Capitol Building

Maryland Register


Issue Date: February 1, 2019

Volume 46 • Issue 3 • Pages 95—164

IN THIS ISSUE

Governor

Regulatory Review and Evaluation

Open Meetings and Compliance Board

Regulations

Errata

Special Documents

General Notices

 

Pursuant to State Government Article, §7-206, Annotated Code of Maryland, this issue contains all previously unpublished documents required to be published, and filed on or before January 14, 2019 5 p.m.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 January 14, 2019.
 
Gail S. Klakring
Acting Administrator, Division of State Documents
Office of the Secretary of State

Seal

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; Fax 410-280-5647. 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.

Lawrence J. Hogan, Jr., Governor; John C. Wobensmith, Secretary of State; Gail S. Klakring, Administrator; Mary D. MacDonald, Senior Editor, Maryland Register and COMAR; Elizabeth Ramsey, Editor, COMAR Online, and Subscription Manager; Tami Cathell, Help Desk, COMAR and Maryland Register Online.

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 ........................................................................  99

 

COMAR Research Aids

Table of Pending Proposals ...........................................................  100

 

Index of COMAR Titles Affected in This Issue

COMAR Title Number and Name                                                  Page

03        Comptroller of the Treasury ...............................................  106

08        Department of Natural Resources ......................................  106

09        Department of Labor, Licensing, and Regulation .......  106, 110

10        Maryland Department of Health .........................................  111

11        Department of Transportation ............................................  107

12        Department of Public Safety and Correctional Services .....  107

13A     State Board of Education ....................................................  107

14        Independent Agencies ........................................................  108

20        Public Service Commission ...............................................  147

22        State Retirement and Pension System ................................  108

26        Department of the Environment .........................................  153

 

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.

 

The Governor

EXECUTIVE ORDER 01.01.2019.02 ..................................  103

 

Open Meetings Compliance Board

SUMMARY OF OPINIONS ISSUED FROM OCTOBER 1—
   DECEMBER 31, 2018
.......................................................  104

 

Regulatory Review and Evaluation

OFFICE OF ADMINISTRATIVE HEARINGS

Notice of Availability of Evaluation Reports .  105

 

Final Action on Regulations

03  COMPTROLLER OF THE TREASURY

SALES AND USE TAX

Sales and Use Tax ....................................................................  106

08  DEPARTMENT OF NATURAL RESOURCES

FISHERIES SERVICE

General  106

Aquaculture Permits .  106

Oysters .  106

Shellfish Aquaculture and Leasing .  106

09  DEPARTMENT OF LABOR, LICENSING, AND
   REGULATION

HOME IMPROVEMENT COMMISSION

Fees .  106

11  DEPARTMENT OF TRANSPORTATION

TRANSPORTATION SERVICE HUMAN RESOURCES
   SYSTEM

Leave Benefits .  107

12  DEPARTMENT OF PUBLIC SAFETY AND 
   CORRECTIONAL SERVICES

CORRECTIONAL TRAINING COMMISSION

General Regulations .  107

13A STATE BOARD OF EDUCATION

STATE SCHOOL ADMINISTRATION

Appeals to the State Board of Education .  107

CERTIFICATION

General Provisions .  107

14  INDEPENDENT AGENCIES

COMMISSION ON CRIMINAL SENTENCING POLICY

General Regulations .  108

22  STATE RETIREMENT AND PENSION SYSTEM

GENERAL REGULATIONS

Definitions and General Provisions .  108

Public Information Act Requests .  108

Domestic Relations Order  108

Average Final Compensation .  108

Proof of Date of Birth .  109

Designation of Beneficiary .  109

Refund of Accumulated Contributions .  109

COMPLIANCE WITH THE INTERNAL REVENUE CODE

Code Compliance .  109

 

Proposed Action on Regulations

09  DEPARTMENT OF LABOR, LICENSING, AND
   REGULATION

RACING COMMISSION

Thoroughbred Rules .  110

Prohibited Acts .  110

10  MARYLAND DEPARTMENT OF HEALTH

DISEASES

Communicable Diseases — Rabies .  111

MEDICAL CARE PROGRAMS

Chronic Hospitals .  111

DRUGS

Emergency Use Auto-Injectable Epinephrine Program at
   Institutions of Higher Education .  112

FOOD

Production, Processing, Transportation, Storage, and
   Distribution of Manufactured Grade Milk .  114

HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION
   AND ACQUIRED IMMUNODEFICIENCY SYNDROME
   (AIDS)

Maryland AIDS Drug Assistance Program: Temporary
   Assistance Program ..  126

Maryland AIDS Drug Assistance Program: Eligibility .  126

Maryland AIDS Drug Assistance Program: Pharmacy
   Services .  126

Maryland AIDS Drug Assistance Program: Health Insurance
   (MADAP-PLUS)  126

Urgent Maryland AIDS Drug Assistance Program ..  126

BOARD OF EXAMINERS IN OPTOMETRY

Continuing Education Requirements .  131

Therapeutic Pharmaceutical Agents .  131

BOARD OF PHYSICIANS

Sexual Misconduct  133

BOARD OF EXAMINERS OF NURSING HOME
   ADMINISTRATORS

Nursing Home Administrators .  135

HEALTH SERVICES COST REVIEW COMMISSION

Rate Application and Approval Procedures .  135

BOARD OF CHIROPRACTIC EXAMINERS

Chiropractic Externship Program ..  136

PREVENTIVE MEDICINE

Maryland HIV Prevention Case Management Program ..  138

BOARD OF NURSING — ELECTROLOGY PRACTICE
   COMMITTEE

Definitions .  144

Licensure .  144

Electrology Examination .  144

Continuing Education .  144

Standards of Practice and Conduct  144

Electrology Programs .  144

Fees .  144

20  PUBLIC SERVICE COMMISSION

TERMINATIONS OF SERVICE

General Regulations .  147

Restrictions on Terminations .  147

SERVICE SUPPLIED BY WATER COMPANIES

Establishing Rates for Small Water Companies .  149

SERVICE SUPPLIED BY SEWAGE DISPOSAL
   COMPANIES

Establishing Rates for Small Sewage Disposal
   Companies .  151

26  DEPARTMENT OF THE ENVIRONMENT

WATER SUPPLY, SEWERAGE, SOLID WASTE, AND
   POLLUTION CONTROL PLANNING AND FUNDING

Bay Restoration Fund Implementation — Onsite Sewage
   Disposal System Fund .  153

REGULATION OF WATER SUPPLY, SEWAGE DISPOSAL,
   AND SOLID WASTE

Sewage Disposal and Certain Water Systems for Homes and
   Other Establishments in the Counties of Maryland Where a
   Public Sewage System Is Not Available .  154

WATER POLLUTION

General  155

Permits .  155

WATER MANAGEMENT

Stormwater Management  156

 

Errata

COMAR 12.10.01 .  159

 

Special Documents

DEPARTMENT OF THE ENVIRONMENT

SUSQUEHANNA RIVER BASIN COMMISSION

Public Hearing .  160

 

General Notices

MARYLAND COLLECTION AGENCY LICENSING BOARD

Public Meeting .  162

MARYLAND CORRECTIONAL ENTERPRISES

Public Meeting .  162

BOARD OF DIETETIC PRACTICE

Public Meeting .  162

FIRE PREVENTION COMMISSION

Public Meeting .  162

MARYLAND DEPARTMENT OF HEALTH

Waiver for Children with Autism Spectrum Disorder —
   Renewal Application — Request for Public
   Comment  162

Community Pathways Waiver, Family Supports Waiver, and
   Community Supports Waiver — Amendment Applications
   — Request for Public Comment  162

MARYLAND INSURANCE ADMINISTRATION

Public Hearing .  163

MARYLAND STATE LOTTERY AND GAMING CONTROL
   COMMISSION

Public Meeting .  163

MARYLAND HEALTH CARE COMMISSION

Formal Start of Review ..  163

DEPARTMENT OF NATURAL RESOURCES/FISHING AND
   BOATING SERVICES

Public Notice — 2019 Chesapeake Bay Commercial Striped
   Bass Permanent Transfer Rules — Effective 1/14/19 ............  163

Public Notice — 2019 Atlantic Ocean Commercial Striped
   Bass Transfer Rules — Effective 1/14/19 .  164

Public Notice — 2019 Chesapeake Bay Commercial Striped
   Bass Temporary Transfer Rules — Effective 1/14/19 .  164

STATE ADVISORY COUNCIL ON QUALITY CARE AT
   THE END OF LIFE

Public Meeting .  164

RACING COMMISSION

Public Meeting .  164

BOARD OF WELL DRILLERS

Public Meeting .  164

WORKERS' COMPENSATION COMMISSION

Public Meeting .  164

 

 

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.state.md.us, 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 July 2019

 

Issue
Date

Emergency

and Proposed

Regulations

5 p.m.*

Final

Regulations

10:30 a.m.

Notices, etc.

10:30 a.m.

February 15

January 28

February 6

February 4

March 1

February 11

February 20

February 15**

March 15

February 25

March 6

March 4

March 29

March 11

March 20

March 18

April 12

March 25

April 3

April 1

April 26

April 8

April 17

April 15

May 10

April 22

May 1

April 29

May 24

May 6

May 15

May 13

June 7

May 20

May 29

May 24**

June 21

June 3

June 12

June 10

July 5

June 17

June 26

June 24

July 19

July 1

July 10

July 22

 

*   Due date for documents containing 8 to 18 pages — 48 hours before date shown; due date for documents exceeding 18 pages — 1 week before date shown

NOTE:  ALL DOCUMENTS MUST BE SUBMITTED IN TIMES NEW ROMAN, 9-POINT, SINGLE-SPACED FORMAT. THE REVISED 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 pertaining to proposed regulations are listed, followed by “(err)”. 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.

 


01 EXECUTIVE DEPARTMENT

 

01.02.11.01—.10,.14,.16—.22 • 45:23 Md. R. 1073 (11-9-18)

 

03 COMPTROLLER OF THE TREASURY

 

03.03.05.04 • 45:18 Md. R. 835 (8-31-18)

 

04 DEPARTMENT OF GENERAL SERVICES

 

04.05.01.07 • 45:26 Md. R. 1250 (12-21-18)

04.05.02.02 • 45:26 Md. R. 1250 (12-21-18)

 

05 DEPARTMENT OF HOUSING AND COMMUNITY DEVELOPMENT

 

05.02.01.01—.07 • 46:1 Md. R. 16 (1-4-19) (ibr)

05.02.02.01—.12 • 46:1 Md. R. 16 (1-4-19)

05.02.03.01—.07 • 46:1 Md. R. 16 (1-4-19)

05.02.04.01—.18 • 46:1 Md. R. 16 (1-4-19) (ibr)

05.02.06.01,.02 • 46:1 Md. R. 16 (1-4-19)

05.02.07.01—.09 • 46:1 Md. R. 16 (1-4-19) (ibr)

05.16.01.01—.08 • 46:1 Md. R. 16 (1-4-19)

 

08 DEPARTMENT OF NATURAL RESOURCES

 

08.01.07.13 • 46:1 Md. R. 15 (1-4-19)

08.02.03.03,.06,.11 • 46:2 Md. R. 55 (1-18-19)

08.02.05.15 • 45:26 Md. R. 1251 (12-21-18)

08.07.01.03,.17 • 46:1 Md. R. 15 (1-4-19)

 

09 DEPARTMENT OF LABOR, LICENSING, AND REGULATION

 

09.08.01.27 • 45:24 Md. R. 1167 (11-26-18)

09.10.01.64 • 46:3 Md. R. 110 (2-1-19)

09.10.03.04 • 46:3 Md. R. 110 (2-1-19)

09.12.50.01—.07 • 46:1 Md. R. 16 (1-4-19) (ibr)

09.12.51.01—.09 • 46:1 Md. R. 16 (1-4-19) (ibr)

09.12.52.01—.18 • 46:1 Md. R. 16 (1-4-19) (ibr)

09.12.53.01—.12 • 46:1 Md. R. 16 (1-4-19)

09.12.54.01—.07 • 46:1 Md. R. 16 (1-4-19)

09.12.55.01,.02 • 46:1 Md. R. 16 (1-4-19)

09.12.58.01—.08 • 46:1 Md. R. 16 (1-4-19)

09.14.02.08 • 46:1 Md. R. 22 (1-4-19)

09.17.01.04 • 45:21 Md. R. 979 (10-12-18)

09.21.02.01 • 45:24 Md. R. 1168 (11-26-18)

09.23.01.04 • 46:2 Md. R. 56 (1-18-19)

09.26.01.07 • 45:26 Md. R. 1253 (12-21-18)

09.28.02.07 • 45:24 Md. R. 1168 (11-26-18)

09.29.01.06 • 45:24 Md. R. 1169 (11-26-18)

09.32.01.05 • 45:19 Md. R. 869 (9-14-18)

09.34.01.11,.13 • 45:21 Md. R. 982 (10-12-18)

 

10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE

 

         Subtitles 01—08 (1st volume)

 

10.01.04.02 • 45:24 Md. R. 1169 (11-26-18)

10.06.02.03 • 46:3 Md. R. 111 (2-1-19)

 

          Subtitle 09 (2nd volume)

 

10.09.05.01—.05,.07 • 46:1 Md. R. 22 (1-4-19)

                                     46:2 Md. R. 90 (1-18-19) (err)

10.09.07.01,.03—.06 • 46:2 Md. R. 57 (1-18-19)

10.09.07.08 • 45:23 Md. R. 1077 (11-9-18)

10.09.08.05 • 46:2 Md. R. 58 (1-18-19)

10.09.10.07,.08,.11,.13 • 45:23 Md. R. 1080 (11-9-18)

10.09.20.14 • 45:23 Md. R. 1077 (11-9-18)

10.09.24.02,.03,.08-2 • 45:26 Md. R. 1253 (12-21-18)

10.09.27.06 • 45:23 Md. R. 1077 (11-9-18)

10.09.28.01—.04,.06 • 46:2 Md. R. 59 (1-18-19)

10.09.53.07 • 45:23 Md. R. 1077 (11-9-18)

10.09.54.22 • 45:23 Md. R. 1077 (11-9-18)

10.09.56.22 • 45:23 Md. R. 1077 (11-9-18)

10.09.61.01,.03,.06 • 46:2 Md. R. 57 (1-18-19)

10.09.69.04,.14,.17 • 46:2 Md. R. 61 (1-18-19)

10.09.70.02 • 46:2 Md. R. 61 (1-18-19)

10.09.84.24 • 45:23 Md. R. 1077 (11-9-18)

10.09.93.01,.05,.07,.08 • 46:3 Md. R. 111 (2-1-19)

 

     Subtitles 10 — 22 (3rd Volume)

 

10.12.06.01—.10 • 46:2 Md. R. 62 (1-18-19)

10.13.03.01—.04 • 45:13 Md. R. 675 (6-22-18)

10.13.04.01—.03 • 46:3 Md. R. 112 (2-1-19)

10.15.09.01—.22 • 46:3 Md. R. 114 (2-1-19) (ibr)

10.17.01.05,.06,.06-1,.07—.11,.55 • 46:2 Md. R. 64 (1-18-19)

10.18.01.02,.04,.05 • 46:3 Md. R. 126 (2-1-19)

10.18.05.01—.04,.09 • 46:3 Md. R. 126 (2-1-19)

10.18.06.01,.03,.04,.04-1,.04-2,.05,.09,
     .11
• 46:3 Md. R. 126 (2-1-19)

10.18.07.01—.04,.06,.07,.11 • 46:3 Md. R. 126 (2-1-19)

10.18.10.02—.05 • 46:3 Md. R. 126 (2-1-19)

10.21.04.01—.12 • 45:7 Md. R. 357 (3-30-18)

10.21.16.01—.16 • 45:7 Md. R. 357 (3-30-18)

10.21.17.01—.17 • 45:7 Md. R. 357 (3-30-18)

10.21.18.01—.13 • 45:7 Md. R. 357 (3-30-18)

10.21.19.01—.11 • 45:7 Md. R. 357 (3-30-18)

10.21.20.01—.11 • 45:7 Md. R. 357 (3-30-18)

10.21.21.01—.13 • 45:7 Md. R. 357 (3-30-18)

10.21.22.01—.12 • 45:7 Md. R. 357 (3-30-18)

10.21.25.03-2,.05—.13 • 45:7 Md. R. 357 (3-30-18)

10.21.26.01—.12 • 45:7 Md. R. 357 (3-30-18)

10.21.27.01—.08 • 45:7 Md. R. 357 (3-30-18)

10.21.28.01—.12 • 45:7 Md. R. 357 (3-30-18)

10.21.29.01—.09 • 45:7 Md. R. 357 (3-30-18)

10.22.17.06,.07,.08 • 45:26 Md. R. 1255 (12-21-18)

10.22.18.04 • 45:26 Md. R. 1255 (12-21-18)

 

     Subtitles 23 — 36 (4th Volume)

 

10.24.08.01 • 45:25 Md. R. 1210 (12-7-18) (ibr)

10.24.20.01 • 45:25 Md. R. 1211 (12-7-18) (ibr)

10.27.01.01,.13 • 45:24 Md. R. 1170 (11-26-18)

10.27.06.01—.06 • 45:26 Md. R. 1264 (12-21-18)

10.27.17.01—.06 • 45:26 Md. R. 1265 (12-21-18)

10.28.02.02,.04,.05,.07 • 46:3 Md. R. 131 (2-1-19)

10.28.12.02 • 46:3 Md. R. 131 (2-1-19)

10.32.05.01—.07 • 45:24 Md. R. 1171 (11-26-18)

10.32.17.01—.03 • 46:3 Md. R. 133 (2-1-19)

10.33.01.13,.16 • 46:3 Md. R. 135 (2-1-19)

10.34.05.05 • 45:26 Md. R. 1267 (12-21-18)

                      46:1 Md. R. 27 (1-4-19) (err)

10.34.09.02 • 45:26 Md. R. 1267 (12-21-18)

10.34.30.01—.06 • 46:2 Md. R. 68 (1-18-19)

10.36.10.01—.06 • 46:2 Md. R. 69 (1-18-19)

 

     Subtitles 37—66 (5th Volume)

 

10.37.10.26 • 46:3 Md. R. 135 (2-1-19)

10.42.01.01,.02,.04—.18 • 45:21 Md. R. 989 (10-12-18)

10.42.02.02—.06 • 45:21 Md. R. 989 (10-12-18)

10.42.03.01—.07 • 46:2 Md. R. 71 (1-18-19)

10.42.04.11 • 46:2 Md. R. 71 (1-18-19)

10.42.06.04—.11 • 46:2 Md. R. 71 (1-18-19)

10.42.08.01—.11 • 45:21 Md. R. 989 (10-12-18)

10.42.09.01,.04,.07 • 45:21 Md. R. 989 (10-12-18)

10.43.05.01—.04 • 46:3 Md. R. 136 (2-1-19)

10.47.02.01—.11 • 45:7 Md. R. 357 (3-30-18)

10.47.03.01—.07 • 45:7 Md. R. 357 (3-30-18)

10.47.04.01—.08 • 45:7 Md. R. 357 (3-30-18)

10.47.05.01—.05 • 45:7 Md. R. 357 (3-30-18)

10.47.08.01—.12 • 46:2 Md. R. 73 (1-18-19)

10.52.08.01—.16 • 46:3 Md. R. 138 (2-1-19)

10.53.01.01 • 46:3 Md. R. 144 (2-1-19)

10.53.02.02—.04,.06,.07,.09 • 46:3 Md. R. 144 (2-1-19)

10.53.03.01—.04 • 46:3 Md. R. 144 (2-1-19)

10.53.04.01—.04 • 46:3 Md. R. 144 (2-1-19)

10.53.05.02,.03 • 46:3 Md. R. 144 (2-1-19)

10.53.06.05,.07 • 46:3 Md. R. 144 (2-1-19)

10.53.12.01 • 46:3 Md. R. 144 (2-1-19)

10.58.06.01—.06 • 46:2 Md. R. 77 (1-18-19)

10.60.02.06 • 45:26 Md. R. 1268 (12-21-18)

10.62.01.01 • 45:26 Md. R. 1268 (12-21-18)

10.62.02.05 • 45:26 Md. R. 1268 (12-21-18)

10.62.08.05 • 45:26 Md. R. 1268 (12-21-18)

10.62.19.04 • 45:26 Md. R. 1268 (12-21-18)

10.62.25.05 • 45:26 Md. R. 1268 (12-21-18)

10.63.07.02,.03,.05,.06 • 46:2 Md. R. 78 (1-18-19)

 

11 DEPARTMENT OF TRANSPORTATION

 

     Subtitles 11—23 (MVA)

 

11.12.01.01,.22 • 46:1 Md. R. 25 (1-4-19)

11.12.02.03,.06 • 46:1 Md. R. 25 (1-4-19)

 

12 DEPARTMENT OF PUBLIC SAFETY AND CORRECTIONAL SERVICES

 

12.04.01.01,.04 • 45:20 Md. R. 936 (9-28-18)

                            45:22 Md. R. 1033 (10-26-18) (err)

12.04.08.01—.05 • 45:25 Md. R. 1212 (12-7-18)

 

13A STATE BOARD OF EDUCATION

 

13A.04.07.01—.04,.06 • 45:26 Md. R. 1269 (12-21-18)

                                       46:1 Md. R. 26 (1-4-19) (err)

13A.12.01.08-1 • 45:23 Md. R. 1087 (11-9-18)

13A.12.04.03 • 45:26 Md. R. 1270 (12-21-18)

                         46:1 Md. R. 26 (1-4-19)

 

13B MARYLAND HIGHER EDUCATION COMMISSION

 

13B.02.03.02,.20 • 45:26 Md. R. 1271 (12-21-18)

13B.08.10.01—.17 • 45:24 Md. R. 1172 (11-26-18)

13B.08.20.01—.13 • 45:24 Md. R. 1179 (11-26-18)

13B.08.21.01—.22 • 45:26 Md. R. 1272 (12-21-18)

 

14 INDEPENDENT AGENCIES

 

14.09.02.04 • 46:2 Md. R. 79 (1-18-19)

14.09.03.02 • 46:2 Md. R. 79 (1-18-19)

14.09.04.03 • 46:2 Md. R. 79 (1-18-19)

14.09.07.00 • 46:2 Md. R. 79 (1-18-19)

14.35.01.02 • 45:23 Md. R. 1088 (11-9-18)

14.35.07.01—.21 • 45:23 Md. R. 1089 (11-9-18)

14.35.14.01—.10 • 45:23 Md. R. 1099 (11-9-18)

14.35.15.01—.11 • 45:23 Md. R. 1102 (11-9-18)

14.35.16.01—.12 • 45:23 Md. R. 1105 (11-9-18)

14.35.17.01—.09 • 45:23 Md. R. 1109 (11-9-18)

 

15 DEPARTMENT OF AGRICULTURE

 

15.15.13.03,.05 • 45:7 Md. R. 380 (3-30-18)

 

20 PUBLIC SERVICE COMMISSION

 

20.31.01.02 • 46:3 Md. R. 147 (2-1-19)

20.31.03.06 • 46:3 Md. R. 147 (2-1-19)

20.53.06.02,.06,.07 • 45:25 Md. R. 1215 (12-7-18)

20.53.07.07 • 45:25 Md. R. 1216 (12-7-18)

20.53.08.01—.07 • 45:25 Md. R. 1216 (12-7-18)

20.59.06.06,.07 • 45:25 Md. R. 1217 (12-7-18)

20.59.07.07 • 45:25 Md. R. 1217 (12-7-18)

20.59.08.01—.07 • 45:25 Md. R. 1218 (12-7-18)

20.70.09.01—.06 • 46:3 Md. R. 149 (2-1-19)

20.75.08.01—.06 • 46:3 Md. R. 151 (2-1-19)

 

21 STATE PROCUREMENT REGULATIONS

 

21.01.02.01 • 45:20 Md. R. 942 (9-28-18)

21.01.03.01 • 45:20 Md. R. 942 (9-28-18)

21.02.01.05 • 45:20 Md. R. 942 (9-28-18)

21.02.05.04 • 45:20 Md. R. 942 (9-28-18)

21.05.01.01,.02,.05 • 45:20 Md. R. 942 (9-28-18)

21.05.02.04,.05 • 45:20 Md. R. 942 (9-28-18)

21.05.03.01—.03 • 45:20 Md. R. 942 (9-28-18)

21.05.06.01 • 45:20 Md. R. 942 (9-28-18)

21.05.07.01,.04,.05 • 45:20 Md. R. 942 (9-28-18)

21.05.08 • 45:20 Md. R. 942 (9-28-18)

21.05.09.04,.05,.08 • 45:20 Md. R. 942 (9-28-18)

21.05.13.01—.07 • 45:20 Md. R. 942 (9-28-18)

21.07.01.19,.25 • 45:20 Md. R. 942 (9-28-18)

21.07.02.10 • 45:20 Md. R. 942 (9-28-18)

21.07.03.07,.08 • 45:20 Md. R. 942 (9-28-18)

