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Maryland Register
Issue Date: September 22, 2023 Volume 50 • Issue 19 • Pages 845 — 872
Judiciary Regulations Special Documents General Notices
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| Pursuant to State Government Article, §7-206, Annotated Code of Maryland, this issue contains all previously unpublished documents required to be published, and filed on or before September 1, 2023 5 p.m.
Pursuant to State Government Article, §7-206, Annotated Code of Maryland, I hereby certify that this issue contains all documents required to be codified as of September 1, 2023. Gail S. Klakring Acting Administrator, Division of State Documents Office of the Secretary of State |
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Information About the Maryland Register and COMAR
MARYLAND REGISTER
The Maryland Register is an official State publication published every
other week throughout the year. A cumulative index is published quarterly.
The Maryland Register is the temporary supplement to the Code of
Maryland Regulations. Any change to the text of regulations published in COMAR, whether by adoption, amendment,
repeal, or emergency action, must first be published in the Register.
The following information is also published regularly in the Register:
• Governor’s Executive Orders
• Attorney General’s Opinions in full text
• Open Meetings Compliance Board Opinions in full text
• State Ethics Commission Opinions in full text
• Court Rules
• District Court Administrative Memoranda
• Courts of Appeal Hearing Calendars
• Agency Hearing and Meeting Notices
• Synopses of Bills Introduced and Enacted
by the General Assembly
• Other documents considered to be in the public interest
CITATION TO THE
MARYLAND REGISTER
The Maryland Register is cited by volume, issue, page number, and date.
Example:
• 19:8 Md. R. 815—817 (April 17,
1992) refers to Volume 19, Issue 8, pages 815—817 of the Maryland Register
issued on April 17, 1992.
CODE OF MARYLAND
REGULATIONS (COMAR)
COMAR is the official compilation of all regulations issued by agencies
of the State of Maryland. The Maryland Register is COMAR’s temporary
supplement, printing all changes to regulations as soon as they occur. At least
once annually, the changes to regulations printed in the Maryland Register are
incorporated into COMAR by means of permanent supplements.
CITATION TO COMAR
REGULATIONS
COMAR regulations are cited by title number, subtitle number, chapter
number, and regulation number. Example: COMAR 10.08.01.03 refers to Title 10,
Subtitle 08, Chapter 01, Regulation 03.
DOCUMENTS INCORPORATED
BY REFERENCE
Incorporation by reference is a legal device by which a document is made
part of COMAR simply by referring to it. While the text of an incorporated
document does not appear in COMAR, the provisions of the incorporated document
are as fully enforceable as any other COMAR regulation. Each regulation that
proposes to incorporate a document is identified in the Maryland Register by an
Editor’s Note. The Cumulative Table of COMAR Regulations Adopted, Amended or
Repealed, found online, also identifies each regulation incorporating a document.
Documents incorporated by reference are available for inspection in various
depository libraries located throughout the State and at the Division of State
Documents. These depositories are listed in the first issue of the Maryland
Register published each year. For further information, call 410-974-2486.
HOW TO RESEARCH REGULATIONS
An
Administrative History at the end of every COMAR chapter gives information
about past changes to regulations. To determine if there have been any
subsequent changes, check the ‘‘Cumulative Table of COMAR Regulations Adopted,
Amended, or Repealed’’ which is found online at http://www.dsd.state.md.us/PDF/CumulativeTable.pdf.
This table lists the regulations in numerical order, by their COMAR number,
followed by the citation to the Maryland Register in which the change occurred.
The Maryland Register serves as a temporary supplement to COMAR, and the two
publications must always be used together. A Research Guide for Maryland
Regulations is available. For further information, call 410-260-3876.
SUBSCRIPTION
INFORMATION
For subscription forms for the Maryland Register and COMAR, see the back
pages of the Maryland Register. Single issues of the Maryland Register are $15.00
per issue.
CITIZEN PARTICIPATION IN
THE REGULATION-MAKING PROCESS
Maryland citizens and other interested
persons may participate in the process by which administrative regulations are
adopted, amended, or repealed, and may also initiate the process by which the
validity and applicability of regulations is determined. Listed below are some
of the ways in which citizens may participate (references are to State
Government Article (SG),
Annotated
Code of Maryland):
• By submitting data or views on proposed
regulations either orally or in writing, to the proposing agency (see
‘‘Opportunity for Public Comment’’ at the beginning of all regulations
appearing in the Proposed Action on Regulations section of the Maryland
Register). (See SG, §10-112)
• By petitioning an agency to adopt, amend,
or repeal regulations. The agency must respond to the petition. (See SG
§10-123)
• By petitioning an agency to issue a
declaratory ruling with respect to how any regulation, order, or statute
enforced by the agency applies. (SG, Title 10, Subtitle 3)
• By petitioning the circuit court for a
declaratory judgment
on
the validity of a regulation when it appears that the regulation interferes
with or impairs the legal rights or privileges of the petitioner. (SG, §10-125)
• By inspecting a certified copy of any
document filed with the Division of State Documents for publication in the
Maryland Register. (See SG, §7-213)
Maryland Register (ISSN
0360-2834). Postmaster: Send
address changes and other mail to: Maryland Register, State House, Annapolis,
Maryland 21401. Tel. 410-260-3876. Published biweekly, with cumulative indexes
published quarterly, by the State of Maryland, Division of State Documents,
State House, Annapolis, Maryland 21401. The subscription rate for the Maryland
Register is $225 per year (first class mail). All subscriptions post-paid to
points in the U.S. periodicals postage paid at Annapolis, Maryland and
additional mailing offices.
Wes Moore, Governor; Susan C. Lee, Secretary of State; Gail S. Klakring, Administrator; Mary D. MacDonald, Senior Editor,
Maryland Register and COMAR; Elizabeth
Ramsey, Editor, COMAR Online, and Subscription Manager;
Front cover: State House, Annapolis, MD, built 1772—79.
Illustrations by Carolyn Anderson, Dept. of General Services
Note: All
products purchased are for individual use only. Resale or other compensated
transfer of the information in printed or electronic form is a prohibited
commercial purpose (see State Government Article, §7-206.2, Annotated Code of
Maryland). By purchasing a product, the buyer agrees that the purchase is for
individual use only and will not sell or give the product to another individual
or entity.
Closing Dates for the Maryland
Register
Schedule of Closing Dates and
Issue Dates for the
Maryland Register ..................................................................... 848
COMAR Research Aids
Table of Pending Proposals ........................................................... 849
Index of COMAR Titles Affected in
This Issue
COMAR
Title Number and Name Page
08 Department of Natural Resources ............................. 852, 855
09 Maryland Department of Labor ......................................... 853
13A State Board of Education ................................................... 856
14 Independent Agencies ............................................... 854, 861
33 State Board of Elections .................................................... 854
PERSONS
WITH DISABILITIES
Individuals
with disabilities who desire assistance in using the publications and services
of the Division of State Documents are encouraged to call (410) 974-2486, or
(800) 633-9657, or FAX to (410) 974-2546, or through Maryland Relay.
DISCIPLINARY PROCEEDINGS .................................. 851
Emergency Action on
Regulations
08
DEPARTMENT OF NATURAL RESOURCES
09
MARYLAND DEPARTMENT OF LABOR
MARYLAND BOARD OF ELECTRICIANS
PRESCRIPTION DRUG AFFORDABILITY BOARD
Prescription Drug Affordability Fund
Public Information Act .............................................................
Judges’ Manuals and Training .................................................
Initiation of Recounts ...............................................................
Early Voting Center Equipment and
Materials ........................
SAME DAY REGISTRATION AND ADDRESS CHANGES
Definitions; General Provisions
Proposed Action on
Regulations
08
DEPARTMENT OF NATURAL RESOURCES
Shellfish Aquaculture and Leasing
Appeals to the State Board of
Education
Nondiscrimination in Education
PRESCRIPTION DRUG AFFORDABILITY BOARD
WATER AND SCIENCE ADMINISTRATION
Water Quality Certification 23-WQC-0001 .........................
Water Quality Certification
23-WQC-0022 .........................
NOTICE OF MODIFICATIONS TO
DECLARATIONS OF
TRUST ........................................................................... 871
STATE COLLECTION AGENCY LICENSING BOARD
(SCALB)
Public Meeting .........................................................................
MARYLAND DEPARTMENT OF HEALTH/MEDICAID
PHARMACY AND THERAPEUTICS COMMITTEE
MARYLAND DEPARTMENT OF LABOR/CAREER AND
TECHNICAL EDUCATION (CTE) COMMITTEE
MARYLAND COLLEGE COLLABORATION FOR
STUDENT VETERANS COMMISSION
Public Meeting .........................................................................
MARYLAND DEPARTMENT OF VETERANS
AFFAIRS/MARYLAND VETERANS COMMISSION
WORKERS’ COMPENSATION COMMISSION
COMAR
Online
The Code of Maryland
Regulations is available at www.dsd.state.md.us as a free service of the Office
of the Secretary of State, Division of State Documents. The full text of
regulations is available and searchable. Note, however, that the printed COMAR
continues to be the only official and enforceable version of COMAR.
The Maryland Register is
also available at www.dsd.state.md.us.
For additional
information, visit www.dsd.maryland.gov, Division
of State Documents, or call us at (410) 974-2486 or 1 (800) 633-9657.
Availability
of Monthly List of
Maryland Documents
The Maryland Department of
Legislative Services receives copies of all publications issued by State
officers and agencies. The Department prepares and distributes, for a fee, a
list of these publications under the title ‘‘Maryland Documents’’. This list is
published monthly, and contains bibliographic information concerning regular
and special reports, bulletins, serials, periodicals, catalogues, and a variety
of other State publications. ‘‘Maryland Documents’’ also includes local
publications.
Anyone wishing to receive ‘‘Maryland Documents’’ should write to: Legislative Sales, Maryland Department of Legislative Services, 90 State Circle, Annapolis, MD 21401.
CLOSING DATES AND ISSUE DATES THROUGH
DECEMBER 2024†
|
Issue |
Emergency and Proposed Regulations 5
p.m.* |
Notices,
etc. 10:30
a.m. |
Final Regulations 10:30
a.m. |
|
2023 |
|||
|
October 6 |
September 18 |
September 25 |
September 27 |
|
October 20 |
October 2 |
October 6** |
October 11 |
|
November 3 |
October 16 |
October 23 |
October 25 |
|
November 17 |
October 30 |
November 6 |
November 8 |
|
December 1 |
November 13 |
November 20 |
November 22 |
|
December 15 |
November 27 |
December 4 |
December 6 |
|
December 29 |
December 11 |
December 18 |
December 20 |
|
2024 |
|||
|
January 12 |
December
22** |
December
29** |
January 3 |
|
January 26 |
January 8 |
January 12** |
January 17 |
|
February 9 |
January 22 |
January 29 |
January 31 |
|
February 23 |
February 5 |
February 12 |
February 14 |
|
March 8 |
February 16** |
February 26 |
February 28 |
|
March 22 |
March 4 |
March 11 |
March 13 |
|
April 5 |
March 18 |
March 25 |
March 27 |
|
April 19 |
April 1 |
April 8 |
April 10 |
|
May 3 |
April 15 |
April 22 |
April 24 |
|
May 17 |
April 29 |
May 6 |
May 8 |
|
May 31 |
May 13 |
May 20 |
May 22 |
|
June 14 |
May 24** |
June 3 |
June 5 |
|
June 28 |
June 10 |
June 17 |
June 18** |
|
July 12 |
June 24 |
July 1 |
July 3 |
|
July 26 |
July 8 |
July 15 |
July 17 |
|
August 9 |
July 22 |
July 29 |
July 31 |
|
August 23 |
August 5 |
August 12 |
August 14 |
|
September 6 |
August 19 |
August 26 |
August 28 |
|
September 20 |
August 30** |
September 9 |
September 11 |
|
October 4 |
September 16 |
September 23 |
September 25 |
|
October 18 |
September 30 |
October 7 |
October 9 |
|
November 1 |
October 11** |
October 21 |
October 23 |
|
November 15 |
October 28 |
November 4 |
November 6 |
|
December
2*** |
November 8** |
November 18 |
November 20 |
|
December 13 |
November 25 |
December 2 |
December 4 |
|
December 27 |
December 9 |
December 16 |
December 18 |
† Please
note that this table is provided for planning purposes and that the Division of
State Documents (DSD) cannot guarantee submissions will be published in an
agency’s desired issue. Although DSD strives to publish according to the
schedule above, there may be times when workload pressures prevent adherence to
it.
* Also note that proposal deadlines are for
submissions to DSD for publication
in the Maryland Register and do not take into account the 15-day AELR review
period. The due date for documents containing 8 to 18 pages is 48 hours before
the date listed; the due date for documents exceeding 18 pages is 1 week before
the date listed.
NOTE: ALL DOCUMENTS MUST BE SUBMITTED IN TIMES NEW
ROMAN, 9-POINT, SINGLE-SPACED FORMAT. THE PAGE COUNT REFLECTS THIS FORMATTING.
** Note closing date changes.
*** Note issue date changes.
The regular closing date for Proposals and
Emergencies is Monday.
Cumulative Table of COMAR Regulations
Adopted, Amended, or Repealed
This table, previously printed in the Maryland Register lists the regulations, by COMAR title, that have been adopted, amended, or repealed in the Maryland Register since the regulations were originally published or last supplemented in the Code of Maryland Regulations (COMAR). The table is no longer printed here but may be found on the Division of State Documents website at www.dsd.state.md.us.
Table of Pending Proposals
The table below lists proposed changes to COMAR regulations. The proposed changes are listed by their COMAR number, followed by a citation to that issue of the Maryland Register in which the proposal appeared. Errata and corrections pertaining to proposed regulations are listed, followed by “(err)” or “(corr),” respectively. Regulations referencing a document incorporated by reference are followed by “(ibr)”. None of the proposals listed in this table have been adopted. A list of adopted proposals appears in the Cumulative Table of COMAR Regulations Adopted, Amended, or Repealed.
