Louisiana Regulations
Department of Health/Board of Pharmacy
Vol. 47, No. 5, Louisiana Register 2021-05-20 pp.590-592
PUBLICATION DATE: 05/20/2021
ACTION DATE: 05/20/2021
EFFECTIVE DATE: 05/20/2021
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2105-016
REGISTER SOURCE: Vol. 40, No. 10, Louisiana Register 2020-10-20 pp.1438-1440
PUBLICATION DATE: 10/20/2020
ACTION DATE: 10/20/2020
COMMENT DEADLINE: 11/25/2020
PUBLICATION TYPE: Register
DOCUMENT NUMBER: 2010-034

RULE

Department of Health

Board of Pharmacy

Pharmacy Benefit Managers (LAC 46:LIII.Chapter 30)

In accordance with the provisions of the Administrative Procedure Act (R.S. 49:950 et seq.), the Pharmacy Benefit Manager Licensing Law (R.S. 40:2861 et seq.), and the Pharmacy Practice Act (R.S. 37:1161 et seq.), the Louisiana Board of Pharmacy has promulgated a new chapter of rules for pharmacy benefit managers (PBMs). The new Rule will implement the provisions of Act 124 of the 2019 Legislature which requires the Board of Pharmacy to license and regulate PBMs when they engage in one or more of the following activities construed to be within the scope of the practice of pharmacy: (1) adjudication of appeals or grievances related to prescription drug coverage. (2) disease management programs. (3) drug formularies. (4) drug regimen reviews. (5) prescription drug management programs. (6) processing of prior authorization requests. (7) quality care dosing services. (8) step therapy procedures. (9) utilization management and utilization reviews. (10) any other act, service, operation, or transaction incidental to or forming a part of the compounding, filling, dispensing, exchanging, giving, offering for sale, or selling drugs, medicines, poisons, or devices in this state by pharmacists or pharmacies, pursuant to a prescription or an order of physicians, dentists, veterinarians, or other licensed practitioners, requiring, involving, or employing the science or art of any branch of the pharmacy profession, study, or training. Section 3001 provides for definitions of certain terms. Section 3003 requires a PBM engaged in any of the activities enumerated within R.S. 40:2868 to obtain a PBM permit from the board, requires the PBM to register with the secretary of state, and provides that a PBM permit is not transferable from one owner to another. Section 3005 provides the procedures for the board to follow with respect to applications for the initial issuance of the permit, the renewal of the permit, applications for the reinstatement of disciplined permits, as well as the permanent closure of a permit. This Rule is hereby adopted on the day of promulgation. Pharmacy benefit managers engaged in any of the ten aforementioned activities within the state of Louisiana shall submit a complete application for the pharmacy benefit manager permit no later than August 1, 2021.

Malcolm J Broussard

Executive Director

2105#016

Title 46

PROFESSIONAL AND OCCUPATIONAL

STANDARDS

Part LIII. Pharmacists

Chapter 30. Pharmacy Benefit Managers

§3001. Definitions

A. The following terms shall have the meaning ascribed to them in this Section:

Audited Financial Statement—the financial statement and related disclosures prepared by an independent certified public accountant in accordance with United States Generally Accepted Accounting Principles (GAAP) of the specific entity or licensee intending to operate or operating in Louisiana.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1253.

HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 47:591 (May 2021).

§3003. Pharmacy Benefit Manager Permit

A. A pharmacy benefit manager, as defined at R.S. 40:2863, shall obtain and maintain a pharmacy benefit manager permit from the board prior to conducting business in Louisiana if it administers, develops, maintains, performs, or provides one or more of the pharmacy services enumerated in R.S. 40:2868 in the state or that affects one or more beneficiaries of a pharmacy benefit management plan, as defined at R.S. 40:2863, administered by the pharmacy benefit manager.

B. A pharmacy benefit manager permit shall authorize the permit holder to administer pharmacy benefit management services.

C. The board shall not issue a pharmacy benefit manager permit to any person or other entity which has not yet registered with the Louisiana Secretary of State to conduct business within the state.