21.10.04.04 • 45:20 Md. R. 942 (9-28-18)

21.11.01.01,.04—.06 • 45:20 Md. R. 942 (9-28-18)

21.11.03.10,.12,.12-1 • 45:20 Md. R. 942 (9-28-18)

21.11.05.01,.04,.07 • 45:20 Md. R. 942 (9-28-18)

21.11.13.01 • 45:20 Md. R. 942 (9-28-18)

21.13.01.17 • 45:20 Md. R. 942 (9-28-18)

                      45:21 Md. R. 1008 (10-12-18) (err)

 

26 DEPARTMENT OF THE ENVIRONMENT

 

     Subtitles 01—07 (Part 1)

 

26.03.13.04 • 46:3 Md. R. 153 (2-1-19)

26.04.02.01,.05 • 46:3 Md. R. 154 (2-1-19)

 

     Subtitles 08—12 (Part 2)

 

26.08.01.01 • 46:3 Md. R. 155 (2-1-19)

26.08.04.01 • 46:3 Md. R. 155 (2-1-19)

 

     Subtitles 13 — 18 (Part 3)

 

26.17.02.08,.09 • 46:3 Md. R. 156 (2-1-19)

 

31 MARYLAND INSURANCE ADMINISTRATION

 

31.03.13.02,.04 • 45:14 Md. R. 708 (7-6-18)

                            45:25 Md. R. 1219 (12-7-18)

31.04.15.04 • 46:2 Md. R. 80 (1-18-19)

31.09.02.11 • 46:2 Md. R. 81 (1-18-19)

31.09.04.03 • 46:2 Md. R. 82 (1-18-19)

31.10.06.02,.28,.30,.31 • 45:23 Md. R. 1119 (11-9-18)

31.10.25.04 • 46:2 Md. R. 83 (1-18-19)

31.10.28.05 • 46:2 Md. R. 83 (1-18-19)

31.12.07.05 • 46:2 Md. R. 83 (1-18-19)

31.15.12.03 • 46:2 Md. R. 84 (1-18-19)

 

 

33 STATE BOARD OF ELECTIONS

 

33.13.01.01 • 45:21 Md. R. 1003 (10-12-18)

33.13.07.01,.02 • 45:21 Md. R. 1003 (10-12-18)

33.13.10.02 • 45:21 Md. R. 1003 (10-12-18)

33.13.15.13 • 45:21 Md. R. 1003 (10-12-18)

33.13.17.01,.02 • 45:21 Md. R. 1003 (10-12-18)

33.13.19.01—.04 • 45:21 Md. R. 1003 (10-12-18)

33.13.20.01,.02 • 45:21 Md. R. 1003 (10-12-18)

33.13.22.01—.07 • 45:21 Md. R. 1003 (10-12-18)

 

34 DEPARTMENT OF PLANNING

 

34.04.01.09 • 46:2 Md. R. 85 (1-18-19)

34.04.02.08 • 46:2 Md. R. 85 (1-18-19)

34.04.07.02,.03,.05,.06 • 46:2 Md. R. 87 (1-18-19)

34.04.09.08 • 46:2 Md. R. 85 (1-18-19)

 

35 DEPARTMENT OF VETERANS AFFAIRS

 

35.07.01.01—.04 • 46:2 Md. R. 88 (1-18-19)

 


The Governor

EXECUTIVE ORDER 01.01.2019.02

Commission to Study Mental and Behavioral Health in Maryland

 

WHEREAS, One in five adults experiences a mental health condition every year and one in 17 lives with a serious mental illness;

 

WHEREAS, Adults in the United States living with serious mental illness die on average 25 years earlier than others, largely because of treatable medical conditions;

 

WHEREAS, Untreated mental illness creates immense economic and human problems, including, but not limited to, homelessness, burdens on the judicial system, victimization, suicide, and violence;

 

WHEREAS, Mental illness not only affects the person suffering from it, but also the person’s friends, family, and community; 

 

WHEREAS, Available and accessible early-intervention services can more quickly stabilize, and significantly reduce, preventable behavioral health crises and divert individuals from the criminal justice system, emergency departments, and inpatient hospitalization;

 

WHEREAS, 50 percent of those with mental illness experience its effects by age 14 and 75 percent by age 24, making early engagement and support critical for effective intervention;

 

WHEREAS, There is a well-documented link between substance-use and mental health disorders as approximately 7.9 million adults in the United States have co-occurring disorders;

 

WHEREAS, In order to further its ongoing efforts to address the heroin, opioid, and fentanyl crisis, the State must continue to ensure a coordinated, high-quality system of care; and

 

WHEREAS, Coordination among State agencies, local governments, and community partners is necessary to establish best practices and improve the State’s Public Mental Health System;

 

NOW, THEREFORE, I, LAWRENCE J. HOGAN, JR., GOVERNOR OF THE STATE OF MARYLAND, BY VIRTUE OF THE AUTHORITY VESTED IN ME BY THE CONSTITUTION AND LAWS OF MARYLAND, HEREBY PROCLAIM THE FOLLOWING EXECUTIVE ORDER, EFFECTIVE IMMEDIATELY:

     A. Establishment. There is a Governor’s Commission to Study Mental and Behavioral Health in Maryland (the “Commission”).

     B. Membership.

         (1) The Commission shall consist of the following members:

              (a) The Lieutenant Governor;

              (b) An appointee of the President of the Maryland Senate;

              (c) An appointee of the Speaker of the Maryland House of Delegates;

              (d) A representative of the Judicial system of the State, appointed by the Chief Judge of the Court of Appeals;

              (e) The Secretary of the Department of Health, or the Secretary’s designee;

              (f) The Deputy Secretary for Behavioral Health, or the Secretary’s designee;

              (g) The Secretary of the State Police, or the Secretary’s designee;

              (h) The Secretary of Public Safety and Correctional Services, or the Secretary’s designee;

              (i) The Secretary of Human Services, or the Secretary’s designee;

              (j) The Maryland Insurance Commissioner, or the Commissioner’s designee;

              (k) The Executive Director of the Opioid Operational Command Center; and

              (l) Six public members, to be appointed by the Governor, representing a range of experience related to mental health, including lived experiences, clinical expertise, work within the criminal justice system, and the provision of social services.

         (2) The members serve at the pleasure of the Governor.

         (3) Staff members from the Offices of the Governor and Lieutenant Governor, the Governor’s Office of Crime Control and Prevention, and the Maryland Department of Health will also be regular participants.

         (4) The Chair may also invite other units of State or U.S. government, including law enforcement agencies, to designate representatives for participation.

     C. Duties. The Commission shall:

         (1) Advise and assist the Governor in improving access to a continuum of mental-health services across the State;

         (2) Consider the findings of the Maryland Behavioral Health Advisory Council 2017 Strategic Plan: 24/7 Crisis Walk-in and Mobile Crisis Team Services;

         (3) Conduct regional summits in various parts of the State to study how mental illness may impact parts of the State differently;

         (4) Submit an interim report no later than six months from the date of this Executive Order on its findings relating to access to mental-health treatment services in the State; and

         (5) Submit a final report to the Governor by December 31, 2019, that includes, but is not limited to, recommendations for policy, regulations, or legislation to address the following:

              (a) Improving the statewide, comprehensive crisis response system; and

              (b) Ensuring parity of resources to meet mental-health needs.

     D. Procedures.

         (1) The Lieutenant Governor shall be Chair of the Commission. The Chair shall:

              (a) Oversee the implementation of this Executive Order and the work of the Commission;

              (b) Determine the Commission’s agenda; and

              (c) Identify additional support needs of the Commission.

         (2) The Commission shall convene within 90 days of this Executive Order and meet as frequently as necessary to satisfy the deadlines established herein.

         (3) A majority of the Commission shall constitute a quorum for the transaction of any business.

         (4) The Commission may adopt other procedures as necessary to ensure the orderly transaction of business.

 

GIVEN Under My Hand and the Great Seal of the State of Maryland, in the City of Annapolis, effective this 10th Day of January, 2019. 

LAWRENCE J. HOGAN, JR.
Governor

ATTEST:

JOHN C. WOBENSMITH
Secretary of State

[19-03-22]

 


Open Meetings Compliance Board

SUMMARY OF OPINIONS ISSUED FROM OCTOBER 1—DECEMBER 31, 2018*

12 Official Opinions of the Compliance Board 98 (2018)

Baltimore City Public School Board Community Panel

October 3, 2018

Topics Discussed: Public Body Definition, Meeting Definition, Advisory Function, and Notice Requirement

Opinion: The Board found that the Panel is a public body subject to the Act and that it held a meeting on November 20, 2017. The Panel convened to discuss public business on the November date without giving advance notice required by the Act and thus violated § 3-302. Because the Panel appears to have no “official or entity” appointed to it, guidance was sent to Baltimore City and well as its School Board for future reference.

Violations: § 3-302

 

12 Official Opinions of the Compliance Board 102 (2018)

Mayor and Town Council of the Town of Forest Heights

October 4, 2018

Topics Discussed: Meeting Definition.

Opinion: Without knowing what was actually discussed at the May board retreat, the Board was unable to reach a conclusion as to whether the public was entitled to observe the discussion. The Board offered guidance to the Council for future such events.

Violations: Unable to reach conclusion.

 

12 Official Opinions of the Compliance Board 104 (2018)

Baltimore City Board of School Commissioners

October 25, 2018

Topics Discussed: Administrative Function Exclusion

Opinion: The Chief Executive Officer’s status report on legal staff’s progress, and the closed-session review of a “script” when it solely entailed rehearsing procedures already set by law and did not include discussion of a decision to be made, were both found by the Board to be within the administrative function exclusion. The Compliance Board found no violation but noted that the school board could avoid any appearance of secrecy if it handled administrative functions during the public portion of its meetings or at a separately convened meeting prior to its public meeting.

Violations: None.

 

12 Official Opinions of the Compliance Board 108 (2018)

Housing Authority of Queen Anne’s County

November 19, 2018

Topics Discussed: Method of Notice, Agenda Requirement, Notice Procedures for Objection to Closing, Closing Statement, and Closed Session Summary

Opinion: The Board found that the housing authority violated the Act by not following required procedures after an objection to close. The Board also found that the housing authority failed to provide information required by the Act in its closing statement and closed session summary. The Board found that there was no meeting notice violation and noted that there is no requirement for public bodies to post meeting agendas online.

Violations: §§ 3-302, 3-305, 3-306

12 Official Opinions of the Compliance Board 112 (2018)

Transportation Committee of the Mayor and City Council of the Town of Ocean City

December 10, 2018

Topics Discussed: Meeting Minutes and Announcement of Violation.

Opinion: The Board found no violation of the method by which the committee’s minutes are prepared, adopted, or amended and noted that this process is within public body’s discretion. The Board also found that there was no violation of the announcement requirements of the Act as the Committee had timely made the announcement about the Board’s earlier opinion.

Violations: None

 

12 Official Opinions of the Compliance Board 114 (2018)

County Commissioners of Worcester County

December 10, 2018

Topics Discussed: Administrative Function Exclusion and Closed Session Summary

Opinion: The Board found that the County Commission’s consideration of a penalty in a particular code enforcement matter is within administrative function exclusion. The Board also found that the County Commission violated the Act by failing to include a summary about the closed administrative session in the minutes of its open-session.

Violations: § 3-104

 

12 Official Opinions of the Compliance Board 117 (2018)

Board of Trustees Montgomery College

December 31, 2018

Topics Discussed: Method of Notice, Closed Session Vote, and Closing Statement

Opinion: The Board found no violations in the method of notice for the closed session or the closed session vote during the challenged time period. The Board also found that the Board of Trustees violated the Act by failing to provide all of the information required by the Act in its closing statements.

Violations: § 3-305(d)

 

* The Compliance Board’s opinions are posted at http://www.marylandattorneygeneral.gov/Pages/OpenGov/OpenMeetings/index.aspx. Statutory references are to the General Provisions Article of the Maryland Annotated Code.

 


Regulatory Review and Evaluation

Regulations promulgated under the Administrative Procedure Act will undergo a review by the promulgating agency in accordance with the Regulatory Review and Evaluation Act (State Government Article, §§10-130 — 10-139; COMAR 01.01.2003.20). This review will be documented in an evaluation report which will be submitted to the General Assembly’s Joint Committee on Administrative, Executive, and Legislative Review.  The evaluation reports have been spread over an 8-year period (see COMAR 01.01.2003.20 for the schedule).  Notice that an evaluation report is available for public inspection and comment will be published in this section of the Maryland Register.


 


TITLE 28
OFFICE OF ADMINISTRATIVE HEARINGS

Notice of Availability of Evaluation Reports

Pursuant to Executive Order 01.01.2003.20, Implementation of the Regulatory Review and Evaluation Act, notice is hereby given that the Evaluation Reports concerning COMAR 28.01—28.03 are available for public inspection and comment for a period of 60 days following the date of this notice.

These reports may be reviewed at the library of the Office of Administrative Hearings, 11101 Gilroy Road, Hunt Valley, Maryland 21031, Monday through Friday, 9 a.m. through 4 p.m., except State holidays, or online at http://www.oah.maryland.gov/Proposedregs2.aspx.

Information may be obtained by contacting Therese Kurtze, Staff Attorney, at 410-229-4296 or by email at therese.kurtze@maryland.gov.

[19-03-10]

 

 


Final Action on Regulations

 

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.

 

 


Title 03
COMPTROLLER OF THE TREASURY

Subtitle 06 SALES AND USE TAX

03.06.01 Sales and Use Tax

Authority: Tax General Article, §2-103, Annotated Code of Maryland

Notice of Final Action

[18-228-F]

On January 22, 2019, the Comptroller of the Treasury adopted amendments to Regulation .33 under COMAR 03.06.01 Sales and Use Tax. This action, which was proposed for adoption in 45:19 Md. R. 867—869 (September 14, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

PETER FRANCHOT
Comptroller

 

Title 08
DEPARTMENT OF NATURAL RESOURCES

Subtitle 02 FISHERIES SERVICE

Notice of Final Action

[18-322-F]

On January 22, 2019, the Secretary of Natural Resources adopted:

(1) New Regulation .16 under COMAR 08.02.01 General; and

(2) Amendments to Regulation .10 under COMAR 08.02.14 Aquaculture Permits.

This action, which was proposed for adoption in 45:24 Md. R. 1166—1167 (November 26, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

MARK J. BELTON
Secretary of Natural Resources

 

Subtitle 02 FISHERIES SERVICE

Notice of Final Action

[18-326-F-I]

On January 22, 2019, the Secretary of Natural Resources adopted:

(1) Amendments to Regulation .17 under COMAR 08.02.04 Oysters; and

(2) Amendments to Regulation .03 and the repeal of Regulation .05 under COMAR 08.02.23 Shellfish Aquaculture and Leasing.

This action, which was proposed for adoption in 45:25 Md. R. 1208—1210 (December 7, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

MARK J. BELTON
Secretary of Natural Resources

 

Title 09
DEPARTMENT OF LABOR, LICENSING, AND REGULATION

Subtitle 08 HOME IMPROVEMENT COMMISSION

09.08.07 Fees

Authority: Business Regulation Article, §§2-106.11, 2-106.12, 8-207, 8-209, 8-210, 8-213, 8-302, 8-303, 8-308, and 8-308.1, Annotated Code of Maryland

Notice of Final Action

[18-208-F]

On December 6, 2018, the Home Improvement Commission adopted new Regulations .01 and .02 under a new chapter, COMAR 09.08.07 Fees. This action, which was proposed for adoption in 45:20 Md. R. 923 — 924 (September 28, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

DAVID FINNERAN
Executive Director
Home Improvement Commission

 

Title 11
DEPARTMENT OF TRANSPORTATION

Subtitle 02 TRANSPORTATION SERVICE HUMAN RESOURCES SYSTEM

11.02.03 Leave Benefits

Authority: State Personnel and Pensions Article, §9-1108; Transportation Article, §§2-102 and 2-103.4; Annotated Code of Maryland

Notice of Final Action

[18-309-F]

On January 2, 2019, the Secretary of Transportation adopted amendments to Regulation .10 under COMAR 11.02.03 Leave Benefits. This action, which was proposed for adoption in 45:23 Md. R. 1082—1083 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

PETE K. RAHN
Secretary of Transportation

 

Title 12
DEPARTMENT OF PUBLIC SAFETY AND CORRECTIONAL SERVICES

Subtitle 10 CORRECTIONAL TRAINING COMMISSION

12.10.01 General Regulations

Authority: Correctional Services Article, §§2-109 and 8-208, Annotated Code of Maryland

Notice of Final Action

[18-166-F]

On October 10, 2018, the Secretary of Public Safety and Correctional Services, in cooperation with the Correctional Training Commission, adopted amendments to Regulation .19 under COMAR 12.10.01 General Regulations. This action, which was proposed for adoption in 45:14 Md. R. 706—707 (July 6, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

STEPHEN T. MOYER
Secretary Public Safety and Correctional Services

 

Title 13A
STATE BOARD OF EDUCATION

Subtitle 01 STATE SCHOOL ADMINISTRATION

13A.01.05 Appeals to the State Board of Education

Authority: Education Article, §§2-205, 4-205, 6-202, and 7-305; State Government Article, §§10-122 and 10-201 et seq.; Annotated Code of Maryland

Notice of Final Action

[18-289-F]

On January 22, 2019, the Maryland State Board of Education adopted amendments to Regulations .01—.04 and .07—.11, new Regulations .05 and .12, amendments to and the recodification of existing Regulation .05 to be Regulation .06, and the repeal of existing Regulation .06 under COMAR 13A.01.05 Appeals to the State Board of Education. This action, which was proposed for adoption in 45:23 Md. R. 1083—1086 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

KAREN B. SALMON, Ph.D.
State Superintendent of Schools

 

Subtitle 12 CERTIFICATION

13A.12.01 General Provisions

Authority: Education Article, §§2-205, 2-303(g), and 6-701—6-706, Annotated Code of Maryland

Notice of Final Action

[18-307-F]

On January 22, 2019, the Maryland State Board of Education adopted amendments to Regulation .05 under COMAR 13A.12.01 General Provisions. This action, which was proposed for adoption in 45:23 Md. R. 1087 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

KAREN B. SALMON, Ph.D.
State Superintendent of Schools

 

Title 14
INDEPENDENT AGENCIES

Subtitle 22 COMMISSION ON CRIMINAL SENTENCING POLICY

14.22.01 General Regulations

Authority: Criminal Procedure Article, §6-211, Annotated Code of Maryland

Notice of Final Action

[18-335-F]

On January 22, 2019, the Maryland State Commission on Criminal Sentencing Policy adopted amendments to Regulation .01 under COMAR 14.22.01 General Regulations.  This action, which was proposed for adoption in 45:25 Md. R. 1215 (December 7, 2018), has been adopted as proposed.

Effective Date: March 1, 2019.

DAVID SOULE
Executive Director

 

Title 22
STATE RETIREMENT AND PENSION SYSTEM

Subtitle 01 GENERAL REGULATIONS

22.01.01 Definitions and General Provisions

Authority: State Personnel and Pensions Article, §§21-108 and 21-110, Annotated Code of Maryland

Notice of Final Action

[18-293-F]

On January 15, 2019, the Board of Trustees for the State Retirement and Pension System adopted amendments to Regulations .01 and .02 under COMAR 22.01.01 Definitions and General Provisions. This action, which was proposed for adoption in 45:23 Md. R. 1111—1112 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

Subtitle 01 GENERAL REGULATIONS

22.01.02 Public Information Act Requests

Authority: General Provisions Article, §§4-101 - 4-601; State Personnel and Pensions Article, §§21-110, 21-123, 21-128, 21-504, and 30-208; Annotated Code of Maryland

Notice of Final Action

[18-292-F]

On January 15, 2019, the Board of Trustees for the State Retirement and Pension System adopted the repeal of existing Regulations .01—.16 and new Regulations .01—.16 under COMAR 22.01.02 Public Information Act Requests. This action, which was proposed for adoption in 45:24 Md. R. 1181—1185 (November 26, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

Subtitle 01 GENERAL REGULATIONS

22.01.03 Domestic Relations Order

Authority: State Personnel and Pensions Article, §§21-110, 21-502, and 21-603, Annotated Code of Maryland

Notice of Final Action

[18-294-F]

On January 15, 2019, the Board of Trustees for the State Retirement and Pension System adopted amendments to Regulations .02, .03, .05, and .07 under COMAR 22.01.03 Domestic Relations Orders. This action, which was proposed for adoption in 45:23 Md. R. 1112—1113 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

Subtitle 01 GENERAL REGULATIONS

22.01.04 Average Final Compensation

Authority: State Personnel and Pensions Article, §§20-204, 20-205, 20-205.1, and 21-110, Annotated Code of Maryland

Notice of Final Action

[18-295-F]

On January 15, 2019, the Board of Trustees for the State Retirement and Pension System adopted amendments to Regulations .02—.05 under COMAR 22.01.04 Average Final Compensation. This action, which was proposed for adoption in 45:23 Md. R. 1113—1115 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

Subtitle 01 GENERAL REGULATIONS

22.01.05 Proof of Date of Birth

Authority: State Personnel and Pensions Article, §21-110, Annotated Code of Maryland

Notice of Final Action

[18-296-F]

On January 15, 2019, the Board of Trustees for the State Retirement and Pension System adopted the repeal of existing Regulation .01, new Regulation .01, and amendments to Regulation .02 under COMAR 22.01.05 Proof of Date of Birth. This action, which was proposed for adoption in 45:23 Md. R. 1116 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

Subtitle 01 GENERAL REGULATIONS

22.01.07 Designation of Beneficiary

Authority: State Personnel and Pensions Article, §21-110; Title 21, Subtitle 4; and Title 29, Subtitle 2; Annotated Code of Maryland

Notice of Final Action

[18-297-F]

On January 15, 2019, the Board of Trustees of the State Retirement and Pension System adopted amendments to Regulations .02 and .03 under COMAR 22.01.07 Designation of Beneficiary. This action, which was proposed for adoption in 45:23 Md. R. 1116—1117 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

Subtitle 01 GENERAL REGULATIONS

22.01.08 Refund of Accumulated Contributions

Authority: State Personnel and Pensions Article, §§21-110, 21-603, and
29-501, Annotated Code of Maryland

Notice of Final Action

[18-298-F]

On January 15, 2019, the Board of Trustees for the State Retirement and Pension System adopted amendments to Regulations .01—.03 under COMAR 22.01.08 Refund of Accumulated Contributions. This action, which was proposed for adoption in 45:23 Md. R. 1117—1118 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

Subtitle 07 COMPLIANCE WITH THE INTERNAL REVENUE CODE

22.07.02 Code Compliance

Authority: State Personnel and Pensions Article, §§21-110 and 21-603, Annotated Code of Maryland

Notice of Final Action

[18-299-F]

On January 15, 2019, the Board of Trustees for the State Retirement and Pension System adopted new Regulation .05 under COMAR 22.07.02 Code Compliance. This action, which was proposed for adoption in 45:23 Md. R. 1118—1119 (November 9, 2018), has been adopted as proposed.

Effective Date: February 11, 2019.

R. DEAN KENDERINE
Executive Director
Maryland State Retirement and Pension System

 

 


Proposed Action on Regulations

 


 



Title 09
DEPARTMENT OF LABOR, LICENSING, AND REGULATION

Subtitle 10 RACING COMMISSION

09.10.01 Thoroughbred Rules

Authority: Business Regulation Article, §11-210, Annotated Code of Maryland

Notice of Proposed Action

[19-050-P]

The Maryland Racing Commission proposes to repeal existing Regulation .64 and adopt new Regulation .64 under COMAR 09.10.01Thouroughbred Rules. This action was considered by the Maryland Racing Commission during a public meeting held on December 13, 2018.

Statement of Purpose

The purpose of this action is to provide for a written agreement between a majority of owners and trainers and a majority of jockeys riding in Maryland in determining the amount to be earned by a jockey riding a horse in a race.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 J. Michael Hopkins, Executive Director, Maryland Racing Commission, 300 East Towsontown Blvd., Towson, MD 21286, or call 410-296-9682, or email to mike.hopkins@maryland.gov, or fax to 410-296-9687. Comments will be accepted through March 15, 2019. A public hearing has not been scheduled.

.64 Jockey Fees.

Subject to the approval of the Commission, the amount earned by a jockey for finishing first, second, third, or unplaced shall be determined by a written agreement between the organizations that represent the majority of owners and trainers and a majority of jockeys riding in Maryland .

J. MICHAEL HOPKINS
Executive Director
Racing Commission

 

Subtitle 10 RACING COMMISSION

09.10.03 Prohibited Acts

Authority: Business Regulation Article, §11-210, Annotated Code of Maryland

Notice of Proposed Action

[19-051-P]

The Maryland Racing Commission proposes to amend Regulation .04 under COMAR 09.10.03 Prohibited Acts. This action was considered by the Maryland Racing Commission at a public meeting held on December 13, 2018.

