filing of a 5
birth certificate. 6
(8) If a birth occurs on a moving conveyance within the United States and the child is 7
first removed from the conveyance in the Commonwealth, the birth shall be 8
registered in the Commonwealth, and the place where the child is first removed 9
shall be considered the place of birth. If a birth occurs on a moving conveyance 10
while in international waters or air space or in a foreign country or its air space and 11
the child is first removed from the conveyance in the Commonwealth, the birth 12
shall be registered in the Commonwealth, but the certificate shall show the actual 13
place of birth insofar as can be determined. 14
(9) The following provisions shall apply if the mother was married at the time of either 15
conception or birth or anytime between conception and birth: 16
(a) If there is no dispute as to paternity, the name of the husband shall be entered 17
on the certificate as the father of the child. The surname of the child shall be 18
any name chosen by the parents; however, if the parents are separated or 19
divorced at the time of the child's birth, the choice of surname rests with the 20
parent who has legal custody following birth; 21
(b) If the mother claims that the father of the child is not her husband and the 22
husband agrees to such a claim and the putative father agrees to the statement, 23
a three (3) way affidavit of paternity may be signed by the respective parties 24
and duly notarized. The state registrar of vital statistics shall enter the name of 25
a nonhusband on the birth certificate as the father and the surname of the child 26
shall be any name chosen by the mother; and 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(c) If a question of paternity determination arises which is not resolved under 1
paragraph (b) of this subsection, it shall be settled by the District Court. 2
(10) The following provisions shall apply if the mother was not married at the time of 3
either conception or birth or between conception and birth or the marital 4
relationship between the mother and her husband has been interrupted for more than 5
ten (10) months prior to the birth of the child: 6
(a) The name of the father shall not be entered on the certificate of birth. The 7
state registrar shall upon acknowledgment of paternity by the father and with 8
consent of the mother pursuant to KRS 213.121, enter the father's name on the 9
certificate. The surname of the child shall be any name chosen by the mother 10
and father. If there is no agreement, the child's surname shall be determined 11
by the parent with legal custody of the child; 12
(b) If an affidavit of paternity has been properly completed and the certificate of 13
birth has been filed accordingly, any further modification of the birth 14
certificate regarding the paternity of the child shall require an order from the 15
District Court; 16
(c) In any case in which paternity of a child is determined by a court order, the 17
name of the father and surname of the child shall be entered on the certificate 18
of birth in accordance with the finding and order of the court; and 19
(d) In all other cases, the surname of the child shall be any name chosen by the 20
mother. 21
(11) If the father is not named on the certificate of birth, no other information about the 22
father shall be entered on the certificate. In all cases, the maiden name of the 23
gestational mother shall be entered on the certificate. 24
(12) Any child whose surname was restricted prior to July 13, 1990, shall be entitled to 25
apply to the state registrar for an amendment of a birth certificate showing as the 26
surname of the child, any surname chosen by the mother or parents as provided 27 UNOFFICIAL COPY 25 RS SB 17/GA
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under this section. 1
(13) The birth certificate of a child born as a result of artificial insemination shall be 2
completed in accordance with the provisions of this section. 3
(14) Each birth certificate filed under this section shall include all Social Security 4
numbers that have been issued to the parents of the child. 5
(15) Either of the parents of the child, or other informant, shall attest to the accuracy of 6
the personal data entered on the certificate in time to permit the filing of the 7
certificate within five (5) days prescribed in subsection (1) of this section. 8
(16) When a birth certificate is filed for any birth that occurred outside a health 9
facility[an institution], the Cabinet for Health and Family Services shall forward 10