D. A pharmacy benefit manager permit is not transferable from the original owner. The permit shall not be subject to sale, assignment or other transfer, voluntary or involuntary. Moreover, in the event the ownership of the pharmacy benefit manager changes by 50 percent or more after the initial issuance of the permit, the ownership will be deemed sufficiently different as to require a new pharmacy benefit manager permit. The continued operation of a pharmacy benefit manager permit after its ownership has changed by 50 percent or more shall constitute sufficient basis for the board to issue a finding for the operation of a pharmacy benefit manager without a valid permit, in violation of R.S. 40:2865.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1253.

HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 47:591 (May 2021).

§3005. Permitting Procedures

A. Application for Initial Issuance of Permit

1. The board shall develop an application form suitable for the pharmacy benefit manager permit. The board may revise that application form on its own initiative in order to collect the information it deems necessary to properly evaluate an applicant.

2. The application shall include copies of the following documents:

a. governance documents, including articles of incorporation, articles of association, partnership agreements, trade name certificates, trust agreements, shareholder agreements, and all amendments to such documents; b. the applicant's standard generic contract template which it uses for contracts entered into by the applicant and pharmacies or pharmacy services administrative organizations in this state in the administration of pharmacy benefits for healthcare insurers, providers, or payors; c. an audited financial statement for the applicant's previous fiscal year.

3. The board shall not process applications received by facsimile, or that are incomplete, or submitted with the incorrect fee.

4. Once received by the board, an application for the permit shall expire one year thereafter.

5. In the event any information contained in the application or accompanying documents changes after being submitted to the board and before the issuance of the permit, the applicant shall immediately notify the board in writing and provide corrected information.

6. The applicant may be required to personally appear before the board or any of its committees prior to any decision on the permit application.

7. Upon approval of the application, the board shall issue the pharmacy benefit manager permit to the applicant.

B. Application for Renewal of Permit

1. All pharmacy benefit manager permits shall expire two years after the date of its initial issuance and the renewals shall expire every two years thereafter on that anniversary date.

2. The board shall not process applications received by facsimile, or that are incomplete.

3. In the event a pharmacy benefit manager does not submit a properly completed renewal application to the board prior to the expiration of the permit, the permit shall be rendered null and void. The continued operation of a pharmacy benefit manager with an expired permit shall constitute sufficient basis for the board to issue a finding for the operation of a pharmacy benefit manager without a valid permit, in violation of R.S. 40:2865.

4. A pharmacy benefit manager permit not renewed by 30 days after the expiration date shall be automatically terminated by the board.

C. Application for Reinstatement of Terminated, Suspended, or Revoked Permit

1. The applicant shall complete the application form for this specific purpose supplied by the board.

2. Upon the receipt of a properly completed application form, the board staff shall refer the application to the board's reinstatement committee for its consideration and shall notify the applicant of the time and place for the committee meeting.

D. Maintenance of Permit

1. A pharmacy benefit manager permit shall be valid for the entity to whom it is issued and shall not be subject to sale, assignment or other transfer, voluntary or involuntary.

2. Upon receipt of a written request and payment of the fee authorized in R.S. 37:1184, the board shall issue a duplicate or replacement permit to the applicant; however, such duplicate or replacement permit shall not serve or be used as an additional or second permit.

E. Permanent Closure of Permit

1. In the event the pharmacy benefit manager contemplates permanent closure of the pharmacy benefit manager business, the owner of the permit shall notify the board, in writing, 10 days prior to the anticipated date of closure and surrender its permit.

2. The notice required in this Subsection shall include an acknowledgement of the firm's obligation to maintain copies of all records for all patients and pharmacies in Louisiana for a minimum of two years following the date of closure and surrender of its permit, and further, the point of contact for all inquiries and requests for such records during that two-year period of time.

AUTHORITY NOTE: Promulgated in accordance with R.S. 37:1253.

HISTORICAL NOTE: Promulgated by the Department of Health, Board of Pharmacy, LR 47:591 (May 2021).