Statement of Purpose

The purpose of this action is to amend COMAR to conform to national uniformity.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

 

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 J. Michael Hopkins, Executive Director, Maryland Racing Commission, 300 East Towsontown Blvd., Towson, MD 21286, or call 410-296-9682, or email to mike.hopkins@maryland.gov, or fax to 410-296-9687. Comments will be accepted through March 15, 2019. A public hearing has not been scheduled.

.04 Drug Prohibition — Horses.

A. Other than Lasix administered in accordance with the regulations in this chapter, an individual may not administer, cause to be administered, participate, or attempt to participate in any way in the administration of any drug or medication to a horse:

(1) During the 24-hour period before the scheduled post time for the [first] race [of the program] in which the horse is to participate; and

(2) (text unchanged)

B.—G. (text unchanged)

J. MICHAEL HOPKINS
Executive Director
Racing Commission

 

Title 10
MARYLAND DEPARTMENT OF HEALTH

Subtitle 06 DISEASES

10.06.02 Communicable Diseases — Rabies

Authority: Health-General Article, §§18-102, 18-313, and 18-317, Annotated Code of Maryland

Notice of Proposed Action

[19-044-P]

The Secretary of Health proposes to amend Regulation .03 under COMAR 10.06.02 Communicable Diseases—Rabies.

Statement of Purpose

The purpose of this action is to update COMAR 10.06.02.03 to include language describing how the Department will ensure that no person is denied rabies postexposure treatment due to the inability to pay.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.03 Human Rabies.

A.—C. (text unchanged)

D. Treatment; Postexposure.

(1)—(2) (text unchanged)

(3) The Department shall [provide postexposure treatment, under the guidelines issued by the Public Health Veterinarian and the State Epidemiologist, free of charge to any person who is unable to pay for treatment] ensure no one is denied rabies postexposure treatment due to the inability to pay when the treatment is provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist and recommended by a licensed health care provider.

(4) The local health officer [shall make the final determination on an individual’s ability to pay for treatment based on the ability-to-pay schedule of the Department] of the jurisdiction where the resident resides shall ensure access to rabies postexposure treatment provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist.

(5) [The local health officer of the county which provides treatment is responsible for making a reasonable effort to obtain monies to pay for treatment through available resources] When rabies postexposure treatment is provided in accordance with the guidelines issued by the Public Health Veterinarian and the State Epidemiologist, the Department shall pay the charge of the rabies biologics for persons unable to pay for them:

(a) Based on the current ability-to-pay schedule of the Department; and

(b) Only after all available benefits and discounts are applied.

ROBERT NEALL
Secretary of Health

 

Subtitle 09 MEDICAL CARE PROGRAMS

10.09.93 Chronic Hospitals

Authority: Health-General Article, §§2-104(b), 15-102.8, 15-103, and 15-105, Annotated Code of Maryland

Notice of Proposed Action

[19-030-P]

The Secretary of Health proposes to amend Regulations .01, .05, .07, and .08 under COMAR 10.09.93 Chronic Hospitals.

Statement of Purpose

The purpose of this action is to:

(1) Clarify that the definition of “chronic hospital” does not mean “long-term care facility” for purposes of Medicaid reimbursement;

(2) Clarify the nature and frequency of rehabilitation services provided by a chronic hospital; and

(3) Establish a new period for concurrent review of the continued medical necessity of a participant’s chronic hospital services.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(7) (text unchanged)

(8) Chronic Hospital.

(a) (text unchanged)

(b) “Chronic hospital” does not mean a:

(i) [long-term] Long-term care hospital, as defined at 42 CFR §412.23(e); or

(ii) Long-term care facility, as defined at 42 CFR §483.5(a).

(9)—(15) (text unchanged)

[(16) “Level of care” means an assessment that an individual needs the level of services provided in a special psychiatric hospital.] 

[(17)] (16)[(25)] (24) (text unchanged)

.05 Covered Services.

A. Chronic hospitals shall provide the following services:

(1)—(3) (text unchanged)

(4) For participants admitted for [intensive] medically necessary rehabilitation services, [at least two sessions, 5 days per week, of] physical therapy, occupational therapy, or speech therapy [focused on language pathology], directed by an interdisciplinary team; and

(5) (text unchanged)

B.—E. (text unchanged)

.07 Medical Eligibility.

A. General Requirements.

(1) (text unchanged)

(2) An admission to a chronic hospital is medically necessary for a participant who [needs intensive]:

(a) Requires rehabilitation services [other] of a lesser intensity or frequency than [those] the acute inpatient rehabilitation services provided in a special rehabilitation hospital; and

(b) May have comorbidities or a level of medical complexity that preclude admission to a special rehabilitation hospital.

(3) (text unchanged)

B. (text unchanged)

.08 Utilization Review.

A. Admission and Prior Approval.

(1) (text unchanged)

(2) For a participant to be preauthorized for services in a brain injury community integration program, [the] a provider that meets the requirements of Regulation .04 of this chapter shall request a determination from the Department or its designee that the participant meets the criteria set forth in Regulation .07B of this chapter.

(3) (text unchanged)

B. Concurrent Review.

(1) (text unchanged)

(2) Concurrent review shall be conducted every 14 days as long as the participant remains hospitalized[, based on the participant’s diagnosis and condition,] to ensure the medical necessity of the participant’s inpatient stay[, at the following intervals:

(a) After an initially authorized 30-day stay, or at the end of the expected length of stay identified at admission, whichever comes first; and

(b) Every 14 days following the initial concurrent review, including clinical updates, on a form determined by the Department or its designee].

(3) (text unchanged)

C. (text unchanged)

ROBERT R. NEALL
Secretary of Health

 

Subtitle 13 DRUGS

10.13.04 Emergency Use Auto-Injectable Epinephrine Program at Institutions of Higher Education

Authority: Health-General Article, §§2-104 and 13-7A-03, Annotated Code of Maryland

Notice of Proposed Action

[19-028-P]

The Secretary of Health proposes to adopt new Regulations .01—.03 under a new chapter, COMAR 10.13.04 Emergency Use Auto-Injectable Epinephrine Program at Institutions of Higher Education.

Statement of Purpose

The purpose of this action is to codify in regulations the Emergency Use Auto-Injectable Epinephrine Program at Institutions of Higher Education established in Health-General Article, §§13-7A-01—13-7A-09, Annotated Code of Maryland. These regulations will establish the policies and procedures for the administration of the program.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.01 Scope.

This chapter applies to employees of food service facilities or recreation and wellness facilities on the premises of an institution of higher education as defined in Education Article, §10-101, Annotated Code of Maryland.

.02 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Affiliated individual” means an individual who is 18 years old or older who has been designated in writing by an eligible institution to serve either as a school health supervisor or as a certificate holder.

(2) “Agent” means an individual who:

(a) Is 18 years old or older;

(b) Has successfully completed, at the expense of the eligible institution, an emergency epinephrine educational training program approved by the Department; and

(c) Is designated in writing by a certificate holder to administer auto-injectable epinephrine in an emergency situation.

(3) “Anaphylaxis” means a sudden, severe, and potentially life–threatening allergic reaction that occurs when an individual is exposed to an allergen.

(4) “Applicant” means an individual applying for a Certificate for Emergency Epinephrine.

(5) “Auto-injectable epinephrine” means a portable, disposable drug delivery device that contains a premeasured single dose of epinephrine that is used to treat anaphylaxis in an emergency situation.

(6) “Certificate for emergency epinephrine” means a certificate issued by the Maryland Department of Health to an individual employed or designated by an eligible institution to obtain, store, and administer auto-injectable epinephrine.

(7) “Certificate holder” means an individual who is authorized by the Maryland Department of Health to obtain, store, and administer auto-injectable epinephrine to be used in an emergency situation.

(8) “Department” means the Maryland Department of Health.

(9) “Eligible institution” means an institution of higher education that has a food service facility or a recreation and wellness facility on the premises and that otherwise meets the requirements of this chapter.

(10) “Food service facility” has the meaning stated in COMAR 10.15.03.

(11) “School health supervisor” means an individual who:

(a) Provides health services for an institution of higher education; and

(b) Is licensed by the State as a:

(i) Physician;

(ii) Certified nurse practitioner; or

(iii) Registered nurse.

(12) “Successfully completed” means to pass a written examination with a grade of 75 percent or higher.

.03 Emergency Epinephrine.

A. An individual may apply, on a form prescribed by the Department, for a certificate for emergency epinephrine, which shall be valid for up to 1 year if the applicant:

(1) Is employed by a food service facility or a recreation and wellness facility at an eligible institution;

(2) Is 18 years old or older; and

(3) Has successfully completed, at the expense of the eligible institution, an emergency epinephrine educational training program approved by the Department.

B. The applicant shall submit to the Department with the form required in §A of this regulation a written policy that includes:

(1) Designation of agents and affiliated individuals;

(2) The name of the approved emergency epinephrine educational training program; and

(3) Procedures to:

(a) Store emergency auto-injectable epinephrine;

(b) Maintain the emergency auto-injectable epinephrine in a secure manner;

(c) Report use of emergency auto-injectable epinephrine according to §L of this regulation;

(d) Train an emergency epinephrine certificate holder and agent annually; and

(e) Maintain documentation of an emergency epinephrine certificate holder and agent training for 3 years.

C. A provider of an emergency epinephrine educational training program shall meet the requirements of COMAR 10.16.07.15C and D.

D. An individual teaching an emergency epinephrine educational training program shall be licensed as a physician, a registered nurse, or a certified nurse practitioner.

E. The Department shall:

(1) Issue a certificate for emergency epinephrine to an applicant who meets the requirements in §§A and B of this regulation;

(2) Deny the issuance of a certificate for emergency epinephrine to an applicant who does not meet the requirements in §§A and B of this regulation;

(3) Revoke or suspend the certificate for emergency epinephrine of an individual who does not meet the requirements in §§A and B of this regulation;

(4) Approve an emergency epinephrine educational training program if the training program meets the requirements of §C of this regulation;

(5) Disapprove an emergency epinephrine educational training program if the training program does not meet the requirement of §C of this regulation; and

(6) On or before January 31 of each year, publish a report summarizing the information obtained from the reported uses of emergency auto-injectable epinephrine at eligible institutions according to §L of this regulation.

F. A physician licensed to practice medicine in the State may prescribe auto-injectable epinephrine in the name of a certificate holder.

G. A pharmacist licensed to practice pharmacy in the State, or a physician, may dispense auto-injectable epinephrine under a prescription issued to a certificate holder.

H. A certificate holder may:

(1) On presentment of a certificate for emergency epinephrine, receive from any physician licensed to practice medicine in the State a prescription for auto-injectable epinephrine; and

(2) Possess and store prescribed auto-injectable epinephrine.

I. An eligible institution:

(1) Shall ensure that there is a written plan for the emergency epinephrine program that:

(a) Is approved annually, in writing, by a school health supervisor;

(b) Is on file at the eligible institution and is available for inspection; and

(c) Includes at a minimum:

(i) The name, title, and license number of the health supervisor;

(ii) Information on the emergency epinephrine educational training program used;

(iii) Procedures for disseminating information to staff on the emergency epinephrine program;

(iv) Procedures for the proper storage and handling of medication;

(v) Procedures for the use of emergency services and 911 services; and

(vi) Procedures for documenting incidents involving the administration of auto-injectable epinephrine by a certificate holder in accordance with §L of this regulation;

(2) Shall ensure that a certificate holder who is employed by, or a designated affiliated individual of, the institution complies with all provisions of this chapter;

(3) Shall provide the Department with access to records and documents required under this chapter;

(4) Shall designate in writing the certificate holders who will be responsible for the storage, maintenance, and control of the supply of auto-injectable epinephrine;

(5) May not obtain or store auto-injectable epinephrine unless the eligible institution has at least two certificate holders; and

(6) Shall maintain a copy of the certificate issued to a certificate holder under §E of this regulation for at least 3 years.

J. Certificate Holders.

(1) Subject to §I(4) of this regulation, a certificate holder may obtain:

(a) A prescription for a supply of auto-injectable epinephrine from a licensed physician as provided in §F of this regulation; and

(b) A supply of auto-injectable epinephrine from a licensed pharmacist or a licensed physician as provided in §G of this regulation.

(2) A certificate holder shall store a supply of auto-injectable epinephrine obtained under §J(1) of this regulation:

(a) In accordance with the manufacturer’s instructions; and

(b) In a location that is readily accessible to certificate holders and agents in an emergency situation.

K. In an emergency situation when physician or emergency medical services are not immediately available, a certificate holder or agent may administer auto-injectable epinephrine to an individual who is experiencing or believed in good faith by the certificate holder or agent to be experiencing anaphylaxis.

L. An eligible institution shall ensure that an incident that occurred on the premises of a food service facility or recreation and wellness facility at an eligible institution that involved the administration of auto-injectable epinephrine by a certificate holder or agent is reported:

(1) Immediately to the school health supervisor and, in the case of a minor, to the minor’s parent or guardian; and

(2) To the Department within 5 business days of the incident on a form prescribed by the Department.

ROBERT R. NEALL
Secretary of Health

 

Subtitle 15 FOOD

10.15.09 Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk

Authority: Health-General Article, [§21-406] §§2-104, 2-105, 21-207, 21-208, 21-210, 21-211, 21-405, 21-406, and 21-428, Annotated Code of Maryland

Notice of Proposed Action

[19-048-P-I]

The Secretary of Health proposes to repeal existing Regulations .01—.20 and adopt new Regulations .01—.22 under COMAR 10.15.09 Production, Processing, Transportation, Storage, and Distribution of Manufactured Grade Milk.

Statement of Purpose

The purpose of this action is to amend COMAR 10.15.09 in order to update language to match other similar regulations and to align with the most recent guidelines including the Federal Food, Drug, and Cosmetic Act; the Nutrition Labeling and Education Act of 1990; Evaluation of Milk Laboratories; the Bulk Milk Hauler/Sampler Manual; the Grade “A” Pasteurized Milk Ordinance; Milk for Manufacturing Purposes and its Production and Processing; the Maryland Laboratory Evaluation Program Manual; and Standard Methods for the Examination of Dairy Products, which are being added to the incorporation by reference regulation of this chapter. The proposal also phases in certain new requirements of the FDA Food Safety Modernization Act.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. These changes will not have an impact on the Maryland Department of Health, but will have an indeterminable economic impact on the regulated dairy industry. Some businesses may incur costs as a result of bringing their business practices into alignment with new requirements of the updated Food Safety Modernization Act.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

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:

(-)

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.)

D. This proposal will have an indeterminable economic impact on the regulated dairy industry. Some businesses may incur costs associated with changes that will bring their business practices into alignment with new requirements of the updated Food Safety Modernization Act. Some of these new requirements include conducting risk assessments, constructing a food safety plan, writing standard operating procedures, designing environmental sampling programs, and new ingredient requirements. Because of variations in current equipment and practices at each business, it is not possible to predict what the overall impact of these changes will be.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

 

Editor’s Note on Incorporation by Reference

     Pursuant to State Government Article, §7-207, Annotated Code of Maryland, the following have been declared documents generally available to the public and appropriate for incorporation by reference:

         (1) Maryland Laboratory Evaluation Program Manual 2017 (Center for Milk & Dairy Product Safety, Office of Food Protections, Maryland Department of Health);

         (2) Evaluation of Milk Laboratories, 2015 Revision.

         (3) Grade “A” Pasteurized Milk Ordinance, 2015 Revision, only: Sections 5-6; Standards for Grade “A” Raw Milk Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all items except for Item 9r Administrative Procedures 1.a; Standards for Grade “A” Pasteurized, Ultra-Pasteurized Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p, Administrative Procedures 2.1. Item 11p Administrative Procedures 2.and 6, Item 18p, and Item 19p; Section 8; Section 12-15; Section 18; Appendices A-I; Appendices K-O; and Appendices Q-S;

         (4) Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, Effective July 21, 2011, only: Subpart C, Sec. C 12(a)(2)(ii) and C 12(a)(3)(ii); Subpart E, Sec. E 1, E 1.4(2)-(e); Subpart E, Sec. E 1, E1.15; Subpart E, Sec. E 1, E1.16; Subpart E, Sec. E 2, except for E.2.2.5, E2.4.8, and E2.4.9; Subpart E, Sec. E 3; Subpart E, Sec. E 4, except for E.4.3.2; and Subpart E, Sec. E 6;

         (5) Standard Methods for the Examination of Dairy Products, 17th Edition 2004 (American Public Health Association); and

     For this reason, these documents will not be printed in the Maryland Register or the Code of Maryland Regulations (COMAR). Copies of these documents are filed in special public depositories located throughout the State. A list of these depositories was published in 46:1 Md. R. 9 (January 4, 2019), and is available online at www.dsd.state.md.us. These documents may also be inspected at the office of the Division of State Documents, 16 Francis Street, Annapolis, Maryland 21401.

.01 Scope.

A. In accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, this chapter:

(1) Governs permits for the sale of milk for manufacturing processes;

(2) Describes the requirement for a permit for the sale of milk for manufacturing purposes; and

(3) Regulates the inspection of manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.

B. This chapter also sets forth:

(1) Standards for milk manufacturing;

(2) The plan review process for manufactured grade dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products;

(3) The enforcement process for the examination, labeling, pasteurization, aseptic processing, retort processing, packaging, and distribution and sale of manufactured grade milk and milk products;

(4) Penalties pursuant to Health-General Article, §§21-211, 21-252 — 21-256, 21-418, 21-419, 21-428, 21-1202, and 21-1203, Annotated Code of Maryland; and

(5) Requirements for dairy farms and milk facilities that produce, process, transport, store, or distribute manufactured grade milk or milk products.

.02 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “3-A Sanitary Standards” means the standards for dairy equipment and accepted practices formulated by the 3-A Sanitary Standards Committee representing the:

(a) American Dairy Products Institute;

(b) International Dairy Foods Association;

(c) Food Processing Suppliers Association; and

(d) International Association for Food Protection.

(2) “Agistment agreement” means the sale of shares or interest in a:

(a) Cow, goat, or other lactating hooved mammal; or

(b) Herd of cows, goats, or other lactating hooved mammals.

(3) “Approved” means meeting the criteria set forth in this chapter.

(4) “Aseptic processing and packaging” means the filling of a commercially sterilized cooled product into pre-sterilized containers, followed by aseptic hermetical sealing, with a pre-sterilized closure, in an atmosphere free of microorganisms.

(5) “Bobtailer” means a person who operates or controls a manufactured milk product route and distributes a manufactured milk product that the person buys from a distributer or manufactured milk processor.

(6) “Bulk milk hauler/sampler” means an individual who:

(a) Collects official samples;

(b) Transports raw milk from a farm, or raw milk products to or from a:

(i) Milk plant;

(ii) Receiving station; or

(iii) Transfer station;

(c) Possesses a permit from any state to sample milk or raw milk products; and

(d) If they are sampling raw milk in the State, possesses a Maryland Bulk Milk Hauler license.

(7) “Butter” means the food product that is made exclusively from milk or cream, or both, with or without salt, and with or without additional coloring matter, and that contains not less than 80 percent by weight of milk fat.

(8) “Certified industry dairy farm inspector” means a person who is certified by the Secretary under Health-General Article, §21-414, Annotated Code of Maryland, to perform as specified in that section.

(9) “Cheese” means the fresh or matured product that:

(a) Is obtained by draining after coagulation of milk, cream, skimmed or partly skimmed milk, or a combination of some or all of these products; and

(b) Meets the standards of identity in 21 CFR Part 133.

(10) “Commercial sterility” means the condition achieved by a treatment that renders equipment, containers, and food free of viable microorganisms that are capable of reproducing in the food under normal nonrefrigerated conditions of storage and distribution.

(11) “Dairy farm” means a place where at least one cow, goat, or other hooved mammal is kept, and from which the milk from these animals is sold or offered for sale.

(12) “Dairy plant sampler” mean a person responsible for the collection of official samples for regulatory purposes outlined in Section 6 of the Pasteurized Milk Ordinance.

(13) “Department” means the Maryland Department of Health or its designee.

(14) “Departmental inspection area” means the area in which the Department routinely makes inspections, which consists of that area within the boundaries of Maryland and any other area as may be designated by the Secretary.

(15) “Distribution station” means a place or vehicle where, for redistribution and resale, a manufactured grade milk product routinely is received, stored, or transferred.

(16) “Distributor” means a person who offers for sale a manufactured grade milk product.

(17) “Heat treated cream” means milk that has been heated during separation to temperatures greater than 52ºC (125ºF) but less than 75ºC (166ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping cream for bulk shipments.

(18) “Heat treated milk” means milk that has been heated one time during separation to temperatures greater than 52ºC (125ºF) but less than 72ºC (161ºF), then immediately cooled to 7ºC (45ºF) or less for the purpose of producing and shipping heat treated nonfat skim milk, reduced fat milk, or lowfat milk for bulk shipments.

(19) “Industry plant sampler” means a person employed at a milk plant, a receiving station, or a transfer station who is responsible for the collection of official samples for regulatory purposes at the milk plant, receiving station, or transfer station.

(20) “Instant nonfat dry milk” means nonfat dry milk that has been produced in such a manner as to substantially improve its dispersing and reconstitution characteristics over that produced by the conventional processes.

(21) “Manufactured grade milk” means the milk of a cow, goat, or other hooved mammal that is produced, processed, pasteurized, packaged, or prepared for human consumption in accordance with the standards set forth in this chapter.

(22) “Manufactured grade milk product” means:

(a) Butter;

(b) Cheese, natural or processed;

(c) Condensed skim milk, plain or sweetened;

(d) Condensed whole milk;

(e) Cream;

(f) Dry buttermilk;

(g) Dry whey;

(h) Dry whole milk;

(i) Evaporated milk, whole or skim;

(j) Nonfat dry milk;

(k) Quark; or

(l) Any other product made with manufactured grade milk that is regulated by the Department.

(23) “Milk” means the lacteal secretion of a cow, goat, or other hooved mammal, practically free from colostrum, obtained by the complete milking of one or more healthy hooved mammals.

(24) “Milk facility” means a:

(a) Distribution station;

(b) Milk plant;

(c) Milk processor;

(d) Milk tank truck cleaning facility;

(e) Receiving station; or

(f) Transfer station.

(25) “Milk hauler” means an individual who is in charge of a milk tank truck while it is receiving, transporting, or delivering milk or a milk product.

(26) “Milk marketing agency” means a person who negotiates the price of milk to be offered for sale and supplies milk.

(27) Milk Plant.

(a) “Milk plant” means a place where milk products are:

(i) Received and stored;

(ii) Processed;

(iii) Pasteurized;

(iv) Packaged; or

(v) Prepared for distribution.

(b) “Milk plant” does not include a place where milk products are sold at retail only.

(28) “Milk processor” means a person who owns, operates, or controls a milk plant.

(29) “Milk producer” means a person who:

(a) Operates a dairy farm; and

(b) Provides, sells, or offers milk for sale to a:

(i) Milk plant;

(ii) Receiving station; or

(iii) Transfer station.

(30) “Milk product” means butter, cream, natural or processed cheese, dry milk or whey product, whole or skim evaporated milk, condensed whole milk, and plain or sweetened condensed skim milk, all of which are defined or described in this chapter, or at 21 CFR 131, 133, and 184, and any other product that may be developed and made from manufactured grade milk.

(31) “Milk tank truck” means a truck and its equipment that are used to transport milk or milk products.

(32) “Milk tank truck cleaning facility” means a place, premises, or establishment, separate from a milk plant, receiving station, or transfer station, where a milk tank truck is cleaned and sanitized.

(33) “Milk tank truck driver” means an individual who transports raw or pasteurized milk or milk products to or from a milk plant, receiving station, or transfer station and does not sample producer raw milk.

(34) “Milk transport container” means a vessel meeting 3-A Sanitary Standards or equivalent standards used by on-farm processors to transport milk from the dairy farm to the milk plant.

(35) “National Conference on Interstate Milk Shipments (NCIMS)” means a nonprofit organization made up of persons involved in the dairy industry, who make the laws governing all aspects of the milk sanitation program.

(36) Nonfat.

(a) “Nonfat” means a product contains less than 0.5 percent fat.

(b) “Nonfat” has the same meaning as skim or fat free.

(37) “Official laboratory” means a biological, chemical, or physical laboratory that is operated by the Department.

(38) “Officially designated laboratory” means a commercial laboratory authorized to conduct testing of milk and milk products on behalf of the Department or a milk industry laboratory officially designated by the Department for the examination, pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, of:

(a) Producer samples of Grade “A” raw milk for pasteurization; or

(b) Comingled milk tank truck samples of Grade “A” raw milk.

(39) “On-farm processor” means a licensed milk plant that is located on the same premises as a licensed milk producer.