information regarding the need for an auditory screening for an infant and a list of 11
options available for obtaining an auditory screening for an infant. The list shall 12
include the Office for Children with Special Health Care Needs, local health 13
departments as established in KRS Chapter 212, health facilities[hospitals] offering 14
obstetric or midwifery services, [alternative birthing centers required to provide an 15
auditory screening under KRS 216.2970, ]audiological assessment and diagnostic 16
centers approved by the Office for Children with Special Health Care Needs in 17
accordance with KRS 211.647 and licensed audiologists, and shall specify the 18
hearing methods approved by the Office for Children with Special Health Care 19
Needs in accordance with KRS 216.2970. 20
(17) As used in this section, "health facility" has the same meaning as in Section 2 of 21
this Act. 22
Section 9. KRS 214.155 is amended to read as follows: 23
(1) The Cabinet for Health and Family Services shall operate a newborn screening 24
program for heritable and congenital disorders that includes but is not limited to 25
procedures for conducting initial newborn screening tests on infants twenty-eight 26
(28) days or less of age and definitive diagnostic evaluations provided by a state 27 UNOFFICIAL COPY 25 RS SB 17/GA
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university-based specialty clinic for infants whose initial screening tests resulted in 1
a positive test. The secretary of the cabinet shall, by administrative regulation 2
promulgated pursuant to KRS Chapter 13A: 3
(a) Prescribe the times and manner of obtaining a specimen and transferring a 4
specimen for testing; 5
(b) Prescribe the manner of procedures, testing specimens, and recording and 6
reporting the results of newborn screening tests; and 7
(c) Establish and collect fees to support the newborn screening program. 8
(2) The administrative officer or other person in charge of each health 9
facility[institution] caring for infants twenty-eight (28) days or less of age and the 10
person required in pursuance of the provisions of KRS 213.046 shall register the 11
birth of a child and cause to have administered to every such infant or child in[ its 12
or] his, her, or the facility's care tests for heritable disorders, including but not 13
limited to phenylketonuria (PKU), sickle cell disease, congenital hypothyroidism, 14
galactosemia, medium-chain acyl-CoA dehydrogenase deficiency (MCAD), very 15
long-chain acyl-CoA deficiency (VLCAD), short-chain acyl-CoA dehydrogenase 16
deficiency (SCAD), maple syrup urine disease (MSUD), congenital adrenal 17
hyperplasia (CAH), biotinidase disorder, cystic fibrosis (CF), 3-methylcrotonyl-18
CoA carboxylase deficiency (3MCC), 3-OH 3-CH3 glutaric aciduria (HMG), 19
argininosuccinic acidemia (ASA), beta-ketothiolase deficiency (BKT), carnitine 20
uptake defect (CUD), citrullinemia (CIT), glutaric acidemia type I (GA I), Hb 21
S/beta-thalassemia (Hb S/Th), Hb S/C disease (Hb S/C), homocystinuria (HCY), 22
isovaleric acidemia (IVA), long-chain L-3-OH acyl-CoA dehydrogenase deficiency 23
(LCAD), methylmalonic acidemia (Cbl A,B), methylmalonic acidemia mutase 24
deficiency (MUT), multiple carboxylase deficiency (MCD), propionic acidemia 25
(PA), trifunctional protein deficiency (TFP), tyrosinemia type I (TYR I), spinal 26
muscular atrophy (SMA), and krabbe disease. The listing of tests for heritable 27 UNOFFICIAL COPY 25 RS SB 17/GA
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disorders to be performed shall include all conditions consistent with the 1
recommendations of the American College of Medical Genetics. 2
(3) The administrative officer or other person in charge of each health 3
facility[institution] caring for infants twenty-eight (28) days or less of age and the 4
person required in pursuance of the provisions of KRS 213.046 shall register the 5
birth of a child and cause to have administered to every such infant or child in[ its 6
or] his, her, or the facility care a screening for critical congenital heart disease 7
(CCHD) prior to discharge unless CCHD has been ruled out or diagnosed with prior 8
echocardiogram or prenatal diagnosis of CCHD. 9
(4) Each health care provider of newborn care shall provide an infant's parent or 10
guardian with information about the newborn screening tests required under 11
subsections (2) and (3) of this section. The health facility[institution] or health care 12
provider shall arrange for appropriate and timely follow-ups to the newborn 13
screening tests, including but not limited to additional diagnoses, evaluation, and 14
