Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
194A.050,
211.180,
211.651,
211.655,
211.660,
211.670,
Chapter 216B
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
194A.050(1) requires the
Cabinet for Health and Family Services to promulgate administrative regulations
necessary to operate the programs and fulfill the responsibilities vested in
the cabinet.
KRS
211.660(1) requires the
department to establish the Kentucky Birth Surveillance Registry based on the
need to provide information on the incidence, prevalence, and trends of
congenital anomalies, stillbirths and high risk conditions; provide information
as to possible causes; and develop preventive strategies to reduce their
incidence and the secondary complications associated with them.
KRS
211.660(6) authorizes the
department to implement the provisions of
KRS
211.651 to
211.670
through the promulgation of administrative regulations. This administrative
regulation establishes uniform procedures for collection of data for the
registry.
Section 1. Definitions.
(1) "Agent" means an entity with which the
department may:
(a) Contract pursuant to
carrying out the duties of the registry; and
(b) Designate to act on the behalf of the
registry to edit or analyze data from hospitals.
(2) "Cabinet" is defined by
KRS
211.651(1).
(3) "Coding and transmission specifications"
means the required data elements and codes to be included on the UB-04 CMS 1450
Form.
(4) "Department" is defined
by
KRS
211.651(3).
(5) "Free-standing birthing center" means a
non-hospital affiliated alternative birthing center licensed under the
provisions of KRS Chapter 216B.
(6)
"Hospital" means an acute care hospital licensed under the provisions of KRS
Chapter 216B.
(7) "Hospitalization"
means the inpatient medical episode identified by a patient's birth, admission
date, length of stay and discharge date, and further identified by a
provider-assigned patient control number unique to that inpatient
episode.
(8) "ICD-10 Code" means
the International Classification of Diseases, Tenth Revision, Clinical
Modification system used by physicians and other health care providers to
classify and code all diagnoses, symptoms and procedures recorded in
conjunction with hospital care.
(9)
"Laboratory" means a medical laboratory licensed under KRS Chapter
333.
(10) "Medical record" means
the patient's actual medical record maintained by a hospital's or free-standing
birth center's medical record department or by a laboratory.
(11) "Record" means documentation in UB-04
data format, in paper or electronic submission, of:
(a) A hospitalization;
(b) An outpatient visit; or
(c) A laboratory result.
(12) "Registry" means the Kentucky Birth
Surveillance Registry.
(13) "UB-04
data" means the standard claim format used by birthing centers, hospitals and
laboratory providers to transmit a healthcare claim.
Section 2. Data Collection.
(1) Hospitalization records. A hospital shall
document, in the UB-04 data format, each inpatient hospitalization of a child
up to age five (5) years who is diagnosed with a congenital birth anomaly or
high-risk condition, as defined by the department in accordance with
KRS
211.660(2), and included in
Section 5 of this administration regulation. Each hospital shall provide to the
registry the data specified in Section 6 of this administrative
regulation.
(2) Outpatient and
laboratory records.
(a) In accordance with
KRS
211.660(3)(b), a laboratory
shall maintain medical records for each child up to the age of five (5) years
who has a primary diagnosis or laboratory test result indicating a congenital
anomaly or high-risk condition, as defined by the department and included in
Section 5 of this administrative regulation.
(b) A laboratory, and a hospital voluntarily
maintaining an outpatient list as described at
KRS
211.660(3)(a), shall provide
the data specified in Section 6 of this administrative regulation.
(3) Access to medical records. A
hospital, free-standing birthing center, or laboratory shall provide an agent
of the department access to the medical record of:
(a) Patients meeting the criteria in
subsections (1) or (2) of this section;
(b) An infant who dies before his or her
first birthday;
(c) Any stillborn
child; and
(d) Maternal prenatal
medical records for a patient meeting the criteria in:
1. Subsections (1) or (2) of this section;
and
2. Paragraphs (b) and (c) of
this subsection.
(4) Maternal prenatal medical records shall
be used to assist in determining the possible causes of congenital anomalies,
stillbirths, and high risk conditions, and aid in the development of prevention
strategies to reduce their incidence as authorized by
KRS
211.655.
