Current through Register Vol. 50, No. 9, March 1, 2024
RELATES TO:
KRS
13B.050,
13B.080,
13B.090,
13B.110,
13B.120,
218A.182
NECESSITY, FUNCTION, AND CONFORMITY: In accordance with
KRS
218A.182, which takes effect on January 1,
2021, electronic prescribing for all schedule II-V controlled substances is
required by each practitioner who issues the prescription to a pharmacy.
KRS
218A.182(1) identifies
certain prescriptions that are exempt from the electronic prescribing mandate,
including a temporary waiver for entities that demonstrate economic hardship,
technological limitations, or other exceptional circumstances.
KRS
218A.182(3) requires the
cabinet to promulgate administrative regulations to implement the electronic
prescribing mandate, including enforcement mechanisms, waivers of requirements,
and the appropriate penalties for violations. This administrative regulation
establishes requirements related to the electronic prescribing of controlled
substances (EPCS).
Section 1.
Prescription Requirements.
(1) Beginning
January 1, 2021, a prescription for a controlled substance shall:
(a) Be transmitted electronically to a
pharmacy, except as provided by
KRS
218A.182(1)(a)-(l);
and
(b) Contain the:
1. Full legal name, gender, address, and date
of birth of the person for whom the controlled substance is intended;
2. Name, address, Drug Enforcement
Administration (DEA) registration number, telephone number, and electronic
signature of the prescribing practitioner;
3. Drug name, strength, dosage form, quantity
prescribed, specific directions for use, and number of refills (if authorized);
and
4. Date upon which the
prescription was issued and signed electronically by the prescribing
practitioner.
(2) In accordance with
KRS
218A.182(2), a pharmacist
who receives a written, oral, or faxed prescription for a controlled substance:
(a) Shall not be required to verify that the
prescription is subject to an exception provided in
KRS
218A.182(1)(a)-(l);
and
(b) May dispense a controlled
substance pursuant to an otherwise valid written, oral, or fax
prescription.
Section
2. Waiver from the EPCS Mandate.
(1) A practitioner who is unable to comply
with the EPCS mandate may petition the cabinet for a temporary waiver based
upon:
(a) Economic hardship;
(b) Technological limitations that are not
reasonably within the control of the practitioner; or
(c) Other exceptional
circumstances.
(2) A
practitioner seeking an initial waiver from the EPCS mandate shall submit a
completed Temporary Exemption Form, no later than November 1, 2020.
(3) A request for renewal of an approved
waiver shall be submitted on the Temporary Exemption Form at least sixty (60)
days in advance of the expiration of the waiver.
(4) A completed Temporary Exemption Form
shall include:
(a) The name, practice address,
phone number of the practice point of contact, professional license number, and
Drug Enforcement Administration (DEA) registration number of the practitioner
seeking the waiver;
(b) The
practitioner's current electronic prescribing capabilities;
(c) The reason the practitioner is seeking
the waiver;
(d) Supporting
documentation to justify the reason for the waiver, including the following
mandatory documentation:
1. For an economic
hardship exemption:
a. Attestation of the
practitioner's current gross annual income; and
b. At least two (2) quotes documenting the
cost to the practitioner of implementing EPCS;
2. For a technological limitation exemption:
a. Documentation showing the:
(i) Available internet service
providers;
(ii) Speed and bandwidth
available from each provider; and
(iii) Any data caps imposed by the internet
service provider; and
b.
Documentation showing the minimum technological requirements from at least two
(2) electronic prescribing platform vendors;
(e) The anticipated date of compliance with
the EPCS mandate; and
(f) If the
practitioner is requesting renewal of an approved waiver:
1. Information relating to the practitioner's
actions during the previous waiver period to work toward compliance with the
EPCS mandate; or
2. An explanation
as to why no progress has been made.
(5) Upon consideration of all information
provided by the practitioner on a Temporary Exemption Form, the cabinet shall
approve or deny the request for an initial or renewal waiver based on the
criteria established by this subsection.
(a)
If the reason for the waiver is economic hardship and the cost, to the
practitioner, of compliance with the EPCS mandate would exceed five (5) percent
of the practitioner's gross annual income as self-reported, the cabinet shall
approve the request.
(b) If the
reason for the waiver is technological limitations and the internet service
providers available do not have the technological capabilities required by the
electronic prescribing platform, the cabinet shall approve the
request.
(c) If the reason for the
waiver is other exceptional circumstances, the cabinet shall evaluate the
description of the exceptional circumstances on a case-by-case basis.
(d) If the practitioner seeks renewal of a
previous waiver, the cabinet shall consider:
1. Updated information as it relates to the
practitioner working toward compliance with the EPCS mandate; or
2. The explanation as to why no progress has
been made.
(6)
(a) The cabinet may approve a waiver, or the
renewal of a current waiver, for a specified period of time not to exceed one
(1) year from the date of approval.
(b) The cabinet shall not approve more than
two (2) renewal waivers.
Section 3. Enforcement. It shall be the duty
of the cabinet to enforce the provisions of this administrative
regulation.
Section 4. Penalties.
(1) The cabinet shall make a referral to the
appropriate professional licensing board and impose a fine of $1,000 against a
practitioner for each violation, not to exceed $2,000 during a twelve (12)
month period, in which the cabinet substantiates that the practitioner has:
(a) Falsified information on the Temporary
Exemption Form or the form's supporting documentation;
(b) Failed to request a timely waiver in
accordance with
KRS
218A.182(1)(i) and Section
2(1) to (4) of this administrative regulation and the practitioner is
noncompliant with the EPCS mandate; or
(c) Failed to transmit a prescription for a
controlled substance electronically to a pharmacy after expiration of the
practitioner's waiver, except for prescriptions that meet the exemption
criteria of
KRS
218A.182(a)-(h) and
(j)-(l).
(2) A
practitioner may file an appeal with the cabinet within twenty (20) calendar
days of the cabinet's written notice of the violation and fine.
(3) If the practitioner requests an
administrative hearing, the cabinet shall:
(a) Appoint a hearing officer; and
(b) Proceed pursuant to
KRS
13B.050.
(4) The administrative hearing shall be
conducted by a hearing officer appointed by the secretary and held in
accordance with
KRS 13B.080,
13B.090,
and
13B.110.
(5) The secretary shall issue a final order
in accordance with
KRS
13B.120.
Section 5. Incorporation by Reference.
(1) The OIG 55:130, "Temporary Exemption
Form", October 2019 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.
STATUTORY AUTHORITY:
KRS
218A.182