treatment when indicated. 15
(5) Nothing in this section shall be construed to require the testing of any child whose 16
parents are members of a nationally recognized and established church or religious 17
denomination, the teachings of which are opposed to medical tests, and who object 18
in writing to the testing of his or her child on that ground. 19
(6) The cabinet shall make available the names and addresses of health care providers, 20
including but not limited to physicians, nurses, and nutritionists, who may provide 21
postpartum home visits to any family whose infant or child has tested positive for a 22
newborn screening test. 23
(7) A parent or guardian shall be provided information by the health 24
facility[institution] or health care provider of newborn care about the availability 25
and costs of screening tests not specified in subsections (2) and (3) of this section. 26
The parent or guardian shall be responsible for costs relating to additional screening 27 UNOFFICIAL COPY 25 RS SB 17/GA
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tests performed under this subsection, and these costs shall not be included in the 1
fees established for the cabinet's newborn screening program under subsection (1) 2
of this section. All positive results of additional screening of these tests shall be 3
reported to the cabinet by the health facility[institution] or health care provider. 4
(8) (a) For the purposes of this subsection, a qualified laboratory means a clinical 5
laboratory not operated by the cabinet that is accredited pursuant to 42 U.S.C. 6
sec. 263a, licensed to perform newborn screening testing in any state, and 7
reports its screening results using normal pediatric reference ranges. 8
(b) The cabinet shall enter into agreements with public or private qualified 9
laboratories to perform newborn screening tests if the laboratory operated by 10
the cabinet is unable to screen for a condition specified in subsection (2) of 11
this section. 12
(c) The cabinet may enter into agreements with public or private qualified 13
laboratories to perform testing for conditions not specified in subsection (2) of 14
this section. Any agreement entered into under this paragraph shall not 15
preclude a health facility[an institution] or health care provider from 16
conducting newborn screening tests for conditions not specified in subsections 17
(2) and (3) of this section by utilizing other public or private qualified 18
laboratories. 19
(9) The secretary for health and family services or his or her designee shall apply for 20
any federal funds or grants available through the Public Health Service Act and 21
may solicit and accept private funds to expand, improve, or evaluate programs to 22
provide screening, counseling, testing, or specialty services for newborns or 23
children at risk for heritable disorders. 24
(10) As used in this section, "health facility" has the same meaning as in Section 2 of 25
this Act. 26
(11) This section shall be cited as the James William Lazzaro and Madison Leigh Heflin 27 UNOFFICIAL COPY 25 RS SB 17/GA
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Newborn Screening Act. 1
Section 10. KRS 214.565 is amended to read as follows: 2
As used in KRS 214.565 to 214.571: 3
(1) "Department" means the Department for Public Health in the Cabinet for Health 4
and Family Services; 5
(2) "Health care provider" means a licensed provider who has the care of pregnant 6
women within his or her professional scope of practice; and 7
(3) "Health facility" has the same meaning as in KRS 216B.015[; and 8
(3) "Physician" means any person licensed to practice medicine under KRS Chapter 9
311]. 10
Section 11. KRS 214.567 is amended to read as follows: 11
(1) The department shall make available to the public on its website[Web site] 12
educational resources regarding the incidence of congenital cytomegalovirus, 13
including information about: 14
(a) The transmission of congenital cytomegalovirus before and during pregnancy; 15
(b) Birth defects caused by congenital cytomegalovirus; 16
(c) Methods of diagnosing congenital cytomegalovirus; 17
(d) Available preventive measures; and 18
(e) Resources available to the family of an infant born with congenital 19
cytomegalovirus. 20
(2) The department may solicit and accept the assistance of relevant medical 21
associations or community resources to develop, promote, and distribute the public 22
educational resources. 23
(3) A health facility or health care provider[physician] providing obstetric or prenatal 24