(40) “Pasteurization” means the process of heating every particle of milk or milk product, in approved and properly designed equipment, by:

(a) Heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:

(i) 63°C (145°F) for 30 minutes;

(ii) 72°C (161°F) for 15 seconds;

(iii) 89°C (191°F) for 1 second;

(iv) 90°C (194°F) for 0.5 seconds;

(v) 94°C (201°F) for 0.1 seconds;

(vi) 96°C (204°F) for 0.05 seconds; or

(vii) 100°C (212°F) for 0.01 seconds;

(b) For milk or milk products with fat content of 10 percent or greater, a total solids of 18 percent or greater, or containing added sweeteners, heating the product to one of the following minimum temperatures and holding at this temperature continuously for at least the specified time:

(i) 66°C (150°F) for 30 minutes;

(ii) 75°C (166°F) for 15 seconds; or

(iii) The temperatures and times listed in §B(34)(a)(iii)—(vii) of this regulation;

(c) For milk or milk products that the USDA requires a specific product pasteurization temperature for, heating the product to the temperature requirement outlined in the USDA Milk for Manufacturing Purposes and its Production and Processing, Recommend Requirements; or

(d) Utilizing another process found equivalent to pasteurization for milk and milk products, which has been recognized and approved by FDA as provided in the Federal Food, Drug and Cosmetic Act, 21 U.S.C. §343(h)(3).

(41) “Permit” means an official document with a manufactured grade classification issued by the Secretary in accordance with Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, that authorizes the holder of the permit to do an act that is within the scope of the permit.

(42) “Permittee” means a person who holds a permit as defined in this chapter.

(43) Person.

(a) “Person” means an individual, receiver, trustee, guardian, personal representative, fiduciary, or representative of any kind and any partnership, firm, association, corporation, or other entity.

(b) “Person” includes:

(i) An operator of a facility that is owned by a State or local unit of government; or

(ii) A State or local unit of government if the State or local unit of government is the operator of the facility.

(44) “Raw milk” means unpasteurized milk, which includes:

(a) Heat treated nonfat skim milk;

(b) Heat treated reduced fat milk;

(c) Heat treated lowfat milk; and

(d) Heat treated cream.

(45) “Receiving station” means a place, premises, or establishment where raw milk is received, collected, handled, stored, or cooled and prepared for further transporting.

(46) “Recombined” means that a milk or a milk product is made by combining water and nonfat dry milk solids with:

(a) Cream;

(b) Butterfat; or

(c) Milk fat.

(47) “Reconstituted” means that a milk or a milk product has resulted from either:

(a) Combining dry whole milk solids with the appropriate amount of water; or

(b) Adding water to evaporated milk.

(48) “Retort processed after packaging” means that the milk or milk product, or both, have been subjected to sufficient heat processing after being packaged in a hermetically sealed container, to:

(a) Conform with applicable requirements under 21 CFR Parts 108, 113, and 117; and

(b) Maintain commercial sterility of the milk or milk products under nonrefrigerated conditions.

(49) “Sale” means a transaction that involves the:

(a) Transfer, dispensing, or serving of milk and milk products with or without charge; or

(b) Right to acquire milk and milk products:

(i) Through barter or contractual arrangement; or

(ii) In exchange for another form of compensation including, but not limited to, an agistment agreement.

(50) “Sanitization” means the application of an effective method or substance to clean surfaces to destroy pathogens and other microorganisms that does not damage the surface or adversely affect the milk or milk product that may come into contact with the surface.

(51) “Seasonal milk producer” means a milk producer that holds a permit to produce milk seasonally and stops producing milk for 30 days or more and then starts producing milk again within 12 months year after year.

(52) “Secretary” means the Secretary of Health or the Secretary’s designee.

(53) “Sell” means to offer for sale.

(54) Skim.

(a) “Skim” means a product contains less than 0.5 percent fat.

(b) “Skim” has the same meaning as nonfat or fat free.

(55) “Transfer station” means a place, premises, or establishment where milk or milk products are transferred directly from one milk tank truck to another.

(56) “Whey” means the liquid substance obtained by separating the coagulum from milk, cream, or nonfat milk in cheese making that meets the requirements of 21 CFR §184.1979.

.03 Incorporation by Reference.

In this chapter the following documents are incorporated by reference:

A. Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f, as amended;

B. Nutrition Labeling and Education Act of 1990 (Public Law 101-535), as amended;

C. Bulk Milk Hauler/Sampler Manual, 2016 (Center for Milk & Dairy Product Safety, Office of Food Protection, Maryland Department of Health), which has been incorporated by reference in COMAR 10.15.06.03;

D. Maryland Laboratory Evaluation Program Manual, 2017 (Center for Milk and Dairy Product Safety, Office of Food Protection, Maryland Department of Health);

E. 21 CFR Parts 100—101, as amended;

F. 21 CFR Part 117;

G. 21 CFR Parts 130—133, as amended;

H. 21 CFR Parts 170—189, as amended;

I. FDA Food Safety Modernization Act, 21 U.S.C §§2201—2252, as amended;

J. Evaluation of Milk Laboratories, 2015 Revision (Food and Drug Administration and the National Conference on Interstate Milk Shipments, U.S. Department of Health and Human Services);

K. Grade “A” Pasteurized Milk Ordinance, 2017 Revision (U.S. Department of Health and Human Services, Public Health Service, Food and Drug Administration), only:

(1) Section 5. Inspection of Dairy Farms and Milk Plants;

(2) Section 6. The Examination of Milk and/or Milk Products;

(3) Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.;

(4) Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.;

(5) Section 8. Animal Health;

(6) Section 12. Plans for Construction and Reconstruction;

(7) Section 13. Personnel Health;

(8) Section 14. Procedure when Infection or High Risk of Infection is Discovered;

(9) Section 15. Enforcement;

(10) Section 18. Separability Clause;

(11) Appendix A. Animal Disease Control;

(12) Appendix B. Milk Sampling, Hauling, and Transportation;

(13) Appendix C. Dairy Farm Construction Standards and Milk Production;

(14) Appendix D. Standards for Water Sources;

(15) Appendix E. Examples of 3-out-of-5 Compliance Enforcement Procedures;

(16) Appendix F. Cleaning and Sanitization;

(17) Appendix G. Chemical and Bacteriological Tests;

(18) Appendix H. Pasteurization Equipment and Procedures and Other Equipment;

(19) Appendix I. Pasteurization Equipment and Controls — Tests;

(20) Appendix K. HACCP Program;

(21) Appendix L. Applicable Regulations, Standards of Identity for Milk and Milk Products, The Federal Food, Drug, and Cosmetic Act, and the Federal Insecticide, Fungicide, and Rodenticide Act;

(22) Appendix M. Reports and Records;

(23) Appendix N. Drug Residue Testing and Farm Surveillance;

(24) Appendix O. Vitamin Fortification of Fluid Milk Products;

(25) Appendix Q. Operation of Automatic Milking Installations for the Production of Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging;

(26) Appendix R. Determination of Time/Temperature Control for Safety Milk and/or Milk Products; and

(27) Appendix S. Aseptic Processing and Packaging Program and Retort Processed after Packaging Program;

L. Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, Effective July 21, 2011 (United States Department of Agriculture, Agricultural Marketing Service, Dairy Programs), only:

(1) Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);

(2) Subpart E, Sec. E1, E 1.4(a)—(e);

(3) Subpart E, Sec. E1, E 1.15;

(4) Subpart E, Sec. E1, E 1.16;

(5) Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9;

(6) Subpart E, Sec. E 3;

(7) Subpart E, Sec. E 4, except for E 4.3.2; and

(8) Subpart E, Sec. E 6; and

M. Standard Methods for the Examination of Dairy Products (American Public Health Association, Seventeenth Edition, 2004).

.04 General Requirements.

A. The Department shall ensure that all inspections, sampling, testing, and enforcement actions performed by the State are carried out as set forth in and in compliance with the standards, requirements, and procedures specified at:

(1) Health-General Article, Title 21, Annotated Code of Maryland;

(2) Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§321—350f;

(3) Nutrition Labeling and Education Act of 1990 (Public Law 101-535);

(4) Bulk Milk Hauler/Sampler Manual;

(5) Maryland Laboratory Evaluation Program Manual;

(6) Grade “A” Pasteurized Milk Ordinance, only:

(a) Sections 5.—6.;

(b) Standards for Grade “A” Raw Milk for Pasteurization, Ultra-Pasteurization, Aseptic Processing and Packaging or Retort Processed after Packaging, all Items except for Item 9r. Administrative Procedures 1.a.;

(c) Standards for Grade “A” Pasteurized, Ultra-Pasteurized, Aseptically Processed and Packaged Low-Acid Milk and/or Milk Products, and Retort Processed after Packaged Low-Acid Milk and/or Milk Products, all Items except for Item 10p. Administrative Procedures 2.a., Item 11p. Administrative Procedures 2.a. and 6., Item 18p., and Item 19p.;

(d) Section 8.;

(e) Sections 12.—15.;

(f) Section 18.;

(g) Appendices A.—I.;

(h) Appendices K.—O.; and

(i) Appendices R.—S.;

(7) Milk for Manufacturing Purposes and its Production and Processing, Recommended Requirements, only:

(a) Subpart C, Sec. C12(a)(2)(ii) and C12(a)(3)(ii);

(b) Subpart E, Sec. E1, E 1.4(a)—(e);

(c) Subpart E, Sec. E1, E 1.15;

(d) Subpart E, Sec. E1, E 1.16;

(e) Subpart E, Sec. E 2, except for E 2.2.5, E 2.4.2, E 2.4.8, and E 2.4.9;

(f) Subpart E, Sec. E 3;

(g) Subpart E, Sec. E 4, except for E 4.3.2; and

(h) Subpart E, Sec. E 6; and

(8) Beginning January 1, 2019, FDA Food Safety Modernization Act, 21 U.S.C. §§2201—2252, as amended.

B. A person engaged in an occupation involving manufactured grade milk and milk products shall conduct all activities as set forth in and in compliance with the standards, requirements, and procedures specified in §A of this regulation.

.05 Permits Required.

A. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17, to the Department before that person may:

(1) Be a:

(a) Bobtailer;

(b) Bulk milk hauler/sampler;

(c) Certified industry dairy farm inspector;

(d) Milk processor;

(e) Milk producer; or

(f) Seasonal milk producer; or

(2) Operate a:

(a) Distribution station;

(b) Milk tank truck cleaning facility;

(c) Milk transportation company;

(d) Receiving station; or

(e) Transfer station.

B. Under Health-General Article, §§21-410 and 21-412, Annotated Code of Maryland, a person shall obtain a permit from the Department and pay the required fee, as specified in COMAR 10.01.17 for a milk tank truck.

C. Decals.

(1) When issued a permit, a permittee shall supply and display a decal.

(2) The permittee’s decal shall display the following at a height of at least 3 inches:

(a) The milk tank truck Maryland permit number; and

(b) The words “MD Milk Trans.” in a circle around the permit number.

(3) The permittee’s decal shall be displayed on the rear tank of each milk tank truck.

D. Under Health-General Article, §21-410(c), Annotated Code of Maryland, a permit is not required for:

(1) A milk producer who is outside the departmental inspection area if the raw milk from that milk producer is processed by a milk processor who holds a permit issued under this chapter;

(2) A bulk milk hauler/sampler who receives raw milk from outside the departmental inspection area;

(3) A grocery store, restaurant, soda fountain, or similar establishment where milk products are served or sold at retail if:

(a) The establishment complies with all applicable provisions of Health-General Article, Title 21, Subtitle 4, Annotated Code of Maryland, and all applicable rules or regulations; and

(b) The milk product is received from a permittee; or

(4) An individual who only transports milk in a sealed tanker to a milk plant.

.06 Permitting Process.

A. Except as otherwise provided in Health-General Article, §§21-410 and 21-411, Annotated Code of Maryland, a person shall obtain a permit from the Secretary before that person may:

(1) Bring, send, or receive a milk product into the State for sale;

(2) Offer a milk product for sale;

(3) Give away a milk product;

(4) Store a milk product;

(5) Transport a milk product; or

(6) Collect official milk samples.

B. Per Health-General Article, §§21-411, 21-412 and 21-417, Annotated Code of Maryland, an applicant for a permit shall:

(1) Submit a complete application to the Secretary for each place of operation on the form that the Secretary provides;

(2) Pay to the Secretary an annual fee established by the Secretary under Health-General Article, §2-104, Annotated Code of Maryland, and COMAR 10.01.17; and

(3) Be an employee of a milk transportation company, if applying for a Maryland Bulk Milk Hauler license, or be an owner of a milk transportation company, if applying for a Milk Transportation Company permit.

C. The Secretary shall issue a permit to an applicant who:

(1) Submits a complete application; and

(2) Meets the requirements of this chapter for each place of operation.

D. A permit issued by the Secretary:

(1) Is not transferable; and

(2) Is not valid if there is a change of owner, corporation, partnership, or physical location.

E. A bulk milk hauler/sampler who holds a permit in another state and picks up and samples raw milk at fewer than three Maryland farms shall obtain a Maryland milk hauler/sampler permit by providing:

(1) Documentation of a current bulk hauler/sampler permit from the licensing state, which clearly states the permit expiration date;

(2) Documentation of a current field evaluation from the licensing state; and

(3) A statement concerning the number of Maryland dairy farms from which the bulk milk hauler/sampler will pick up.

F. A bulk milk hauler/sampler who holds a permit from another state may pick up and sample raw milk from no more than three Maryland farms without a Maryland field evaluation or written exam.

G. If a bulk milk hauler/sampler who holds a permit from another state routinely picks up and samples raw milk at three or more Maryland farms, a Maryland field evaluation shall be conducted.

.07 Sale of Raw Milk.

A. Under Health-General Article, §21-434, Annotated Code of Maryland, a person may not sell or give away raw milk for human consumption.

B. A permitted milk producer may sell raw milk from the milk producer’s dairy farm only to a permitted:

(1) Receiving station;

(2) Transfer station;

(3) Milk plant; or

(4) Milk marketing agency.

.08 Standards for Milk for Manufacturing Purposes.

A. The individual in charge of an official laboratory or officially designated laboratory shall ensure that:

(1) The laboratory is operated according to the requirements established by the Maryland Laboratory Evaluation Program Manual; and

(2) Testing required for raw milk for pasteurization, pasteurized milk products, and dairy product containers and lids is performed according to the requirements established by the Maryland Laboratory Evaluation Program Manual.

B. A permittee shall ensure that all raw milk for pasteurization and all pasteurized milk and milk products conform to the standards and requirements established by:

(1) The Federal Food, Drug, and Cosmetic Act, 21 U.S.C. §§341—350f;

(2) The Nutrition Labeling and Education Act of 1990 (Public Law 101-535);

(3) Health-General Article, §§21-422 and 21-434, Annotated Code of Maryland;

(4) 21 CFR Parts 100—101 Food for Human Consumption, General and Food Labeling;

(5) 21 CFR Parts 131—133 Milk and Cream, Cheeses and Related Cheese Products; and

(6) The standards in the following table:

 

Product

Measure

Standard

Buttermilk (Condensed)

Temperature

7˚C (45˚F) or less

 

Coliform

Less than or equal to 10/gram

 

Cream Condensed

Temperature

Less than or equal to 7˚C (45˚F)

 

Coliform

Less than or equal to 10/gram

 

Cream (Dry)

 

Bacteria

Less than or equal to 50,000/gram

 

Coliform

Less than or equal to 10/gram

 

Dry Buttermilk and Dry Buttermilk Products

Coliform

Less than or equal to 10/gram

Dry Milk and Milk Products

Bacteria

Less than or equal to 50,000/gram

 

Coliform

Less than or equal to 10/gram

 

Instant Nonfat Dry Milk

 

Bacteria

 

Less than or equal to 30,000/gram

Coliform

 

Less than or equal to 10/gram

 

Manufactured Grade Raw Milk and Milk Products for Pasteurization, Ultra-Pasteurization or Aseptic Processing

Temperature

Bulk cooled to 10ºC (50ºF) or less within 4 hours or less of the commencement of the first milking, and to 7°C (45ºF) or less with­in 2 hours after the completion of milking. Pro­vided that the blend temperature after the first milking and subsequent milkings does not exceed 10ºC (50ºF). Milk transported in cans maintained at 7ºC (45ºF) or less. Note: Milk sample submitted for testing cooled and maintained at 0ºC (32ºF) to 4.5ºC (40ºF), where sample temperature is greater than 4.5 ºC (40ºF), but less than or equal to 7.0ºC (45oF) and less than 3 hours after collection has not increased in temperature.

Bacterial Limits

Individual producer milk not to exceed 500,000 per mL before commingling with other producer milk.

Not to exceed 1,000,000 per mL as com­mingl­ed milk before pas­teurization.

Note: Tested in conjunction with the drug residue test.

Drugs

No positive results on drug residue detection methods as referenced in Grade “A” Pasteurized Milk Ordinance, Section 6 — Laboratory Techniques.

Somatic Cell Count

Individual producer milk not to exceed 750,000 per mL except for individual producer goat milk, which is not to exceed 1,500,000 per mL.

 

Abnormalities

Has normal odor and appearance. Free from excessive coarse sediment visually. Milk may not show any abnormal condition (such as, but not limited to curded, ropy, bloody, or mastitic) as indicated by sight or test procedures.

 Odor

The odor shall be fresh, sweet, and free from objectionable feed or other off odors that adversely affect the finished product.

Modified Whey Products (Condensed)  

Temperature

7˚C (45˚F) or less

 

Coliform

Less than or equal to 10/gram

 

Modified Whey Products (Dry)

Coliform

Less than or equal to 10/gram

Nonfat Dry Milk (NFDM)

Bacteria

 

Less than or equal to 75,000/gram

Coliform

 

Less than or equal to 10/gram

Pasteurized Condensed Milk and Milk Products

Temperature

7˚C (45˚F) or less

 

Coliform

Less than or equal to 10/gram

 

Pasteurized Whey (Condensed) or Whey Products

Temperature

7˚C (45˚F) or less

 

Coliform

Less than or equal to 10/gram, or less than or equal to 100/gram in the case of bulk transport tank shipments.

Whey Cream

Temperature

 

Less than or equal to 7˚C (45˚ F)

Coliform

Less than or equal to 10/gram

 

Whey Cream Blends

Temperature

 

Less than or equal to 7˚C (45˚ F)

Coliform

Less than or equal to 10/gram

 

Whey (Dry)

Coliform

Less than or equal to 10/gram

 

Whey (Liquid) for Condensing or Drying

Temperature

 7˚C (45˚F) or less

.09 Inspection and Evaluation of Milk Production, Milk Processing, and Milk Transportation.

A. Under the standards set forth in Section 5 of the Grade “A” Pasteurized Milk Ordinance, the Secretary shall inspect a:

(1) Milk plant;

(2) Milk producer;

(3) Milk tank truck;

(4) Milk tank truck cleaning facility;

(5) Receiving station;

(6) Seasonal milk producer; and

(7) Transfer station.

B. The Secretary shall inspect a distribution station at least once every 6 months.

C. The Secretary shall inspect a bobtailer at least once every 12 months.

D. The Secretary shall inspect a seasonal milk producer before the first shipment of milk and at least every 6 months until milk production for sale has ceased.

E. Under the standards set forth in Health-General Article, §21-809, Annotated Code of Maryland, and the Grade “A” Pasteurized Milk Ordinance Item 16p.(D)2, the Secretary shall perform equipment tests and examinations at least once every 3 months.

F. The Secretary shall inspect a milk plant without a pasteurizer at least once every 6 months.

G. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, the Secretary shall evaluate the:

(1) Ability of the certified industry dairy farm inspector to perform dairy farm inspections and raw milk sampling;

(2) Pick-up and sampling procedures that a bulk milk hauler/sampler performs; and

(3) Sampling procedures of the industry plant sampler.

H. The Secretary shall inspect and evaluate the bulk milk hauler/sampler as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 5 and Appendix B, Sections I through III.

I. The Secretary shall inspect each milk tank truck as set forth in the Grade “A” Pasteurized Milk Ordinance, Appendix B, Section IV.

J. Under the standards set forth in the Maryland Laboratory Evaluation Program Manual, Evaluation of Milk Laboratories, Standard Methods for the Examination of Dairy Products, and the forms required by the Department, the Secretary shall evaluate a:

(1) Laboratory performing manufactured grade milk product testing for official use;

(2) Laboratory performing tests for drug residue screening, or tests for both drug residue screening and confirmation; and

(3) Laboratory analyst performing required testing.

K. Reinspections.

(1) If an inspection discloses the existence of a violation of a requirement set forth in this chapter, the Secretary shall re-inspect within 30 days, but not before 3 days, to determine compliance with the requirements of Regulation .13 of this chapter.

(2) If the Secretary finds on the second inspection a violation of the same requirement in this chapter, the Secretary shall issue a notice of intent to suspend the permit.

(3) If the Secretary finds a violation of the same requirement as specified on the notice of intent to suspend the permit on an inspection following the date of compliance as specified in the notice of intent to suspend the permit, the Secretary shall suspend the permit in accordance with Regulation .21 of this chapter and Health-General Article, §§21-418 and 21-419, Annotated Code of Maryland, or initiate appropriate court action.

L. Inspection Reports.

(1) The Secretary shall:

(a) Give one copy of the inspection report to the permittee or other responsible individual; or

(b) Post the inspection report in a conspicuous place on an inside wall of the establishment immediately after the conclusion of the inspection.

(2) The permittee may not deface the inspection report and shall make the inspection report available to the Department upon request.

(3) The Secretary shall keep a copy of the inspection report on file for 3 years.

M. Access Required. Upon request of the Secretary, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall permit the Secretary access to all parts of the milk establishment, facility, or transporting vehicle to determine compliance with the provisions of this chapter and Health-General Article, Title 21, Subtitles 2 and 4, Annotated Code of Maryland.

N. Information Required. Upon request, a milk producer, milk hauler, distributor, milk processor, receiving station operator, transfer station operator, or bobtailer shall furnish the Secretary:

(1) A statement of quantities of milk and milk product of each grade purchased and sold;

(2) A list of all sources of this milk and milk product; and

(3) Records of inspections, tests, and pasteurization times and temperatures.

.10 Sampling and Evaluation.

A. The following individuals may collect official samples:

(1) A dairy plant sampler;

(2) An industry plant sampler;

(3) A bulk milk hauler/sampler; and

(4) A certified Industry Dairy Farm Inspector.

B. An individual collecting official milk samples shall collect samples in accordance with the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B.

C. The Secretary shall evaluate the sampling and examination procedures of manufactured grade milk and milk products to ensure that the sampling and examination procedures are conducted according to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 6 and Appendix B.

D. Can milk shall be sampled and analyzed in accordance with Milk for Manufacturing Purpose and Processing, Section C12(2)(ii) and C12(3)(ii).

E. Under the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Item 7p. Administrative Procedures, and Appendix D, the Secretary shall conduct bacteriological testing of individual water supplies:

(1) Upon initial approval of the physical structure;

(2) Every 6 months after initial approval; and

(3) When a repair or alteration of the water supply system has been made.

F. The Secretary shall record and retain for at least 5 years all sample analysis results required under this regulation.

.11 Additional Requirements for Transporting of Manufactured Grade Milk.

A. A bulk milk hauler/sampler shall:

(1) Carry a bulk milk hauler’s permit when operating a milk tank truck, except when a raw milk producer is hauling raw milk from the producer’s farm only to the milk processing plant;

(2) Ensure that no interval greater than 2 hours elapses between milk pick-ups from farm to farm, and no more than 24 hours elapses from the first pick-up to delivery of the raw milk to the processing plant;

(3) Ensure bulk raw milk is picked up from every dairy farm at least every 3 days;

(4) Ensure bulk raw milk is delivered or received by the processor or receiving station within 84 hours of the initial milking;

(5) Ensure the temperature of the bulk raw milk does not exceed 50°F;

(6) Ensure operations are in accordance with the Bulk Milk Hauler/Sampler Manual; and

(7) In accordance with Standard Methods for the Examination of Dairy Products, 3.042, A, ensure proper agitation of the farm bulk tank raw milk.

B. A person may not transfer milk or milk products from a milk transport container or milk tank truck to another container or milk tank truck unless the transfer occurs:

(1) From a bulk milk tank to another permitted bulk milk tank truck on the dairy farm where the milk is produced;

(2) In a receiving station;

(3) In a transfer station; or

(4) In a milk plant.

C. Vehicles used for the transportation of can milk or cream shall be enclosed and constructed to protect the product from extreme temperature, dust, or other adverse conditions.

D. Stainless steel cans used in transporting milk from the dairy farm to a milk facility shall be constructed according to 3-A Sanitary Standards.

E. Milk transport containers used in transporting milk from the dairy farm to a milk facility shall be approved by the Secretary.

F. Vehicles used for the transportation of milk from the dairy farms to a milk facility may not be used for any other purpose.

G. Vehicles used for the transportation of milk shall be equipped with decking boards or racks when more than one tier of milk containers are carried.

H. The milk tank truck driver shall take responsibility for any official samples that may accompany the milk tank truck.

.12 Improper Handling of Milk Products.

A. Under Health-General Article, §21-428, Annotated Code of Maryland, the Secretary shall impound improperly handled milk or milk products that are intended for human consumption.