05 DEPARTMENT OF HOUSING
AND COMMUNITY DEVELOPMENT
05.03.09.01—.11 •
50:7 Md. R. 304 (4-7-23)
05.20.05.01—.12 •
49:25 Md. R. 1054 (12-2-22)
08 DEPARTMENT OF NATURAL
RESOURCES
08.02.02.01—.10,.12
• 50:18 Md. R. 803 (9-8-23)
08.02.04.03,.16 •
50:18 Md. R. 803 (9-8-23)
08.02.04.17 •
50:17 Md. R. 770 (8-25-23) (ibr)
08.02.07.01—.05 • 50:18 Md. R. 803 (9-8-23)
08.02.08.02,.07,.09,.11,.12 • 50:18 Md. R. 803 (9-8-23)
08.02.23.05 •
50:19 Md. R. 855 (9-22-23)
08.07.08.08 •
50:18 Md. R. 809 (9-8-23)
09 MARYLAND DEPARTMENT OF LABOR
09.03.06.28 • 50:18 Md. R. 810 (9-8-23)
09.03.14.01—.18 • 50:4 Md. R. 125 (2-24-23)
50:7 Md. R. 307 (4-7-23) (corr)
50:18 Md. R. 812 (9-8-23)
09.09.01.03 • 50:17 Md. R. 771 (8-25-23)
09.09.02.01 • 50:17 Md. R. 771 (8-25-23)
09.10.01.07 • 50:15 Md. R. 684 (7-28-23)
09.10.01.17 • 50:15 Md. R. 685 (7-28-23)
09.12.32.01—06 • 49:21 Md. R. 953 (10-7-22)
09.22.01.13 • 50:3 Md. R. 92 (2-10-23)
09.36.07.02 •
50:17 Md. R. 772 (8-25-23)
10 MARYLAND DEPARTMENT OF HEALTH
Subtitle 09 (2nd volume)
10.09.04.01,.03,.04,.07
• 50:7 Md. R. 307 (4-7-23)
10.09.06.02,.04,.06,.07,.09
• 50:11 Md. R. 448 (6-2-23)
10.09.07.08 •
50:7 Md. R. 309 (4-7-23)
10.09.08.01—.06,.09,.10
• 50:13 Md. R. 520 (6-30-23)
10.09.12.06,.07 •
50:6 Md. R. 222 (3-24-23)
10.09.16.01—.13 •
50:4 Md. R. 136 (2-24-23)
10.09.24.03 •
50:18 Md. R. 814 (9-8-23)
10.09.28.01,.02,.04,.06
• 50:13 Md. R. 522 (6-30-23)
10.09.30.01—.11 •
50:15 Md. R. 685 (7-28-23)
10.09.31.01,.03—.06
• 49:22 Md. R. 982 (10-21-22)
10.09.33.01,.02,.06,.07,.09
• 50:6 Md. R. 227 (3-24-23)
10.09.36.03-2 •
50:18 Md. R. 814 (9-8-23)
10.09.40.01—.06 •
50:1 Md. R. 13 (1-13-23)
10.09.41.03,.04,.07 • 50:16 Md. R. 730 (8-11-23)
10.09.52.01—.06 •
50:1 Md. R. 13 (1-13-23)
10.09.54.01,.04,.14,.16,.17,.22
• 50:3 Md. R. 94 (2-10-23)
10.09.56.22 •
50:4 Md. R. 140 (2-24-23)
10.09.62.01—.15 •
50:16 Md. R. 732 (8-11-23)
10.09.63.01—.06 •
50:13 Md. R. 526 (6-30-23)
10.09.69.04,.14,.17
• 50:16 Md. R. 737 (8-11-23)
10.09.76.01,.03,.05
• 50:1 Md. R. 13 (1-13-23)
10.09.89.09—.12,.14
• 50:6 Md. R. 230 (3-24-23)
Subtitles 10—22 (3rd volume)
10.11.04.02,.04 • 50:15 Md. R.
689 (7-28-23)
10.14.08.01—.08 • 50:13 Md. R.
528 (6-30-23)
10.15.03.02,.27 • 50:15 Md. R.
690 (7-28-23)
10.19.07.02 • 50:13 Md. R. 530
(6-30-23)
10.19.08.01—.06 • 50:13 Md. R.
530 (6-30-23)
10.21.01.04,.08 • 49:23 Md. R.
1000 (11-4-22)
Subtitles 23—36 (4th volume)
10.24.01.01—.22 •
50:14 Md. R. 597 (7-14-23)
10.26.02.02—.05 •
50:15 Md. R. 691 (7-28-23)
10.26.06.01—.03 •
50:15 Md. R. 691 (7-28-23)
10.27.01.05 •
50:13 Md. R. 532 (6-30-23)
10.34.34.02—.12 •
50:13 Md. R. 533 (6-30-23)
Subtitles 37—52 (5th volume)
10.37.01.02 •
50:17 Md. R. 772 (8-25-23) (ibr)
10.38.08.01—.08 •
50:15 Md. R. 693 (7-28-23)
10.40.02.03. •
50:18 Md. R. 815 (9-8-23)
10.41.01.01—.04 •
50:16 Md. R. 738 (8-11-23)
10.41.02.01,.02,.04
• 50:16 Md. R. 738 (8-11-23)
10.41.03.02,.03,.05,.06
• 50:16 Md. R. 738 (8-11-23)
10.41.04.01,.02,.06,.08
• 50:16 Md. R. 738 (8-11-23)
10.41.05.01—.07 •
50:16 Md. R. 738 (8-11-23)
10.41.08.01-1,.02,.06,.08,.11,.12,.14
• 50:16 Md. R. 738 (8-11-23)
10.41.09.02 •
50:16 Md. R. 738 (8-11-23)
10.41.11.01—.10 •
50:16 Md. R. 738 (8-11-23)
10.41.13.02,.04 •
50:16 Md. R. 738 (8-11-23)
10.42.06.02,.03,.05—.11
• 50:15 Md. R. 695 (7-28-23)
Subtitles 53—68 (6th volume)
10.52.08.01—.16 •
50:18 Md. R. 816 (9-8-23)
10.53.08.05 •
50:17 Md. R. 773 (8-25-23)
10.53.09.01—.04 •
50:17 Md. R. 773 (8-25-23)
10.60.01.03,.05 •
50:18 Md. R. 816 (9-8-23)
10.63.01.02,.05 •
50:4 Md. R. 143 (2-24-23)
10.63.02.02 •
50:4 Md. R. 143 (2-24-23)
10.63.03.20,.21 •
50:4 Md. R. 143 (2-24-23)
10.64.01.15 •
50:15 Md. R. 698 (7-28-23)
10.65.01.04—.16 •
50:18 Md. R. 817 (9-8-23)
10.65.07.01—04 • 50:18 Md. R. 817 (9-8-23)
10.65.11.01—.10 •
50:18 Md. R. 817 (9-8-23)
10.67.01.01 •
50:16 Md. R. 732 (8-11-23)
10.67.02.01 •
50:16 Md. R. 732 (8-11-23)
10.67.06.26-6 • 49:22 Md. R. 982 (10-21-22)
10.67.06.26-7 • 50:13 Md. R. 526 (6-30-23)
10.67.08.02 •
50:14 Md. R. 618 (7-14-23)
11 DEPARTMENT OF
TRANSPORTATION
Subtitles 11—23 (MVA)
11.11.05.03 •
50:16 Md. R. 750 (8-11-23)
11.11.05.04 •
50:16 Md. R. 751 (8-11-23)
11.12.01.14 •
50:15 Md. R. 698 (7-28-23)
11.13.12.01,.04,.05,.09
• 50:16 Md. R. 752 (8-11-23)
11.15.40.01—.04 •
50:16 Md. R. 753 (8-11-23)
11.17.09.05 • 50:16 Md. R. 750 (8-11-23)
11.17.21.05 •
50:16 Md. R. 750 (8-11-23)
13A STATE BOARD OF EDUCATION
13A.01.05.01—.04,.08,.10,.12
• 50:19 Md. R. 856 (9-22-23)
13A.01.07.01—.07
• 50:19 Md. R. 858 (9-22-23)
13A.02.06.01,.02,.05—.07
• 50:14 Md. R. 620 (7-14-23)
13A.07.06.01—.15
• 50:14 Md. R. 621 (7-14-23) (ibr)
13A.08.04.01—.07
• 50:18 Md. R. 825 (9-8-23)
13A.12.01.01—.14
• 50:14 Md. R. 633 (7-14-23)
13A.12.02.01—.29
• 50:14 Md. R. 633 (7-14-23)
13A.12.03.01—.12
• 50:14 Md. R. 633 (7-14-23)
13A.12.04.01—.16
• 50:14 Md. R. 633 (7-14-23)
13A.12.05.01—.15
• 50:14 Md. R. 633 (7-14-23)
13A.12.06.01—.09
• 50:14 Md. R. 633 (7-14-23)
13A.12.07.01—.08
• 50:14 Md. R. 633 (7-14-23)
50:15 Md. R. 707 (7-28-23) (err)
13A.15.02.02 •
50:17 Md. R. 774 (8-25-23)
13A.16.02.02 •
50:17 Md. R. 774 (8-25-23)
13A.16.06.09-1,.10-1
• 50:17 Md. R. 776 (8-25-23)
13A.17.02.02 •
50:17 Md. R. 774 (8-25-23)
13A.18.02.02 •
50:17 Md. R. 774 (8-25-23)
13A.18.06.06-1 •
50:17 Md. R. 776 (8-25-23)
13B MARYLAND HIGHER
EDUCATION COMMISSION
13B.08.20.02—.13
• 50:4 Md. R. 158 (2-24-23)
14 INDEPENDENT AGENCIES
14.01.01.01—.05 •
50:19 Md. R. 861 (9-22-23)
14.01.04.01—.05 •
50:19 Md. R. 864 (9-22-23)
14.22.02.02 •
50:18 Md. R. 830 (9-8-23)
14.35.07.22 • 50:13 Md. R. 535 (6-30-23)
14.35.19.03 •
50:16 Md. R. 754 (8-11-23)
14.35.20.01—.12 •
50:13 Md. R. 536 (6-30-23)
14.39.02.05 •
50:17 Md. R. 778 (8-25-23)
14.40.04.01—.03 •
50:15 Md. R. 700 (7-28-23)
14.40.05.03,.04 •
50:15 Md. R. 702 (7-28-23)
15 MARYLAND DEPARTMENT OF
AGRICULTURE
15.01.12.01,.03,.04
• 50:18 Md. R. 835 (9-8-23)
21 STATE PROCUREMENT
REGULATIONS
21.05.02.14 • 50:13 Md. R. 539
(6-30-23)
21.05.03.03 • 50:13 Md. R. 539
(6-30-23)
21.11.03.10 • 50:13 Md. R. 539
(6-30-23)
26 DEPARTMENT OF THE
ENVIRONMENT
Subtitles 01—07 (Part 1)
26.04.01.01,.01-1,.20,.37 • 50:3
Md. R. 106 (2-10-23) (ibr)
Subtitles 08—12 (Part 2)
26.11.17.01,.04 •
50:11 Md. R. 455 (6-2-23)
26.11.43.01—.05 •
50:18 Md. R. 836 (9-8-23) (ibr)
30 MARYLAND INSTITUTE FOR
EMERGENCY MEDICAL SERVICES SYSTEMS (MIEMSS)
30.09.12.04 •
50:13 Md. R. 541 (6-30-23)
30.09.14.04 •
50:13 Md. R. 541 (6-30-23)
33 STATE BOARD OF
ELECTIONS
33.01.01.01 • 50:15 Md. R. 703
(7-28-23)
33.01.05.06 • 50:17 Md. R. 779
(8-25-23)
33.07.11.01,.02 • 50:15 Md. R.
703 (7-28-23)
33.13.21.01—.05 •
50:15 Md. R. 705 (7-28-23)
33.15.02.01 •
50:15 Md. R. 703 (7-28-23)
33.15.03.01,.02 •
50:15 Md. R. 703 (7-28-23)
33.16.02.01 •
50:17 Md. R. 779 (8-25-23)
33.18.01.02 •
50:15 Md. R. 705 (7-28-23)
33.21.03.02 • 50:17 Md. R. 779 (8-25-23)
This is to certify that by an Order of this Court dated August 31, 2023, ASHER NEWTON WEINBERG (CPF# 1307300006), as of August 31, 2023, Asher Newton Weinberg has been indefinitely suspended, effective immediately and his name has been stricken from the register of attorneys in this Court. Notice of this action is given in accordance with Maryland Rule 19-761(b).
* * * * * * * * * *
This is to certify that by an Order of this Court dated August 31, 2023, NATASHA VEYTSMAN ROSSBACH (CPF# 0206190226), as of August 31, 2023, Natasha Veytsman Rossbach has been indefinitely suspended, effective immediately and her name has been stricken from the register of attorneys in this Court. Notice of this action is given in accordance with Maryland Rule 19-761(b).
* * * * * * * * * *
This is to certify that by an Order of this Court dated August 31, 2023, MARGOT ELIZABETH ROBERTS (CPF# 1606210229), as of August 31, 2023, Margot Elizabeth Roberts’ name has been replaced on the register of attorneys permitted to practice law in the Supreme Court of Maryland. Notice of this action is given in accordance with Maryland Rule 19-761(b).
* * * * * * * * * *
This is to certify that by an Order of this Court dated August 31, 2023, JOSEPH ROBERT LAUMANN (CPF# 9806240013), as of August 31, 2023, Joseph Robert Laumann’s name has been replaced on the register of attorneys permitted to practice law in the Supreme Court of Maryland. Notice of this action is given in accordance with Maryland Rule 19-761(b).
[23-19-21]
Emergency Action on Regulations
Symbol Key
• Roman
type indicates text existing before emergency status was granted.
• Italic
type indicates new text.
• [Single brackets] indicate deleted text.
Emergency Regulations
Under State
Government Article, §10-111(b), Annotated Code of Maryland, an agency may
petition the Joint Committee on Administrative, Executive, and Legislative
Review (AELR), asking that the usual procedures for adopting regulations be set
aside because emergency conditions exist. If the Committee approves the
request, the regulations are given emergency status. Emergency status means
that the regulations become effective immediately, or at a later time specified
by the Committee. After the Committee has granted emergency status, the
regulations are published in the next available issue of the Maryland Register.
The approval of emergency status may be subject to one or more conditions,
including a time limit. During the time the emergency status is in effect, the
agency may adopt the regulations through the usual promulgation process. If the
agency chooses not to adopt the regulations, the emergency status expires when
the time limit on the emergency regulations ends. When emergency status
expires, the text of the regulations reverts to its original language.