services shall provide pregnant women or women who may become pregnant with 25
the information listed in subsection (1) of this section or provide the patients with a 26
link to the website[Web site] described in subsection (1) of this section. 27 UNOFFICIAL COPY 25 RS SB 17/GA
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Section 12. KRS 214.569 is amended to read as follows: 1
Every infant in this state who is given an auditory screening test described in KRS 2
216.2970, and fails the initial two (2) screenings or has other risk factors associated with 3
congenital cytomegalovirus, shall be tested for congenital cytomegalovirus not later than 4
twenty-one (21) days after the date of birth by the health facility or health care 5
provider[physician] providing services to the infant, unless the parents or guardians of 6
the infant opt out of testing. 7
Section 13. KRS 216.2920 is amended to read as follows: 8
As used in KRS 216.2920 to 216.2929, unless the context requires otherwise: 9
(1) "Ambulatory facility" means an outpatient facility, including an ambulatory 10
surgical facility, [freestanding birth center, ]freestanding or mobile technology unit, 11
or an urgent treatment center, that is not part of a hospital and that provides one (1) 12
or more ambulatory procedures to patients not requiring hospitalization; 13
(2) "Cabinet" means the Cabinet for Health and Family Services; 14
(3) "Charge" means all amounts billed by a hospital or ambulatory facility, including 15
charges for all ancillary and support services or procedures, prior to any adjustment 16
for bad debts, charity contractual allowances, administrative or courtesy discounts, 17
or similar deductions from revenue. However, if necessary to achieve comparability 18
of information between providers, charges for the professional services of hospital-19
based or ambulatory-facility-based physicians shall be excluded from the 20
calculation of charge; 21
(4) "Facility" means any hospital, health care service, freestanding birthing center, or 22
other health care facility, whether operated for profit or not; 23
(5) "Health care[Health-care] provider" or "provider" means any pharmacist as defined 24
pursuant to KRS Chapter 315, and any of the following independent practicing 25
practitioners: 26
(a) Physicians, osteopaths, and podiatrists licensed pursuant to KRS Chapter 311; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(b) Chiropractors licensed pursuant to KRS Chapter 312; 1
(c) Dentists licensed pursuant to KRS Chapter 313; 2
(d) Optometrists licensed pursuant to KRS Chapter 320; 3
(e) Physician assistants regulated pursuant to KRS Chapter 311; 4
(f) Nurse practitioners licensed pursuant to KRS Chapter 314; and 5
(g) Other health-care practitioners as determined by the Cabinet for Health and 6
Family Services by administrative regulation promulgated pursuant to KRS 7
Chapter 13A; 8
(6) "Hospital" means a facility licensed pursuant to KRS Chapter 216B as either an 9
acute-care hospital, psychiatric hospital, rehabilitation hospital, or chemical 10
dependency treatment facility; 11
(7) "Procedures" means those surgical, medical, radiological, diagnostic, or therapeutic 12
procedures performed by a provider, as periodically determined by the cabinet in 13
administrative regulations promulgated pursuant to KRS Chapter 13A as those for 14
which reports to the cabinet shall be required. "Procedures" also includes 15
procedures that are provided in hospitals or other ambulatory facilities, or those that 16
require the use of special equipment, including fluoroscopic equipment, computer 17
tomographic scanners, magnetic resonance imagers, mammography, ultrasound 18
equipment, or any other new technology as periodically determined by the cabinet; 19
(8) "Quality" means the extent to which a provider renders care that obtains for patients 20
optimal health outcomes; and 21
(9) "Secretary" means the secretary of the Cabinet for Health and Family Services. 22
Section 14. KRS 216.2970 is amended to read as follows: 23
(1) As a condition of licensure or relicensure, all health facilities[hospitals] offering 24
obstetric or midwifery services [and alternative birthing centers with at least forty 25
(40) births per year ]shall provide an auditory screening for all infants using one (1) 26
of the methods approved by the Office for Children with Special Health Care Needs 27 UNOFFICIAL COPY 25 RS SB 17/GA
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by administrative regulation promulgated in accordance with KRS Chapter 13A. 1
(2) An auditory screening report that indicates a finding of potential hearing loss shall 2
