Section II. Licensure
Requirements
A. Initial License and Renewal.
On or after January 1, 2024, a PSAO seeking to do business in SC shall apply
for a license on a form and in accordance with a licensing schedule prescribed
by the Director or his designee. The terms "Director" and "designee" have the
meaning set forth in Section
38-1-20 of the Code of Laws of
South Carolina 1976, as amended.
B.
The initial licensing schedule shall be set by bulletin or order of the
Director. In 2024, and thereafter, a PSAO license shall be renewed annually no
later than March 1 of each year.
C.
Each application for a license shall be certified by an officer or authorized
representative of the applicant and shall contain a statement that certifies
the PSAO is in compliance with Section
38-71-2310 et seq. of the Code of
Laws of South Carolina 1976, as amended. All proprietary information submitted
by the PSAO under Section II of this regulation shall be considered
confidential under Sections
38-71-2340 and
30-4-40 of the Code of Laws of
South Carolina 1976, as amended.
D.
The PSAO shall provide as part of the application for licensure the following:
(1) A non-refundable filing fee of $1,000 for
initial licensure and $500 for renewal licenses;
(2) A copy of the basic organizational
document of the PSAO such as the articles of incorporation, articles of
association, partnership agreement, trust agreement or other applicable
documents, and all amendments thereto;
(3) A copy of the bylaws, organizational or
similar document(s), if any, regulating the conduct or the internal affairs of
the applicant;
(4) A copy of the
PSAO's provider manual and written agreement(s) entered into with pharmacists
or pharmacies;
(5) For the two
preceding calendar years, a listing of pharmacy providers with which the PSAO
was contracted in this State to perform services;
(6) The relevant documentation, such as a
policies and procedures manual, that demonstrates the PSAO has adopted
processes to ensure compliance with the requirements in Section
38-71-2330 of the Code of Laws of
South Carolina 1976, as amended;
(7) A certified statement that indicates
whether the applicant or officer with management or control:
(a) has been refused or denied a
registration, license or certification to act as or provide the services of a
PSAO in any state, providing specific details separately for each refusal or
denial, if any, including the date, nature and disposition of the action;
and
(b) has had any registration,
license or certification to act as or provide the services of a PSAO suspended,
revoked or nonrenewed for any reason by any state or federal entity, providing
specific details separately for each such suspension, revocation or nonrenewal,
if any, including the date, nature and disposition of the action, and attaching
a copy of any relevant final order or similar document imposing the suspension,
revocation or nonrenewal;
(8) A description of whether the applicant
has had a business relationship with a- pharmacy or pharmacist terminated for
any fraudulent or illegal activities in connection with the administration of a
pharmacy benefits plan (if so, attach specific details separately explaining
this termination, including the date, and nature of the termination);
(9) Has an officer with management or control
of the PSAO been convicted of a felony or violated any of the requirements of
state law applicable to PSAOs; and
(10) Any other relevant information deemed
necessary by the Director or his designee to evaluate the application for
licensure or compliance with the requirements of the Act and this
regulation.
E. Review
Process
(1) Initial and Renewal License
Applications
For initial and renewal license applications, the Director or his
designee shall review the application under Section II. D of this regulation,
and may:
(a) approve the application
and issue the applicant a PSAO license; or
(b) notify the applicant, in writing, that
the application is incomplete and request additional information to complete
the review; and, if the missing or requested information is not received within
thirty (30) calendar days from the date of the notification, the Director or
his designee may deny the application; or
(c) deny the application; and
(i) provide written notice to the applicant
that the application has been denied stating or explaining the basis of the
denial; and
(ii) advise the
applicant that it may appeal the denial by requesting a hearing in accordance
with Section
38-3-210 of the Code of Laws of
South Carolina 1976, as amended, before the South Carolina Administrative Law
Court.
(2)
Standards of Review
(a) The Director or his
designee shall deny an initial or renewal application for licensure for the
following reasons:
(i) the PSAO operates, or
proposes to operate, in a hazardous condition and the services it administers,
or proposes to administer, for a pharmacist or pharmacy in this State may be
hazardous to the public; or
(ii)
the PSAO has violated the requirements of the Act, this regulation or other
applicable South Carolina law; or
(iii) the PSAO has failed to timely submit
information to complete review of the application under Section II of this
regulation.
(b) In lieu
of a denial of a renewal application, the Director or his designee may permit
the PSAO to submit to the Director or his designee a corrective action plan to
cure or correct deficiencies falling under Section II of this regulation,
impose an administrative penalty under Section
38-2-10 et seq. of the Code of
Laws of South Carolina, 1976 as amended, or both.