Title 08
DEPARTMENT OF NATURAL RESOURCES
Authority: Natural Resources Article, §§4-215 and 4-803, Annotated Code of Maryland
Notice of Emergency Action
[23-167-E]
The Joint Committee on Administrative, Executive, and Legislative Review has granted emergency status to amendments to Regulations .01 and .14 under COMAR 08.02.03 Blue Crabs.
Emergency status began:
August 31, 2023.
Emergency status
expires: December 31, 2023.
Estimate of Economic Impact
I. Summary of Economic Impact. The proposed action may have an indeterminable positive economic impact by allowing commercial harvesters to use an alternative container to hold mature female blue crabs. Due to the limited availability of the current legal containers, failure to allow an alternative container may result in negative economic impacts.
II. Types of Economic Impact.
|
Impacted Entity |
Revenue
(R+/R-) Expenditure
(E+/E-) |
Magnitude |
|
A. On issuing agency: |
NONE |
|
|
B. On other State agencies: |
NONE |
|
|
C. On local governments: |
NONE |
|
|
|
|
|
|
|
Benefit
(+) Cost
(-) |
Magnitude |
|
D. On regulated industries or trade groups: |
|
|
|
Commercial harvesters |
(+) |
Indeterminable |
|
E. On other industries or trade groups: |
|
|
|
Commercial picking houses |
(+) |
Indeterminable |
|
F. Direct and indirect effects on public: |
|
|
|
General public |
(+) |
Indeterminable |
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
D. Allowing commercial harvesters to utilize an alternative container rather than the currently allowed bushels and barrels will allow commercial harvesters to continue to harvest mature female crabs. It is not clear the extent to which harvesters are or will be constrained by the current lack of availability of legal containers. It is the Department’s understanding that while some bushel baskets are currently available, there will not be enough bushel baskets available to last the industry for the whole season if the industry is to harvest the full amount that current limits would allow.
E. Crab picking houses rely heavily on mature female crabs for their operations. By allowing harvesters to use lugs, picking houses will be assured to have access to all of the mature female crabs that the current limits will allow harvesters to catch. If harvesters cannot deliver their catch to the processors, supply of crab to the public may be disrupted. This may ultimately lead to lost market share for Maryland processors and long-term negative consequences.
F. The public expects to have a consistent supply of Maryland crab, both available for purchase at markets and restaurants, as well as in the form of pasteurized crab meat. If commercial harvesters are not able to acquire the necessary containers in which to store their harvest, that supply will be disrupted. This will result in higher prices for available crabs and negative economic impacts on the public.
Economic Impact on Small Businesses
The emergency action has a meaningful economic impact on small businesses. An analysis of this economic impact follows.
The proposed action may have an indeterminable positive economic impact on small business. See Section IIID and E for additional information.
.01 Crabbing Gear.
A.—B (text unchanged)
C. Commercial Gear.
(1)—(6)
(text unchanged)
(7) “Lug” means a
rectangular-shaped container that does not exceed the following inside
dimensions: 22-7/8 inches in length across the top, 14-7/8 inches in width
across the top; 21 inches length across the bottom; 13 inches width across the
bottom; and 12-3/8 inches height.
.14 General.
A. (text unchanged)
B. Commercial — General.
(1)—(4) (text unchanged)
(5) Mature female hard crabs shall be kept in separate bushels, lugs, or barrels from male hard crabs or peeler crabs.
(6) Hard crabs on board a vessel shall
be stored in the same type of containers of similar dimensions.
[(6)] (7)—[(13)]
(14) (text unchanged)
C.—G. (text unchanged)
JOSH KURTZ
Secretary of Natural Resources
Title 09
MARYLAND DEPARTMENT OF LABOR
Subtitle 09 MARYLAND BOARD OF ELECTRICIANS
Notice of Emergency Action
[23-171-E]
The Joint Committee on Administrative, Executive, and Legislative Review has granted emergency status to amendments to:
(1) Regulation .03 under
COMAR 09.09.01 Fees and Deadlines; and
(2) Regulation .01 under COMAR 09.09.02 Continuing Education.
Emergency status began:
August 31, 2023.
Emergency status
expires: December 31, 2023.
Editor’s Note: The text of
this document will not be printed here because it appeared as a Notice of
Proposed Action in 50:17 Md. R. 771—772 (August 25, 2023), referenced as
[23-171-P].
CHET BROWN
Chairman
Maryland Board of Electricians
Symbol Key
• Roman type
indicates text already existing at the time of the proposed action.
• Italic
type indicates new text added
at the time of proposed action.
• Single underline, italic indicates new text added at the time of final
action.
• Single
underline, roman indicates existing text added at the time of final action.
• [[Double
brackets]] indicate text deleted at the time of final action.
Subtitle 01 PRESCRIPTION DRUG AFFORDABILITY BOARD
14.01.02 Prescription Drug Affordability Fund
Authority: Health-General Article, §§21-2C-03(f) and 21-2C-11, Annotated Code of Maryland
Notice of Final Action
[23-139-F]
On September 13, 2023, the Maryland Prescription Drug Affordability Board adopted amended Regulations .02 and .03 under COMAR 14.01.02 Prescription Drug Affordability Fund. This action, which was proposed for adoption in 50:15 Md. R. 699—700 (July 28, 2023), has been adopted as proposed.
Effective Date: October 2, 2023.
ANDREW W. YORK
Executive Director
Subtitle 01 PRESCRIPTION DRUG AFFORDABILITY BOARD
14.01.03 Public Information Act
Authority: General Provisions
Article §§4-101—4-601; Health-General Article, §21-2C-03(f)(1); Annotated Code
of Maryland
Notice of Final Action
[23-126-F]
On September 13, 2023, the Maryland Prescription Drug Affordability Board adopted new Regulations .01—.17 under a new chapter, COMAR 14.01.03 Public Information Act. This action, which was proposed for adoption in 50:14 Md. R. 659—661 (July 14, 2023), has been adopted as proposed.
Effective Date: October 2, 2023.
ANDREW W. YORK
Executive Director
Title 33
STATE BOARD OF ELECTIONS
Notice of Final Action
[23-086-F]
On August 29, 2023, the State Board of Elections adopted:
(1) New Regulations .01 and .05, the recodification of existing Regulations .01 and .02 to be Regulations .02 and .03, amendments to and the recodification of existing Regulation .03 to be Regulation .04, and the repeal of existing Regulation .04 under COMAR 33.02.03 Judges' Manuals and Training;
(2) Amendments to Regulation .01 under COMAR 33.12.02 Initiation of Recounts;
(3) Amendments to Regulation .06 under COMAR 33.17.04 Early Voting Center Equipment and Materials;
(4) Amendments to Regulation .03 under COMAR 33.17.05 Election Judges;
(5) Amendments to Regulation .01 under COMAR 33.17.07 Non-Voting Hours Procedures;
(6) Amendments to Regulation .01 under COMAR 33.19.01 Definitions; General Provisions; and
(7) Amendments to Regulation .01 under COMAR 33.19.02 Public Notice.
This action, which was proposed for adoption in 50:13 Md. R. 542—544 (June 30, 2023), has been adopted as proposed.
Effective Date: October 2, 2023.
MORGAN RHODEN
Deputy Director of Election Reform and Management
Subtitle 13 CAMPAIGN FINANCING
Notice of Final Action
[23-087-F]
On August 29, 2023, the State Board of Elections adopted:
(1) New Regulation .05 under COMAR 33.13.10 Prohibitions; and
(2) Amendments to Regulation .06 under COMAR 33.13.13 Administrative Accounts.
This action, which was proposed for adoption in 50:12 Md. R. 492—493 (June 16, 2023), has been adopted as proposed.
Effective Date: October 2, 2023.
MORGAN RHODEN
Deputy Director of Election Reform and Management
Proposed Action on Regulations
Title 08
DEPARTMENT OF NATURAL RESOURCES
08.02.23 Shellfish Aquaculture and Leasing
Authority: Natural Resources Article, §4-11A-12, Annotated Code of Maryland
Notice of Proposed Action
[23-197-P]
The Secretary of Natural Resources proposes to adopt new Regulation .05 under COMAR 08.02.23 Shellfish Aquaculture and Leasing.
Statement of Purpose
The purpose of this action is to create a pilot program permit structure for future aquaculture pilot programs. The Department would then be able to conduct certain voluntary pilot projects for the practical demonstration and evaluation of alternative aquaculture management methods to increase accountability as well as efficiency and value within the industry. The Department believes the regulatory burden on both the management agency and the aquaculture industry can be reduced by emphasizing improved harvest accountability techniques and resulting increased efficiency value in the industry. However, rather than temporarily create additional regulations that only apply to permit holders, the Department is proposing conducting pilot projects developed in cooperation with the aquaculture industry. Individuals participating in these projects would receive permits from the Department. The permits would specify the details of the project. Additionally, Natural Resource Police would be informed of all permit holders and projects. Pilot projects for demonstration and evaluation of alternative accountability practices would potentially enhance development and application of improved management practices.
Estimate of Economic Impact
I. Summary of Economic Impact. The proposed action alone will not have any economic impact. Any future pilot program undertaken by the Department under this authority may have an indeterminable positive economic impact on the aquaculture industry by lowering certain regulatory burdens, but given that the Department is not currently proposing any specific pilot program any actual economic impact is indeterminable.
II. Types of Economic Impact.
|
Impacted Entity |
Revenue
(R+/R-) Expenditure
(E+/E-) |
Magnitude |
|
A. On issuing agency: |
|
|
|
Department of Natural Resources |
(E-) |
Indeterminable |
|
B. On other State agencies: |
NONE |
|
|
C. On local governments: |
NONE |
|
|
|
|
|
|
|
Benefit
(+) Cost
(-) |
Magnitude |
|
D. On regulated industries or trade groups: |
|
|
|
Aquaculture leaseholders |
(+) |
Indeterminable |
|
E. On other industries or trade groups: |
NONE |
|
|
F. Direct and indirect effects on public: |
NONE |
|
III. Assumptions. (Identified by Impact Letter and Number from Section II.)
A. This action may have an indeterminable impact on the Department, depending on if the Department creates pilot programs under this regulation, and depending on the type of pilot program the Department creates. The ultimate goal of any pilot program undertaken would likely include a reduction in the administrative burden on the agency, in addition to the industry, resulting in lower expenditures by the agency.
D. This action may have an indeterminable impact on aquaculture leaseholders by reducing their regulatory burden, depending on if the Department creates pilot programs under this regulation, and depending on the type of pilot program the Department creates. The ultimate goal of any pilot program undertaken would likely reduce the regulatory burden on leaseholders, resulting in an indeterminable positive economic impact.
Economic Impact on Small Businesses
The proposed action has a meaningful economic impact on small
businesses. An analysis of this economic impact follows:
This action may have long-term positive impacts on small businesses engaged in shellfish aquaculture by reducing their regulatory burden, depending on if the Department creates pilot programs under this regulation and depending on the type of pilot program the Department creates. Any program created under this authority would be discussed and vetted through the Aquaculture Coordinating Council, which is made up of a wide range of industry participants and overseers and provides the Department advice on how to manage the industry.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Shellfish Aquaculture — Pilot Program Authority, Regulatory Staff, Department of Natural Resources, 580 Taylor Avenue, E-4, Annapolis, MD 21401, or call 410-260-8300, or submit comments to https://dnr.maryland.gov/fisheries/pages/regulations/changes.aspx#aqua. Comments will be accepted through October 23, 2023. A public hearing has not been scheduled.
.05 Aquaculture Pilot Programs.
A. The Department may conduct
pilot projects to demonstrate and evaluate new approaches to managing shellfish
aquaculture in the State.
B. The Department may select
and designate certain persons named on a Shellfish Aquaculture Harvester Permit
or Shellfish Aquaculture Harvester Registration Card to participate in a pilot
project. A participating permittee or registrant shall:
(1) Apply for a pilot program
permit on forms provided by the Department;
(2) Have a pilot program
permit in order to participate in a pilot program;
(3) Comply with any
conditions of the permit; and
(4) Be eliminated from the
pilot project at the discretion of the Department.
C.
The Department shall:
(1) Develop pilot projects in cooperation with the aquaculture
industry; and
(2) Provide adequate notice of a pilot
program through various media so that an interested individual has a reasonable
opportunity to be informed.
JOSH KURTZ
Secretary of Natural Resources
Title 13A
STATE BOARD OF EDUCATION
Subtitle 01 STATE SCHOOL ADMINISTRATION
13A.01.05 Appeals to the State Board of Education
Authority: Authority: Education Article, §§2-205, 4-205, 6-202, and 7-305[, and 23-406]; State Government Article, §§10-122 and 10-201 et seq.; Annotated Code of Maryland
Notice of Proposed Action
[23-196-P]
The State Board of Education proposes to amend Regulations .01—.04, .08, .10, and .12 under COMAR 13A.01.05 Appeals to the State Board of Education. This
action was considered by the State Board of Education at their July 25, 2023
meeting.
Statement of Purpose
The purpose of this action is to provide further direction to those submitting appeals to the State Board of Education and efficiency to the appeal process.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Michelle Phillips, Administrative Officer, Office of the Attorney General, 200 St. Paul Place, Baltimore, MD 21202, or call 410-576-6465, or email to mphillips@oag.state.md.us. Comments will be accepted through October 23, 2023. A public hearing has not been scheduled.
.01 Definitions.
A. (text unchanged)
B. Terms Defined.
(1)—(4) (text unchanged)
(5) "File" means:
(a) In regard to an initial appeal, petition for declaratory ruling, or request for removal of a local board member:
(i) Delivery of the papers to the State Board in hard copy on or
before the date the papers are due; [or]
(ii) Depositing the papers in the United States mail as registered
or certified mail or Express Mail, or deposited with a delivery service, such
as Fed Ex, UPS, or DHL, that provides verifiable tracking of the item from the
point of origin on or before the date the papers are due[.];
or
(iii) Submitting the papers electronically to the State Board on
or before the date the papers are due.
(b) In regard to all other motions, memoranda, and responses:
(i)—(ii) (text unchanged)
(iii) Submitting the papers electronically to the State Board on or before the date the papers are due.
(6)—(10) (text unchanged)
.02 Appeals.
