The proposed revision to the Children’s Medical Services Rules 64C-6.001, 64C-6.002, and 64C-6.003 updates the specific rulemaking authority, program definitions, and the incorporation of updated program standards of the Regional Perinatal Intensive ...

 

DEPARTMENT OF HEALTH

Division of Children's Medical Services

RULE NO.:RULE TITLE:

64C-6.001Definitions - General

64C-6.002Standards - General

64C-6.003Standards - Specific

PURPOSE AND EFFECT: The proposed revision to the Children’s Medical Services Rules 64C-6.001, 64C-6.002, and 64C-6.003, F.A.C. updates the specific rulemaking authority, program definitions, and the incorporation of updated program standards of the Regional Perinatal Intensive Care Centers Program.

SUMMARY: Definitions, general standards, and specific standards for the Regional Perinatal Intensive Care Centers Program.

SUMMARY OF STATEMENT OF ESTIMATED REGULATORY COSTS AND LEGISLATIVE RATIFICATION:

The Agency has determined that this will not have an adverse impact on small business or likely increase directly or indirectly regulatory costs in excess of $200,000 in the aggregate within one year after the implementation of the rule. A SERC has not been prepared by the Agency.

The Agency has determined that the proposed rule is not expected to require legislative ratification based on the statement of estimated regulatory costs or if no SERC is required, the information expressly relied upon and described herein: Based on the SERC checklist, this rulemaking will not have an adverse impact on regulatory costs in excess of $1 million within five years as established in s.120.541(2)(a), F.S.

Any person who wishes to provide information regarding a statement of estimated regulatory costs, or provide a proposal for a lower cost regulatory alternative must do so in writing within 21 days of this notice.

RULEMAKING AUTHORITY: 383.19(1) FS

LAW IMPLEMENTED: 383.16, 383.17, 383.19 FS

IF REQUESTED WITHIN 21 DAYS OF THE DATE OF THIS NOTICE, A HEARING WILL BE SCHEDULED AND ANNOUNCED IN THE FAR.

THE PERSON TO BE CONTACTED REGARDING THE PROPOSED RULE IS: Lalania White, CMS RPICC Nursing Consultant, [phone] or [e-mail].

 

THE FULL TEXT OF THE PROPOSED RULE IS:

64C-6.001 Definitions - General.

(1) “Assisted Ventilation” – The use of mechanical or other devices to help maintain respiration, usually delivering air or oxygen under positive pressure. Assisted ventilation may be invasive (i.e., oscillator, ventilator) or non-invasive, (i.e., CPAP, SiPAP, BiPAP, nCPAP).

(2) “Children’s Medical Services (CMS)” – The organizational unit within the Florida Department of Health which is responsible for general statewide administration of the Children’s Medical Services Programs.

(3) “CMS RPICC Physician” – A health professional who is licensed to practice medicine or osteopathic medicine in the State of Florida.

(3) “Regional Perinatal Intensive Care Centers (RPICC or centers)” Specialized units within hospitals specifically designed to provide a full range of health services to women with high risk pregnancies and a full range of newborn intensive care services which have been designated by the Department of Health, and which meet the standards as defined herein for facilities, staffing and services or commit themselves to meeting and maintaining these standards within three years of designation as a center.

(4) “Maternal Fetal Medicine (MFM) Physician” – A CMS RPICC physician, who is board certified in Obstetrics and Gynecology (OB/GYN) and board certified in Maternal Fetal Medicine, or has passed the written MFM exam and is eligible to take the oral MFM exam for board certification, and is in the process of pursuing board certification.

(5)(1) No change.

(6)(2) “Neonatologist” – A CMS RPICC CMS consultant physician, as defined in Rule 64C-4.001, F.A.C., who is board certified in Neonatal-Perinatal Medicine, or is eligible to take the written Neonatal-Perinatal exam for board certification, and is in the process of pursuing board certification by an appropriate board in the area of neonatal-perinatal medicine. 

(7) “Obstetrician” – A CMS RPICC physician who is board certified in OB/GYN, or has passed the written examination of the OB/GYN board certification process, and is in the process of pursuing board certification.

(8)(4) “RPICC Data System” – A comprehensive automated information system which collects and correlates data from both all 3 components of the Regional Perinatal Intensive Care Centers Program and provides periodic analysis of RPICC Program data.

(9)(5) “RPICC Level II Neonatal Intensive Care Patient Station Bed” – A patient care station in a RPICC with the capability of delivering special care to newborns including oxygen therapy, supplemental parenteral alimentation, constant electronic monitoring of vital signs, and with a minimum ratio of one member of the nursing staff to four patients.