Section 3. Data Finalization and Submission.
(1) Submission of final data. Data shall be
final for purposes of submission to the registry as soon as a record is
sufficiently final that the provider could submit it to a payor for billing
purposes, whether or not the record has actually been submitted to a payor.
(a) Finalized data shall not be withheld from
submission to the registry on grounds that it remains subject to adjudication
by a payor; and
(b) Data on a
hospitalization shall not be submitted to the registry before the patient is
discharged.
(2) Data
editing.
(a) If the registry identifies a
record as incomplete or invalid, the submitting hospital shall submit a
corrected copy within thirty (30) days of notification.
(b) The date of notification shall be the
date postmarked on the registry's mailed notice of required
correction.
(c) Resubmission shall
be by either electronic transmission or mailing.
(3) Transmission of records.
(a) Data submitted to the registry shall be
uniformly completed and formatted according to coding and transmission
specifications;
(b) Hospitals,
free-standing birthing centers, and laboratories that have the capacity shall
submit data on computer-readable electronic media;
(c) Hospitals, free-standing birthing
centers, and laboratories shall provide backup security against accidental
erasure or loss of the data until any incomplete or inaccurate records
identified by the registry have been corrected and resubmitted; and
(d) Data submitted by mail shall be by
certified mail or other traceable carrier, such as United Parcel Service, and
be postmarked on or before the due date.
Section 4. Data Submission Timetable.
Quarterly submission. A hospital, free-standing birthing center, or laboratory
shall submit data at least once for each calendar quarter. A quarterly
submission shall contain data from records of patients which became final
during that quarter, as specified in Section 3(1) of this administrative
regulation. The data shall be submitted to the registry not later than
forty-five (45) days after the last day of that quarter.
(1) If the 45th day falls on a weekend or
holiday, the submission due date shall become the next following working
day.
(2) Outpatient data shall be
submitted directly to the registry within thirty (30) days of the written
request.
(3) A hospital,
free-standing birthing center, or laboratory shall, within thirty (30) days of
receipt of a written request from the registry, submit a medical records report
for specified ICD-10 codes for a designated quarter.
Section 5. Required Reporting Conditions.
Hospitals, free-standing birthing centers, and laboratories shall submit to the
registry the following information with respect to all patients up to the age
of five (5) years, diagnosed with the following ICD-10 codes:
(1) All congenital anomalies codes Q00-Q99,
and all subcategories;
(2)
Metabolic storage disorder codes D80-D82, E70-E72, E74-E83, EBB, and all
subcategories;
(3) Teratogens
(noxious influences) codes P04.0-P04.9, and all subcategories;
(4) Zika virus disease code A92.5;
and
(5) Any additional condition
necessary for public health surveillance.
Section 6. Required Data Elements.
(1) UB-04 data. Hospitals and free-standing
birthing centers shall ensure that each copy of UB-04 data submitted to the
registry contains the following data elements:
UB-04 data FIELD #
|
ELEMENT NAME
|
B
|
Patient Name
|
9
|
Patient Address
|
10
|
Birth Date
|
11
|
Sex
|
12
|
Admission Date
|
50
|
Payer Name
|
5B
|
Insured's Name
|
59
|
Patient Relationship (P. REL)
|
60
|
Insured's Unique ID
|
66
|
Diagnosis Codes
|
67
|
Principle Diagnosis Code
|
76
|
Attending Physician National Provider
Identifier
|
(2)
Outpatient and laboratory data. A laboratory and a hospital voluntarily
maintaining a list of outpatients, in accordance with
KRS
211.660(3)(a), shall ensure
that the data submitted to the registry includes the following data elements:
patient name, patient address, birth date, sex, principal diagnosis, other
diagnoses, and reporting source.
Section 7. Incorporation by Reference.
(1) "UB-04 CMS 1450 Form", 03-01-2007, is
incorporated by reference.
(2) This
material may be inspected, copied, or obtained, subject to applicable copyright
law, at the Kentucky Birth Surveillance Registry, Division of Maternal and
Child Health, Department for Public Health, 275 East Main Street, Frankfort,
Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m.
STATUTORY AUTHORITY:
KRS
194A.050(1),
211.660(6)