Md. Code Regs. 31.10.50.03

Current through Register Vol. 51, No. 21, October 18, 2024

Section 31.10.50.03 - Submission Requirements

A. Pursuant to the requirements of Insurance Article, § 15-2010, Annotated Code of Maryland, and except as provided in §E of this regulation, a PSAO shall submit to the Commissioner all pharmacy services administrative contract forms and amendments to pharmacy services administrative contract forms.

B. Unless it is disapproved by the Commissioner, and except as provided in §E of this regulation, a PSAO may not use a contract form or amendment to a contract form unless it has been filed with the Commissioner and:

(1) 60 days have passed since the filing was acknowledged by the Commissioner in writing as having been received; or

(2) Subject to the filing corrections under §C of this regulation, a PSAO receives written notice from the Commissioner that the contract form or amendment to a contract form may be used in Maryland.

C. A PSAO that receives written notice from the Commissioner that its contract form or amendment to a contract form contains defects and is disapproved, may re-submit the disapproved forms indicating the corrections made.

D. Except for the circumstances in §C of this regulation, a PSAO may not file a contract form or amendment form that has been previously disapproved by the Commissioner.

E. Amendments to Contracts.

(1) A PSAO that amends any of the following provisions of a previously filed contract shall file the amendment form with the Commissioner:

(a) Any provision dealing with prohibitions on certain communications between a pharmacy or pharmacist and a beneficiary, as described in Insurance Article, § 15-1611, Annotated Code of Maryland;

(b) Any provision dealing with the responsibility of a PBM to disclose specified information to a pharmacy, as described in Insurance Article, § 15-1628, Annotated Code of Maryland;

(c) Any provision dealing with fees for credentialing a pharmacy or pharmacist to participate in the network of a PBM or purchaser or the frequency of credentialing renewals, as described in Insurance Article, § 15-1628, Annotated Code of Maryland;

(d) Any provision describing the sources used to determine maximum allowable cost pricing, the process for updating pricing information, or the process to appeal, investigate, and resolve disputes regarding maximum allowable cost pricing, as described in Insurance Article, § 15-1628.1, Annotated Code of Maryland;

(e) Any provision describing the process to appeal, investigate, and resolve disputes regarding cost pricing and reimbursement, as described in Insurance Article, § 15-1628.2, Annotated Code of Maryland;

(f) Any provision dealing with a pharmacy being charged or held responsible for a fee or performance-based reimbursement related to the adjudication of a claim or an incentive program or being subject to a reduction in payment due to a reconciliation process, as described in Insurance Article, § 15-1628.3, Annotated Code of Maryland;

(g) Any provision describing the process to audit pharmacies, as described in Insurance Article, § 15-1629, Annotated Code of Maryland;

(h) Any provision dealing with retroactive denials or modifications of reimbursement to a pharmacy or pharmacist, as described in Insurance Article, § 15-1631, Annotated Code of Maryland;

(i) Any provision dealing with therapeutic interchanges, as described in Insurance Article, §§ 15-1633, 15-1634, 15-1635, 15-1636, and 15-1637, Annotated Code of Maryland;

(j) Any provision dealing with the PSAO providing copies of contracts, amendments, payment schedules, or reimbursement rates to a pharmacy, as described in Insurance Article, § 15-2011, Annotated Code of Maryland;

(k) Any provision dealing with notification to a pharmacy of a material change in ownership or control of certain organizations affiliated with the PSAO, as described in Insurance Article, §§ 15-2013, Annotated Code of Maryland;

(l) Any provision dealing with the PSAO passing claims remittances from a PBM or purchaser to a pharmacy, as described in Insurance Article, § 15-2015, Annotated Code of Maryland;

(m) Any provision describing an arrangement for a pharmacy to purchase drugs, biologics, or medical devices from an entity under common ownership with the PSAO, as described in Insurance Article, § 15-2016, Annotated Code of Maryland;

(n) Any provision dealing with the applicability of Maryland law; or

(o) Any provision of the contract that is revised to comply with Maryland law.

(2) An amendment to a previously filed contract form that does not amend a provision described in §E(1) of this regulation is not required to be filed with the Commissioner.

F. A filing made under this chapter shall include a cover letter which includes the following:

(1) A list of the contract forms and amendment forms included in the submission; and

(2) A brief description of the purpose of each contract form and amendment form included in the submission.

G. Each page of a contract or amendment shall be identified by a form number which is unique to that form. This number shall be printed in the lower left-hand corner of each page, and no other number shall appear in close proximity to the form number.

H. A filing made under this chapter shall include a signed certification from a responsible officer of the PSAO that, to the best of the officer's knowledge and belief, the contract forms and amendment forms comply with applicable statutes and regulations.

I. A PSAO may not file a contract form or amendment form before the PSAO has successfully registered as a PSAO with the Commissioner.

Md. Code Regs. 31.10.50.03

Regulation .03 adopted effective 49:26 Md. R. 1081, eff. 12/26/2022