be forwarded by the health facility[hospital or alternative birthing center] within 3
twenty-four (24) hours of receipt to the: 4
(a) Attending physician or health care provider; 5
(b) Parents; 6
(c) Office for Children with Special Health Care Needs for evaluation or referral 7
for further evaluation in accordance with KRS 211.647; and 8
(d) Audiological assessment and diagnostic center approved by the office if a 9
follow-up assessment has been scheduled prior to the infant's discharge from 10
the hospital. 11
(3) An auditory screening report that does not indicate a potential hearing loss shall be 12
forwarded within one (1) week to the Office for Children with Special Health Care 13
Needs with no information that personally identifies the child. 14
Section 15. KRS 216.2921 is amended to read as follows: 15
(1) The Cabinet for Health and Family Services shall collect, pursuant to KRS 16
216.2925, analyze, and disseminate information in a timely manner on the cost, 17
quality, and outcomes of health services provided by health facilities and health 18
care[health-care] providers in the Commonwealth. The cabinet shall make every 19
effort to make health data findings that can serve as a basis to educate consumers 20
and providers for the purpose of improving patient morbidity and mortality 21
outcomes available to the public, and state and local leaders in health policy, 22
through the cost-effective and timely use of the media and the internet and through 23
distribution of the findings to health facilities and health care[health-care] 24
providers for further dissemination to their patients. 25
(2) The secretary of the Cabinet for Health and Family Services shall serve as chief 26
administrative officer for the health data collection functions of KRS 216.2920 to 27 UNOFFICIAL COPY 25 RS SB 17/GA
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216.2929. 1
(3) Neither the secretary nor any employee of the cabinet shall be subject to any 2
personal liability for any loss sustained or damage suffered on account of any action 3
or inaction of under KRS 216.2920 to 216.2929. 4
Section 16. KRS 216.2923 is amended to read as follows: 5
(1) For the purposes of carrying out the provisions of KRS 216.2920 to 216.2929, the 6
secretary may: 7
(a) Appoint temporary volunteer advisory committees, which may include 8
individuals and representatives of interested public or private entities or 9
organizations; 10
(b) Apply for and accept any funds, property, or services from any person or 11
government agency; 12
(c) Make agreements with a grantor of funds or services, including an agreement 13
to make any study allowed or required under KRS 216.2920 to 216.2929; and 14
(d) Contract with a qualified, independent third party for any service necessary to 15
carry out the provisions of KRS 216.2920 to 216.2929; however, unless 16
permission is granted specifically by the secretary a third party hired by the 17
secretary shall not release, publish, or otherwise use any information to which 18
the third party has access under its contract. 19
(2) For the purposes of carrying out the provisions of KRS 216.2920 to 216.2929, the 20
secretary shall: 21
(a) Periodically participate in or conduct analyses and studies that relate to: 22
1. Health-care costs; 23
2. Health-care quality and outcomes; 24
3. Health care[Health-care] providers and health services; and 25
4. Health insurance costs; 26
(b) Promulgate administrative regulations pursuant to KRS Chapter 13A that 27 UNOFFICIAL COPY 25 RS SB 17/GA
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relate to its meetings, minutes, and transactions related to KRS 216.2920 to 1
216.2929; and 2
(c) Prepare annually a budget proposal that includes the estimated income and 3
proposed expenditures for the administration and operation of KRS 216.2920 4
to 216.2929. 5
(3) The cabinet may promulgate administrative regulations pursuant to KRS Chapter 6
13A that impose civil fines not to exceed five hundred dollars ($500) for each 7
violation for knowingly failing to file a report as required under KRS 216.2920 to 8
216.2929. The amount of any fine imposed shall not be included in the allowed 9
costs of a facility for Medicare or Medicaid reimbursement. 10
Section 17. KRS 216.2925 is amended to read as follows: 11
(1) The Cabinet for Health and Family Services shall establish by promulgation of 12
administrative regulations pursuant to KRS Chapter 13A those data elements 13
required to be submitted to the cabinet by all hospitals and ambulatory facilities, 14
