South Carolina Code of Regulations › Chapter 69 - DEPARTMENT OF INSURANCE › Section 69-78 - Pharmacy Services Administrative Organizations

Current through Register Vol. 48, No. 6, June 28, 2024
Section I.
		  Purpose
The purpose of this regulation is to implement Act No. 30 of 2023
			 ("the Act") regarding Pharmacy Services Administrative Organizations ("PSAOs")
			 and to provide licensing, reporting and activity standards for
			 PSAOs.
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.