Proposed Regulations



NOTICE OF PROPOSED ACTION:

The Maryland Prescription Drug Affordability Board proposes to:
(1) Amend Regulation .01 under COMAR 14.01.01 General Provisions;
(2) Adopt new Regulation .06 under COMAR 14.01.01 General Provisions;
(3) Adopt new Regulations .01—.09 under a new chapter, COMAR 14.01.05 Policy Review, Final Action, Upper Payment Limits.

The text of the proposed amendments and regulations are available in the January 10, 2025 edition of the Maryland Register located here.
Comments may be sent to:
Christina Shaklee, Health Policy Analyst Advanced
Maryland Prescription Drug Affordability Board
16900 Science Drive, Suite 112-114 
Bowie, MD 20715;
or call 410-703-7015;
or email to christina.shaklee1@maryland.gov​

 Comments will be accepted through February 10, 2025. 


ARCHIVED ACTIONS:


COMAR 14.01.04 Cost Review Study Process -Emergency Action

The Prescription Drug Affordability Board seeks emergency action on proposed amendments to .05 under COMAR 14.01.04 Cost Review Study Process.  The text of the proposed amendments is available here​. 


COMAR 14.01.04 Cost Review Study Process
The Maryland Prescription Drug Affordability Board proposes to amend Regulation .05 under COMAR 14.01.04 Cost Review Study Process. The text of the proposed amendments were available in the November 1, 2024 version of the Maryland register located here. ​
Comments were accepted through December 2, 2024
  • Written Comment Packet
    • Comments were received from the following entities:
      • AbbVie
      • Biotechnology Innovation Organization
      • PhRMA


Draft Proposed Regulations for Comment (Posted: 10/28/2024)
The PDAB solicited comments informing the development of draft regulations. Comments were due  by November 8, 2024 on the draft regulations listed below. 
 


COMAR 14.01.02 Prescription Drug Affordability Fund

The Maryland Prescription Drug Affordability Board proposes to amend Regulations .02 under COMAR 14.01.02 Prescription Drug Affordability Fund. The text of the proposed amendments are available in the May 31, 2024 version of the Maryland register located here

Comments were accepted through July 1, 2024.

COMAR 14.01.04 Cost Review Study Process

The Prescription Drug Affordability Board proposes to adopt a new chapter of regulations 14.01.04 Cost Review Study Process. Notice of this proposed action was published in the Maryland Register on September 22, 2023. The text of the proposed amendments is available.

Comments were accepted through October 23, 2023.

COMAR 14.01.01 General Provisions

The Prescription Drug Affordability Board proposes to amend Regulation .01 and adopt new Regulations .02—.05 under COMAR 14.01.01 General Provisions. Notice of this proposed action was published in the Maryland Register on September 22, 2023​. The text of the proposed amendments is available.

Comments were accepted through October 23, 2023.



Statutes

Statutes - The statutes governing the Maryland Prescription Drug Affordability Board are located at Md. Code Annotated, Health-General Article §§ 21-2C-01 – 16. The Maryland General Assembly provides an online catalog of the Maryland Code here: https://mgaleg.maryland.gov/mgawebsite/laws/statutes

Regulations