including a timetable for submission and acceptable data forms. Each hospital and 15
ambulatory facility shall be required to report on a quarterly basis information 16
regarding the charge for and quality of the procedures and health-care services 17
performed therein, and as stipulated by administrative regulations promulgated 18
pursuant to KRS Chapter 13A. The cabinet shall accept data that, at the option of 19
the provider, is submitted through a third party, including but not limited to 20
organizations involved in the processing of claims for payment, so long as the data 21
elements conform to the requirements established by the cabinet. The cabinet may 22
conduct statistical surveys of a sample of hospitals, ambulatory facilities, or other 23
providers in lieu of requiring the submission of information by all hospitals, 24
ambulatory facilities, or providers. On at least a biennial basis, the cabinet shall 25
conduct a statistical survey that addresses the status of women's health, specifically 26
including data on patient age, ethnicity, geographic region, and payor sources. The 27 UNOFFICIAL COPY 25 RS SB 17/GA
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cabinet shall rely on data from readily available reports and statistics whenever 1
possible. 2
(2) The cabinet shall require for submission to the cabinet by any group of providers, 3
except for physicians providing services or dispensaries, first aid stations, or clinics 4
located within business or industrial establishments maintained solely for the use of 5
their employees, including those categories within the definition of provider 6
contained in KRS 216.2920 and any further categories determined by the cabinet, at 7
the beginning of each fiscal year after January 1, 1995, and within the limits of the 8
state, federal, and other funds made available to the cabinet for that year, and as 9
provided by cabinet promulgation of administrative regulations pursuant to KRS 10
Chapter 13A, the following: 11
(a) A list of medical conditions, health services, and procedures for which data on 12
charge, quality, and outcome shall be collected and published; 13
(b) A timetable for filing information provided for under paragraph (a) of this 14
subsection on a quarterly basis; 15
(c) A list of data elements that are necessary to enable the cabinet to analyze and 16
disseminate risk-adjusted charge, quality, and outcome information, including 17
mortality and morbidity data; 18
(d) An acceptable format for data submission that shall include use of the 19
uniform: 20
1. Health claim form pursuant to KRS 304.14-135 or any other universal 21
health claim form to be determined by the cabinet if in the form of hard 22
copy; or 23
2. Electronic submission formats as required under the federal Health 24
Insurance Portability and Accountability Act of 1996, 42 U.S.C. sec. 25
300gg et seq., in the form of magnetic computer tape, computer 26
diskettes, or other electronic media through an electronic network; 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(e) Procedures to allow health care[health-care] providers at least thirty (30) days 1
to review information generated from any data required to be submitted by 2
them, with any reports generated by the cabinet to reflect valid corrections by 3
the provider before the information is released to the public; and 4
(f) Procedures pertaining to the confidentiality of data collected. 5
(3) The cabinet shall coordinate but not duplicate its data-gathering activities with other 6
data-collection activities conducted by the Department of Insurance, as well as 7
other state and national agencies that collect health-related service, utilization, 8
quality, outcome, financial, and health-care personnel data, and shall review all 9
administrative regulations promulgated pursuant to KRS 216.2920 to 216.2929 to 10
prevent duplicate filing requirements. The cabinet shall periodically review the use 11
of all data collected under KRS 216.2920 to 216.2929 to assure its use is consistent 12
with legislative intent. 13
(4) The cabinet shall conduct outcome analyses and effectiveness studies and prepare 14
other reports pertaining to issues involving health-care charges and quality. 15
(5) The cabinet may independently audit any data required to be submitted by providers 16
as needed to corroborate the accuracy of the submitted data. Any audit may be at 17
the expense of the cabinet and shall, to the extent practicable, be coordinated with 18
other audits performed by state agencies. 19