(10)(6) “RPICC Level III and Level IV Neonatal Intensive Care Patient Station Bed” – A patient care station with the capability of delivering total intensive care to newborns including total respiratory support, supplemental parenteral alimentation, constant electronic monitoring of vital signs, long term arterial catheterization, and with a minimum ratio of one member of the nursing staff to two patients, at all times, for the critical care of unstable neonates.

(7) “Waiver” – A written statement or verbal statement, followed by written documentation, by the Assistant Secretary for Children’s Medical Services which abandons the enforcement of any specific requirement of these standards for a specified period of time.

(11) “RPICC Level IV Neonatal Intensive Care Services” – Level IV units have all the capabilities of a Level III neonatal intensive care unit and are located within institutions that can provide on-site surgical repair of serious congenital or acquired malformations (complex neonatal surgery), including support related to antenatally diagnosed congenital malformations requiring surgical repair either in utero or within the first hours of life.  Level IV neonatal intensive care units have ready access to a full range of pediatric surgeons and pediatric surgical specialists and pediatric anesthesiologists to perform major surgery.  Advanced imaging with interpretation on an urgent basis such as CT, MRI, and echocardiography are available on-site 24 hours a day and 7 days a week.  In addition, a full range of pediatric medical and pediatric genetic specialists are available for consultation.

(12)  “RPICC Program Consultants” – A CMS RPICC Neonatologist and a CMS RPICC Maternal Fetal Medicine Physician that accompany the CMS Central Office RPICC staff on RPICC Center site visits.

Rulemaking Authority 383.19(1) FS. Law Implemented 383.16, 383.17, 383.19 FS. History–New 9-1-81, Amended 4-25-83, Formerly 10J-7.01, Amended 6-13-87, 5-15-96, Formerly 10J-7.001, Amended            . 

 

64C-6.002 Standards - General.

(1) No change.

(2) The Regional Perinatal Intensive Care Centers (RPICC) Program provides services in designated hospitals through two interrelated components:

(a) Neonatal including Level II and Level III neonatal intensive care. RPICC Level IV neonatal intensive care services described herein is an optional component of a RPICC center;

(b) No change.

(3) Facilities and Location.

(a) Upon review of available information or upon the request of an individual or institution the CMS Program office shall make a determination of the need for the establishment of a center within a geographic area. This determination shall be based upon the following factors:

1. The number of centers and live births per year, as required in Section 383.19, F.S.

2. No change.

(b) through (c) No change.

(d) In order to be designated a center, a hospital must be approved by the Deputy State Health Officer Assistant Secretary for Children’s Medical Services, based on the recommendation from the on-site review.

(e) through (f) No change.

(g) If all standards for facilities, staffing, and services, as set forth herein, are not met without appropriate waiver, then designation as a center shall be removed unless the Deputy State Health Officer Assistant Secretary for CMS determines that removal will reduce essential services.

(4) through (5) No change.

(6) Waivers.

(a) In the event that compliance with any facility or personnel standard is not attained, a provider may request a waiver of that standard.

(b) All requests for waiver of a specific standard shall be made in writing to the Children’s Medical Services Program office and shall include documentation of the need of the waiver.

(c) A waiver of a specific standard shall be granted only for a specific period of time.

(d) Final approval or disapproval of all requests for waiver shall be made by the Assistant Secretary for Children’s Medical Services. The Assistant Secretary for CMS shall base the decision to grant or deny a specific request for waiver of a standard upon the documentation submitted with the request.

Rulemaking Authority 383.19(1) FS. Law Implemented 120, 383.171, 383.16, 383.17, 383.19 FS. History–New 9-1-81, Amended 4-25-83, Formerly 10J-7.01, Amended 6-13-87, 5-15-96, Formerly 10J-7.001, Amended            .

 

64C-6.003 Standards - Specific.

(1) Standards for Neonatal Component – RPICC Level IV III Neonatal Intensive Care – The following standards pertain to the facilities, services, and population to be served under the neonatal component for RPICC Level IV III neonatal intensive care services.

(a). Personnel

1. Physicians

a. RPICC Level IV neonatal intensive care services shall be directed by a neonatologist or group of neonatologists who are on active staff of the hospital with unlimited privileges and provide 24 hour, seven day a week coverage, and who are either board certified with maintenance of certification or board admissible in neonatal-perinatal medicine.

b. In addition, facilities with RPICC Level IV neonatal intensive care services shall be required to maintain pediatric medical and surgical subspecialist(s), pediatric anesthesiologist(s), pediatric surgeon(s), and pediatric ophthalmologist(s) as well as one or more maternal fetal medical specialist(s) on active staff of the hospital with unlimited staff privileges.

c. Specialty children’s hospitals with fetal therapy programs are required to have one or more maternal fetal specialists skilled in fetal diagnosis and therapy.