B. After impounding the milk or milk product, the Secretary may issue an order requiring one or more of the following actions:

(1) Disposing of the milk or milk product;

(2) Making the milk or milk product unusable for consumption; or

(3) Under Health-General Article, §21-428, Annotated Code of Maryland, imposing a civil monetary penalty, as set forth in §C of this regulation.

C. The Secretary shall determine the amount of the civil monetary penalty by multiplying the current milk price, as announced by the Federal Milk Market Administrator, on the date of the impounding by the volume of the milk listed on the shipping documents.

D. A person subject to an impoundment order may seek legal recourse as set forth in Health-General Article, §21-428, Annotated Code of Maryland, by:

(1) Appealing a civil penalty; or

(2) Bringing an action for damages.

.13 Labeling.

A. A permittee shall ensure that milk product labels conform to the standards and requirements established by:

(1) The Federal Food, Drug, and Cosmetic Act, 21 U.S.C., §§341—350f;

(2) The Nutrition Labeling and Education Act of 1990 (Public Law 101-535);

(3) 21 CFR Parts 101, 130, 131, 133, and 170—189;

(4) The Grade “A” Pasteurized Milk Ordinance Section 4; and

(5) Health-General Article, §§21-422, 21-424, and 21-425, Annotated Code of Maryland.

B. A milk processor shall conspicuously mark each package containing manufactured milk products with:

(1) The name of the product;

(2) The name of the manufacturer;

(3) The address of the manufacturer:

(a) If listed in the local phone book, the address may consist of the city and state;

(b) If not listed in the local phone book, the street address shall be included;

(4) Each ingredient in order of predominance;

(5) The net weight of the product in English and metric units;

(6) The batch identification of the product;

(7) Required nutritional information;

(8) If the product is made by reconstitution or recombination, the word “reconstituted” or “recombined” as applicable;

(9) If the product is or is made from milk from a hooved mammal other than cattle, the common name of the hooved mammal producing the milk preceding the name of the milk or milk product;

(10) In the case of condensed or dry milk products, if distributed by another party, the name and address of the distributor shown by a statement such as “Distributed by”; and

(11) The word “Heat-Treated” for heat-treated milk and milk products.

C. A milk producer shall label all cans of raw milk from the producer’s dairy farm with the milk producer’s name or permit number.

.14 Animal Health.

All raw milk and milk products produced, processed, packaged, and stored under this chapter shall meet the Animal Health requirements as set forth in the Grade “A” Pasteurized Milk Ordinance, Section 8.

.15 Dairy Farm Construction and Plan Submission.

Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 12, for construction, reconstruction, or extensive alteration of a dairy farm, a person shall submit to the Department:

A. A plan and specifications before:

(1) Constructing or reconstructing a:

(a) Milk house;

(b) Milking barn;

(c) Milking stable; or

(d) Milking parlor;

(2) Converting or remodeling an existing building or structure for use as a:

(a) Milk house;

(b) Milking barn;

(c) Milking stable; or

(d) Milking parlor; or

(3) Adding, modifying, or replacing:

(a) A bulk milk tank;

(b) An entire milking system;

(c) Any part of a milking system;

(d) A washing system;

(e) Any part of a washing system; or

(f) A cooling system, including a plate cooler or bulk tank cooling system;

B. A plan and drawing bearing the name of a professional engineer or a representative of the company performing the work;

C. Contact information for the dairy farm, including:

(1) The full name, title, and telephone number of each applicant;

(2) The name of the dairy farm;

(3) The mailing address;

(4) The location; and

(5) Directions to the site;

D. A site drawing showing:

(1) The location of:

(a) The milk house;

(b) The milking barn;

(c) The milking stable;

(d) The milking parlor; and

(e) Each animal housing area; and

(2) Approximate distances in feet from the locations in §D(1) of this regulation, to:

(a) Cow yards;

(b) Ditches;

(c) Frost free style watering hydrants;

(d) Manure pits;

(e) Septic systems;

(f) Silos;

(g) Streams; and

(h) Wells or other approved water systems;

E. A detailed drawing:

(1) Of the interior, indicating dimensions, of:

(a) The milk house;

(b) The milking barn;

(c) The milking stable;

(d) The milking parlor; and

(e) Each animal housing area; and

(2) Showing the location of:

(a) Backflow prevention devices;

(b) Chemical dispensers;

(c) Compressors;

(d) Equipment;

(e) Floor drains;

(f) Frost free style watering hydrants;

(g) Hose bibs;

(h) Lighting;

(i) Pre-coolers;

(j) Toilets;

(k) Washing systems; and

(l) Watering troughs;

F. For pipeline and milking system installations:

(1) The make, model number, quantity, and specifications of milking equipment including pipeline and milking units;

(2) The make and model number of pumps used in the milking system, including specifications such as horsepower and cubic feet per minute;

(3) A drawing of the parlor or barn showing the location of:

(a) Milking equipment;

(b) Pipelines, including size and length of the piping;

(c) Wash lines, including size and length of each wash line;

(d) Receivers, if applicable;

(e) Pre-coolers, if applicable;

(f) Any other milk equipment; and

(g) The milk house, bulk tank, and animal housing area in relation to the milking parlor or milking barn;

(4) A description and diagram of the location of the backflow protection methods or devices that will be installed to protect the:

(a) Potable water supply on all plate coolers;

(b) Chemical pumps:

(c) Water lines; and

(d) Other fixtures;

(5) The type, such as gas or electric, and capacity of the hot water heating system; and

(6) Information and specifications for booster or supplemental heating systems, if utilized; and

G. For bulk tank or milk cooling systems installation:

(1) A drawing of the milk house with bulk tank location, floor drain locations, and clearance dimensions on both sides, in front, and above the manhole of the bulk tank;

(2) If part of a new installation, specific floor, wall, and ceiling finishes;

(3) Bulk tank specifications and cooling system specifications, including:

(a) Make;

(b) Model number; and

(c) Capacity; and

(4) Pre-cooler type and British thermal units capability, if applicable.

.16 Dairy Farm Requirements.

A. The inspection area for a dairy farm includes the:

(1) Adjacent storage areas;

(2) Cow yard and cattle housing areas;

(3) Milk house;

(4) Milking barn, stable, or parlor;

(5) Surrounding area;

(6) Waste disposal areas; and

(7) Water supply and its distribution system.

B. A milk producer shall ensure that:

(1) Construction of all equipment, milking barns, stables, parlors, milk houses, and each animal housing area complies with the requirements of the Grade “A” Pasteurized Milk Ordinance and Regulation .15 of this chapter, as applicable;

(2) Water used at a dairy farm:

(a) Be obtained from a water supply system that complies with:

(i) Environment Article, Title 9, Annotated Code of Maryland;

(ii) COMAR 26.04.04.; and

(iii) The Grade “A” Pasteurized Milk Ordinance;

(b) Be installed in a manner that prevents backflow or back-siphoning;

(c) Be separate from a nonpotable water supply system so that nonpotable water cannot be drawn or discharged into the potable water supply system;

(d) Provide hot and cold running water in areas where milk processing equipment is washed; and

(e) Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system;

(3) Hand sinks have:

(a) Either:

(i) Hot and cold running water under pressure; or

(ii) Warm running water;

(b) A supply of hand-cleaning soap or detergent; and

(c) A sanitary means of drying hands, such as individual towels or a hand-drying device;

(4) A sewage system is constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;

(5) Toilet facilities are constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;

(6) Plumbing is sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations; and

(7) Electrical systems and lighting requirements comply with State and local electrical laws, ordinances, and regulations, and the Grade “A” Pasteurized Milk Ordinance.

.17 Milk Facility Construction and Plan Submission.

Pursuant to the standards set forth in the Grade “A” Pasteurized Milk Ordinance, Section 12 for construction, reconstruction, or extensive alteration of a milk facility, a person shall submit to the Department:

A. A plan and specifications before:

(1) Constructing, reconstructing, or extensively altering a milk facility;

(2) Converting or remodeling an existing building or structure for use as a milk facility;

(3) Adding, replacing, relocating, or modifying a milk facility process; or

(4) Adding, modifying, or replacing a clean-in-place (CIP) or other washing system or any part of a clean-in-place or other washing system;

B. Plans and drawings bearing the name of a professional engineer or a representative of the company performing the work;

C. Contact information for the facility, including:

(1) The full name, title, and telephone number of each applicant;

(2) The name of the plant;

(3) The mailing address;

(4) The location; and

(5) Directions to the site;

D. A narrative describing the scope and purpose of the project, including a projected timeline from start to completion;

E. An estimate of finished product output per day;

F. Sample product labels for each product;

G. A list of:

(1) All products to be produced;

(2) Raw cream and nonfat, condensed, or any other milk or milk products to be sold; and

(3) Single service container sources;

H. A scale drawing showing the layout and arrangement of areas within and around the milk facility, including areas for:

(1) Processing;

(2) Chemical storage;

(3) Dry storage;

(4) Ingredient and product storage;

(5) Receiving;

(6) Load out;

(7) Laboratories;

(8) Offices;

(9) Restroom facilities;

(10) Lockers or a facility for the storage of personal items; and

(11) Employees to eat and drink beverages;

I. A scale drawing showing the location of all equipment, including:

(1) Pasteurizers and sterile systems;

(2) Milk processing equipment;

(3) Fillers;

(4) Raw and pasteurized tanks and silos;

(5) Clean-in-place (CIP) systems;

(6) Glycol water tanks;

(7) Recirculating cooling water tanks;

(8) Boilers;

(9) Boiler makeup tanks;

(10) Culinary steam systems; and

(11) Blow mold systems;

J. A scale drawing showing the location of plumbing and plumbing fixtures, including:

(1) Water lines;

(2) Sewer lines;

(3) Hand sinks;

(4) Toilets;

(5) Utility sinks;

(6) Utensil washing sinks;

(7) Floor drains;

(8) Floor sinks;

(9) Hose stations; and

(10) All backflow prevention devices;

K. A legend for each drawing;

L. Specifications for:

(1) Ventilation including, but not limited to, the type and location of:

(a) An air filter;

(b) An air pump; and

(c) A compressor;

(2) Construction materials for the building and interior finishes; and

(3) Pasteurizer plate coolers, if separate from the pasteurization system;

M. A list and description of all boiler, glycol, and recirculating water additives and water treatment;

N. A description of the:

(1) Type of disposal for wastewater and sewage;

(2) Source and system for the facility’s potable water supply;

(3) Lighting fixtures and placement; and

(4) Recirculating cooling system;

O. Specification sheets, including manufacturer and model number of all milk facility equipment;

P. A document that lists the flow for all products through the plant, grouped in categories, identifying each functional piece of equipment and each process used in processing and packaging, including:

(1) Reclamation systems;

(2) Standardization procedures or formulation procedures, or both;

(3) Vitamin addition protocol; and

(4) Draining of product lines;

Q. Plans, specifications, drawings, and flow diagrams for each high temperature short time (HTST) and higher heat short time (HHST) system, showing each functional component;

R. Clean-in-place (CIP) flow diagrams from the makeup tanks through all equipment;

S. If applicable, information and drawings on how separation from product lines will be accomplished;

T. Written step-by-step standard operating procedures (SOPs and SSOPs) for the following, if not included in §W of this regulation:

(1) Receiving, processing, storing, and packaging of each product;

(2) Drug residue testing;

(3) Cleaning and sanitization for all equipment;

(4) Cleaning and sanitization for the facility; and

(5) Product trace back, inclusive of production/make sheet;

U. A pest control program;

V. Employee training and personal hygiene practices; and

W. A food safety plan that complies with 21 CFR Part 117 and at a minimum includes:

(1) A written hazard analysis;

(2) Written preventive controls that address:

(a) Process preventive controls;

(b) Food allergens;

(c) Sanitation;

(d) Supply-chain controls;

(e) A product recall plan; and

(f) Other hazards identified in the hazard analysis as requiring a preventive control;

(3) Written procedures for monitoring the implementation of the preventive controls as appropriate to the nature of the preventative control and its role in the facility’s food safety system;

(4) Written corrective action procedures as appropriate to the nature of the hazard and the nature of the preventive control; and

(5) Written verification procedures as appropriate to the nature of the preventative control and its role in the facility’s food safety system.

.18 Milk Physical Plant Requirements.

A. Water used at the facility shall:

(1) Be obtained from a potable water supply system that complies with:

(a) Environment Article, Title 9, Annotated Code of Maryland;

(b) COMAR 26.04.04; and

(c) The Grade “A” Pasteurized Milk Ordinance;

(2) Be installed in a manner that prevents backflow or back-siphoning;

(3) Be separate from a nonpotable water supply system so that nonpotable water can be drawn or discharged into the potable water supply system;

(4) Provide hot and cold running water in areas where milk processing equipment is washed; and

(5) Have sufficient water capacity, pressure, and hot water generation and distribution available to meet peak demands throughout the washing system.

B. Hand sinks shall have:

(1) Either:

(a) Hot and cold running water under pressure; or

(b) Warm running water;

(2) A supply of hand-cleaning soap or detergent; and

(3) A sanitary means of drying hands, such as individual towels or a hand-drying device.

C. A sewage system shall be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance.

D. Plumbing shall be sized, installed, and maintained in accordance with applicable State and local plumbing laws, ordinances, and regulations.

E. Toilet facilities shall:

(1) Be constructed and operated in conformance with applicable State and local laws, ordinances, and regulations and the Grade “A” Pasteurized Milk Ordinance;

(2) For a milk plant that is not an on-farm processor, be available within the physical plant for use by employees; and

(3) For a milk plant that is an on-farm processor, if not located within the physical plant building:

(a) Be located within 500 feet of the physical plant building;

(b) Be accessible at all times that the plant is in operation;

(c) Have documented and implemented measures for re-entry into the plant to protect against facility and product contamination; and

(d) Have documentation from the local approval authority that an on-site sewage disposal system, if present, is adequate for the total number of users and meets all other requirements of 26.04.02.

F. All electrical systems at the facility shall:

(1) Comply with State and local electrical laws, ordinances, and regulations;

(2) Provide adequate lighting sources that furnish at least 40 foot-candles of light in all working areas in all rooms where:

(a) Milk or milk products are handled, processed, packaged, or stored; or

(b) Containers, utensils, and equipment are washed; and

(3) Provide adequate lighting sources that furnish at least 20 foot-candles of light in dry storage and cold storage rooms.

.19 Plan Review Approval.

A. An applicant may not construct, reconstruct, or extensively alter a plant without prior plan approval from the Department.

B. An applicant for a permit shall submit a plan to the Department that includes the requirements set forth in:

(1) Regulations .15 and .16 of this chapter for a dairy farm permit; or

(2) Regulations .17 and .18 of this chapter for a milk facilities permit.

C. The Department shall:

(1) Review the plan submitted under this regulation to ensure compliance with the requirements set forth in Regulations .15, .16, .17, and .18 of this chapter; and

(2) Inform the applicant:

(a) That the plan has been received;

(b) If additional information is required to complete the plan review;

(c) Whether the plan is approved or denied; and

(d) Of the appeals process if the plan is denied.

.20 Confidentiality.

The Department shall maintain confidentiality of records submitted by a person in accordance with General Provisions Article, §4-335, Annotated Code of Maryland.

.21 Suspension and Revocation of Permits.

A. When a permittee is found in violation of this chapter and the Grade “A” Pasteurized Milk Ordinance, the Secretary may suspend or revoke a permit as set forth in this regulation and Health-General Article, §§21-211, 21-418, or 21-419, Annotated Code of Maryland, or the Grade “A” Pasteurized Milk Ordinance.

B. Except as otherwise provided in this regulation, before suspending a permit, the Secretary shall give to the permittee notice of intent to suspend as provided by Health-General Article, §21-418, Annotated Code of Maryland.

C. The Department may suspend a permit if the permittee fails or neglects to correct a violation within the specified time period.

D. If a permit has been suspended more than once, the Secretary may revoke the permit.

E. The Department shall ensure that an opportunity for a hearing is provided to a person whose permit has been suspended or revoked.

F. When an immediate and substantial danger is found to exist to public health, safety, or welfare that imperatively requires emergency action, pursuant to Health-General Article, §21-418(c), and State Government Article, §10-226(c)(2), Annotated Code of Maryland, the:

(1) Department shall:

(a) Summarily suspend the permit;

(b) Order the permittee to cease operation immediately; and

(c) Promptly provide the permittee with:

(i) A written notice of the suspension of the permit;

(ii) The reasons for the suspension; and

(iii) An opportunity to be heard; and

(2) Permittee shall immediately cease operation upon the receipt of the summary suspension order.

.22 Appeals Process.

In accordance with the Administrative Procedures Act and Health-General Article, §21-419, Annotated Code of Maryland, the Department shall ensure that an opportunity for a hearing is provided to a permittee whose plan review or permit has been:

A. Denied;

B. Suspended; or

C. Revoked.

ROBERT NEALL
Secretary of Health

 

Subtitle 18 HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION AND ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)

Notice of Proposed Action

[19-046-P]

The Secretary of Health proposes to:

(1) Amend Regulations .02, .04, and .05 under COMAR 10.18.01 Maryland AIDS Drug Assistance Program: Temporary Assistance Program;

(2) Amend Regulations .01—.04 and .09 under COMAR 10.18.05 Maryland AIDS Drug Assistance Program: Eligibility;

(3) Amend Regulations .01, .03, .04, .04-1, .05, .09, and .11, and repeal Regulation .04-2, under COMAR 10.18.06 Maryland AIDS Drug Assistance Program: Pharmacy Services;

(4) Amend Regulations .01—.04, .06, .07, and .11 under COMAR 10.18.07 Maryland AIDS Drug Assistance Program: Health Insurance (MADAP-PLUS); and

(4) Amend Regulations .02—.05 under COMAR 10.18.10 Urgent Maryland AIDS Drug Assistance Program.

Statement of Purpose

The purpose of this action is to:

(1) Streamline MADAP application and verification of eligibility procedures for MADAP participants per an assessment finding by the US Health Resources and Services Administration (HRSA);

(2) Revise COMAR to reflect MADAP’s move to an Open Formulary for covered prescription drugs and devices;

(3) Repeal the MADAP Advisory Board; and

(4) Make additional clarifying changes throughout the MADAP COMAR chapters.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. This proposal will have a fiscal impact on the Department. Switching to an open formulary will increase costs associated with drugs paid for by MADAP due to more drugs being covered. Switching to an open formulary will also have an indeterminable positive impact on MADAP participants because they will be able to access more medications through MADAP. There will be an additional indeterminable positive impact on participants, case managers, and providers due to streamlining the application process for MADAP.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure (E+/E-)

Magnitude


A. On issuing agency:

(E+)

$281,512.39

B. On other State agencies:

NONE

C. On local governments:

NONE

 

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

NONE

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

(+)

Indeterminable

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. Switching to an open formulary will result in increased costs to MADAP. MADAP estimates that the cost of this change for State Fiscal Year (SFY) 2020 is $281,512.39. This estimate is based on the number of MADAP participants that utilize the pharmacy benefit, both insured and uninsured, and assumes that participants will, on average, be covered for one additional prescription per year due to adopting an open formulary. For uninsured participants (11.9 percent of total participants), MADAP would pay for the cost of the additional drug (the estimate is based on the average cost for drugs that will no longer be restricted). For insured participants (88.1 percent of total participants), MADAP would pay the associated copay. Further details are in the tables below.

 

Table 1 is the breakdown of MADAP clients (insured and uninsured) that are pharmacy utilizers for SFY 2019 and 2020. This estimate assumes an approximately 1.8 percent increase in clients per year.

 

Table 1 — Number of MADAP Pharmacy Utilizers

SFY

Pharmacy Utilizers

Uninsured MADAP Clients

Insured MADAP Clients

Total

2019 — Base Yr (6 months)

No. Clients (rounded)

377

2,788

3,165

2020

No. Clients (rounded)

384

2,846

3,230

 

Table 2 is the estimated average drug cost of an additional prescription for uninsured MADAP clients, which assumes a 3 percent increase in prices per year.

 

Table 2 — Average Annual Rx Cost for Uninsured Clients (Full-Pay)

SFY

Annual Rx Cost Increase Applied

Estimated Average Cost per Rx

# Rx (90-day refills)

Average Cost per Rx

2019 — Base Yr (6 months)

$105.98

2.00

$211.96

2020

3%

$109.16

4.00

$436.65

 

MADAP will benefit from 340B negotiated rebates on prescriptions; however, these estimates do not take the rebates into account.  Because it is not possible to forecast what additional prescriptions will be purchased as a result of this change, any rebates cannot be included in this calculation. It is likely that the cost of the additional prescriptions for uninsured participants will be less than what is estimated here due to the availability of a 340B rebate.

 

Table 3 shows the estimated increase in copayments for insured clients associated with an additional prescription. The copay is estimated to be $10 because the additional drugs covered under the open formulary will likely be generic.

 

Table 3 — Average Annual Rx Cost for Insured Clients (Co-Pays only)

SFY

Est. Avg. Co-Pay Cost per Rx

# Rx (90-day refills)

Avg. Cost per Rx

2019 — Base Yr (6 months)

$10.00

2.00

$20.00

2020

$10.00

4.00

$40.00

 

Table 4 is the estimated total increased costs for SFY 2019—2020. As mentioned above, the estimate takes into account an expected 3 percent increase in drug prices each year and reflects one additional prescription per MADAP participant. If participants were covered for two additional prescriptions, the estimate would double.

 

Table 4 — Total Increased Costs to MADAP

SFY

Uninsured

Insured

Totals

2019 — Base Yr (6 months.)

$79,910.61

$55,760.00

$135,670.61

2020

$167,672.39

$113,840.00

$281,512.39

F. There will be an indeterminable positive impact on participants in MADAP. The positive impact would result from: (1) participants having access to more medications under MADAP (the number of additional prescriptions and associated covered costs will vary from participant to participant), and (2) streamlining the application process, which will reduce burden on participants and case managers who participate in MADAP.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

 

10.18.01 Maryland AIDS Drug Assistance Program: Temporary Assistance Program

Authority: Health-General Article, §§2-104(b), 2-104(j), 2-105(a), and 18-102(a), Annotated Code of Maryland

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(6) (text unchanged)

[(7) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]

[(8)] (7)[(12)] (11) (text unchanged)

(12) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department per COMAR 10.18.06.04-1.

(13)—(15) (text unchanged)

.04 Application and Enrollment.

A. (text unchanged)

B. Enrollment.

(1) A recipient shall be approved for coverage beginning the first day of the month in which the:

(a) TAP application was received; or

(b) Recipient will need access to medications through TAP.

(2) (text unchanged)

.05 Covered Services.

A. (text unchanged)

B. [TAP] The Department shall pay for [each] a prescription drug or other product [within the limits established by the Department on] not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for a recipient.

 

10.18.05 Maryland AIDS Drug Assistance Program: Eligibility

Authority: Health General Article, §§2-104(b) and (i) [and], 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(5) (text unchanged)

 [(6) “Enrollment period” means the period of time a recipient may receive Maryland AIDS Drug Assistance Program benefits.

(7) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]

(6) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.

[(8)] (7) “Gross household income” means the income derived from sources provided in [Regulation .02] Regulation .02E of this chapter.

[(9)] (8)[(12)] (11) (text unchanged)

(12) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.

(13)—(14) (text unchanged)

(15) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to Regulation .03B(1)(a) of this chapter.

.02 Eligibility.

A.—C. (text unchanged)

D. Medical Criteria. To meet the medical criteria the individual shall be:

(1) (text unchanged)

(2) Prescribed or will be prescribed, within 3 months from the date the completed application was received by the Department, one or more [of the] antiretroviral drugs [in the formulary] not excluded from the open formulary.

E. Financial Criteria.

(1) To meet the financial criteria the individual shall have a projected gross household income less than or equal to 500 percent of the Federal Poverty Level Guidelines as updated annually in the Federal Register by the U.S. Department of Health and Human Services under authority of 42 U.S.C. §9902(2).

(2) Projected gross household income shall be determined based on what can reasonably be expected to be received during the 12-month period beginning with the month in which the completed application is filed or verification of eligibility is submitted.

(3) Gross household income includes income derived from:

(a)—(b) (text unchanged)

(c) Unemployment [compensation] income;

(d)—(e) (text unchanged)

(f) Retirement [or pension] income;

[(g) Investments, including dividends or interest;]

(g) Pension income;

(h) Investment income;

[(h)] (i) [(i)] (j) (text unchanged)

(4) Gross household income under this chapter does not include income derived from:

(a)—(f) (text unchanged)

.03 Application and Enrollment.

A. (text unchanged)

B. Enrollment.

(1) A recipient shall:

(a) Attest to continuing eligibility [by completing and submitting the eligibility verification form provided by the Department during the sixth month of the current enrollment period; or] every 6 months:

(i) In writing; or

(ii) By telephone; and

[(b) Lose MADAP benefits, effective at the end of the seventh month of the current enrollment period, if the recipient fails to attest to continued eligibility for MADAP benefits during the sixth month of the current enrollment period;]

(b) If the Department requests it, complete and submit verification of eligibility and supporting documentation on the form provided by the Department.

