Regulations
Proposed Regulations
Proposed regulations go here
Final Regulations
Title 14- Independent Agencies
Subtitle 01- Prescription Drug Affordability Board
Chapter
.01 Definitions
.03 Open Meetings
.04 Confidential, Trade-Secret and Proprietary Information
.06 Hearing Procedures
02- Prescription Drug Affordability Fund
.01 Prescription Drug Affordability Fund
.02 Fee Assessment, Exemption, and Collection
.04 Use of Funds
.05 Surplus Funds
.01 Scope
.02 Policy
.03 Definitions
.05 Request for Public Records
.06 Written Request May Be Required
.07 Contents of Written Request
.08 Addressee
.10 Notice to Person Potentially Affected by Disclosure
.12 Public Record Destroyed or Lost
.13 Availability of Judicial and Administrative Review
.14 Disclosure Against Public Interest
.15 Fees
.16 Time and Place of Inspection
.01 Public Reporting of Drug Affordability Issues
.02 Identifying Drugs Eligible for Cost Review
.03 Selecting Drugs for Cost Review
.04 Request for Information for Cost Review
05- Policy Review, Final Action, Upper Payment Limits Authority
.01 Definitions
.02 Criteria for Setting and Upper Payment Limit
.03 Policy Review and Final Action Process Overview
.04 Policy Review–Information Gathering
.05 Policy Review–Preliminary Policy Recommendations
.06 Policy Review–Process for Establishing a UPL
.07 Policy Review–Final Policy Action
.08 Establishing and Monitoring a UPL
.09 Reconsideration
Archived Actions
The Maryland Prescription Drug Affordability Board proposed to adopt new Regulations .01—.04 under a new chapter, COMAR 14.01.06 Implementation and Monitoring of Upper Payment Limits.
The text of the proposed regulations are available in the June 12, 2026 edition of the Maryland Register.
Comments accepted through: 7/13/26
The PDAB solicited comments on proposed revisions to COMAR 14.01.04.01 Cost Review Study Process-Circumstances Under Which Use of a Drug May Create an Affordability Challenge.
View the draft regulations - PDF - 98.79 KB
Please note: the current section "Public Reporting of Drug Affordability Issues" will be moving to a different section to COMAR 14.01.04 and will not be removed.
Comments accepted through: 6/12/26
The PDAB solicited comments on proposed revisions to COMAR 14.01.04 Cost Review Study Process.
Posted: 5/1/2026
Comments accepted through: June 1, 2026
Amendments to COMAR 14.01.04- Cost Review Study Process - PDF - 296.97 KB
Written Comment Packet - PDF - 2.92 MB
Comments Received from the following:
- AbbVie
- Biotechnology Innovation Organization (BIO)
- Community Access National Network
- Diabetes Patient Advocacy Coalition (DPAC)
- EACH/PIC Coalition
- HealthHIV
- Maryland Tech Council
- National Association of Chain Drug Stores
- PhRMA
- Value of Care Coalition
The PDAB solicited comments on draft proposed regulations: COMAR 14.01.07.02- Upper Payment Limit for Ozempic under COMAR 14.0101.05B(4).
Posted: 4/22/26
Comments accepted through: 5/1/26
Draft COMAR 14.01.07.02- Upper Payment Limit for Ozempic - PDF - 95.24 KB
Written Comment Packet - PDF - 1.11 MB
Comments Received from the following:
- AARP
- EACH/PIC Coalition
- Healthcare for All
- PhRMA
- Public Citizen
- Value of Care Coalition
The PDAB solicited comments on draft UPL regulations for Farxiga and Jardiance under COMAR 14.0101.05B(4).
Posted: 3/16/26
Comments accepted through: 3/30/26
Draft COMAR 14.01.06- Implementation and Monitoring of Upper Payment Limits - PDF - 103.07 KB
Draft COMAR 14.01.07- Upper Payment Limit - PDF - 161.92 KB
Written Comment Packet - PDF - 1.46 MB
Comments Received from the following:
- AARP
- AbbVie
- AstraZenca
- Boehringer Ingelheim
- Diabetes Patient Advocacy Coalition (DPAC)
- Frederick County Government
- PhRMA
- Value of Care Coalition
The Maryland Prescription Drug Affordability Board proposed to:
- Amend Regulation .01 under COMAR 14.01.01 General Provisions;
- Adopt new Regulation .06 under COMAR 14.01.01 General Provisions;
- 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 action can be found in the January 10, 2025 version of the Maryland register.
Comments accepted through: 2/10/25
Written Comment Packet - PDF - 8.39 MB
Comments were received from the following entities:
- AARP
- AbbVie
- Aimed Alliance
- Biotechnology Innovation Organization and Maryland Tech Council
- CareFirst
- Each-Pic Coalition
- Global Healthy Living Foundation
- Healthcare for All
- Lilly
- National Active & Retired Federal Employees
- Partnership to Improve Patient Care
- PhRMA
- Supply Chain Coalition
The Prescription Drug Affordability Board seeks emergency action on proposed amendments to .05 under COMAR 14.01.04 Cost Review Study Process.
The Maryland Prescription Drug Affordability Board proposed 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.
Comments accepted through: 12/2/24
Written Comment Packet - PDF - 1.17 MB
Comments were received from the following entities:
- AbbVie
- Biotechnology Innovation Organization
- PhRMA
The PDAB solicited comments informing the development of draft regulations.
Amendments to COMAR 14.01.01.01 (Definitions) - PDF - 138.89 KB
New Regulation COMAR 14.01.01.06 (Hearing Procedures)
New Chapter - COMAR 14.01.05 (Policy Review, Final Action, Upper Payment Limits) - PDF - 184.65 KB
Posted: 10/28/24
Comments accepted through: 11/8/24
Written Comment Packet - PDF - 6.14 MB
Comments were received from the following entities:
- AbbVie
- Aimed Alliance
- Alliance for Patient Access
- Arthritis and Rheumatism Associations, P.C.
- Arthritis Foundation
- AstraZeneca
- Biotechnology Innovation Organization
- CareFirst BCBS
- Coalition of State Rheumatology Organizations
- Community Access National Network
- Ensuring Access through Collaborative Health (EACH)
- Healthcare Distribution Alliance
- Lilly
- Maryland/DC Society of Clinical Oncology/ Association for Clinical Oncology
- National Association of Chain Drug Stores
- PhRMA
The Maryland Prescription Drug Affordability Board proposed 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.
Comments accepted through: 7/1/24
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.
View the proposed amendment - PDF - 189.73 KB
Comments accepted through: 10/23/23
The Prescription Drug Affordability Board proposed 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.
View the proposed amendment - PDF - 199.88 KB
Comments accepted through: 10/23/23