A. Contents. The request for an appeal shall:
(1) [Specify the] Be signed by each party [or parties] taking the appeal[, along with current] and include the printed name, regular mail address, and email [addresses] address of each party;
(2)—(9) (text unchanged)
B. Deadlines.
(1)—(2) (text unchanged)
(3) An appeal shall be deemed to have been filed within the 30-day period of time permitted under §B(1) of this regulation if, before the expiration of the time, it has been:
(a) Delivered to the State Board; [or]
(b) Deposited in the United States mail, as registered or certified
mail or Express Mail, or deposited with a delivery service, such as Fed Ex,
UPS, or DHL, that provides verifiable tracking of the item from the point of
origin[.]; or
(c) Submitted electronically to the State Board.
(4) (text unchanged)
[(5) Appeals will not be accepted in electronic format.]
C. (text unchanged)
.03 Response to Appeals.
A. Time for Response. [Within 20 days after the State Board
sends a copy of the appeal to the local superintendent, the respondent shall
file a memorandum in response to the appeal or a motion to dismiss, whichever
is appropriate.]
(1) Within 20 days after the State Board sends a copy of the
appeal to the local superintendent, the respondent shall file a memorandum in
response to the appeal or a motion to dismiss, whichever is appropriate.
(2) For appeals to be transferred to the Office of
Administrative Hearings pursuant to Regulation .07 of this chapter, §A(1) of
this regulation does not apply unless the respondent files a motion to dismiss.
B.—C. (text unchanged)
D. Record.
(1) (text unchanged)
(2) The record shall include a table of contents, and each page
of the record shall be consecutively numbered.
[(2)] (3)—[(3)] (4) (text unchanged)
[(4)] (5) Waiver of Transcription Costs.
(a) An individual appellant who by reason of indigence is unable to pay the cost of transcription may file a request for waiver of the costs, with the State [Superintendent] Board President.
(b) (text unchanged)
(c) The State [Superintendent] Board President shall review the request for waiver of costs and the accompanying affidavit and may require the appellant to supplement or explain any of the matters set forth in the papers.
(d) If the State [Superintendent] Board President is satisfied that the appellant is unable by reason of indigence to pay the cost of transcription, the State [Superintendent] Board President may waive the payment of cost, and the cost shall be paid by the local board.
(e) (text unchanged)
.04 General Procedures.
A. (text unchanged)
B. Requests to Shorten or Extend Time Requirements.
(1) (text unchanged)
(2) The State Board may not extend the time limitations set
forth in this chapter before an appeal is filed.
[(2)] (3) (text unchanged)
C.—D. (text unchanged)
E. Filing Motions, Memoranda, and Responses.
(1)—(6) (text unchanged)
(7) [Motions, memoranda, and responses may be submitted in
electronic format if the party also provides the State Board with a hard copy.]
The State Board may strike any motion, memoranda, response, or other
submission that is outside of the briefing process or otherwise fails to comply
with the requirements of this regulation.
F.—G. (text unchanged)
H. At the rest of the State Board, a party shall submit hard
copies of any documents that were filed in electronic format.
I. A party submitting video evidence shall provide a transcribed
copy of the video and, for a video that contains portions that are not relevant
to the appeal, provide the time stamp location of the relevant portions of the
video.
.08 Hearing Record and Transcript.
A. (text unchanged)
B. The proceedings before the administrative law judge shall be transcribed at the expense of the [parties] party filing exceptions to the administrative law judge’s proposed decision.
[C. Costs of an expedited transcript shall be paid by the
party requesting the expedited transcript.]
[D.] C. The [parties] party filing exceptions to the administrative law judge’s proposed decision shall file a copy of the transcript with the State Board, and the transcript shall be made a part of the record.
D. Waiver of Transcription Costs.
(1) An individual appellant who by reason of indigence is unable
to pay the cost of transcription may file a request for waiver of the costs
with the State Board President.
(2) The request for waiver of costs shall be accompanied by an
affidavit verifying the facts set forth in the request and the appellant’s
inability to pay.
(3) The State Board President shall review the request for
waiver of costs and the accompanying affidavit and may require the appellant to
supplement or explain any of the matters set forth in the papers.
(4) If the State Board President is satisfied that the appellant
is unable by reason of indigence to pay the cost of transcription, the State
Board President may waive the payment of cost, and the cost shall be paid by
the State Board.
(5) A waiver of transcription costs shall only be available to
an individual appellant and not to a group or other entity.
(6) The waiver process does not extend the deadline for filing
exceptions to the administrative law judge’s proposed decision, but an
appellant may amend the exceptions once the transcript is issued in order to
provide copies of the pages of the transcript that support the argument as
required by Regulation .07 of this chapter.
.10 Reconsideration.
A. A party may file a request for reconsideration of a State Board decision within 30 days of the date of the decision using the method of filing prescribed by Regulation .01B(5)(a) of this chapter for initial appeals.
B.—G. (text unchanged)
.12 Procedures Applicable to Requests to Remove a Local Board Member.
A. (text unchanged)
B. Content of the Request.
(1) The request to issue charges shall:
(a) [set] Set forth in a detailed
affidavit, with all supporting documentation, the factual basis to support a
statutory ground for removal[.]; and
(b) Be signed with a statement submitting the affidavit under
penalties of perjury by including the following language: “I solemnly affirm
under the penalties of perjury that the contents of the foregoing are true to
the best of my knowledge, information, and belief.”
(2) (text unchanged)
C. Method of Submission.
(1) The request shall be filed with the State Board in the manner
prescribed in Regulation .01B(5)(a) of this chapter. [Requests
submitted by email will not be accepted.]
(2)—(3) (text unchanged)
D.—K. (text unchanged)
MOHAMMED
CHOUDHURY
State Superintendent of Schools
Subtitle 01 STATE SCHOOL ADMINISTRATION
13A.01.07 Nondiscrimination in Education
Authority: Education Article,
§§2-303, 4-108, and 26-701 et seq.; State Government Article, §§10-122 and
10-201 et seq., Annotated Code of Maryland; Federal Statutory References: 29
U.S.C. §794 et seq. and
42 U.S.C. §12101 et seq.
Notice of Proposed Action
[23-176-P]
The State Board of Education proposes to adopt new Regulations .01—.07 under a new chapter, COMAR 13A.01.07 Nondiscrimination in
Education. This action was considered by the State Board of Education at
their meeting on May 23, 2023.
Statement of Purpose
The purpose of these regulations is to prohibit unlawful discrimination and retaliation in education in Maryland public and nonpublic schools that receive State funds per enacted legislation amending Education Article §2-303(b), Annotated Code of Maryland.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
Comments may be sent to Akilah Alleyne, Ph.D., Executive Director, Governmental Affairs, Education Policy, and External Relations, Maryland State Department of Education, 200 West Baltimore Street, Baltimore, MD 21201, or call 410-767-0504, or email to akilah.alleyne@maryland.gov. Comments will be accepted through October 23, 2023. A public hearing has not been scheduled.
Open Meeting
Final action on the proposal will be considered by the State Board of Education during a public meeting to be held on December 5, 2023, at 9 a.m., at 200 West Baltimore Street, Baltimore, MD 21201.
.01 Scope.
B. This chapter applies to the following entities in Maryland:
(1) All county boards of education;
(2) All public prekindergarten programs;
(3) All public primary and secondary schools;
(4) All nonpublic prekindergarten programs that receive State
funds; and
(5) All nonpublic primary or secondary schools that receive State
funds.
C. This chapter does not apply to:
(1) With respect to discrimination on the basis of sex, a
prekindergarten program or school that limits admission to students of only one
sex;
(2) With respect to discrimination on the basis of religion, a
nonpublic prekindergarten program or nonpublic school that is affiliated with a
religious institution:
(a) Providing instruction on the religious beliefs of the
religion with which the program or school is affiliated;
(b) Declining to provide instruction in beliefs that are
different from the religion with which the program or school is affiliated;
(c) Requiring student attendance at religious events inherent to
the religion with which the program or school is affiliated;
(d) Having a preference in or limiting admission to a student of
certain religious beliefs or a student who is a member or is part of a family
that is a member of the religious institution affiliated with the program or
school, if the program or school has had the preference or limitation
continually since the date on which the program or school was established; or
(e) Granting tuition discounts for a student of certain
religious beliefs or who is a member or is part of a family that is a member of
the religious institution affiliated with the program or school if the practice
of granting the discounts was established the later of before July 1, 2022, or
since the date on which the program or school was established; and
(3) With respect to discrimination on the basis of disability, a
nonpublic prekindergarten program or nonpublic school that is in compliance
with §504 of the Rehabilitation Act of 1973, 29 U.S.C. §794 et seq., or the
Americans with Disabilities Act, 42 U.S.C. §12101 et seq., as applicable.
.02 Definitions.
A. In this
chapter, the following terms have the meanings indicated.
B. Terms Defined.
(1) “Administrative law judge” means a hearing officer
designated by the Maryland Office of Administrative Hearings to render the
final decision of the Superintendent in a hearing.
(2) “Complainant” means a person who files a complaint alleging
a discriminatory act under this chapter.
(3) “Department” means the Maryland State Department of
Education.
(4) “Discriminatory act” means an act prohibited under this
chapter.
(5) “Gender identity” means the gender-related identity,
appearance, expression, or behavior of a person, regardless of the person's
assigned sex at birth, which may be demonstrated by:
(a) Consistent and uniform assertion of the person's gender
identity; or
(b) Any other evidence that the gender identity is sincerely
held as part of the person's core identity.
(6) “Office of Administrative Hearings” means the administrative
unit of Maryland government which is responsible for processing requests for
hearings, for scheduling and conducting hearings, and for rendering decisions
pursuant to State Government Article, §9-1601 et seq., Annotated Code of
Maryland.
(7) “Party” or “parties” means the complainant and the
respondent.
(8) “Protective hairstyle” includes braids, twists, and locks.
(9)“Race” includes traits associated with race, including hair
texture, afro hairstyles, and protective hairstyles.
(10) “Respondent” means a person accused in a complaint of a
discriminatory act.
(11) “Sexual orientation” means the identification of an
individual as to male or female homosexuality, heterosexuality, or bisexuality.
(12) “Superintendent” means the State Superintendent of Schools.
.03 Nondiscrimination in Education.
A. Educational entities have a responsibility to protect every
student’s right to learn in an environment free from unlawful discrimination.
B. Entities identified in Regulation .01B of this chapter may
not:
(1) Discriminate against a current student, a prospective
student, or the parent or guardian of a current or prospective student on the
basis of race, ethnicity, color, religion, sex, age, national origin, marital
status, sexual orientation, gender identity, or disability;
(2) Refuse enrollment of a prospective student, expel a current
student, or withhold privileges from a current student, a prospective student,
or the parent or guardian of a current or prospective student because of an
individual's race, ethnicity, color, religion, sex, age, national origin,
marital status, sexual orientation, gender identity, or disability; or
(3) Discipline, invoke a penalty against, or take any other
retaliatory action against a student or parent or guardian of a student who
files a complaint alleging that the program or school discriminated against the
student, regardless of the outcome of the complaint.
C. Entities identified in Regulation .01B(1) of this chapter
shall adopt and maintain a written antidiscrimination policy that prohibits
unlawful discrimination as described in §B of this regulation.
(1) Title VI of the
federal Civil Rights Act of 1964; and
(2) Title 26, Subtitle
7 of the Education Article of the Maryland Code, which states that public and
publicly funded schools and programs may not:
(a) Discriminate
against a current student, a prospective student, or the parent or guardian of
a current or prospective student on the basis of race, ethnicity, color,
religion, sex, age, national origin, marital status, sexual orientation, gender
identity, or disability;
(b) Refuse enrollment
of a prospective student, expel a current student, or withhold privileges from a
current student, a prospective student, or the parent or guardian of a current
or prospective student because of an individual's race, ethnicity, color,
religion, sex, age, national origin, marital status, sexual orientation, gender
identity, or disability; or
(c) Discipline, invoke
a penalty against, or take any other retaliatory action against a student or
parent or guardian of a student who files a complaint alleging that the program
or school discriminated against the student, regardless of the outcome of the
complaint.”
.04 Complaints.
A. A complainant alleging discrimination in violation of
Education Article, §26-704, Annotated Code of Maryland, may file a complaint in
writing with the Superintendent.
B. A parent or guardian of a minor alleging discrimination may
file a complaint on behalf of the minor.
C. The complaint shall be delivered by regular mail or
electronic mail to the Department.
D. The complaint shall be in writing and include the following
information:
(1) The complainant’s name, mailing address, email address,
telephone number, and signature;
(2) The respondent’s name, mailing address, email address, and
telephone number;
(3) The date of any alleged
discriminatory acts;
(4) A statement of
facts describing any discriminatory acts;
(5) A statement of the
relief requested; and
(6) Any supporting
documents, exhibits, and affidavits.
E. The
complaint shall be no longer than 15 pages, excluding attachments.
F. Deadlines.
(1) A complaint shall be filed within 60 days from the later of
the date of the last discriminatory act or when the complainant learned of the
discrimination.
(2) A complaint shall be deemed to have been filed within the
60-day period if, before the expiration of the 60-day period, it has been:
(a) Delivered to the Department; or
(b) Deposited in the United States mail, as registered or
certified mail or Express Mail, or deposited with a delivery service, such as
Fed Ex, UPS, or DHL, that provides verifiable tracking of the item from the
point of origin.
G. Concurrent Jurisdiction with State Board.
(1) The State Board may stay action of an appeal filed pursuant
to COMAR 13A.01.05 that also alleges discrimination in violation of Education
Article, §26-701 et seq., Annotated Code of Maryland, pending a mediation
agreement or final decision on a complaint filed under this chapter.
(2) The parties shall immediately provide to the State Board
written notice of the mediation agreement or final decision.
(3) The provisions of this chapter do not extend any filing
deadlines for any appeals filed with the State Board pursuant to COMAR
13A.01.05.
.05 Response to Complaints.
A. Upon receiving a complaint, the Department shall provide
written notice of the complaint to the program or school that is the subject of
the complaint and, if applicable, the county board in which the program or
school is located.
B. Within 30 days of receipt of written notice of the complaint,
the county board, program, or school shall submit a written response to the
Superintendent setting out its position.