[(2) A recipient who seeks to continue enrollment shall reapply by submitting a new completed application at least ten business days prior to the end of the current 12-month enrollment period; and]

(2) A recipient shall lose MADAP benefits, effective at the end of the month following the month the verification of eligibility is due, if the recipient fails to attest to continued eligibility for MADAP.

(3) The Department shall:

(a) Enroll an applicant who has been determined eligible [for a 12-month enrollment period] with the stipulation that continued eligibility must be verified by the Department [during the sixth month of the enrollment period] every 6 months;

(b) Establish [the 12-month] enrollment [period] in MADAP beginning on the first day of the month in which the:

 (i) Department approves the application; or

 (ii) Recipient will need to access medications through MADAP;

(c) (text unchanged)

(d) Send any relevant [application or eligibility] verification of eligibility forms at least 45 calendar days before [the end of the:

(i) First 6 months of the current enrollment period; and

(ii) Current enrollment period.] the forms are due to be submitted to the Department.

.04 Changes in Eligibility and Disenrollment.

A. A recipient shall notify the Department within 10 business days of a change in:

(1) (text unchanged)

(2) Gross household income; or

(3) (text unchanged)

B.—C. (text unchanged)

D. If the recipient is determined to be ineligible before the [end of the current enrollment period] next verification of eligibility is due to be submitted to the Department because of a change in [residency, medical, or financial] eligibility [criteria], the disenrollment shall be the earlier of:

(1) The date on which the recipient’s [current enrollment ends] next verification of eligibility is due to be submitted to the Department; or

(2) (text unchanged)

E. (text unchanged)

.09 Availability of Funding and Program Termination.

A. (text unchanged)

B. If MADAP is terminated the Department shall provide benefits for each current recipient until the earlier of:

(1) The [end of the recipient’s enrollment period] date on which the next verification of eligibility is due to be submitted to the Department; or

(2) (text unchanged)

 

10.18.06 Maryland AIDS Drug Assistance Program: Pharmacy Services

Authority: Health General Article, §§2-104(b) and (i), 2-105(a) and (b), and 18-102(a), Annotated Code of Maryland

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(3) (text unchanged)

[(4) “Enrollment period” means the period of time a recipient may receive Maryland AIDS Drug Assistance Program benefits.

(5) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in Regulation .04-1 of this chapter.]

(4) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.

[(6)] (5)[(9)] (8) (text unchanged)

(9) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to Regulation .04-1 of this chapter.

(10)—(12) (text unchanged)

(13) “Prescription” means a direction, usually written by a health care provider authorized to prescribe drugs and other products and sent to the pharmacist for the preparation, dispensing, and directions for use of a drug or other product [included in the MADAP formulary] not excluded from the open formulary.

(14) (text unchanged)

.03 Conditions for Participation.

A. To participate in MADAP, a pharmacy shall:

(1) Be enrolled in Medical Assistance, be a mail order company that accepts payments from the Department, or submit a request for exception to, and receive approval from, the Department;

(2) Accept payment by [MADAP] the Department as payment in full for the professional services rendered and make no additional charges to the recipient or the recipient’s family;

(3)—(4) (text unchanged)

[(5) Include information required by the Department on all pharmacy invoices;]

[(6)] (5) Provide services without regard to race, color, creed, age, sex, sexual orientation, gender identity, national origin, marital status, or disability; and

[(7) Verify an individual’s eligibility; and]

[(8)] (6) (text unchanged)

B. (text unchanged)

.04 Covered Services.

A. (text unchanged)

B. The Department shall pay for a prescription drug or other product [on] not excluded from the open formulary [within the limits established by the Department] if the prescription is ordered and signed by a health care practitioner for the recipient.

.04-1 Formulary.

The Department shall:

A. Maintain [an updated formulary that is available electronically] a list of drugs and other products excluded from the open formulary; and

B. Make available electronically [copies of] the [formulary; and] list of drugs and other products excluded from the open formulary.

[C. Consider the recommendations of the MADAP Advisory Board in revising the formulary, in accordance with Regulation .04-2G of this chapter.]

.05 Limitations on Covered Services.

A. (text unchanged)

B. The Department may not pay for:

(1) (text unchanged)

(2) Drugs or other products [indicated as restricted on the] excluded from the open formulary, unless the:

(a)—(b) (text unchanged)

.09 Cause for Suspension or Removal and Imposition of Sanctions.

A. If the Department determines that a pharmacy or the pharmacy’s employee, or both, has failed to comply with federal or State laws and regulations, the Department may:

(1) (text unchanged)

(2) Withhold payment to the pharmacy [by MADAP]; or

(3) (text unchanged)

B.—E. (text unchanged)

.11 Confidentiality.

Unless otherwise authorized by law, the Department:

A. (text unchanged)

B. May not disclose personal information kept on [an applicant or] a recipient without written consent of the:

[(1) Applicant;]

[(2)] (1) Recipient; or

[(3) Applicant’s parent or legal guardian; or

(4)] (2) Recipient’s parent or legal guardian;

C.—D. (text unchanged)

 

10.18.07 Maryland AIDS Drug Assistance Program: Health Insurance (MADAP-PLUS)

Authority: Health-General Article, §§2-104(b) and (i) and 2-105(a) and (b), Annotated Code of Maryland

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(4) (text unchanged)

[(5) “Enrollment period” means the period of time a recipient may receive Maryland AIDS Drug Assistance Program—Plus coverage.

 (6) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]

(5) “Enrolled in MADAP” means that an applicant has been approved to receive Maryland AIDS Drug Assistance Program benefits.

[(7)] (6)[(9)] (8) (text unchanged)

[(10)] (9) “Maryland AIDS Drug Assistance Program—Plus (MADAP-Plus)” means the program administered by the Department to pay insurance premiums, copays, coinsurance, and deductibles for [formulary] drugs and core medical services.

[(11)] (10) (text unchanged)

(11) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.

(12) (text unchanged)

(13) “Verification of eligibility” means the information a recipient provides to the Department to confirm that the recipient is still eligible to receive MADAP benefits according to COMAR 10.18.05.03B(1)(a).

.02 Eligibility.

A. To be eligible for MADAP-Plus coverage, an individual shall be:

[A.] (1)[B.] (2) (text unchanged)

B. An individual who is eligible for employer-sponsored health insurance with a prescription drug formulary that includes antiretroviral medications may not receive premium assistance unless the individual is:

(1) Enrolled in the employer-sponsored health plan; and

(2) Paying 50 percent or more of the total monthly health insurance premiums.

.03 Application and Enrollment.

A.—B. (text unchanged)

C. The duration of the recipient’s enrollment [period for MADAP-Plus shall be the same as] in MADAP-Plus may not extend beyond the duration of the recipient’s enrollment in MADAP [enrollment period in 10.18.05.03B].

.04 Covered Services.

A. The Department shall pay for health and prescription plan premiums with a prescription drug formulary [comparable to the MADAP formulary] that includes antiretroviral medications.

B. Within the limits established by the Department and in accordance with policy guidance issued by the Health Resources and Services Administration, the Department:

(1) Shall pay for copays, coinsurance, and deductibles for [formulary] drugs; and

(2) May pay for [visits] copays, coinsurance, and deductibles associated with core medical services.

[C. An individual who is eligible for employer sponsored health insurance with a prescription drug formulary comparable to the MADAP formulary may not receive premium assistance unless the individual is:

(1) Enrolled in the employer sponsored health plan; and

(2) Paying 50 percent or more of the total monthly health insurance premiums.]

.06 Reconsideration and Appeal.

A.—E. (text unchanged)

F. If the final decision finds in favor of the Department, the Department shall, upon the date of the decision, cease paying the health insurance costs allowed under this chapter and seek recovery in accordance with [regulation] Regulation .08 of this chapter.

.07 Payment Procedures.

A. (text unchanged)

B. The Department:

(1) [May not] Shall process a payment request [that is not submitted] as required by this chapter;

(2)—(3) (text unchanged)

(4) Shall make subsequent payments:

(a) [On the designated due date or on a later date as] As permitted under a health or prescription drug plan; or

(b) (text unchanged)

.11 Availability of Funding and Program Termination.

A. (text unchanged)

B. If MADAP-Plus is terminated, the Department shall provide coverage for each current recipient until the earlier of:

(1) The [end of the recipient’s enrollment period] date on which the next verification of eligibility is due to be submitted to the Department; or

(2) (text unchanged)

 

10.18.10 Urgent Maryland AIDS Drug Assistance Program

Authority: Health-General Article, §§2-104(b), 2-104(j), 2-105(a), and 18-102(a), Annotated Code of Maryland

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(6) (text unchanged)

[(7) “Formulary” means a list of prescription drugs and other products covered by the Maryland AIDS Drug Assistance Program as specified in COMAR 10.18.06.04-1.]

[(8)] (7)[(10)] (9) (text unchanged)

(10) “Open formulary” means all U.S. Food and Drug Administration-approved prescription medications and related devices that are not on the list of excluded drugs and other products maintained by the Department according to COMAR 10.18.06.04-1.

(11)—(12) (text unchanged)

.03 Eligibility.

To be eligible for coverage, an individual shall be eligible for MADAP as specified in COMAR 10.18.05.02 and:

A. (text unchanged)

B. Have an acute medical condition needing immediate access to [formulary] medication as attested by the agent; or

C. (text unchanged)

.04 Application and Enrollment.

A. Application.

(1) The agent of the applicant shall:

(a) Submit a complete Urgent MADAP application to the Department on the form designated by the Department; and

(b) [Submit a copy of the complete or incomplete MADAP application; and

(c) Attest to submitting supporting documentation to complete the MADAP application within 30 calendar days after submission of the Urgent MADAP application.] Within 30 business days of submitting the application, submit all supporting documentation required by the Department.

(2)—(3) (text unchanged)

B. Enrollment.

(1) A recipient shall be approved for coverage beginning the first day of the month in which the:

(a) Urgent MADAP application was received; or

(b) Recipient will need access to medications through Urgent MADAP.

(2) (text unchanged)

.05 Covered Services.

A. (text unchanged)

B. [Urgent MADAP] The Department shall pay for [each] a prescription drug or other product [within the limits established by the Department on the] not excluded from the open formulary if the prescription is ordered and signed by a health care practitioner for a recipient.

ROBERT R. NEALL
Secretary of Health

 

Subtitle 28 BOARD OF EXAMINERS IN OPTOMETRY

Notice of Proposed Action

[19-029-P]

The Secretary of Health proposes to amend:

(1) Regulations .02, .04, .05, and .07 under COMAR 10.28.02 Continuing Education Requirements; and

(2) Regulation .02 under COMAR 10.28.12 Therapeutic Pharmaceutical Agents.

This action was considered by the Board of Examiners in Optometry at a public meeting held on October 23, 2018, notice of which was given by publication on the Board’s website at https://health.maryland.gov/optometry/Pages/index.aspx pursuant to General Provisions Article, §3–302(c), Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to amend:

(1) And clarify accreditation language;

(2) Certain continuing education requirements; and

(3) Therapeutic Pharmaceutical Agent certification requirements.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

 

10.28.02 Continuing Education Requirements

Authority: Health Occupations Article, §§11-205, 11-308(c), and 11-309, Annotated Code of Maryland

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) “Accredited” means continuing education activities produced and delivered by:

(a) COPE administrators in compliance with COPE accreditation criteria, standards for commercial support, and policies and procedures; or

(b) Non-COPE administrators in compliance with a program accepted as substantially equivalent to the Accreditation Council for Continuing Medical Education (ACCME) accreditation system.

[(1)] (2)”Council on Optometric Practitioner Education (COPE)” means the [committee] program of the Association of Regulatory Boards of Optometry, which [acts as a national clearinghouse for continuing] accredits continuing education courses [of a state-wide, regional, or national scope] and activities accepted as substantially equivalent to the Accreditation Council for Continuing Medical Education (ACCME) accreditation system for optometrists.

[(2)] (3) “Credit hour” means [participation in 1 hour of education] the increment of educational instruction time.

[(3)] (4) (text unchanged)

.04 Continuing Education Audit Procedure.

A. At the time of renewal, the Board shall audit [randomly] a minimum of 20 percent of the renewal applications.

B.—C. (text unchanged)

.05 Required Credit and Other Course Credit.

A. Credit for continuing professional education [will] shall be [approved]:

(1) Accredited; or

(2) Approved by the Board solely on whether or not it constitutes improvement, advancement, and extension of one’s professional skill and knowledge relating to the practice of optometry.

B. In-Person Trainings.

(1) Except for those identified in §H of this regulation, an optometrist who is issued a license by the Board shall complete a minimum of 10 hours of continuing professional education per renewal cycle by attending in-person trainings conducted in Maryland by an accredited administrator. The in-person trainings may include:

(a) Courses given by:

(i) The Maryland Optometric Association;

(ii) Another Statewide association; or

(iii) A nonprofit organization approved by the Board;

(b) Observation of ophthalmic procedures at sites approved by the Board; or

(c) Other continuing professional education activities given by:

(i) The Maryland Optometric Association;

(ii) Another Statewide association; or

(iii) A nonprofit organization approved by the Board.

(2) If requested pursuant to Regulation .04 of this chapter, an optometrist shall provide to the Board a certificate of attendance or other method of verifying attendance at an event conducted by an accredited event administrator.

(3) In accordance with §A of this regulation, events conducted by an accredited event administrator shall have Board approval.

[B.] C. [Credit] Other than those required in §B of this regulation, credit hours may be approved for the following:

(1) (text unchanged)

(2) Courses, either in-person, online, or both, that have received [COPE approval] accreditation; however, the Board reserves the right to refuse credit when its established criteria are not met;

(3) Courses, either in-person, online, or both, on Practice Management directly related to optometric care, up to a maximum of 4 hours per renewal cycle;

(4) (text unchanged)

(5) Courses, seminars, and lectures prepared and given by Maryland licensed optometrists for which credit will be awarded at the rate of 2 hours for preparation and 1 hour for lecture, up to a maximum of [12] 16 hours per renewal cycle;

(6) (text unchanged)

(7) Courses given in optometric or other professional journals with a post test, or [Internet] online courses with a post test, up to a maximum of [20] 30 hours per renewal cycle; however, these courses are subject to approval by the Board;

(8) Observation of ophthalmic procedures at sites approved by the Board, up to a maximum of [6] 8 hours per renewal cycle;

(9) Courses, either in-person, online, or both, in optometric ethics, Maryland optometric jurisprudence, or both, as approved by the Board, up to a maximum of 4 hours per renewal cycle;

(10) Pro bono work providing patient eye care as outlined in [§H] §I of this regulation; [and]

(11) Public board meeting attendance as outlined in [§I] §J of this regulation[.];

(12) Courses, either in-person or online, and certification in cardiopulmonary resuscitation (CPR) up to a maximum of 3 hours per renewal cycle; and

(13) Courses in cultural competency, up to a maximum of 4 hours per renewal cycle.

[C.] D. Credit hours will be allowed on the basis of 50 minutes being equivalent to an hour [for an hour], except for pro bono work. [To receive 1 hour’s credit, one shall attend or participate 1 full hour. There shall be no fractional hour credits] Fractional credit hours are allowed.

[D.] E.—[F.] G. (text unchanged)

[G.] H. The Board [shall] may waive continuing education requirements for, but not limited to, licensees who:

(1)—(2) (text unchanged)

[H.] I.[I.] J. (text unchanged)

.07 Change of Annual Requirements of Number of Hours.

The Board [of Examiners], by majority [voice] vote, may change the number of required hours of continuing education, [not to exceed 50 hours every 2 years] subject to the requirements in Health Occupations Article, §11-309, Annotated Code of Maryland. [Each] An optometrist shall be notified of any change at the time of the renewal of the optometrist’s license. The change is effective for the year following that renewal.

 

10.28.12 Therapeutic Pharmaceutical Agents

Authority: Health Occupations Article, §§11-101, 11-205, and 11-404, Annotated Code of Maryland

.02 Requirements for Certification.

A. Except for an optometrist who qualifies under §B or C of this regulation, the Board shall certify an optometrist licensed to practice in Maryland as qualified to use TPAs if the licensed optometrist submits to the Board evidence satisfactory to the Board that the optometrist:

(1) Has successfully completed at least 110 hours of Board-approved TPA [continuing] education [within 3 years] before applying for certification to use TPAs;

(2)—(3) (text unchanged)

(4) Has successfully completed [a] 8 hours of Board-approved [8-hour course] and accredited courses in the management of topical steroids, which includes anterior segment pharmacological treatment.

B. (text unchanged)

C. If an optometrist who has graduated on or after July 1, 2005, from an accredited school of optometry recognized by the Board, is not certified within 3 years of graduation, the Board shall certify the optometrist to use TPAs if the optometrist:

(1) Has successfully completed at least 110 hours of Board-approved TPA [continuing] education [within 3 years] before applying for certification to use TPAs;

(2) Has successfully passed a pharmacology exam under [§A] §A(2) of this regulation; and

(3) (text unchanged)

D. The Board may consider pharmacology courses that an optometrist successfully completed during a course of study at an accredited school of optometry recognized by the Board when calculating the 110 hours of Board-approved TPA education required under §§A(1) and C(1) of this regulation. If accepted by the Board, then each:

(1) Semester credit hour will equal 15 hours of TPA education; and

(2) Quarter credit hour will equal 10 hours of TPA education.

[D.] E. (text unchanged)

ROBERT R. NEALL
Secretary of Health

 

Subtitle 32 BOARD OF PHYSICIANS

10.32.17 Sexual Misconduct

Authority: Health Occupations Article, §1-212, Annotated Code of Maryland

Notice of Proposed Action

[19-031-P]

The Secretary of Health proposes to amend Regulations .01—.03 under COMAR 10.32.17 Sexual Misconduct.

This action was considered at a public meeting held on August 22, 2018, notice of which was given by publication on the Maryland Board of Physicians’ Website at https://www.mbp.state.md.us/forms/Aug18Bagenda.pdf from August 7, 2018, through August 22, 2018, pursuant to General Provisions Article, §3-302(c), Annotated Code of Maryland.

This action also was considered at a public meeting held on October 31, 2018, notice of which was given by publication on the Maryland Board of Physicians’ Website at https://www.mbp.state.md.us/forms/Oct18Fullagenda.pdf from October 19, 2018, through October 31, 2018, pursuant to General Provisions Article, §3-302(c), Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to:

(1) Revise the scope under COMAR 10.32.17.01;

(2) Add or delete certain definitions under COMAR 10.32.17.02;

(3) Move language from certain deleted definitions to COMAR 10.32.17.03;

(4) Update COMAR 10.32.17.03 to state that sexual misconduct includes, but is not limited to, sexual harassment of a “patient, key third party, employee, student, or coworker,” regardless of whether the sexual harassment occurs inside or outside of a professional setting; and

(5) Update COMAR 10.32.17.03 to include factors to consider in determining whether a sexual or romantic relationship with a key third party or former patient is prohibited.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.01 Scope.

This chapter prohibits sexual misconduct [against patients or key third parties] by [individuals licensed or certified under Health Occupations Article, Titles 14 and 15, Annotated Code of Maryland.] health care practitioners.

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) “Health care practitioner” means an individual licensed under Health Occupations Article, Titles 14 and 15, Annotated Code of Maryland.

[(1)] (2) Key Third Party.

(a) (text unchanged)

(b) “Key third party” includes, but is not limited to the following individuals:

(i)—(ii) (text unchanged)

(iii) [Parent] Family member;

(iv)—(vi) (text unchanged)

[(2) Sexual Impropriety.

(a) “Sexual impropriety” means behavior, gestures, or expressions that are seductive, sexually suggestive, or sexually demeaning to a patient or a key third party regardless of whether the sexual impropriety occurs inside or outside of a professional setting.

(b) “Sexual impropriety” includes, but is not limited to:

(i) Failure to provide privacy for disrobing;

(ii) Performing a pelvic or rectal examination without the use of gloves;

(iii) Using the health care practitioner-patient relationship to initiate or solicit a dating, romantic, or sexual relationship; and

(iv) Initiation by the health care practitioner of conversation regarding the health care practitioner’s sexual problems, sexual likes or dislikes, or fantasies.

(3) “Sexual misconduct” means a health care practitioner’s behavior toward a patient, former patient, or key third party, which includes:

(a) Sexual impropriety;

(b) Sexual violation; or

(c) Engaging in a dating, romantic, or sexual relationship which violates the code of ethics of the American Medical Association, American Osteopathic Association, American Psychiatric Association, or other standard recognized professional code of ethics of the health care practitioner’s discipline or specialty.

(4) Sexual Violation.

(a) “Sexual violation” means health care practitioner-patient or key third party sex, whether or not initiated by the patient or key third party, and engaging in any conduct with a patient or key third party that is sexual or may be reasonably interpreted as sexual, regardless of whether the sexual violation occurs inside or outside of a professional setting.

(b) “Sexual violation” includes, but is not limited to:

(i) Sexual intercourse, genital to genital contact;

(ii) Oral to genital contact;

(iii) Oral to anal contact or genital to anal contact;

(iv) Kissing in a romantic or sexual manner;

(v) Touching the patient’s breasts, genitals, or any sexualized body part;

(vi) Actively causing the patient or key third party to touch the health care practitioner’s breasts, genitals, or any sexualized body part;

(vii) Encouraging the patient to masturbate in the presence of the health care practitioner or masturbation by the health care practitioner while the patient is present;

(viii) Offering to provide practice-related services, such as drugs, in exchange for sexual favors; and

(ix) Intentionally exposing the health care practitioner’s breasts, genitals, or any sexualized body part.]

(3) Sexual Contact.

(a) “Sexual contact” means the knowing touching directly or through clothing, where the circumstances surrounding the touching would be construed by a reasonable person to be motivated by the health care practitioner’s own prurient interest or for sexual arousal or gratification. 

(b) “Sexual contact” includes, but is not limited to:

(i) Sexual intercourse, genital to genital contact;

(ii) Oral to genital contact;

(iii) Oral to anal contact or genital to anal contact;

(iv) Kissing in a romantic or sexual manner; or

(v) Nonclinical touching of breasts, genitals, or any other sexualized body part.

(4) “Sexual harassment” means an unwelcome sexual advance, request for sexual favor, or other verbal or physical conduct of a sexual nature.

.03 Sexual Misconduct.

A. [Individuals licensed or certified under Health Occupations Article, Titles 14 and 15, Annotated Code of Maryland,] Health care practitioners may not engage in sexual misconduct.

B. Health Occupations Article, §§14-404(a)(3), 14-5A-17(a)(3), 14-5B-14(a)(3), 14-5C-17(a)(3), 14-5D-14(a)(3), 14-5E-16(a)(3), 14-5F-18(a)(19), and [15-314(3),] 15-314(a)(3), Annotated Code of Maryland, includes, but is not limited to, sexual misconduct.

C. Sexual misconduct includes, but is not limited to:

(1) Engaging in sexual harassment of a patient, key third party, employee, student, or coworker regardless of whether the sexual harassment occurs inside or outside of a professional setting;

(2) Failing to provide privacy for disrobing;

(3) Performing a pelvic or rectal examination without the use of gloves;

(4) Discussing the health care practitioner’s sexual problems, sexual likes or dislikes, or fantasies;

(5) Using the health care practitioner-patient relationship to initiate or solicit a dating, romantic, or sexual relationship;

(6) Engaging in a dating, romantic, or sexual relationship which violates §D of this regulation or the code of ethics of the American Medical Association, American Osteopathic Association, American Psychiatric Association, or other professional code of ethics;

(7) Participating in any form of sexual contact with a patient or key third party;

(8) Having nonconsensual sexual contact with a coworker or employee;

(9) Causing a patient or key third party to touch the health care practitioner’s breasts, genitals, or any sexualized body part;

(10) Encouraging a patient or key third party to masturbate in the presence of the health care practitioner or masturbation by the health care practitioner while a patient or key third party is present;

(11) Offering to provide practice-related services in exchange for sexual favors; and

(12) Exposing the health care practitioner’s breasts, genitals, or any sexualized body part.

D. Sexual or Romantic Relationships. A health care practitioner may not engage in sexual behavior with:

(1) A current patient;

(2) A key third party if the key third party’s decisions directly affect the health and welfare of the patient or if the relationship could otherwise compromise the patient’s care based on the following considerations, which include, but are not limited to:

(a) The nature of the patient’s medical problem and the likely effect on patient care;

(b) The length of the professional relationship;

(c) The degree of emotional dependence on the health care practitioner;

(d) The importance of the clinical encounter to the key third party and the patient; and

(e) Whether the health care practitioner-patient relationship can be terminated in keeping with ethics guidance and what implications doing so would have for the patient; and

(3) A former patient upon consideration of the following factors:

(a) Duration of the health care practitioner-patient relationship;

(b) Nature of the health care services provided;

(c) Lapse of time since the health care practitioner-patient relationship ended;

(d) Extent to which the former patient confided personal or private information to the health care practitioner;

(e) Degree of emotional dependence that the former patient has or had on the health care practitioner;

(f) Extent to which the health care practitioner used or exploited the trust, knowledge, emotions, or influence derived from the previous health care practitioner-patient relationship; and

(g) Whether the health care practitioner-patient relationship was terminated in order to enter into a romantic or sexual relationship.