(b) Services

1. All RPICC Level III services in addition to:

a. Capability to provide surgical repair of complex congenital or acquired conditions.

(c) Nurses, area and equipment

1. All remaining standards for RPICC Level IV neonatal intensive care are the same as the requirements for RPICC Level III neonatal intensive care, as noted below.

(2) Standards for Neonatal Component – RPICC Level III Neonatal Intensive Care – The following standards pertain to the facilities, services, and population to be served under the neonatal component for RPICC Level III neonatal intensive care services.

(a) Personnel

1. Physicians

a. The director of the RPICC neonatal unit shall be a CMS RPICC consultant neonatologist.

b. Each center shall have available a CMS consultant pediatric surgeon available for emergency services and telephone consultation 24 hours per day, 7 days per week at all times.

c. Each RPICC neonatal unit shall have 24-hour coverage by CMS RPICC consultant neonatologists continuously available for patient care and for communication with physicians in other hospitals 24 hours per day, 7 days per week.

d. A minimum of two neonatologists are required to be on staff. Each center shall have a CMS consultant pediatric cardiologist available at all times.

e. Two neonatologists are required within 3 years of designation of a unit as a RPICC.

2. No change.

3. Respiratory Therapist Therapy Technician–

a. At least one certified or registered respiratory therapist, therapy technician with expertise in the care of neonates, shall be available in the hospital 24 hours per day, 7 days per week at all times.

b. One respiratory therapist for every four infants receiving assisted ventilation is required.

(b) Area and Equipment – All standards in subsection 59C-1.042(10), F.A.C., as amended 3-15-17, which is hereby incorporated herein by reference, are required. A copy is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX. In addition, the following standards are also required.

1. Each patient station in the RPICC Level III and Level IV neonatal intensive care unit shall have:

a. through b. No change.

2. No change.

(c) Patient Eligibility.

1. Eligibility for funding under the RPICC Program shall be limited to neonates admitted to the RPICC Level III or Level IV neonatal intensive care unit in one of the designated RPICCs. All neonates who meet the established medical criteria upon direct referral by the attending physician, must be admitted to the center, regardless of geographic origin in Florida or financial eligibility. The only valid grounds for refusal of admission to a center shall be the lack of functional bed space or unavailability of transport. Admission to a center does not constitute acceptance of a patient for eligibility under the RPICC Program.

2. No change.

3. The following medical criteria will be considered by the RPICC director of neonatology, or designee, to determine medical eligibility for each neonate admitted to the center or under this program:

a. All very low birth weight neonates under 1500 grams.

b. No change.

4. No change.

5. Only neonates whose attending physician is a CMS RPICC consultant neonatologist in a RPICC center are eligible for the RPICC Program. Neonates who are patients of other physicians or neonates referred to other physicians by the neonatologist, are not eligible for the RPICC Program.

(d) Services.

1. Physician Services – The patient record shall contain written comments on the patient’s treatment and condition by the CMS RPICC consultant neonatologist or a resident’s note co-signed by the CMS RPICC neonatologist consultant documenting the neonatologist’s continuing involvement in the care of the neonate.

2. through 7. No change.

(3)(2) Standards for Neonatal Component – RPICC Level II neonatal intensive care unit – The following standards pertain to the facilities, services, and population to be served under the neonatal component for Level II neonatal intensive care services of the RPICC Program.

(a) Personnel.

1. Physicians.

a. Each Level II neonatal intensive care unit shall have 24 hour consultation and primary coverage by CMS RPICC consultant neonatologists for patient care 24 hours per day, 7 days per week.

2. Nurses.

a. A head nurse, who is a registered nurse as defined by the State of Florida, as defined in Chapter 464, F.S., with specialized training and experience in the care of sick infants, will be responsible for the organization and quality of nursing care in the RPICC Level II neonatal intensive care unit. The head nurse of the RPICC Level III or Level IV neonatal intensive care unit may assume this role.

b. Additional staffing for each shift for infants in the Level II neonatal intensive care unit must include one member of nursing staff for every four such infants, with a minimum of half of such nursing personnel being registered nurses. This ratio of nurses to infants must be maintained 24 hours per day, 7 days per week at all times.

3. Respiratory Therapist Therapy Technician – A certified or registered respiratory therapist therapy technician with expertise in the care of neonates shall be available to the RPICC Level II neonatal intensive care unit 24 hours per day, 7 days per week at all times.

(b) Area and Equipment – All standards in subsection 59C-1.042(9), F.A.C., as amended 3-15-17, which is hereby incorporated by reference, are required. A copy is available at http://www.flrules.org/Gateway/reference.asp?No=Ref-XXXXX. In addition, the following standards are also required:

1. No change.

2. Each RPICC Level II neonatal intensive care unit shall have available the capability for short-term assisted ventilation until return to a RPICC Level III or Level IV neonatal intensive care unit is available.