C. The response shall contain the following information:
(1) A statement of facts relevant to the complaint;
(2) An argument on each allegation raised in the complaint,
including citations of authority, reference to relevant legal principles, and
reference to pages of documents and exhibits relied upon, if any;
(3) A statement of the relief requested; and
(4) Any supporting documents, exhibits, or affidavits.
.06 Department Response.
A. The Superintendent is authorized to enforce this chapter
consistent with Education Article, §§2-303(b) and 26-701
et seq., Annotated Code of Maryland.
B. Calculating Deadlines. The last day of the period of time
prescribed by any regulation of this chapter shall be included, unless it is a
Saturday, Sunday, or a State legal holiday, in which event the period ends on
the next day which is not a Saturday, Sunday, or State legal holiday.
C. Mediation.
(1) Within 5 days of receiving the response from the county
board, program, or school, the Department shall contact the parties and
determine if the parties are willing to attempt mediation of an agreement
between the complainant and the respondent to remedy and eliminate the alleged
discrimination.
(2) Mediation is a voluntary process for each of the parties.
(3) If the parties are agreeable to mediation of the complaint,
the Department will refer the complaint to the Office of Administrative
Hearings for mediation to be completed within 60 days of the filing of the
complaint.
(4) Mediation procedures shall be in accordance with the
Administrative Procedure Act, State Government Article, Title 10, Subtitle 2,
Annotated Code of Maryland, and COMAR 28.02.01.18.
(5) If mediation is successful, the Superintendent shall issue a
written statement to both parties of the mediation findings and agreement,
including the timeline within which any agreed actions must be taken.
(6) If a mediation agreement is not reached within the 60-day
time period, the parties shall give written notice to the Superintendent.
D. Superintendent’s Decision.
(1) The Superintendent shall make a decision based on the
filings with the Department unless additional information is requested by the
Department from either of the parties.
(2) Before issuing a decision, the Superintendent may request
the parties to present additional documents, answer any questions, or present
oral argument.
(3) Within 120 days after the complaint is filed, the
Superintendent shall issue a written decision, including:
(a) Findings of fact;
(b) Conclusions of law; and
(c) Notice of appeal rights, including any deadlines for filing
an appeal.
(4) If the Superintendent finds that a county board, program, or
school has violated Education Article, §26-704, Annotated Code of Maryland, the
decision shall specify:
(a) Any actions required to remedy or eliminate the
discrimination, including the timeline within which the actions must be taken;
and
(b) Notification of how to reopen any complaint to remedy or
eliminate the discrimination required by the Superintendent’s final decision.
(5) The Superintendent’s decision may require the Comptroller to
withhold funding from the county board, program, or school in an amount to be
determined by the Superintendent in accordance with Education Article,
§2-303(b), Annotated Code of Maryland.
(6) If the Superintendent does not issue a decision within the 120-day
time period, the complainant may appeal to the Office of Administrative
Hearings as described in Regulation .07 of this chapter.
E. Reopening Complaints.
(1) A complainant alleging that a county board, program, or
school did not remedy or eliminate the discrimination as agreed in mediation or
required by the Superintendent’s decision may reopen a complaint previously
made without having to file a new complaint or engaging in mediation.
(2) If the Superintendent finds that a county board, program, or
school did not remedy or eliminate the discrimination as agreed or required by
the Superintendent’s decision, the Superintendent shall issue an updated
written decision to both parties requiring the Comptroller to withhold funding
from the county board, program, or school in an amount determined by the
Superintendent in accordance with Education Article, §2-303(b), Annotated Code
of Maryland.
.07 Appeals.
A. The Superintendent
has delegated authority to administrative law judges of the Office of
Administrative Hearings to make the final administrative decision on the appeal
of the Superintendent’s decision in a complaint brought under this chapter.
B. Hearing Requests.
(1) Either party may
appeal the Superintendent’s decision to the Office of Administrative Hearings
by filing a request for hearing with the Department.
(2) The hearing request:
(a) Shall be filed within 10 days from the date notice of the Superintendent’s
decision is sent to the party; or
(b) If the Superintendent does not issue a decision within the 120-day
time period required by Regulation .06D(3) of this chapter, may be filed within
130 days after the complaint is filed.
(3) If the subject of the
Superintendent’s decision is also before the State Board on an appeal filed
pursuant to COMAR 13A.01.05 as described in Regulation .04H of this chapter,
the party shall choose between:
(a) Filing a request
for a hearing to appeal the Superintendent’s decision to the Office of
Administrative Hearings and withdrawing the State Board appeal; or
(b) Pursuing the appeal
before the State Board pursuant to COMAR 13A.01.05 and foregoing a hearing
request to appeal the Superintendent’s decision.
(4) The hearing request
shall state:
(a) The name and
address of the parties and any representatives of the parties; and
(b) The date of the
Superintendent’s decision.
(5) The Superintendent
and the Department may not participate as a party in an appeal.
(6) The Department
shall forward a hearing request to the Office of Administrative Hearings within
5 days of the filing date.
C. Hearing Procedures.
(1) Except as otherwise provided in this chapter, hearing procedures shall be in accordance with the
Administrative Procedure Act, State Government Article, Title 10, Subtitle 2,
Annotated Code of Maryland, and COMAR 28.02.
(2) The party filing the appeal and request for a hearing shall
have the burden of proof by a preponderance of the evidence.
(3) The appeal hearing shall be held in the county where the
alleged discrimination occurred.
D. The administrative law judge shall issue, by regular mail, a
decision and order to the parties stating:
(1) Findings of fact;
(2) Conclusions of law; and
(3) If the administrative law judge finds that the respondent
has violated Education Article, §26-704, Annotated Code of Maryland, a
directive:
(a) To cease and desist from engaging in the discrimination; and
(b) To take any affirmative action necessary to effectuate the
purposes of Education Article, §26-701 et seq., Annotated Code of Maryland.
E. A decision by an administrative law judge of the Office of
Administrative Hearings in an appeal under this chapter is the final
administrative decision and may be appealed to the circuit court pursuant to
State Government Article, §10-222, Annotated Code
of Maryland.
MOHAMMED CHOUDHURY
State Superintendent of
Schools
Subtitle 01 PRESCRIPTION DRUG AFFORDABILITY BOARD
Authority: Health-General Article, §21-2C-03(f)(1), Annotated Code of Maryland
Notice of Proposed Action
[23-194-P]
The Maryland Prescription Drug Affordability Board proposes to amend
Regulation .01 and adopt new
Regulations .02—.05 under COMAR 14.01.01 General Provisions. This
action was considered and approved by the Maryland Prescription Drug
Affordability Board at a public meeting held on July 24, 2023, notice of which
was provided by publication on the PDAB’s website at
https://pdab.maryland.gov/2023_board_meeting.html, as required under General
Provisions Article, §3-302(c), Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to establish necessary definitions and procedures for calculating time periods, managing open meetings, handling confidential, trade-secret, and proprietary information, and facilitating public comment.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
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 pdab.regs@maryland.gov. Comments will be accepted through October 23, 2023. A public hearing has not been scheduled.
Open Meeting
Final action on the proposal will be considered by Maryland Prescription Drug Affordability Board during a public meeting to be held on November 27, 2023 at 2 p.m., at an online venue. You may register to attend the meeting and obtain a link and call-in information here: https://us02web.zoom.us/meeting/register/tZUlf--grT4jGdWgYmdCdZSGf_TQoZjsfxcX.
.01 Definitions.
A. (text unchanged)
[B.] (proposed for repeal)
B. Terms Defined.
(1) “Abbreviated new drug
application (ANDA)” means a submission to the FDA for the review and potential
approval for marketing of a generic drug product, including bioequivalence
data, as defined in 21 CFR §314.3 and described under 21 CFR §314.50.
(2) “Accelerated approval”
means the FDA drug approval process defined in 21 U.S.C. §356(c)(1)(A).
(3) “Active ingredient” means
a component of a drug that is intended to provide pharmacological activity or
other direct effect in the diagnosis, cure, mitigation, treatment, or
prevention of disease, or to affect the structure or any function of the body,
as defined in 21 CFR §314.3.
(4) “Active moiety” means the
molecule or ion responsible for the physiological or pharmacological action of
the drug substance, excluding those appended portions of the molecule that
cause the drug to be an ester, salt, or other noncovalent derivative of the
molecule, as defined in 21 CFR §314.3.
(5) “Average cost share”
means the sum of the cost share of a prescription drug product for each patient,
divided by the number of patients.
(6) “Average payor cost per
patient” means the sum of the total dollars paid by all payors over the most
recent calendar year, divided by the number of patients.
(7) “Average sales price
(ASP)” has the meaning stated in 42 U.S.C §1395w-3a(c)(1).
(8) “Average total
out-of-pocket cost” means the sum of all patient total out-of-pocket costs,
divided by the number of patients.
(9) “Average wholesale price
(AWP)” means the average suggested price paid by a retailer to buy a drug from
a wholesaler, excluding price concessions, discounts, and rebates.
(10) “Biologic” means a
biological product, as defined in 42 U.S.C. §262(i)(1).
(11) “Biologics license
application (BLA)” means a request to the FDA to introduce, or deliver for
introduction, a biological product, as defined in 21 CFR §600.3(h), into
interstate commerce, as regulated under 21 CFR §600-680.
(12) “Biosimilar” means a biological
product, as defined in 42 U.S.C. §262(i)(2), that is produced or distributed in
accordance with a biologics license application approved under 42 U.S.C.
§262(k)(3).
(13) “Board” has the meaning
stated in Health-General Article, §21-2C-01, Annotated Code of Maryland.
(14) “Board staff” means an
employee of the Board or a qualified independent third party that has
contracted with the Board and is subject to a nondisclosure or confidentiality
agreement.
(15) “Brand name drug” has
the meaning stated in Health-General Article, §21-2C-01, Annotated Code of
Maryland.
(16) “Carrier” has the
meaning stated in Health-General Article, §19-132, Annotated Code of Maryland.
(17) “Chair” means the chair
of the Board, as provided in Health-General Article, §21-2C-03, Annotated Code
of Maryland.
(18) “Coinsurance” means the
percentage of costs paid by the patient after meeting the deductible.
(19) “Consumer Price Index
for All Urban Consumers (CPI-U)” means the measure of the average change over
time in the prices paid by urban consumers for a defined market basket of
consumer goods and services.
(20) “Copayment” means the
set dollar amount that a patient pays for prescriptions or services covered by
the patient’s health insurance, separate from the deductible.
(21) “Cost share” means the
patient total out-of-pocket costs divided by gross spending.
(22) “Deductible” means the
set amount a patient pays for health and medical services and products each
calendar year before a health insurance plan begins to provide coverage,
usually expressed in dollars.
(23) “Discount” means a
monetary adjustment that reduces the price paid or dollar amount received by an
entity engaging in a prescription drug transaction that occurs during the
prescription drug transaction as reflected on the invoice.
(24) “Disease burden” means
the impact of a health condition measured by financial cost, mortality,
morbidity, severity, and epidemiological indicators.
(25) “Drug class” means the
grouping of medications based on a common active ingredient, or ingredients, or
by pharmacologic or therapeutic class.
(26) “Drug-specific patient
access program” means a program designed to provide a patient with assistance
in affording a prescription drug or paying for a prescription drug, including
but not limited to the provision of a drug to a patient, coupons supplied by
the manufacturer, donations to a nonprofit or foundation associated with the
manufacturer, and donations to an independent nonprofit that are earmarked
expressly for the manufacturer’s drugs.
(27) “Federal Supply Schedule
(FSS)” means the drug pricing program under the collection of multiple award
contracts used by federal agencies, U.S. territories, Indian tribes, and other
specified entities to purchase supplies and services from outside vendors.
(28) “Food and Drug
Administration (FDA)” means the federal agency of the U.S. Department of Health
and Human Services tasked with protecting and promoting public health through
the control and supervision of food safety, tobacco products, dietary
supplements, prescription and over-the-counter pharmaceutical drugs, vaccines,
biopharmaceuticals, medical devices, and certain other consumer products.
(29) “Formulary” has the
meaning stated in Insurance Article, §15-1601, Annotated Code of Maryland.
(30) “Fund” means the
Prescription Drug Affordability Fund, as provided for in Health-General
Article, §21-2C-11, Annotated Code of Maryland.
(31) “Generic drug” has the
meaning stated in Health-General Article, §21-2C-01, Annotated Code of Maryland.
(32) “Gross spending” means
the sum of all monies paid for a prescription drug product for an individual
patient in a calendar year.
(33) “Health economics and
outcomes research” means the form of economic analysis that compares the
relative costs and outcomes of different treatments, such as cost effectiveness
analysis, comparative effectiveness research, health economic information
analysis, and health technology assessments.
(34) “Health maintenance
organization (HMO)” has the meaning stated in Health-General Article, §19-701,
Annotated Code of Maryland.
(35) “Indication” means
labeling that discusses the disease or condition the drug product is intended
to diagnose, treat, prevent, cure, or mitigate, including a description of the
patient population.
(36) “Insurance benefit
design” means the rules that determine the services covered by the plan and any
other cost-sharing measures.
(37) “Managed care
organization (MCO)” has the meaning stated in Health-General Article,
§15-102.4, Annotated Code of Maryland.
(38) “Manufacturer” has the
meaning stated in Health-General Article, §21-2C-01, Annotated Code of
Maryland.
(39) “Maryland Medical Care
Database (MCDB)” means the database established and maintained by the Maryland
Health Care Commission pursuant to Health-General Article, §19-133, Annotated
Code of Maryland.
(40) “Medicaid” means the
public health program jointly administered by the federal government and states
that primarily serves low-income people (children, parents, and, in certain
states, other adults) and some medically needy patients.
(41) “Medicare” means the
health insurance program administered by the federal government for people 65 years
old or older or with certain disabilities.
(42) “National average drug
acquisition cost (NADAC)” means the pricing benchmark calculated from the
Centers for Medicare & Medicaid Services’ (CMS) monthly surveys of retail
pharmacies that reflects the average price pharmacies pay to acquire a drug
from a wholesaler or manufacturer, excluding subsequent discounts or rebates
from manufacturers to wholesalers or pharmacies.
(43) “National Drug Code
(NDC)” means the unique three-segment number used for identification and
reporting as set forth in 21 CFR §207.33.
(44) “Net cost” means the
per-unit cost paid by payors of a drug after accounting for all price
concessions, discounts, and rebates.
