Current through Register Vol. 51, No. 3, September 1, 2024
RELATES TO:
KRS
2.015,
42 C.F.R.
485.500-485.546,
42 C.F.R.
485.618,
45 C.F.R. Part 160, Part
164,
42 U.S.C.
1320d-2-
1320d-8
NECESSITY, FUNCTION, AND CONFORMITY:
KRS
216B.042 requires the Cabinet for Health and
Family Services to promulgate administrative regulations necessary for the
proper administration of the licensure function, which includes establishing
licensure standards and procedures to ensure safe, adequate, and efficient
health facilities and health services. This administrative regulation
establishes the minimum requirements for licensure as a rural emergency
hospital.
Section 1. Definition.
"Rural emergency hospital (REH)" is defined by
42 C.F.R.
485.502 as an entity that:
(1) Operates for the purpose of providing
emergency department services, observation care, and other outpatient medical
and health services specified by the secretary of the U.S. Department of Health
and Human Services in which the annual per patient average length of stay does
not exceed twenty-four (24) hours; and
(2) Shall not provide inpatient services,
except those furnished in a unit that is a distinct part licensed as a skilled
nursing facility to furnish post-REH or post-hospital extended care
services.
Section 2.
Licensure.
(1) A facility shall be eligible to
apply for a license as an REH if the facility is certified as an REH by the
Centers for Medicare and Medicaid Services and was, as of December 27, 2020:
(a) Licensed as a critical access hospital
pursuant to
906 KAR 1:110; or
(b)
1.
Licensed as a general acute care hospital pursuant to
902 KAR 20:016;
2. Had fifty (50) or fewer beds;
and
3. Was considered rural or
treated as being located in a rural area in accordance with
42 C.F.R.
485.506(b) or (c).
(2) Except for beds the
REH maintains in a distinct part unit licensed as a skilled nursing facility,
the facility's inpatient beds shall be delicensed.
(3) A facility that converts to an REH shall
not be relicensed to operate as a critical access hospital or acute care
hospital without first obtaining certificate of need.
Section 3. Application and Fees.
(1) A facility that applies for initial
licensure or annual renewal as an REH shall submit to the Office of Inspector
General:
(a) A completed Application for
Licensure to Operate a Rural Emergency Hospital; and
(b) An accompanying fee in the amount of
$1,000, made payable to the Kentucky State Treasurer.
(2) As a condition of annual renewal, the
application required by subsection (1) of this section shall be submitted to
the cabinet at least sixty (60) days prior to the date of expiration of the
REH's licensure.
Section
4. Change of Status.
(1) An REH
shall report a change of:
(a) Name or location
in accordance with the requirements of
902 KAR 20:008, Section 3(3);
or
(b) Ownership in accordance with
the requirements of
902 KAR 20:008, Section
2(16).
(2) Failure to
renew a license by the annual renewal date shall result in a late penalty
pursuant to
902 KAR 20:008, Section
3(4).
Section 5. Services
and Basic Requirements.
(1) An REH shall
comply with applicable federal, state, and local laws and regulations
pertaining to the operation of the facility, including compliance with
42 C.F.R.
485.506-
485.546.
(2) An REH shall:
(a) Provide emergency department services and
observation care, including compliance with the requirements of:
1.
42 C.F.R.
485.516; and
2.
42 C.F.R.
485.618 with respect to:
a. Twenty-four (24) hour availability of
emergency services;
b. Equipment,
supplies, and medication;
c. Blood
and blood products;
d. Personnel;
and
e. Coordination with emergency
response systems;
(b) Provide basic laboratory services in
accordance with 42 C.F.R.
485.518;
(c) Maintain, or have available, diagnostic
radiologic services in accordance with
42 C.F.R.
485.520;
(d) Have pharmaceutical services that meet
the needs of its patients in accordance with
42 C.F.R.
485.522; and
(e) In accordance with
42 C.F.R.
485.538, have in effect a transfer agreement
with at least one (1) hospital that is a level I or level II trauma center for
the referral and transfer of patients requiring emergency medical care beyond
the capabilities of the REH.
(3) In accordance with
42 C.F.R.
485.524(a), an REH may
provide outpatient and medical health diagnostic and therapeutic items and
services that are commonly furnished in a physician's office or at another
entry point into the health care delivery system, including:
(a) Therapeutic radiologic
services;
(b) Laboratory
services;
(c) Outpatient
rehabilitation;
(d) Surgical
services;
(e) Maternal health
services; or
(f) Behavioral health
services.
(4) An REH may
provide skilled nursing facility services in a distinct part unit in accordance
with 42 C.F.R.
485.546.
Section 6. Personnel. An REH shall assure
that licensed personnel meet the applicable standards required by the
appropriate professional licensing board and provide services within the
applicable scope of practice.
Section
7. Patient Records.
(1)
Ownership.
(a) Medical records shall be the
property of the REH.
(b) The
original medical record shall not be removed except by court order.
(c) Copies of medical records or portions
thereof may be used and disclosed in accordance with the requirements
established in this administrative regulation.
(2) Confidentiality and Security: Use and
Disclosure.
(a) The REH shall maintain the
confidentiality and security of patient records in compliance with the Health
Insurance Portability and Accountability Act of 1996 (HIPAA),
42 U.S.C.
1320d-2 to
1320d-8, and
45 C.F.R. Parts
160 and
164, as amended, including the
security requirements mandated by subparts A and C of 45 C.F.R. Part 164 , or
as provided by applicable federal or state law.
(b) The REH may use and disclose patient
records. Use and disclosure shall be as established or required by HIPAA,
42 U.S.C.
1320d-2 to
1320d-8, and
45 C.F.R. Parts
160 and
164, or as established in this
administrative regulation.
(c) An
REH may establish higher levels of confidentiality and security than those
required by HIPAA, 42 U.S.C.
1320d-2 to
1320d-8, and
45 C.F.R. Parts
160 and
164.
(d) Retention of records. After a patient's
death or discharge, the completed medical record shall be placed in an inactive
file and retained for at least:
1. Six (6)
years; or
2. Three (3) years after
the patient reaches the age of majority in accordance with
KRS
2.015, whichever is longer.
(3) The REH shall:
(a) Designate a specific location for the
maintenance and storage of the agency's medical records;
(b) Have provisions for storage of medical
records in the event the agency ceases to operate; and
(c) Safeguard the record and its content
against loss, defacement, or tampering.
Section 8. Incorporation by Reference.
(1) The form, OIG-20:490, "Application for
Licensure to Operate a Rural Emergency Hospital", December 2022 edition, is
incorporated by reference.
(2) This
material may be inspected, copied, or obtained, subject to applicable copyright
law, at the Office of Inspector General, 275 East Main Street, Frankfort,
Kentucky 40621, Monday through Friday, 8 a.m. to 4:30 p.m. This material may
also be viewed on the Office of Inspector General's Web site at:
https://chfs.ky.gov/agencies/os/oig/dhc/Pages/ltcapplications.aspx.
STATUTORY AUTHORITY:
KRS
216B.042