(6) The cabinet may initiate activities set forth in subsection (1) or (2) of this section at 20
any time after July 15, 1996. 21
(7) The Cabinet for Health and Family Services shall collect all data elements under 22
this section using only the uniform health insurance claim form pursuant to KRS 23
304.14-135, the Professional 837 (ASC X12N 837) format, the Institutional 837 24
(ASC X12N 837) format, or its successor as adopted by the Centers for Medicare 25
and Medicaid Services. 26
Section 18. KRS 216.2927 is amended to read as follows: 27 UNOFFICIAL COPY 25 RS SB 17/GA
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(1) The following types of data shall be deemed as relating to personal privacy and, 1
except by court order, shall not be published or otherwise released by the cabinet or 2
its staff and shall not be subject to inspection under KRS 61.870 to 61.884: 3
(a) Any data, summary of data, correspondence, or notes that identify or could be 4
used to identify any individual patient or member of the general public, unless 5
the identified individual gives written permission to release the data or 6
correspondence; 7
(b) Any correspondence or related notes from or to any employee or employees 8
of a provider if the correspondence or notes identify or could be used to 9
identify any individual employee of a provider, unless the corresponding 10
persons grant permission to release the correspondence; and 11
(c) Data considered by the cabinet to be incomplete, preliminary, substantially in 12
error, or not representative, the release of which could produce misleading 13
information. 14
(2) Health care[Health-care] providers submitting required data to the cabinet shall not 15
be required to obtain individual permission to release the data, except as specified 16
in subsection (1) of this section, and, if submission of the data to the cabinet 17
complies with pertinent administrative regulations promulgated pursuant to KRS 18
Chapter 13A, shall not be deemed as having violated any statute or administrative 19
regulation protecting individual privacy. 20
(3) (a) No less than sixty (60) days after the annual report or reports are published 21
and except as otherwise provided, the cabinet shall make all aggregate data 22
which does not allow disclosure of the identity of any individual patient, and 23
which was obtained for the annual period covered by the reports, available to 24
the public. 25
(b) Persons or organizations requesting use of the data shall agree to abide by a 26
public-use data agreement and by HIPAA privacy rules referenced in 45 27 UNOFFICIAL COPY 25 RS SB 17/GA
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C.F.R. Part 164. The public-use data agreement shall include, at a minimum, a 1
prohibition against the sale or further release of data, and guidelines for the 2
use and analysis of the data released to the public related to provider quality, 3
outcomes, or charges. 4
(4) Collection of data about individual patients shall include information commonly 5
used to identify an individual for assigning a unique patient identifier. Upon 6
assigning a unique patient identifier, all direct identifying information shall be 7
stripped from the data and shall not be retained by the cabinet or the cabinet's 8
designee. 9
(5) All data and information collected shall be kept in a secure location and under lock 10
and key when specifically responsible personnel are absent. 11
(6) Only designated cabinet staff shall have access to raw data and information. The 12
designated staff shall be made aware of their responsibilities to maintain 13
confidentiality. Staff with access to raw data and information shall sign a statement 14
indicating that the staff person accepts responsibility to hold that data or identifying 15
information in confidence and is aware of penalties under state or federal law for 16
breach of confidentiality. Data which, because of small sample size, breaches the 17
confidence of individual patients, shall not be released. 18
(7) Any employee of the cabinet who violates any provision of this section shall be 19
fined not more than five hundred dollars ($500) for each violation or be confined in 20
the county jail for not more than six (6) months, or both, and shall be removed and 21
disqualified from office or employment. 22
Section 19. The Cabinet for Health and Family Services shall promulgate 23
updated administrative regulations in accordance with KRS Chapter 13A to implement 24
the requirements of Section 1 of this Act by December 1, 2025. 25
Section 20. This Act may be cited as the Mary Carol Akers Birth Centers Act. 26