(c) Patient Eligibility.

1. Eligibility for funding under the RPICC Program shall be limited to neonates admitted to the RPICC Level II neonatal intensive care unit from one of the designated RPICC Level III or Level IV neonatal intensive care units.

2. Infants served in RPICC Level II neonatal intensive care units shall be under the care of a CMS RPICC consultant neonatologist, must have received CMS RPICC Program Level III or Level IV NICU care, and may require specialized nutritional support, or may require oxygen which does not exceed 40 percent at ambient pressure, or whose weight or medical or surgical diagnosis precludes discharge to recovery care. 

(d) No change.

(4)(3) Standards for RPICC Obstetrical (OB) Component – The following standards pertain to the facilities, services, and population to be served under the obstetrical component of the RPICC Program.

(a) Personnel.

1. Physicians.

a. The obstetrical service shall have 24-hour coverage by a CMS RPICC consultant obstetrician continuously available for patient care and for communication with physicians in other hospitals 24 hours per day, 7 days per week.

b. through c. No change.

2. Nurses.

a. The nursing supervisor for obstetrics, a registered nurse as defined by the State of Florida, as defined in Chapter 464, F.S., shall have training and experience in the nursing care of normal and high risk obstetric patients, and shall preferably be certified as a clinical nurse specialist or advanced registered nurse practitioner.

b. No change.

(b) Area and Equipment.

1. No change.

2. Labor and Delivery Area – The labor and delivery area shall have, as a minimum:

a. No change.

b. One fetal monitor per 500 five hundred deliveries per year or two fetal monitors for less than 1,500 one thousand five hundred deliveries per year for continuous direct and indirect electronic fetal monitoring.

c. through i. No change.

3. OB Recovery Room

a. A separate recovery room shall be available for patients following delivery deliver and shall be located in close proximity to the delivery room.

b. No change.

4. No change.

(c) Patient Eligibility.

1. through 2. No change.

3. Demographic, medical, and fiscal data must shall be collected on all RPICC Program patients, and entered into the RPICC data system.

4. The director of obstetrics, or his/her designee, shall consider major maternal conditions which may significantly alter the usual management of pregnancy or of the newborn when determining medical eligibility for RPICC Program sponsorship. Major maternal conditions to be considered include, but are not limited to the following:

a. through e. No change.

f. Maternal substance abuse.

5. Only patients whose attending physician is a CMS RPICC consultant obstetrician in a center are eligible for RPICC Program funding.

6. No change.

7. Termination of Program Eligibility.

(d) Services.

1. Physician.

a. Patient management at designated centers shall include, but not be limited to, availability of the following tests:

(I) through (IV) No change.

(V) Fetal scalp blood sampling.

b. Performance or interpretation of these tests shall be made by, or under the supervision of the CMS RPICC consultant obstetrician.

2. through 5. No change.

6. Ancillary health services to include:

a. 24 Twenty-four  hour blood bank services.

b. 24 Twenty-four  hour routinely available X-ray services, with capability for performing diagnostic ultrasound examinations capable of determining placental position and fetal cephalometry, if this service is not provided by the obstetric department.

c. 24 Twenty-four hour laboratory services, with capabilities for performing amniotic fluid analysis, including studies of fetal maturity and fetal well-being; and bio-chemical tests of fetal placental well-being, such as either estriol or human placental lactogen measurements.

d. 24 Twenty-four hour respiratory therapy services to include 24 twenty-four hour blood gas determination with capability for microcapillary technique for scalp blood pH determination.

e. through g. No change.

h. Prenatal classes – Each center must shall provide for, or arrange for access to, prenatal classes for patients, as recommended by the CMS RPICC consultant obstetrician.

Rulemaking Specific Authority 383.19(1) FS. Law Implemented 383.16, 383.17, 383.19 FS. History–New 9-1-81, Amended 4-25-83, Formerly 10J-7.01, Amended 6-13-87, 5-15-96, Formerly 10J-7.001, Amended            .

 

NAME OF PERSON ORIGINATING PROPOSED RULE: Kelli Stannard, Director, CMS Managed Care Plan Operations

NAME OF AGENCY HEAD WHO APPROVED THE PROPOSED RULE: Celeste Philip, MD, MPH, Surgeon General and Secretary

DATE PROPOSED RULE APPROVED BY AGENCY HEAD: June 22, 2018

DATE NOTICE OF PROPOSED RULE DEVELOPMENT PUBLISHED IN FAR: May 22, 2018

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