(45) “Net price” means the
per-unit amount received by manufacturers of a drug after accounting for price
concessions, discounts, and rebates.
(46) “New drug application (NDA)”
means a submission to the FDA for the review and potential approval for
marketing of a drug product, which includes chemical, pharmacological, medical,
biopharmaceutical, and statistical data, as defined in 21 CFR §314.3 and
described under 21 CFR §314.50.
(47) “Other cost-sharing”
means a program, benefit design, or other mechanism that determines a patient’s
responsibility for a prescription drug product, such as a copayment,
coinsurance, deductible, formulary, or other management tool.
(48) “Out-of-pocket costs”
means the expenses for medical care, including prescription drug therapy, that
are not reimbursed by insurance and are paid by a patient, including
copayments, coinsurance, and deductibles for covered services, and the costs
for all non-covered services.
(49) “Patient total
out-of-pocket costs” means the sum of a patient’s out-of-pocket costs,
including items such as copayments, coinsurance, and deductibles, in a calendar
year.
(50) “Payor” means the entity
other than the patient that is responsible for paying for health care costs,
including health insurance carriers, health plan sponsors, PBMs, Medicare,
Medicaid, MCOs, and HMOs.
(51) “Person” means an
individual, limited liability company, partnership, corporation, association,
county, and public or private organization of any character other than an
agency.
(52) “Pharmacy benefit
manager (PBM)” means a third-party administrator of prescription drug programs
as stated in Insurance Article, §15-1601, Annotated Code of Maryland.
(53) “Prescription drug
product” has the meaning stated in Health-General Article, §21-2C-01, Annotated
Code of Maryland.
(54) “Price concession” means
a mechanism other than a rebate or discount that reduces the price paid by a
payor.
(55) “Proprietary” means something
that is used, produced, or marketed under the exclusive legal right of the
inventor, maker, or owner.
(56) “Rebate” means a
monetary adjustment that reduces the price paid or dollar amount received by an
entity engaging in a prescription drug transaction that occurs after the
prescription drug transaction.
(57) “Regulatory exclusivity”
means any exclusive marketing rights or data exclusivity rights conferred by
the FDA with respect to a pharmaceutical product other than patents, including
but not limited to 180-day exclusivity, orphan drug exclusivity, new chemical
entity exclusivity, data exclusivity, and pediatric exclusivity.
(58) “Stakeholder Council”
means the Prescription Drug Affordability Stakeholder Council, as provided for
in Health-General Article, §21-2C-04, Annotated Code of Maryland.
(59) “Standard medical
practice” means the customary treatment by medical professionals:
(a) Based on credible
scientific evidence published in peer reviewed medical literature generally
recognized by the relevant medical community;
(b) Consistent with physician
specialty society recommendations; or
(c) Consistent with the views
of physicians practicing in the relevant clinical areas.
(60) “State actual
acquisition cost (SAAC)” has the meaning stated in COMAR 10.09.03.01B(42).
(61) “Therapeutic
alternative” means a drug product that has the same or similar indications for
use as a particular drug but is not a therapeutic equivalent to that drug.
(62) “Therapeutic class”
means a group of drugs containing active moieties that share scientifically
documented properties and are defined on the basis of any combination of three
attributes: mechanism of action, physiologic effect, and chemical structure.
(63) “Therapeutic equivalent”
has the meaning stated in 21 CFR §314.3.
(64) “Total gross spending”
means the sum of all monies paid for a prescription drug product in a calendar
year.
(65) “Total patient
out-of-pocket cost” means the sum of all patient out-of-pocket costs in a
calendar year, including items such as copayments, coinsurance, and
deductibles.
(66) “Trade secret” has the
meaning stated in Commercial Law Article, §11-1201, Annotated Code of Maryland.
(67) “Wholesale acquisition
cost (WAC)” means the manufacturer’s list price for a prescription drug product
to wholesalers or direct purchasers in the United States, not including prompt
pay or other discounts, rebates, or reductions in price, as reported in a
wholesale price guide or other publication of prescription drug product pricing
data.
(68) “Wholesale distributor”
has the meaning stated in Health Occupations Article, §12-6C-01, Annotated Code
of Maryland.
.02 Rules of Construction.
A. Singular and Plural. In
interpreting and applying this subtitle, the singular includes the plural.
B. Computation of Time.
(1) In computing a period of
time prescribed by this subtitle or an applicable statute, after a day, act, or
event occurs, the following rules apply:
(a) The day of the act,
event, or default after which the designated period of time begins to run is
not included;
(b) If the period of time
allowed is more than 7 days, intermediate Saturdays, Sundays, and legal
holidays are counted;
(c) If the period of time
allowed is 7 days or less, intermediate Saturdays, Sundays, and legal holidays
are not counted; and
(d) The last day of the
computed period is included unless it is a Saturday, Sunday, or legal holiday,
in which event the period runs until the end of the next day that is a work
day.
(2) In computing a period of
time prescribed by this subtitle or an applicable statute, before a day, act,
or event occurs, the following rules apply:
(a) In determining the latest
day for performing an act that is required to be performed a prescribed number
of days before a certain day, act, or event, all days preceding that day,
including intervening Saturdays, Sundays, and legal holidays, are counted in
the number of days so prescribed; and
(b) The latest day is
included in the determination unless it is a Saturday, Sunday, or legal
holiday, in which event the latest day is the first preceding day that is a
work day.
.03 Open Meetings.
A. Public Attendance.
(1) The general public is
invited to attend and observe an open session of the Board.
(2) A member of the public
attending an open session may not participate in the session, except when:
(a) The Board expressly
invites public testimony, questions, comments, or other forms of public
participation; or
(b) Public participation is
otherwise authorized by law or regulation.
(3) The Chair, or the Chair’s
designee, may extend or waive any time requirement in this regulation.
B. Public Comments. A member
of the public may provide oral public comment and written public comment in
accordance with Regulation .05 of this chapter.
C. Disruptive Conduct.
(1) An individual attending
an open session of the Board may not engage in any conduct, including visual
demonstrations such as waving of placards, signs, or banners, that disrupts the
session or that interferes with the right of members of the public to attend
and observe the session.
(2) Restoring Order. The
presiding officer or Chair may:
(a) Order an individual who
persists in conduct prohibited by §C(1) of this regulation, or who has violated
any other regulation concerning the conduct of the open session, to be removed
or disconnected from the session, and may request police assistance to restore
order; and
(b) Recess the session while
order is restored.
.04 Confidential,
Trade-Secret, and Proprietary Information.
A. Collection of Records and
Information.
(1) Identification.
(a) A person submitting
information, including data and records, for the Board’s consideration under
this subtitle and Health-General Article, Title 21, Subtitle 2C, Annotated Code
of Maryland, shall:
(i) Clearly designate the
specific information the person considers to be confidential, trade-secret, or
proprietary; and
(ii) Submit a form certifying
that the information so designated is not otherwise publicly available and has
been handled and maintained to preserve its confidential, trade-secret, or
proprietary nature.
(b) The Board may also
determine that information it has received is confidential, trade-secret, or
proprietary.
(c) The Board may seek
additional information regarding whether the information is confidential,
trade-secret, proprietary, or not otherwise publicly available from:
(i) The person submitting the
information; or
(ii) To the extent the Board
is able to determine who created the document or information, the person who
created the document or information.
(2) Designation. The
information and data obtained by the Board under this subtitle and
Health-General Article, Title 21, Subtitle 2C, Annotated Code of Maryland, that
is not otherwise publicly available, is:
(a) Considered to be a trade
secret and confidential and proprietary information; and
(b) Is not subject to
inspection or disclosure under the Public Information Act.
B. Management of Information
Received by the Board.
(1) Access to Information.
(a) Confidential,
trade-secret, or proprietary information obtained by the Board under this subtitle
and Health-General Article, Title 21, Subtitle 2C, Annotated Code of Maryland,
may be accessed only by:
(i) Board members; and
(ii) Board staff including a
qualified independent third party that has contracted with the Board and is
subject to a nondisclosure agreement prohibiting disclosure of such
information.
(b) A person with access to
confidential, trade-secret, or proprietary information shall maintain the
confidentiality of the information in accordance with State Government Article,
§10-617, and Health-General Article, §21-2C-10, Annotated Code of Maryland.
(2) Consideration by Board.
(a) The Board may discuss
confidential, trade-secret, and proprietary information in a closed session.
(b) The Board may not
disclose confidential, trade-secret, or proprietary information in an open
meeting, its public meeting materials, or its summary report of a cost review
study.
.05 Public Comment
Procedures.
A. Public Oral Comments for a
Board Meeting.
(1) A member of the public
may register to provide oral comments at a Board meeting by:
(a) Submitting a written
notice that:
(i) Contains the individual’s
name and email address or phone number;
(ii) Identifies whether the
individual is affiliated with or commenting on behalf of an organization,
agency, employer, or other entity; and
(iii) Identifies the agenda
item the individual wishes to address; and
(b) Submitting the written
notice to the Board at least 2 work days before the scheduled meeting.
(2) Oral comments shall be made to the Board in
open session.
B. Public Written Comment
Procedures.
(1) General Procedures.
(a) Unless expressly
exempted, these provisions apply to all written public comments.
(b) Except as provided in
§B(5) of this regulation, a member of the public may submit written comments to
the Board by email, courier, or postal service.
(c) An individual submitting
comments on behalf of an organization, agency, employer, or other entity shall:
(i) Submit the comments on
the letterhead of the organization, agency, employer, or other entity; or
(ii) Disclose in writing the
organization, agency, employer, or other entity with which the individual is
affiliated;
(d) Written comments received
by the date prescribed by regulation or set by the Board will be:
(i) Shared with the Board;
(ii) Where applicable, made
part of the record on the issue or matter before the Board where applicable; and
(iii) Posted on the Board’s
website.
(e) Board staff shall redact
sociological information prior to posting the written comments on the Board
website.
(2) Public Written Comments
for a Board Meeting.
(a) A member of the public
may submit written comments concerning any agenda item of the Board or any
decision pending before the Board in accordance with the procedures in §B(1)
and (5) of this regulation.
(b) Written comments received
more than 2 work days before the scheduled Board meeting will be shared with
the Board prior to the Board meeting.
(c) Written comments received
less than 2 work days before the scheduled Board meeting will be shared with
the Board and posted on the Board’s website after the scheduled meeting.
(d) Written comments received
less than 2 work days before the scheduled Board meeting may be considered at
the next Board meeting if the issue, matter, or decision is still pending.
(3) Public Written Comments
Authorized by Regulation. If a
regulation expressly provides for public written comment, a member of the
public may submit written comments to the Board within the time period
prescribed by regulation in accordance with the procedures in §B(1) and (5) of
this regulation.
(4) Public Written Comments
Requested by the Board. If the Board requests public comment by posting notice
of the request and a due date on its website, a member of the public may submit
written comments to the Board within the time period prescribed by the notice
in accordance with the procedures in §B(1) and (5) this regulation.
(5) Public Written Comments
Containing Confidential, Trade-Secret, and Proprietary Information.
(a) A member of the public
that wishes to submit written comments or attachments to written comments that
contain confidential, trade-secret, and proprietary information shall:
(i) Redact the specific
information the person considers to be confidential, trade-secret, or
proprietary from the written comments and attachments;
(ii) Submit a form certifying
that the redacted information is not otherwise publicly available and has been
handled and maintained to preserve its confidential, trade-secret, or
proprietary nature;
(iii) Submit the redacted
comments and attachments to the Board by email, courier, or postal service; and
(iv) Submit the unredacted
comments and attachments to the Board in paper form using a tracked common
carrier, courier, or postal service, or electronically using secure file
transfer.
(b) The Board and Board staff
shall use, protect, and manage written comments and attachments containing
confidential, trade-secret, and proprietary information in compliance with
Regulation .04 of this chapter and Health-General Article, §§21-2C-03 and
21-2C-10, Annotated Code of Maryland.
ANDREW W. YORK
Executive Director
Subtitle 01 PRESCRIPTION DRUG AFFORDABILITY BOARD
14.01.04 Cost Review Study Process
Authority: Health-General
Article, §§21-2C-03(f)(1), 21-2C-08(b), and
21-2C-09, Annotated Code of Maryland
Notice of Proposed Action
[23-195-P]
The Maryland Prescription Drug Affordability Board proposes to adopt
new Regulations .01—.05 under a new
chapter, COMAR 14.01.04 Cost Review
Study Process. This action was considered and approved by the Maryland
Prescription Drug Affordability Board at a public meeting held on July 24,
2023, notice of which was provided by publication on the PDAB's website at
https://pdab.maryland.gov/2023_board_meeting.html, as required under General
Provisions Article, §3-302(c), Annotated Code of Maryland.
Statement of Purpose
The purpose of this action is to establish procedures to identify drugs that may create affordability challenges, refer drugs to the Stakeholder Council for consideration and comment, obtain public input at multiple points through the process, select a drug or drugs for cost review, request information to conduct the cost review, conduct a cost review study, and adopt a written report of that study.
Estimate of Economic Impact
The proposed action has no economic impact.
Economic Impact on Small Businesses
The proposed action has minimal or no economic impact on small businesses.
Impact on Individuals with Disabilities
The proposed action has no impact on individuals with disabilities.
Opportunity for Public Comment
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 pdab.regs@maryland.gov. Comments will be accepted through October 23, 2023. A public hearing has not been scheduled.
Open Meeting
Final action on the proposal will be considered by Maryland Prescription Drug Affordability Board during a public meeting to be held on November 27, 2023, at 2 p.m., at an online venue. You may register to attend the meeting and obtain a link and call-in information here: https://us02web.zoom.us/meeting/register/tZUlf--grT4jGdWgYmdCdZSGf_TQoZjsfxcX.
.01 Public Reporting of Drug
Affordability Issues.
A. Individual members of the
public may report their personal experience with a drug or drugs that have
caused or are causing an affordability issue for the individual.
B. Individuals may report a
drug:
(1) By completing the form available
on the Board’s website electronically; or
(2) By downloading or
obtaining the form from the Board, completing the form, and submitting it to
the Board.
C. Blank forms may be
requested by contacting the Board by email or phone.
.02 Identifying Drugs
Eligible for Cost Review.