ROBERT R. NEALL
Secretary of Health

 

Subtitle 33 BOARD OF EXAMINERS OF NURSING HOME ADMINISTRATORS

10.33.01 Nursing Home Administrators

Authority: General Provisions Article, §4-333; Health Occupations Article, §§1-212, 1-606, and 9-101—9-502; State Government Article, §10-226; Annotated Code of Maryland

Notice of Proposed Action

[19-049-P]

The Secretary of Health proposes to amend Regulations .13 and .16 under COMAR 10.33.01 Nursing Home Administrators. This action was considered by the Board of Examiners of Nursing Home Administrators at public meetings held on September 12, 2018, and November 14, 2018, notice of which was given by publication on the Board’s website at https://health.maryland.gov/bonha/Pages/Index.aspx pursuant to General Provisions Article, §3–302(c), Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to require that a preceptor, who is the administrator of record of the facility in which training is to take place, have a minimum of 30 days in that facility as its administrator. Additionally, a clarification is being made regarding complaints and the authority of the disciplinary subcommittee.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.13 Administrator-in-Training.

A.—E. (text unchanged)

F. Application Requirements.

(1)—(7) (text unchanged)

(8) The preceptor may or may not be the administrator of record of the facility in which the training is to take place, but the preceptor may not be the administrator of record of a facility other than the one designated for training.  If the preceptor is the administrator of record of the facility where the training is to take place, the preceptor shall have had a minimum of 30 days of oversight in the facility in which the training is to take place immediately prior to beginning the AIT program.

(9)—(11) (text unchanged)

G.—L. (text unchanged)

.16 Complaints and Hearing Procedures.

A.—D. (text unchanged)

E. Prosecution of [Complaint] Complaints.

(1) For each complaint, after reviewing the complaint, [and] any investigative material, [the Board, through its] and the disciplinary [subcommittee] subcommittee’s recommendation, the Board shall:

(a)—(c) (text unchanged)

(2)—(3) (text unchanged)

ROBERT R. NEALL
Secretary of Health

 

Subtitle 37 HEALTH SERVICES COST REVIEW COMMISSION

10.37.10 Rate Application and Approval Procedures

Authority: Health-General Article, §§19-214.1 and 19.214.3, Annotated Code of Maryland

Notice of Proposed Action

[19-027-P]

The Health Services Cost Review Commission proposes to amend Regulation .26 under COMAR 10.37.10 Rate Application and Approval Procedures. This action was considered and approved for promulgation by the Commission at a previously announced open meeting held on November 14, 2018, notice of which was given pursuant to General Provisions Article, §3-302(c), Annotated Code of Maryland. If adopted, the proposed amendments will become effective on or about March 5, 2019.

Statement of Purpose

The purpose of this action is to require hospitals to better inform patients of facility fees and their right to request and receive a written estimate of the total charges for the nonemergency hospital services, procedures, and supplies that reasonably are expected to be incurred and billed to the patient by the hospital.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. The proposed action is aimed at better informing hospital patients of what to expect when they are subsequently billed for services provided at hospitals. For example, many if not most patients are unaware of their right to receive a written estimate of what their total charges will be for nonemergency hospital services expected to be provided at the hospital. The proposed action results in better informed patients.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

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:

NONE

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

(+)

Significant

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

F. This assumption is based on the belief that when patients are better informed of the costs of hospital care before those costs are incurred, it is more likely that they will make prudent health care delivery decisions.

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 Diana Kemp, Regulations Coordinator, Health Services Cost Review Commission, 4160 Patterson Avenue, Baltimore, MD 21215, or call 410-764-2576, or email to diana.kemp@maryland.gov, or fax to 410-358-6217. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.26 Patient Rights and Obligations; Hospital Credit and Collection and Financial Assistance Policies.

A. Hospital Information Sheet.

(1) Each hospital shall develop an information sheet that:

(a)—(c) (text unchanged)

(d) Provides contact information for the Maryland Medical Assistance Program; [and]

(e) Includes a statement that physician charges, to both hospital inpatients and outpatients, are generally not included in the hospital bill and are billed separately[.];

(f) Informs patients that the hospital is permitted to bill outpatients a fee, commonly referred to as a “facility fee”, for their use of hospital facilities, clinics, supplies and equipment, and nonphysician services, including but not limited to the services of nonphysician clinicians, in addition to physician fees billed for professional services provided in the hospital;

(g) Informs patients of their right to request and receive a written estimate of the total charges for the hospital nonemergency services, procedures, and supplies that reasonably are expected to be provided and billed for by the hospital.

(2) The information sheet shall be provided to the patient, the patient’s family, or the patient’s authorized representative:

(a) Before the patient receives scheduled medical services;

[(a)] (b)[(c)] (d) (text unchanged)

(3)—(4) (text unchanged)

A-1.—C. (text unchanged)

NELSON SABATINI
Chairman
Health Services Cost Review Commission

 

Subtitle 43 BOARD OF CHIROPRACTIC EXAMINERS

10.43.05 Chiropractic Externship Program

Authority: Health Occupations Article, §§3-205 and 3-301, Annotated Code of Maryland

Notice of Proposed Action

[19-045-P]

The Secretary of Health proposes to amend Regulations .01—.04 under COMAR 10.43.05 Chiropractic Externship Program. This action was considered by the Board of Chiropractic Examiners at a public meeting held on October 11, 2018, notice of which was given by publication on the Board’s website at https://health.maryland.gov/chiropractic/Pages/index.aspx pursuant to General Provisions Article, §3–302(c), Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to update and reflect changes in the chiropractic profession, add preceptorship language, and clarify eligibility requirements established in Ch. 658, Acts of 2018.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.01 Scope.

These regulations apply to all [chiropractic]:

A. Chiropractic externs, chiropractic extern applicants, and licensed chiropractors who are extension faculty members of a chiropractic college accredited by the Council on Chiropractic Education or its successor[.]; and

B. Licensed chiropractors approved by the Board to provide an externship.

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1) “Accredited [college] Board-approved educational institution” means a chiropractic school [or], college, or university accredited by the Council on Chiropractic Education or its successor.

(2) “Approved program” means a program that has been approved by the Board [of Chiropractic Examiners] and the Council on Chiropractic Education or its successor.

(3) (text unchanged)

(4) “Chiropractic extern program” means [a]:

(a) A 2-semester clinical program:

[(a)] (i) In which a chiropractic [externs participate] student, that has completed all requirements to graduate, participates under the direct supervision of a licensed chiropractor who has been approved by the Board to serve as a preceptor; and

[(b)] (ii) That operates in a facility where chiropractic services have been approved by the Board [of Chiropractic Examiners.]; or

(b) A 6-month clinical program in which an individual has:

(i) Begun the process of applying for licensure, but has not met certain requirements set forth under COMAR 10.43.04;

(ii) Graduated from an accredited Board-approved educational institution;

(iii) Taken and passed the examination of the National Board of Chiropractic Examiners (NBCE);

(iv) Been approved for an extern license by the Board; and

(v) Agreed to practice under the direct supervision of a preceptor who is a Board-approved licensed chiropractor while the extern license is in effect.

(5) “Direct supervision” means a licensed chiropractor [remains]:

(a) Remains on the premises at all times [and directly];

(b) Directly supervises and continuously monitors the extern’s performance within the practice; and

(c) Is immediately available to offer assistance.

(6) “Extern” means [an]:

(a) An individual who has [enrolled]:

(i) Enrolled in an accredited [chiropractic college] Board-approved educational institution [who] and has completed all requirements for the Doctor of Chiropractic program except for the final clinical phase of the program[.]; or

(ii) Graduated from an accredited Board-approved educational institution and is in the process of applying to the Board for a license to practice chiropractic, but has yet to meet certain requirements set forth under COMAR 10.43.04 to qualify for a license; or

(b) A chiropractor licensed in another state who is in the process of applying to the Board for a license to practice chiropractic, but has yet to meet certain requirements set forth under COMAR 10.43.04 to qualify for a license.

(7)—(8) (text unchanged)

(9) “Preceptor or extension faculty member” means a licensed chiropractor actively practicing in the State in good standing who has been appointed to the extension faculty of an accredited [chiropractic college and approved by the Board] Board-approved educational institution.

(10) “Preceptor sponsor” means a licensed chiropractor approved by the Board to supervise the following who are in the process of applying for licensure:

(a) A recent graduate that has completed a preceptorship program; or

(b) A chiropractor licensed in another state, whose license is in good standing.

.03 Eligibility.

A. An extern applicant is eligible for approval in the chiropractic extern program if the applicant is [currently]:

(1) Currently enrolled in an approved program that is recognized by the Board [of Chiropractic Examiners] as [requiring]:

(a) Requiring adequate clinical training; and [as maintaining]

(b) Maintaining an acceptable course of chiropractic instruction[.];

(2) A recent graduate that has completed a preceptorship program; or

(3) A chiropractor licensed in another state, whose license is in good standing.

B. An extern applicant shall:

(1) Meet all the qualifications as set forth in Health Occupations Article, §§3-302 and 3-303, Annotated Code of Maryland[.];

(2) Be in good standing [at]:

(a) At the [chiropractic college] accredited Board-approved educational institution[.]; or

(b) In the state currently licensed;

(3) [File the necessary] Submit the completed application forms as required by the Board [and pay];

(4) Pay [an] the application fee as set forth in COMAR 10.43.06[.];

(5) Submit to a criminal background check;

[(4)] (6) Have three letters of recommendation sent directly to the Board [from]:

(a) From clinical science professors at the extern’s [chiropractic college] accredited Board-approved educational institution attesting to the applicant’s good moral character and clinical abilities[.]; or

(b) Two of which shall be from chiropractors attesting to the applicant’s good moral character and one letter from the licensing board of the state in which the applicant is currently licensed attesting that the license is in good standing; and

(7) Be withdrawn from the program if the applicant has not obtained a license to practice chiropractic within 6 months from the date the externship is approved.

.04 Permitted Delegation.

A. A preceptor who is a Board-approved licensed chiropractor or an extension faculty member may delegate duties within the scope of one’s license, which constitute the practice of chiropractic, to an extern in accordance with [these regulations] COMAR 10.43.

B. A preceptor may permit an extern to perform chiropractic duties as part of a clinical program, subject to the following conditions:

(1) The preceptor shall maintain direct supervision of the extern[.];

(2) The clinical training program shall be governed by a written agreement between the extern’s [chiropractic college] accredited Board-approved educational institution and the preceptor that:

(a)—(b) (text unchanged)  

(c) Enumerates the functions the extern may perform; and

(d) Indicates the legal responsibilities assumed by the extern’s [chiropractic college.] accredited Board-approved educational institution;

(3) The [chiropractic college] accredited Board-approved educational institution shall submit to the Board the names of those doctors selected as extension faculty members. The Board shall notify the [college] educational institution of those approved for the program[.];

(4) A licensed chiropractor may not supervise more than one extern during the same period[.];

(5) A licensed chiropractor may delegate or permit only duties and functions which are established as part of the clinical training program [and none other.];

(6) The extern may not supervise chiropractic assistants or trainees[.]; and

(7) An extern applicant that is a licensed chiropractor in another state shall have a preceptor sponsor.

C. A preceptor may permit a licensed extern to perform chiropractic duties as part of the chiropractic practice providing the preceptor:

(1) Maintains direct supervision of the extern; and

(2) Ensures the compliance of the extern to the conditions set forth under Regulation .03B(7) of this chapter.

D. A preceptor with a license to practice chiropractic with physical therapy privileges may supervise an applicant applying for a license to practice chiropractic:

(1) With physical therapy privileges; and

(2) Without physical therapy privileges.

E. A preceptor with a license to practice chiropractic without physical therapy privileges may only supervise an extern applying for a license to practice chiropractic without physical therapy privileges.

[C.] F. Malpractice insurance in an amount defined by the Council on Chiropractic Education shall be obtained:

(1) Before the clinical program begins, by the extern’s [chiropractic college]:

(a) Accredited Board-approved educational institution; and [extension]

(b) Extension faculty member participating in the clinical program [before the beginning of the clinical program]; or

(2) By the preceptor sponsor of an extern applicant.

[D.] G. A licensed chiropractor seeking preceptor status shall:

(1) [Make] Submit a completed written application to the Board;

(2)—(4) (text unchanged) 

ROBERT R. NEALL
Secretary of Health

 

Subtitle 52 PREVENTIVE MEDICINE

10.52.08 Maryland HIV Prevention Case Management Program

Authority: Health-General Article, §§2-104(b) and (j), 2-105(a), and
18-102(a), Annotated Code of Maryland

Notice of Proposed Action

[19-032-P]

The Secretary of Health proposes to adopt new Regulations .01—.16 under a new chapter, COMAR 10.52.08 Maryland HIV Prevention Case Management Program.

Statement of Purpose

The purpose of this action is to establish regulations for the Maryland HIV Prevention Case Management Program (Prevention Program), which provides prevention and wraparound services for individuals at elevated risk for acquiring HIV. These regulations include recipient eligibility criteria for the Prevention Program. Regulations for eligibility criteria are required by Ch. 46 (S.B. 91), Acts of 2016, Public Health — State-Identified HIV Priorities in order to use rebates received by the Maryland Department of Health (the Department) from the Maryland AIDS Drug Assistance Program (MADAP) to fund the Prevention Program.

This proposal further establishes regulations for the Prevention Program related to:

(1) Program funding;

(2) Application for funding from the Department;

(3) Navigation program design and operation;

(4) Recipient screening, care plan, application, and enrollment into the program;

(5) Covered services;

(6) Recovery of payments;

(7) Fraud;

(8) Confidentiality;

(9) Availability of funding and program termination;

(10) Changes in eligibility and enrollment;

(11) Reconsideration and appeal;

(12) Payment procedures; and

(13) Cause for suspension or removal, and imposition of sanctions.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. This proposal will have an economic impact on the Department and local health departments or community-based organizations if a local health department or a community-based organization applies to establish a program to provide HIV prevention and wraparound services funded by the Department. Local health departments and community-based organizations that are approved will receive funding from the Department to provide these services. Because these programs are not yet established, and the Department does not know how many local health departments or community-based organizations will apply, the economic impact is indeterminable. In addition, the cost to establish programs may vary across jurisdictions as costs of services provided will vary widely. MADAP drug rebate funds will be used. The cost of this program will be dependent on the number of approved grant applications, but is not expected to exceed $2,000,000 annually.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure (E+/E-)

Magnitude

 


A. On issuing agency:

(E+)

Up to $2,000,000

B. On other State agencies:

NONE

C. On local governments:

(R+)

Indeterminable

 

 

Benefit (+)

Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

NONE

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

(+)

Indeterminable

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. Through the Maryland HIV Prevention Case Management Program, the Department will provide grant funding to local health departments and community-based organizations to provide HIV prevention and wraparound services. This funding will come from the Department, so there will be an increase in expenditures. Because the Department does not know how many organizations will apply and be approved for funding or how much funding will be needed, this impact is indeterminable, but is not expected to exceed $2,000,000 annually.

C. Local health departments may apply for grant funding to provide HIV prevention and wraparound services. If local health departments apply for and receive funding, these regulations will result in a positive economic impact on local health departments. Because the Department does not know how many local health departments will apply for funding or how much funding will be needed, this impact is indeterminable.

 

F. Through the establishment of the Maryland HIV Prevention Case Management Program, individuals at elevated risk for acquiring HIV will be able to access HIV prevention and wraparound services. These services will benefit these individuals and may include financial assistance. Because the Department does not know how many individuals will participate in the program or how much financial assistance will be needed, this impact in indeterminable.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.01 Purpose.

The purpose of the Maryland HIV Prevention Case Management Program is to:

A. Provide community-based prevention services for individuals at elevated risk for acquiring human immunodeficiency syndrome (HIV) including:

(1) Routine testing;

(2) Risk reduction counseling; and

(3) Pre-exposure prophylaxis (PrEP); and

B. Address the needs of recipients that would otherwise present barriers to accessing prevention services including:

(1) Housing;

(2) Transportation;

(3) Food;

(4) Vocational assistance; and

(5)  Health care needs including:

(a) Primary health care services; and

(b) Behavioral health care services.

.02 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B. Terms Defined.

(1) “Acquired immunodeficiency syndrome (AIDS)” means the medical condition caused by the human immunodeficiency virus.

(2) Agent.

(a) “Agent” means an individual who assists an applicant in submitting an application for prevention services and is employed by an organization that has received funding from the Department under the Maryland HIV Prevention Case Management Program.

(b) “Agent” includes:

(i) A prevention navigator;

(ii) A case manager;

(iii) A licensed social worker;

(iv) A registered nurse; and

(v) Any other related professional who assists an individual in submitting an application to a grantee.

(3) “Annual recertification form” means the form approved by the Department on which a recipient provides information to the Department to verify eligibility for the Prevention Program at the end of each enrollment period.

(4) “Antiretroviral therapy (ART)” means multiple anti-retroviral medications that are prescribed to slow or stop the replication of HIV in the body.

(5) “Applicant” means an individual on whose behalf an application has been submitted to a grantee for services under the Maryland HIV Prevention Case Management Program and whose eligibility status is not yet determined.

(6) “Care plan” means an outline of a recipient’s engagement with a case manager including the:

(a) Services needed by the recipient;

(b) Progress toward meeting those needs; and

(c) Responsibilities of the case manager and recipient toward meeting those goals or needs.

(7) “Case management services” means the assignment of a recipient’s case to a case manager for ongoing assessment and coordination of the various services needed to engage in the Maryland HIV Prevention Case Management Program.

(8) “Community-based organization (CBO)” means a public or private organization that:

(a) Is representative of a community or significant segments of a community; and

(b) Provides educational, health, or social services to individuals in the community.

(9) “Department” means the Maryland Department of Health.

(10) “Engaged” means actively enrolled in services with the case manager including:

(a) Meeting in-person at least quarterly with a case manager; and

(b) Keeping in contact with a case manager by phone, email, or messaging application at least once per month.

(11) “Enrollment period” means the period of time a recipient may receive Maryland HIV Prevention Case Management Program benefits.

(12) “Grantee” means an organization that:

(a) Receives funding from the Maryland Prevention Case Management Program;

(b) Employs at least one agent; and

(c) Provides:

(i) At least one covered service; and

(ii) Financial assistance for the client to engage in covered services offered outside the organization.

(13) “Gross income” means the income derived from sources provided in Regulation .06B of this chapter before any deductions.

(14) “Human immunodeficiency virus (HIV)” means the virus that causes AIDS.

(15) Identity Documents.

(a) “Identity documents” means documents that are used by a recipient to prove identity to access:

(i) Medical services;

(ii) Social services;

(iii) Housing;

(iv) Employment; or

(v) Other services.

(b) “Identity document” includes a:

(i) Social Security card;

(ii) Birth certificate;

(iii) Driver’s license; and

(iv) State identification card.

(16) “LGBTQIA+” means lesbian, gay, bisexual, transgender, queer, intersex, asexual, and other genders and sexual identities.

(17) “Navigation program” means a program established according to Regulations .04 and .05 of this chapter by a grantee that is approved by the Department to provide HIV prevention services to a recipient or to pay for HIV prevention services for a recipient using Prevention Program funds.

(18) “nPEP” means non-occupational Post-Exposure Prophylaxis, which is prescribing ART or other U.S. Food and Drug Administration-approved medications for someone who is currently HIV-negative and at increased risk for HIV acquisition due to a non-work-related known or suspected exposure to HIV that occurred in the preceding 72 hours.

(19) Payor.

(a) “Payor” means an organization that pays for medical, social, or other services as part of the Maryland HIV Prevention Case Management Program.

(b) “Payor” includes a:

(i) Public insurance plan;

(ii) Private insurance plan;

(iii) Foundation or other source of grant funding; and

(iv) Pharmaceutical patient assistance program or foundation pharmaceutical assistance program.

(20) “PrEP” means HIV pre-exposure prophylaxis, which is prescribing ART or other U.S. Food and Drug Administration-approved medications for the prevention of HIV to an individual who is HIV-negative and at increased risk of acquiring HIV due to sexual contact or sharing of injection drug equipment with an individual living with HIV or of unknown HIV status.

(21) “Prevention navigator” means an individual employed by a grantee who:

(a) Assists an applicant or recipient in:

(i) Assessing needs;

(ii) Applying for services; and

(iii) Following up on referrals; and

(b) Provides services to recipients including:

(i) Health education;

(ii) Health literacy support; and

(iii) Prevention counseling.

(22) “Prevention Program” means the Maryland HIV Prevention Case Management Program.

(23) “Recipient” means an individual who is enrolled in Prevention Program services.

(24) “Resident” means an individual:

(a) Who lives in Maryland voluntarily with the intention of making the State the individual’s home and not for a temporary purpose; and

(b) For whom any temporary absence from the State is coupled with an intent to return so as not to interrupt the continuity of residence.

(25) “Sexually transmitted infection (STI)” means an infection passed from one person to another person through sexual contact.

(26) “Visit” means an appointment at the office of a service provider, between the recipient and a case manager, prevention navigator, health care provider, or other professional that is billable by health insurance.

.03 Program Funding.

A. The Department may provide funding to a CBO or a local health department approved to establish and operate a navigation program.

B. Funding may cover:

(1) Case management services provided by an agent at a local health department or CBO;

(2) The estimated cost for a local health department or CBO to directly provide covered services to recipients; and

(3) The estimated cost for a local health department or CBO to provide payments to external organizations for covered services provided to program recipients.

C. A local health department or a CBO that is approved to operate a navagation program:

(1) May apply to the Department for grant funding to cover case management and services each State fiscal year; and

(2) Shall include in the application for grant funding community input and feedback to identify community needs and estimate costs for services for each funding period.

.04 Application for Funding from the Department.

A. A CBO or local health department that applies to receive funding from the Department to establish a navigation program:

(1) Shall submit an application to the Department that includes:

(a) Responses to all applicable questions; and

(b) Any supporting documentation indicated on the application;

(2) May voluntarily withdraw an application at any time; and

(3) May submit a new application at any time.

B. The Department shall:

(1) Request additional information or changes to the application if necessary; and

(2) Respond in writing to the applicant within 60 calendar days indicating the disposition of the application and explanation of the decision.

C. The Department shall:

(1) Review the application; and

(2) Either:

(a) Approve the application if the:

(i) Application is complete; and

(ii) The navigation program meets the requirements of Regulation .05 of this chapter; or

(b) Disapprove the application if the:

(i) Application does not provide sufficient information or documentation on the program; or

(ii) Navigation program does not meet the requirements of Regulation .05 of this chapter.

D. A CBO or local health department whose application is disapproved may appeal the decision to the Director of the Infectious Disease Prevention and Health Services Bureau in the Department by submitting the request in writing within 30 calendar days of the date postmarked on the notice of disapproval.

E. If a CBO or local health department submits an appeal, the Director of the Infectious Disease Prevention and Health Services Bureau shall within 60 days:

(1) Grant or deny the appeal; and

(2) Respond in writing to the CBO or local health department:

(a) Indicating whether the appeal has been granted or denied; and

(b) Providing an explanation of the decision.

.05 Navigation Program Design and Operation.

The grantee approved to operate a navigation program:

A. Shall ensure that all navigaton program staff have:

(1) Appropriate levels of expertise in working with individuals who are members of vulnerable populations such as people of color, members of the LGBTQIA+ community, and people who use drugs;

(2) Knowledge of harm reduction strategies; and

(3) Skills in implementing harm reduction strategies;

B. Shall ensure that all program staff receive training approved by the Department to work with vulnerable populations and to provide referrals to:

(1) Community services;

(2) Counseling; and

(3) Preventative education;

C. Shall ensure that all program staff demonstrate sensitivity to participant differences including:

(1) Cultural;

(2) Behavioral; and

(3) Values;

D. Shall ensure that information collected to identify program participants is kept confidential according to:

(1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

(2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and

E. May not discriminate against participants based on factors including but not limited to:

(1) Culture;

(2) Language;

(3) Ability;

(4) Socioeconomic status;

(5) Sexual orientation;

(6) Gender identity;

(7) Age;

(8) Religion;

(9) Race; and

(10) Ethnicity.

.06 Recipient Eligbility for Program Services.

A. To be eligible for prevention program benefits, an individual shall meet the following criteria:

(1) Be a resident;

(2) Have one of the following factors for increased risk of acquisition of HIV:

(a) A recently diagnosed STI;

(b) A partner known to be living with HIV, if the partner:

(i) Is not prescribed ART; or

(ii) Takes ART inconsistently;

(c) Sharing of injection drug equipment;

(d) Be a member of one of the following populations:

(i) Individuals identifying as a gay, bisexual, or same-gender-loving man;

(ii) Individuals identifying as transgender; or

(iii) Individuals engaging in commercial sex work; or

(e) Be sexually active with no or inconsistent use of condoms in a zip code with:

(i) Increased prevalence or incidence of HIV; or

(ii) Low viral suppression among people living with HIV;

(3) Have a projected gross income that is less than or equal to 138 percent of the Federal Poverty Level Guidelines, as updated annually in the Federal Register by the U.S. Department of Health and Human Services under authority of 42 U.S.C. §9902(2); and

(4) Not be eligible to enroll with or be enrolled with another payor that covers all services provided by the Prevention Program.