A. The Board shall apply the
metrics specified in Health-General Article, §21-2C-08(c), Annotated Code of
Maryland, and this regulation to the following data sets to identify drugs
eligible for selection for a cost review study:
(1) The claims data in the
MCDB;
(2) Available subsets of
claims data in the MCDB, such as the commercial market, Medicaid, and Medicare;
and
(3) The data obtained from
governmental and commercial databases, other databases, and other data sets as
available.
B. The Board may identify the
prescription drug products that meet these statutory metrics and regulatory
criteria on at least an annual basis.
C. Data Management.
(1) For any metric requiring
adjustment for inflation, the adjustment for inflation shall be based on the
Consumer Price Index for All Urban Consumers (CPI-U) as reported by the U.S.
Bureau of Labor Statistics.
(2) For any data-based
metric, the Board may account for data errors and outliers.
D. To the extent practicable,
and in addition to the statutory metrics set forth in Health-General Article,
§21-2C-08(c), Annotated Code of Maryland, the Board may consider the following
additional metrics and criteria to identify prescription drug products eligible
for selection for a cost review study:
(1) Aggregated Spending and
Pricing Data:
(a) The 100 prescription drug
products with the highest total gross spending in the most recent available
calendar year;
(b) The 100 prescription drug
products with the highest total gross spending per patient in the most recent
available calendar year;
(c) The 100 prescription drug
products with the highest percent change increase in WAC over the most recent
available calendar year;
(d) The 100 prescription drug
products with the highest percent change increase in WAC over the most recent
available 5-year period;
(e) The 100 prescription drug
products with the highest dollar increase in WAC per year or course of
treatment over the most recent available calendar year;
(f) The 100 prescription drug
products with the highest dollar increase in WAC over the most recent available
5-year period; and
(g) The 100 prescription drug
products with the highest percent change increase in total gross spending;
(2) Patient Out-of-Pocket
Costs:
(a) The 100 prescription drug
products with the highest patient total out-of-pocket costs in the most recent
available calendar year;
(b) The 100 prescription drug
products with the highest average patient total out-of-pocket costs in the most
recent available calendar year;
(c) The 100 prescription drug
products ranked at the 50th percentile for patient total out-of-pocket costs in
the most recent available calendar year; and
(d) The 100 prescription drug
products ranked at the 90th percentile for patient total out-of-pocket costs;
and
(3) Any prescription drug
product added by the Board to the list of prescription drug products eligible
for cost review under this regulation.
E. At an open meeting, a
Board member may propose one or more additional prescription drug products for
inclusion on the list of drugs eligible for cost review by:
(1) Moving that the
prescription drug product or products be added to the eligible list; and
(2) Identifying how the
prescription drug product or products may create affordability challenges for
the State health care system or patients.
F. After discussion at an
open meeting, the Board may vote to add one or more prescription drug products
to the list of drugs eligible for selection for a cost review study.
.03 Selecting Drugs for Cost
Review.
A. Board staff may provide
the Board with a dashboard containing the prescription drug products identified
under the statutory metrics and regulatory criteria in Regulation .02 of this
chapter.
B. To the extent practicable,
Board staff may provide the following information for each prescription drug
product in the dashboard:
(1) FDA Approval:
(a) The date the FDA first
approved the prescription drug product;
(b) If applicable, the date
the last patent expired or will expire;
(c) Whether the prescription
drug product was approved through an FDA accelerated approval pathway; and
(d) Whether the prescription
drug product is designated by the Secretary of the FDA, under 21 U.S.C. §360bb,
as a drug for a rare disease or condition;
(2) Therapeutic Class:
(a) The class of the
prescription drug product as identified in a recognized classification system;
(b) Whether the prescription
drug product is the only prescription drug product in its class;
(c) Any therapeutic
equivalent prescription drug product identified by examination of the FDA
Orange Book, FDA Purple Book, or other therapeutic equivalence databases; and
(d) The availability and
number of therapeutic equivalents for sale in the State;
(3) Utilization, Spending and
Price Data:
(a) The patient count for the
prescription drug product in the most recent available calendar year;
(b) The total gross spending
for the prescription drug product in the most recent available calendar year;
(c) The total gross spending
per patient for the prescription drug product in the most recent available
calendar year;
(d) The WAC on January 1 of
the current calendar year, on January 1 of the previous calendar year, and at
launch of the product;
(e) The percent increase in
WAC of the prescription drug product over the most recent available calendar
year;
(f) The percent increase in
WAC of the prescription drug product over the most recent available 5-year
period;
(g) The dollar increase in
WAC over the most recent available calendar year;
(h) The dollar increase in
WAC over the most recent available 5-year period;
(i) The dollar increase in
WAC per year or course of treatment over the most recent available calendar
year;
(j) The percent increase in
overall total gross spending for the prescription drug product in the most
recent available calendar year;
(k) The estimated percentage
of manufacturer national net sales to gross sales of a prescription drug
product for the most recently reported year;
(l) The average payor cost
per patient for the prescription drug product in the most recent available
calendar year; and
(m) The average cost share
for the prescription drug product;
(4) Patient Out-of-Pocket:
(a) The total patient
out-of-pocket cost for the prescription drug product in the most recent
available calendar year;
(b) The average total
out-of-pocket costs in the most recent available calendar year;
(c) Patient total
out-of-pocket costs ranked at the 50th percentile in the most recent available
calendar year; and
(d) Patient total
out-of-pocket costs ranked at the 90th percentile in the most recent available
calendar year;
(5) Whether the prescription
drug product is currently in active shortage status; and
(6) Whether the prescription
drug product is currently subject to or has been subject to the Medicare Drug
Price Negotiation Program, under the Inflation Reduction Act (IRA) (Public Law
117-169).
C. Selecting Drugs for
Referral to Stakeholder Council.
(1) The Board may select one
or more prescription drug products identified in Regulation .02 of this chapter
as eligible for cost review to refer to the Stakeholder Council.
(2) Prior to a Board meeting,
a Board member may request that a prescription drug product or products be
placed on the Board’s meeting agenda for consideration for referral to the
Stakeholder Council by submitting the proprietary drug name or nonproprietary
name, as applicable, and NDC to the Board Chair in writing.
(3) The Board Chair may
include the prescription drug product name and dose on the Board’s agenda.
(4) The public may provide
oral and written comments concerning the drugs proposed for referral to the
Stakeholder Council and identified on the meeting agenda in accordance with the
procedures and timelines in COMAR 14.01.01.05A and B(2).
(5) Notwithstanding the
pre-meeting identification of drugs for consideration, the Board may consider
any drug identified in Regulation .02 of this chapter for referral to the
Stakeholder Council.
(6) At an open meeting, the
Board may:
(a) Consider the prescription
drug products identified on the Board’s agenda and any eligible drug proposed
for consideration by a Board member at the meeting; and
(b) Select one or more
prescription drug products by NDC to refer to the Stakeholder Council to
receive input from the Stakeholder Council on the selection of prescription
drug products for cost review.
D. In selecting one or more
prescription drug products to refer to the Stakeholder Council, the Board may
consider:
(1) The prescription drug
products identified under the statutory metrics and regulatory criteria in
Regulation .02 of this chapter;
(2) The information provided
under §B this regulation;
(3) The average cost share of
the prescription drug product, the average patient total out-of-pocket cost,
and the average total payor cost; and
(4) Any written or oral
public comment.
E. The Board shall post
notice of the prescription drug products referred to the Stakeholder Council on
its website.
F. The public may provide
written comments concerning the list of prescription drug products referred to
the Stakeholder Council by:
(1) Complying with the
procedures in COMAR 14.01.01.05B(3); and
(2) Submitting the written
comments to the Board within 30 calendar days of the date the list is posted on
the Board’s website.
G. Stakeholder Council Input.
(1) To the extent
practicable, the Board may provide the Stakeholder Council with:
(a) The information set forth
in §B of this regulation;
(b) Whether the prescription
drug product was reported by an individual member of the public; and
(c) Whether the prescription
drug product was added by the Board for consideration under Regulation .02 of
this chapter.
(2) To the extent
practicable, the Stakeholder Council shall:
(a) Review the information
provided for each referred prescription drug product; and
(b) Discuss the referred
prescription drug products at an open meeting.
(3) Board staff may present
the Stakeholder Council input discussed at the open meeting to the Board.
H. Therapeutic Alternatives.
(1) Board staff may develop a
list of therapeutic alternatives for each prescription drug product referred to
the Stakeholder Council.
(2) Board staff shall post a
list of therapeutic alternatives developed by staff on the Board’s website for
comment.
(3) The public may provide
written comments concerning the list of therapeutic alternatives by:
(a) Complying with the
procedures in COMAR 14.01.01.05B(3); and
(b) Submitting the written
comments to the Board within 30 calendar days of the date the list is posted on
the Board’s website.
(4) Board staff may modify
the list of therapeutic alternatives for consideration by the Board.
(5) The Board shall determine
the therapeutic alternatives for each prescription drug product selected for a
cost review study.
I. Board Selection of Drugs
for Cost Review.
(1) At an open meeting, the
Board may select one or more prescription drug products for a cost review
study.
(2) The public may provide
oral and written comments concerning the selection of a prescription drug
product for cost review in accordance with the procedures and timelines in
COMAR 14.01.01.05A and B(2).
(3) In selecting a
prescription drug product for cost review, the Board shall consider:
(a) The prescription drug
products referred to the Stakeholder Council from the prescription drug
products identified under the statutory metrics and regulatory criteria in
Regulation .02 of this chapter and the information provided under §B of this
regulation;
(b) The average cost share of
the prescription drug product, the average patient total out-of-pocket cost,
the average total payor cost, and publicly available data on direct-to-consumer
advertising spending for the prescription drug product;
(c) Input from the
Stakeholder Council provided under §G of this regulation; and
(d) Input from the public
provided under COMAR 14.01.01.05.
(4) During an open meeting,
the Board may select one or more prescription drug products for cost review
under Regulation .05 of this chapter and provide notice of the selection on its
website within 3 work days of the meeting.
(5) The prescription drug
product shall be identified by:
(a) NDC;
(b) ANDA, NDA, or BLA, as
applicable; and
(c) Active moiety or active
ingredient.
(6) If the Board selects a prescription
drug product for cost review, the Board may identify and approve all NDCs
marketed under the same ANDA, NDA, or BLA to be included in the cost
review.
(7) If the Board selects a
prescription drug product for cost review that is an unapproved generic within
the meaning of Health-General Article, §21-2C-01(f), Annotated Code of
Maryland, the Board may identify and approve all NDCs with the same active
moiety and manufacturer to be included in the cost review study.
(8) If the Board selects a prescription
drug product for cost review, the Board shall approve the therapeutic
alternatives to be used in conducting the cost review study.
.04 Request for Information
for Cost Review.
A. Request for Information.
(1) The Board shall post
notice of the prescription drug product or products selected for cost review
through the process outlined in Regulation .03I of this chapter on the Board’s
website.
(2) To the extent there is no
publicly available information to conduct an aspect of the statutory cost review,
the Board may request information to conduct a cost review study under
Health-General Article, §21-2C-09(a)(2), Annotated Code of Maryland, and this
regulation.
(3) The Board may request
information by sending an email or postal mail to the manufacturer, PBMs,
health insurance carriers, wholesale distributors, HMOs, and MCOs.
(4) The Board shall post
notice of the request for information on its website.
(5) An entity that has not
received a request for information from the Board may submit relevant information
in accordance with this regulation.
(6) Within 30 days of the
date the request for information is posted to the website or transmitted to the
entity, an entity may submit the information requested by the Board, and any
other relevant information, in accordance with §C of this regulation.
(7) An entity may request one
30-day extension of time to submit information under §A(6) of this regulation.
(8) An entity shall submit
the request for a 30-day extension to the Board in writing on or before the
expiration of the initial submission period.
B. For each prescription drug
product under review, the Board may request the following information from:
(1) Manufacturer:
(a) Documents and research
explaining the relationship between the pricing of the prescription drug
product and the cost of development, the relationship between the pricing of
the prescription drug product and the therapeutic benefit, and information that
is otherwise pertinent to the manufacturer’s pricing decision such as:
(i) Life cycle management;
(ii) Net average price in the
State; and
(iii) The estimated value or
cost-effectiveness of the prescription drug product;
(b) The total amount of the
price concessions, discounts, and rebates provided to each payor type operating
in the State;
(c) The total amount of the
price concessions, discounts, and rebates the manufacturer is expected to
provide to each payor type;
(d) The net price received by
manufacturers for the drug product in the State accounting for all price
concessions, discounts, and rebates;
(e) The units of the
prescription drug product sold in the State;
(f) The units of the
prescription drug product sold nationally;
(g) The total dollar amount
of sales of the prescription drug product into the State;
(h) The total dollar amount
of sales of the prescription drug product nationally;
(i) The invoice price per
unit for the prescription drug product charged to purchasers in the United
Kingdom, Germany, France, and Canada, reported in U.S. dollars;
(j) Prices charged to
purchasers in the State, including but not limited to pharmacies, pharmacy
chains, pharmacy wholesalers, and other direct purchasers;
(k) The average profit margin
of the prescription drug product over the prior 5-year period and the projected
profit margin anticipated for the current year for the prescription drug
product;
(l) Maryland and national
gross and net manufacturer revenues for the prescription drug product under
review for the most recent tax year;
(m) Information concerning all
authorized generics as defined by 42 CFR §447.502 for the prescription drug
product;
(n) Information concerning
all other ANDAs, BLAs, and NDAs that pertain to the same active moiety and the
same manufacturer;
(o) The manufacturer’s
research and development costs, as indicated on the manufacturer’s federal tax
filing or information filed with the Federal Securities and Exchange Commission
for the most recent tax year;
(p) The portion of
direct-to-consumer marketing costs eligible for favorable federal tax treatment
in the most recent tax year that are specific to the prescription drug product
under review; and
(q) Any additional factors or
information the manufacturer proposes that the Board consider.
(2) Health Insurance Carrier,
HMO, and MCO:
(a) The total amount of the
price concessions, discounts, and rebates the manufacturer provides to each
health plan operating in the State, expressed as a percent of the WAC;
(b) The average price
concession, discount, and rebate provided in the State for therapeutic
alternatives;
(c) Placement in each
formulary offered or administered in the State and the number of covered lives
for each formulary;
(d) Benefit design around the
prescription drug product, including copayment and coinsurance amounts in the
State;
(e) The net cost incurred by
the insurance carrier for the prescription drug product in the State; and
(f) Any additional factors or
information the health insurance carrier, HMO, or MCO proposes that the Board
consider.
(3) Pharmacy Benefits
Managers:
(a) The therapeutic
alternatives for the prescription drug product(s) under review identified by
each formulary administered by the PBM;
(b) The total amount of the
price concessions, discounts, and rebates the manufacturer provides to each PBM
operating in the State, expressed as a percent of the WAC;
(c) The average price
concession, discount, and rebate provided in the State for therapeutic
alternatives;
(d) Placement in each
formulary offered or administered in the State and the number of covered lives
for each formulary;
(e) Benefit design around the
prescription drug product, including copayment and coinsurance amounts;
(f) Maryland and national
gross and net PBM revenues for the prescription drug product under review for
the most recent tax year; and
(g) Any additional factors or
information the PBM proposes that the Board consider.
(4) Wholesale Distributors:
(a) Prices charged to
purchasers in the State, including but not limited to pharmacies, pharmacy
chains, pharmacy wholesalers, and other direct purchasers;
(b) The total amount of price
concessions and discounts provided by the wholesale distributor to purchasers
in the State, including but not limited to pharmacies, pharmacy chains,
pharmacy wholesalers, and other direct purchasers;
(c) Units of the prescription
drug product sold in the State; and
(d) Any additional factors or
information the wholesale distributor proposes that the Board consider.
C. Submission of Information.
(1) An entity may submit the
information requested in §A of this regulation by:
(a) Completing the data form
developed by the Board; and
(b) Providing supporting
documentation.
(2) A person submitting
information, including data and records, for the Board’s consideration shall
comply with the procedures for designating confidential, trade-secret, and
proprietary information set forth in COMAR 14.01.01.04.
(3) Information may be
submitted to the Board:
(a) In paper form using a
tracked common carrier, courier, or postal service; or
(b) Electronically using
secure file transfer.
.05 Cost Review Study.
A. The Board may determine:
(1) Whether use of the
prescription drug product has led or will lead to:
(a) Affordability challenges
to the State health care system; or
(b) High out-of-pocket costs
for patients; and
(2) Whether the use that has
led to affordability challenges or high out-of-pocket costs is consistent with:
(a) The labeling approved by
the FDA; or
(b) Standard medical
practice.
B. Analyses and Data
Compilation.
(1) To the extent
practicable, Board staff may assemble the data and analyses specified by
Health-General Article §21-2C-09(b), Annotated Code of Maryland, and this
regulation for consideration by the Board, including the data elements and
information provided to the Board under Regulation .03A and B of this chapter.
(2) These data and analyses
may be:
(a) Derived from published
peer-reviewed literature;
(b) Derived from published
public sources such as the FDA Orange Book, the FDA Purple Book, and other
sources;
(c) Reported by or derived
from manufacturers, health insurance plans, HMOs, MCOs, PBMs, and wholesale
distributors;
(d) Produced by Board staff
through analysis;
(e) Derived from external
analyses and modeling studies;
(f) Derived from the MCDB,
any claims set of the MCDB, and other databases; or
(g) Derived from reports
generated by U.S. governmental entities, foreign governmental and
quasi-governmental agencies, and U.S. and foreign non-profit organizations.
C. Factors Considered in Cost
Review Study.
(1) To the extent
practicable, the Board may consider the following data, information, and
analyses in conducting a cost review study:
(a) Drug Pricing for Drug
Product Under Review:
(i) The WAC, AWP, NADAC,
SAAC, ASP, and FSS; and
(ii) Information estimating
manufacturer net price and net sales amounts of the prescription drug product
under review;
(b) Price Concessions,
Discounts, and Rebates:
(i) The average price
concession, discount, and rebate provided by the manufacturer or expected to be
provided to each payor class in the State for the drug under review, expressed
as a number and as a percent of the WAC; and
(ii) The average price
concession, discount, and rebate the manufacturer provided or is expected to
provide for the prescription drug product under review to each PBM operating in
the State, expressed as a number and as a percent of the WAC;
(c) Therapeutic Alternatives:
(i) The average price
concession, discount, or rebate the manufacturer provides or is expected to
provide to health plans in the State for therapeutic alternatives; and
(ii) The WAC, AWP, NADAC,
SAAC, ASP, and FSS at which each therapeutic alternative has been sold in the
State;
(d) Patient Access:
(i) The costs to health plans
based on patient access consistent with FDA-labeled indications or standard
medical practice;
(ii) The estimated impact on
patient access resulting from the cost of the prescription drug product
relative to insurance benefit design; and
(iii) The current or expected
dollar value of drug-specific patient access programs that are supported by the
manufacturer;
(e) Cost and Comparative
Effectiveness Analyses:
(i) The incremental costs
associated with a prescription drug product, including financial impacts to
health, medical, or social services as can be quantified and compared to
baseline effects of existing therapeutic alternatives; and
(ii) Information derived from
health economics and outcomes research that may address the effectiveness of
the prescription drug product in treating the conditions for which it is
prescribed or in improving a patient’s health, quality of life, or overall
health outcomes, and the effectiveness of the prescription drug product
compared with therapeutic alternatives or no treatment.
(f) Cost Sharing:
(i) The average patient copay
and other cost-sharing data for the prescription drug in the State; and
(ii) The average cost share;
and
(g) Additional Board Factors:
(i) Clinical information,
including FDA indications and doses and information concerning standard medical
practice;
(ii) The disease burden of
the condition that is treated by the prescription drug product;
(iii) In the case of generic
prescription drug products, the number of pharmaceutical manufacturers that
produce the prescription drug product;
(iv) The total gross spending
in the State for the prescription drug product under review, the total number
of patients in the State using the prescription drug product, and the percentage
of overall total prescription drug product spending that the product’s spending
represents;
(v) The change in total gross
spending and utilization for a prescription drug product in the State between
the two most recent available calendar years and the percent change in total
gross spending for a prescription drug product in the State between the two
most recent available calendar years;
(vi) The mean, median, and
90th percentile out-of-pocket costs per patient compared to State incomes;
(vii) An assessment of the
impact of the prescription drug product’s cost to access by priority
populations and the impact on equity;
(viii) Information supplied
by the manufacturer, if any, explaining the relationship between the pricing of
the prescription drug product and (a) the cost of development and (b) the
therapeutic benefit of the prescription drug product, or information that is
otherwise pertinent to the manufacturer’s pricing decision;
(ix) Analysis of the
prescription drug product’s approval process;
(x) Analysis of the
prescription drug product’s shortage status;
(xi) Analysis of the
prescription drug product’s lifecycle management, patent management, regulatory
exclusivities, and product copying;
(xii) Input from the public;
and
(xiii) Information and analyses
submitted by an entity under Regulation .04 of this chapter.
(2) The public may provide
written comments concerning the prescription drug product:
(a) Within 60 days of the
date the drug’s selection for cost review study is posted on the Board’s website;
and
(b) In accordance with the
procedures in COMAR 14.01.01.05B(3).
D. At an open meeting, the
Board may:
(1) Hear oral public comments
concerning the prescription drug product in accordance with the procedures in
COMAR 14.01.01.05A;
(2) To the extent permitted
by Health-General Article, §§21-2C-03 and 21-2C-10, Annotated Code of Maryland,
consider written comments submitted in accordance with the procedures in COMAR
14.01.01.05;
(3) To the extent
practicable, and in compliance with Health-General Article,
§21-2C-03(e)(1)(iv), Annotated Code of Maryland, consider the data and analyses
specified by §C of this regulation, including the data elements and information
provided to the Board under Regulation .03 of this chapter;
(4) Close the session to discuss
confidential, trade-secret, and proprietary information; and
(5) Determine whether:
(a) Use of the prescription
drug product, identified by NDC, has led or will lead to:
(i) Affordability challenges
to the State health care system; or
(ii) High out-of-pocket costs
for patients; and
(b) Whether the use that has
led to affordability challenges or high out-of-pocket costs is consistent with:
(i) The labeling approved by
the FDA; or
(ii) Standard medical
practice.
E. If the Board is unable to
determine whether a prescription drug product will produce or has produced
challenges to the affordability of the prescription drug product for the State
health care system, the Board may consider:
(1) The additional factors identified in
Health-General Article, §21-2C-09(b)(3)(i)—(iv), Annotated Code of Maryland;
and
(2) The following additional
factors:
(a) Federal support for the
research and development of the prescription drug product; and
(b) Pricing data from other
countries for the prescription drug product.
F. Cost Review Study
Report. The Board shall create and adopt
a report of the cost review study that, to the extent permitted by
Health-General Article, §§21-2C-03 and 21-2C-10, Annotated Code of Maryland,
summarizes the information considered by the Board in conducting the cost
review study, the Board’s deliberations, and the Board’s determination.
ANDREW W. YORK
Executive Director
WATER AND SCIENCE
ADMINISTRATION
Water Quality
Certification 23-WQC-0001
Tilghman on Chesapeake Community
Assoc.
PO Box 432
Tighlman, MD 21671
Add’l. Info: Pursuant to COMAR 26.08.02.10F(3)(c),
The Maryland Department of the Environment is providing notice of its issuance
of a Water Quality Certification 23-WQC-0001.
Location: Avalon Court, Tilghman, MD 21671
in Talbot County
The
purpose of this project is to prevent shoreline erosion, create shoreline
resiliency against sea level rise, and provide oyster habitat. Install an
approximately 612 linear foot low profile stone, sand containment sill
including 27 concrete oyster break structures; fill and grade with
approximately 2,320 cubic yards of sand and plant approximately 7,327 square
feet of high marsh and 1,420 square feet of low marsh, all extending a maximum
of 90 feet channelward of the mean high water line.
The WQC and its
attachments may be viewed at the following link:
https://mde.maryland.gov/programs/Water/WetlandsandWaterways/Pages/WQC.aspx
Appeal of
Final Decision. This Water Quality Certification is a final agency decision.
Any person aggrieved by the Department’s decision to issue this WQC may appeal
such decision in accordance with COMAR 26.08.02.10F(4). A request for appeal
shall be filed with the Department within 30 days of publication of the final
decision and specify in writing the reason why the final decision should be
reconsidered. A request for appeal shall be submitted to: Secretary of the
Environment, Maryland Department of the Environment, 1800 Washington Boulevard,
Baltimore, MD 21230. Any request for an appeal does not stay the effectiveness
of this WQC.
Contact: Michaela Harrington at michaela.harrington@maryland.gov or 410-537-4182
[23-19-23]
WATER AND SCIENCE ADMINISTRATION
Water Quality Certification 23-WQC-0022
Safe Harbor Marina
22170 Great Oak Landing
Rd
Chestertown, MD 21620
Add’l. Info:
Pursuant to COMAR 26.08.02.10F(1)(d), The Maryland Department of the
Environment is providing notice of a scheduled Public Hearing for Water Quality
Certification 23-WQC-0022.
Location: 22170 Great Oak Landing Rd, Chestertown, MD
21620
The purpose of the
project is to maintain navigable depths within the marina.
1.
Mechanically
maintenance dredge 17.81 acres to a depth of 6.0 feet below mean low water
within the marina basin along Fairlee Creek.
2.
Deposit
approximately 19,649 cubic yards of material at an approved onsite disposal
location or Dudley Orem Pit located at 8415 Rock Hall Road, Chestertown, MD
21620.
The WQC and its
attachments may be viewed at the following link: https://mde.maryland.gov/programs/Water/WetlandsandWaterways/Pages/WQC.aspx
Appeal of Final
Decision. This Water Quality Certification is a final agency decision. Any
person aggrieved by the Department’s decision to issue this WQC may appeal such
decision in accordance with COMAR 26.08.02.10F(4). A request for appeal shall
be filed with the Department within 30 days of publication of the final
decision and specify in writing the reason why the final decision should be
reconsidered. A request for appeal shall be submitted to: Secretary of the
Environment, Maryland Department of the Environment, 1800 Washington Boulevard,
Baltimore, MD 21230. Any request for an appeal does not stay the effectiveness
of this WQC.
Contact: Matt Godbey at matt.godbey@maryland.gov or 410-901-4033.
[23-19-22]
NOTICE OF MODIFICATIONS TO DECLARATIONS OF TRUST
SUMMARY: The purpose of this notice is to
announce modifications to the Declarations of Trust created for the Maryland
Prepaid College Trust (“MPCT”), the Maryland College Investment Plan (“MCIP”)
and the Maryland Achieving a Better Life Experience Program (“ABLE”).
In 1997, the General Assembly passed
legislation establishing a board, most recently known as the Maryland 529
Board, as an independent State agency to oversee Maryland’s education savings
plans. The Maryland 529 Board oversaw the MPCT, MCIP and ABLE programs. Each of
these programs was secured by a separate Declaration of Trust. Each Declaration
of Trust outlined the purpose of the respective Trust and described the
fiduciary duties of the Maryland 529 Board as trustee, as well as how each
Trust was to be managed.
Chapter 113 of the 2023 Laws of Maryland
abolished the Maryland 529 Board and appointed the State Treasurer as its
successor. Chapter 113 also transferred the responsibility for administering the
MPCT, the MCIP and ABLE programs to the State Treasurer effective June 1, 2023.
The Declarations of Trust for each of MPCT, MCIP and ABLE, have all been
amended to reflect the enactment of Chapter 113 and to identify the Treasurer
as the sole trustee under each Declaration of Trust.
ADDRESS: Maryland State Treasurer’s Office,
Goldstein Treasury Building, 80 Calvert Street, Annapolis, Maryland 21401.
FOR FURTHER INFORMATION CONTACT: Laura Atas,
Deputy Treasurer for Public Policy, Phone (410) 260-7292, Email: latas@treasurer.state.md.us
AUTHORITY: Chapter 113 of the 2023 Laws of
Maryland; Annotated Code of Maryland – Education Article, Title 18, §1901 et
seq.
[23-19-19]
Notice
of ADA Compliance
The State of Maryland is committed to
ensuring that individuals with disabilities are able to fully participate in
public meetings. Anyone planning to
attend a meeting announced below who wishes to receive auxiliary aids,
services, or accommodations is invited to contact the agency representative at
least 48 hours in advance, at the telephone number listed in the notice or
through Maryland Relay.