B. Gross Income.

(1) Gross income includes income derived from:

(a) Wages and salaries, including tips;

(b) Net income from self-employment or business;

(c) Unemployment compensation;

(d) Social Security payments, including disability payments;

(e) Alimony;

(f) Retirement or pension;

(g) Investments, including dividends or interest;

(h) Rental income; and

(i) Other taxable income, such as prizes, awards, and gambling winnings.

(2) Gross income does not include income derived from:

(a) Child support;

(b) Gifts;

(c) Supplemental Social Security income;

(d) Veterans’ disability payments;

(e) Workers’ compensation; and

(f) Proceeds from loans, such as student loans, home equity loans, or bank loans.

C. The Prevention Program shall be the payor of last resort for a recipient.

.07 Recipient Screening, Care Plan, Application, and Enrollment into the Program.

A. Screening.

(1) The agent shall complete a needs assessment and a sexual health screening for the applicant or recipient during each visit.

(2) The needs assessed shall include but are not limited to:

(a) Housing;

(b) Access to food;

(c) Employment;

(d) Job readiness;

(e) Educational or vocational needs;

(f) Behavioral health;

(g) Medical needs;

(h) Transportation;

(i) Linguistic needs;

(j) Legal needs; and

(k) Health education and literacy.

(3) A sexual health screening shall include sexual health counseling.

(4) If a recipient is enrolled in a Prevention Program that includes PrEP, the recipient shall meet with a health care provider with prescribing capability on a quarterly basis to complete recommended laboratory tests.

B. Care Plan. The agent shall:

(1) Develop a care plan based on the assessment and screening completed per §A of this regulation; and

(2) Update the care plan during each visit to track progress or identify new needs.

C. Application.

(1) The agent shall assist the client in completing an application on the form designated by the Department that includes:

(a) Responses to all applicable questions; and

(b) A copy of the requested verification documentation, including proof of residence and gross income.

(2) The agent or the applicant may voluntarily withdraw the application at any time without prejudice.

(3) The agent shall submit the application to the grantee for review and approval.

(4) The grantee shall:

(a) Approve the application if the:

(i) The application is complete;

(ii) The applicant is determined to be eligible; and

(iii) All necessary verification documents are included with the application; or

(b) Disapprove the application if the:

(i) Application is incomplete; or

(ii) Applicant fails to provide sufficient information or documentation to determine eligibility.

(5) After a determination has been made in accordance with §C(4) of this regulation, the grantee shall contact the applicant with the status of the application.

D. Enrollment.

(1) A recipient shall be enrolled in the Prevention Program beginning the first day of the month in which the approved application was received.

(2) Prevention Program benefits for the recipient shall be discontinued automatically after 12 months from the date of enrollment if the client does not complete an annual recertification form, or sooner should program funding from the Department be exhausted.

(3) A recipient:

(a) Shall be notified in writing by the agent and grantee 30 days prior to the termination of benefits; and

(b) Subject to application approval and availability of funds, may complete an annual recertification form to receive continuing benefits.

E. Engagement.

(1) To receive Prevention Program benefits, a recipient shall remain engaged with the agent.

(2) If the recipient does not remain engaged with the agent, the recipient may be disenrolled from the Prevention Program.

(3) If a recipient is disenrolled from the Prevention Program due to lack of engagement, the recipient may reapply for Prevention Program services.

.08 Covered Services.

A. If a recipient is enrolled with a payor that provides some of the services provided by the Prevention Program, the Prevention Program shall be billed only for services not covered by the payor.

B. The grantee:

(1) May provide covered program services directly; and

(2) May refer recipients to an outside organization and pay for the services on behalf of the recipient.

C. The agent employed by the grantee shall obtain and keep on file documentation of costs and receipt of payment for services paid for under §B(2) of this regulation. 

D. Prevention Program services covered by a grantee shall include:

(1) Medical services including:

(a) Office visits;

(b) Laboratory services;

(c) Vaccinations;

(d) PrEP or nPEP medications provided to a recipient; and

(e) Durable medical equipment not covered by insurance or another funding source;

(2) Behavioral health services identified in the recipient’s care plan including:

(a) Mental health therapy;

(b) Psychiatric services; and

(c)  Substance use disorder services;

(3) HIV prevention services identified in the recipient’s care plan including:

(a) Testing;

(b) Harm reduction counseling;

(c) Health education;

(d) Risk reduction counseling; and

(e) Navigation, outreach, and case management to improve adherence to PrEP;

(4) If the recipient is able to afford ongoing rental housing payments based on net income, one-time financial assistance for housing that is equal to the recipient’s share of the costs for 1 month’s rent payment required to:

(a) Obtain rental housing; or

(b) If the recipient is under threat of eviction, maintain rental housing;

(5) Financial assistance for up to 12 months of:

(a) Transitional housing;

(b) Emergency housing; or

(c) Rapid rehousing; 

(6) One-time financial assistance not exceeding $1,000 for utility arrears to prevent a utility shut-off;

(7) Emergency food assistance paid via grocery store gift cards;

(8) If other financial aid sources have been exhausted, one-time financial assistance for education including:

(a) Adult literacy course tuition, fees, and books;

(b) Adult basic education course tuition, fees, and books;

(c) GED preparatory class tuition, fees, and books;

(d) GED exam fees;

(e) Tuition for a driver’s license preparation course to enable the recipient to obtain a driver’s license for the purposes of employment as driver for a taxi, rideshare, or delivery company;

(f) Tuition, fees, and materials for a single career preparation course;

(g) Tuition, fees, and materials for completing a career preparation certificate program up to 20 credits or 800 hours at the community college in the recipient’s county of residence; and

(h) Tuition, fees, and materials for completing a career preparation certificate program above 20 credits or 800 hours, subject to approval by the Department and availability of funds;

(9) Job-readiness services, including:

(a) Education on:

(i) Interviewing skills;

(ii) Resume writing; and

(iii) Job searching;

(b) Resume proofreading and editing;

(c) Mock interviews and feedback; and

(d) Provision of donated interview attire;

(10) Child care services needed for the recipient to receive services identified in the recipient’s care plan;

(11) Transportation assistance for the recipient to receive services identified in the recipient’s care plan including but not limited to:

(a) Public transit assistance; and

(b) A voucher for a taxi or car service;

(12) Provided that the services are not available directly from the service provider and the service provider is not required by law to provide the services, linguistic services needed for the recipient to receive medical or social services identified in the recipient’s care plan;

(13) Legal services including:

(a) Assistance with paperwork and fees required for identification to obtain employment, medical care, or other services identified in the recipient’s care plan;

(b) Assistance for a transgender recipient seeking to change the name or gender marker on identity documents; and

(c) Assistance with expungement services to help improve the ability of the recipient to obtain employment or access to educational programs;

(14) Recovery services needed as a result of sexual assault, intimate partner violence, or interpersonal violence of which the recipient was a victim;

(15) Financial literacy education and tax filing education or assistance; and

(16) If private health or dental insurance is necessary for the recipient to receive services identified in the recipient’s care plan, financial assistance for health or dental insurance premiums to purchase a plan on Maryland Health Connection.

.09 Recovery of Payments.

A. If benefits have been incorrectly paid or another payor has been identified, the Department shall seek recovery of the amount of those payments.

B. A grantee shall inform the Department if benefits have been incorrectly paid or another payor has been identified.

.10 Fraud.

A. The Department shall pursue cases of suspected misrepresentation or fraud pursuant to Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.

B. A grantee shall inform the Department of suspected misrepresentation or fraud that may be pursued under the Criminal Law Article, §8-503, Annotated Code of Maryland, or any other applicable statutory provision.

.11 Confidentiality.

Except when otherwise authorized by law, the agent of an applicant, the agent of a recipient, the grantee, and the Department:

A. Shall keep all applicant and recipient personal information confidential;

B. May not disclose personal information kept on an applicant or recipient without written consent of the:

(1) Applicant;

(2) Recipient;

(3) Applicant’s parent or legal guardian; or

(4) Recipient’s parent or legal guardian;

C. Shall comply with the laws and regulations concerning the privacy and security of protected health information under:

(1) Health-General Article, Title 4, Subtitle 3, Annotated Code of Maryland; and

(2) The Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, the HITECH Act, 42 U.S.C. §§17932, et seq., as amended, and 45 CFR Parts 160 and 164, as amended, and their implementing regulations; and

D. Shall ensure that all interactive video technology-assisted communication comply with HIPAA patient privacy and security regulations.

.12 Availability of Funding and Program Termination.

A. If sufficient monies are not available to fund the Prevention Program, the Department shall take the action necessary to eliminate a deficit which may include program termination or restricting eligibility for the program.

B. If the program is terminated, the Department shall continue to provide benefits for each currently enrolled recipient through the earlier of:

(1) The end of the recipient’s 12-month enrollment period; or

(2) 6 months from the date of program termination.

.13 Changes in Eligibility and Disenrollment.

A. A recipient shall notify the agent or Department within 60 business days of a change in:

(1) Availability of third-party or insurance payment for covered services;

(2) Gross income; or

(3) Address.

B. If the agent or Department determines that a change reported in §A of this regulation results in the recipient no longer qualifying for Prevention Program services, the agent or the Department shall disenroll the recipient.

C. The notice of disenrollment shall:

(1) Be mailed to the recipient at least 15 business days before the effective date of disenrollment;

(2) Include an explanation of the action;

(3) Cite the section of regulations supporting the action; and

(4) Explain the right of the recipient to request reconsideration or an appeal of the decision.

D. If the recipient is determined to be ineligible before the end of the current enrollment period because of a change in residency, medical, or financial eligibility criteria, the disenrollment shall be the earlier of:

(1) The date on which the recipient’s current enrollment ends; or

(2) The first day of the month that is at least 15 calendar days after the date of the notice of ineligibility for benefits.

.14 Reconsideration and Appeal.

A. An applicant or recipient who has been notified by the Department or grantee of ineligibility for or disenrollment from Prevention Program benefits may request reconsideration of the decision by submitting a letter of reconsideration with additional supporting documentation or information to the agent or Department within 30 business days of the notification.

B. If an applicant or recipient submits a letter of reconsideration within 30 days of notification of ineligibility or disenrollment from the Prevention Program for reconsideration, the grantee or Department shall:

(1) Review all additional supporting documentation provided by the applicant or recipient within 10 business days of the grantee or Department’s receipt of the request for reconsideration; and

(2) Issue a final decision in writing to the applicant or recipient.

C. An applicant or recipient may appeal the reconsideration decision by requesting in writing a hearing with the Office of Administrative Hearings.

D. The Office of Administrative Hearings shall:

(1) Conduct a hearing according to the procedures set forth in COMAR 28.02.01;

(2) Hold a hearing to review the decision within 45 days of the postmarked date on the letter requesting a hearing; and

(3) Issue a decision in writing to the applicant or recipient.

.15 Payment Procedures.

A. The grantee shall:

(1) Pay for covered services directly to the vendor on behalf of the recipient; and

(2) Report amounts paid for services in the expenditure reports required by the Department.

B. The agent shall obtain documentation of payments due to outside organizations and receipt of payment made on behalf of the recipient.

C. Payment for services, other than gift cards for the purchase of food, may not be provided directly to the recipient.

D. If the recipient has an insurance plan that covers any of the services provided by the Prevention Program, the grantee or Department shall pay the service provider the balance remaining after the insurance plan pays for services.

.16 Cause for Suspension or Removal, and Imposition of Sanctions.

A. If the Department determines that a service provider or service provider’s employee, or both, has failed to comply with federal or State laws and regulations or has engaged in fraud or abuse, the Department may:

(1) Suspend the service provider from receiving payments from Prevention Program funds;

(2) Withhold payment to the service provider; or

(3) Permanently ban the service provider from receiving funds from the Prevention Program and bar future payments to the service provider.

B. If a service provider or the service provider’s employee is barred from Medicaid or Medicare, the Department shall bar the service provider or service provider’s employee.

C. A service provider that is barred or suspended from receiving payments according to this regulation shall notify a recipient that the provider is no longer able to accept payment from the Prevention Program and that the recipient may:

(1) Find a new provider through the recipient’s agent or the Department; or

(2) Pay for services directly to continue with the service provider.

ROBERT R. NEALL
Secretary of Health

 

Subtitle 53 BOARD OF NURSING — ELECTROLOGY PRACTICE COMMITTEE

Notice of Proposed Action

[19-047-P]

The Secretary of Health proposes to amend:

(1) Regulation .01 under COMAR 10.53.01 Definitions;

(2) Regulations .02 —.04, .06, .07, and .09 under COMAR 10.53.02 Licensure;

(3) Regulations .01—.04 under COMAR 10.53.03 Electrology Examination;

(4) Regulations.01—.04 under COMAR 10.53.04 Continuing Education;

(5) Regulations .02 and .03 under COMAR 10.53.05 Standards of Practice and Conduct;

(6) Regulations .05—.07 under COMAR 10.53.06 Electrology Programs; and

(7) Regulation .01 under COMAR 10.53.12 Fees.

This action was considered at a public meeting of the Board of Nursing held on September 26, 2018, notice of which was given by publication on the Board’s website beginning January 3, 2018, through September 25, 2018, pursuant to General Provisions Article, §3-302(c), Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to amend the regulations for the Electrology Practice Committee to reflect current practice, repeal obsolete provisions, and make technical and clarifying changes. The proposal:

(1) Defines the terms “clinical examination” and “national theory exam”;

(2) Clarifies the requirements for licensure by exam, by waiver, for inactive status, for reinstatement, and for electrology instructors;

(3) Makes amendments throughout the regulations to reflect the change to the use of a national theory exam instead of a Board-administered exam;

(4) Requires an applicant who fails the written exam two times to complete an education program before being reexamined;

(5) Amends the continuing education (CEUs) requirements including, but not limited to, clarifying that CEU’s earned between renewal periods may not be carried over for use in the next renewal period;

(6) Repeals the required posting of a Universal Precaution notice;

(7) Amends the requirements for unprofessional conduct regarding the use of electronic devices;

(8) Clarifies that an electrologist is required to maintain current licensure to practice electrology;

(9) Clarifies that Electrology Practice Committee members are permitted to inspect a facility at any time;

(10) Amends the reporting requirements for electrology programs;

(11) Clarifies the fee schedule; and

(12) Repeals the fees for a duplicate license and the electrology law book.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

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 Jake Whitaker, Acting Director, Office of Regulation and Policy Coordination, Maryland Department of Health, 201 West Preston Street, Room 512, Baltimore, MD 21201, or call 410-767-6499 (TTY 800-735-2258), or email to mdh.regs@maryland.gov, or fax to 410-767-6483. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

 

10.53.01 Definitions

Authority: Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-03, Annotated Code of Maryland

.01 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)―(5) (text unchanged)

(6) “Clinical examination” means an examination approved by the Board and administered by the Electrology Practice Committee for testing the clinical competency of applicants for licensure.

[(6)] (7)[(8)] (9) (text unchanged)

(10) “National theory exam” means an exam approved by the Board and the American Electrology Association. 

 

10.53.02 Licensure

Authority: Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-03, Annotated Code of Maryland

.02 Applicants for Licensure.

A. An applicant for licensure in electrology shall:

(1)―(3) (text unchanged)

(4) Have successfully completed an electrology program that is in:

(a) [Is in] Maryland and approved by the Board; or

(b) [The] Another State, territory, or country that the Board determines is substantially equivalent to the program required by the Board in Maryland.

B.―D. (text unchanged)

.03 Licensure by Examination.

A. An applicant for licensure by examination shall submit to the Board [at least 6 weeks before the examination]:

(1) A completed application;

[(1)] (2) The fee for examination as set forth in COMAR 10.53.12 that includes the application and clinical exam fees;

[(2)] (3)[(4)] (5) (text unchanged)

B. An applicant eligible for the [written or] clinical examination shall be [notified at least 30 days before the scheduled examination] given a timely appointment.

C. An applicant eligible for the national theory exam will be notified by the Board as to when the applicant may schedule the theory exam. 

[C.] D.[D.] E. (text unchanged)  

.04 Licensure by Waiver.

A. An applicant who is licensed in another state shall:

(1) (text unchanged)

(2) Submit to the Board:

(a)―(b) (text unchanged)

(c) A certificate of completion from each electrology instruction program attended that was substantially equivalent to the program requirements in this State, with a transcript or verification of the number of hours completed in each theory and clinical training.

B. The Board may waive the examinations if the applicant:

(1) Provides verified documentation that the applicant:

(a) (text unchanged)

(b) Became licensed in the other state after passing in that state, or any other state, [an examination] examinations that [is] are substantially equivalent to the [examination] examinations approved by the Board; and

(c) (text unchanged)

(2) Pays the [license] application fee set forth in COMAR 10.53.12.

C. (text unchanged)

.06 Inactive Status.

A. The Board shall place a license on inactive status if the licensee:

(1) Submits to the Board:

(a) [An application] A written request for inactive status [on a form required by the Board]; and

(b) (text unchanged)

(2) (text unchanged)

B. The Board shall reactivate a license if:

(1)―(2) (text unchanged)

(3) The licensee submits to the Board:

(a)―(c) (text unchanged)

(d) Written, verified evidence that the [renewal] applicant for reactivation of their license has completed an application for a criminal history records check by submitting the following:

(i)―(ii) (text unchanged)

C. A license may not be [issued] reactivated until the Board has:

(1)―(2) (text unchanged)

D. If a license has been inactive for 5 years or more, the individual shall successfully take the [entire] Board-approved theory and clinical electrology [examination] examinations.

E. While on inactive status[, although not authorized to practice as] an electrologist or electrology instructor is not authorized to practice or instruct and  may not use the designation “Electrologist”, “Licensed Electrologist”, “Electrology Instructor”, “Licensed Electrology Instructor”, “L.E.”, or “L.E.I.”.

.07 Reinstatement of Licensure.

A.―C. (text unchanged)

D. An electrologist or electrology instructor whose license has been expired for 5 years or more may become licensed if the individual meets the current requirements for initial licensure by examination [as set forth in Regulation .02 of this chapter].

E. (text unchanged)

.09 Instructor Licensure.

A. (text unchanged)

B. [Procedures for] Licensure Requirements. An electrologist applying for an electrology instructor’s license shall:

(1) (text unchanged)

(2) Sit for the clinical examination [that demonstrates competency in all electrology modalities at any time during the application process and receive a score of 80 percent or higher as determined by the Board] at any time during the application process and demonstrate competency in all electrology modalities with a passing score of 80 percent or higher as determined by the Board. 

C. An electrology instructor shall conspicuously display [the instructor’s license] proof of licensure at the instructor’s site of instruction.

D. (text unchanged)

 

10.53.03 Electrology Examination

Authority: Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-03, Annotated Code of Maryland

.01 [Examination] Theory and Clinical Examinations.

A. The Board, upon the recommendation of the Electrology Practice Committee, shall approve an applicant to sit for the national theory Exam.

[A.] B. The [Board or the Board’s designee shall notify each qualified applicant of the time and place for the written and clinical examinations] applicant, after being notified by the Board that they are eligible for the written national theory exam, shall schedule the time and date for taking the national theory Exam.

[B.] C. The Board or the Board’s designee shall perform the clinical examination covering:

(1) [Universal/standard] Standard precautions;

(2) (text unchanged)

(3) Electrology instruments and technique; [and]

(4) General knowledge of electrology; and

(5) The Maryland Electrology Practice and Regulations.

[C.] D. The passing score for the [theory examination] national theory and the clinical [examination] examinations is 75 percent.

[D.] E. (text unchanged)

.02 Reexamination.

A. (text unchanged)

B. An applicant who fails the written examination two times may [retake the written examination] be re-examined if the applicant:

(1) Completes an education program in areas in which the applicant, as determined by the Board, has demonstrated insufficient knowledge;

[(1)] (2) Retakes the theory examination and the clinical examination; and

[(2)] (3) Pays the full examination fee as set forth in COMAR 10.53.12[; and

(3) Completes an education program in the areas in which the applicant showed inadequate knowledge as determined by the Board].

C. (text unchanged)

.03 Examinations for Applicants with Special Needs.

A. An applicant with a disability may request modifications in examination materials or procedures. The applicant shall:

(1) (text unchanged)

(2) Include in the request:

(a) (text unchanged)

(b) The examination [and date of the examination] to be modified;

(c)―(d) (text unchanged)

B.―C. (text unchanged)

.04 Examination Misconduct.

A. The Board may determine that an individual who subverts or attempts to subvert the licensing [examination] examinations has not passed the [examination] examinations.

B. Conduct that subverts or attempts to subvert the licensing [examination includes] examinations includes, but is not limited to:

(1)―(4) (text unchanged)

(5) Selling, distributing, buying, receiving, or having unauthorized possession of any portion of a future or current [licensing] theory or clinical examination;

(6) Communicating with any other examinee during the administration of the [licensing examination] theory or clinical examinations;

(7) (text unchanged)

(8) Having in one’s possession during the administration of the [licensing] theory or clinical examination any books, photographs, recording devices, notes, written or printed materials, or data of any kind other than the examination materials distributed; or

(9) Falsifying or misrepresenting education credentials or other information for admission to the [licensing examination] theory or clinical examinations by impersonating an examinee.

 

10.53.04 Continuing Education

Authority: Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-03, Annotated Code of Maryland

.01 Definition.

A.―B. (text unchanged)

C. Professional education eligible for continuing education credit shall be:

(1) Relevant to the clinical practice of electrology; and

(2) Directed to a professional audience.  

D. The Board shall have final approval of the relevancy of the program to the practice of electrology.

.02 Continuing Education Requirements.

A. (text unchanged)

[B. Beginning in 2015 and for every subsequent 2-year renewal period, a licensed electrologist shall:

(1) Complete 20 clock hours of Board-approved CEUs by October 28 in each renewal year; and

(2) Provide proof of completion to the Board upon renewal of licensure.]

B. CEUs earned in one renewal period may not be carried over to the next license renewal period.

C. (text unchanged)

.03 Continuing Education Unit.

A.―D. (text unchanged)

[E. CEUs may be obtained each year in the following areas, up to the maximum specified as follows:

(1) 3 CEUs in the area of business management;

(2) 3 CEUs may be in CPR;

(3) 3 CEUs may be in First Aid;

(4) 4 CEUs by home study;

(5) 4 CEUs in alternative therapies; and

(6) 4 CEUs by lecture or published article.

F. Beginning with the 2015 renewal and every subsequent 2-year renewal period,]

E. CEUs may be obtained for the 2-year period, up to the maximum specified as follows:

(1) 6 CEUs in [the area of] business management;

(2)―(4) (text unchanged)

[(5) 8 CEUs in alternative therapies;]

[(6)] (5)―[(7)] (6) (text unchanged)

.04 Approval of Courses.

A. The Board shall approve a course, seminar, or speaker session if it is:

(1) Relevant to the [clinical aspect] practice of electrology; and

(2) Offered by a:

(a)―(b) (text unchanged)

(c) Board-approved electrology program; [or]

(d) Health department or hospital[.];

(e) American Red Cross; or

(f)  American Heart Association.

B. Requests for Approval.

(1) (text unchanged)

(2) CEU Credit for Renewal.

(a) CEUs [earned after October 29 of the last renewal period through September 28 of the next renewal period may be used only for the current license renewal period] shall be completed within the renewal period for which they are submitted between October 29th of the previous renewal period and October 28th of the present renewal period. 

[(b) CEUs earned between October 1 through October 28 may be used for the current renewal period or the next renewal period, but not for both.]

[(c)] (b) CEUs do not carry over to the next renewal period.

[(d)] (c) Credit will not be given for any CEU under §B(1) of this regulation unless the Board approves the program before the licensee attends an event.

(3)―(4) (text unchanged)

 

10.53.05 Standards of Practice and Conduct

Authority: Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-03, Annotated Code of Maryland

.02 Standards of Practice.

A.―E. (text unchanged)

F. Treatment.

(1)―(2) (text unchanged)

(3) An electrologist shall maintain current [qualifications] licensure to practice electrology and satisfy continuing education requirements established by the Board.

.03 Unprofessional Conduct.

A. (text unchanged)

B. An electrologist may not:

(1) Accept a patient for treatment, or continue treatment, if the patient cannot [be] reasonably be expected to benefit from the treatment;

(2)―(5) (text unchanged)

C. (text unchanged)

D. Electronic devices[,] including, but not limited to telephones, may not be used to [record medical records and] take pictures or videos of clients without written client authorization.

E. An electrologist:

(1) (text unchanged)

(2) Shall adhere to the following [principals] principles for the use of electronic devices and social media:

(a)―(d) (text unchanged) 

F. (text unchanged)

 

10.53.06 Electrology Programs

Authority: Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-03, Annotated Code of Maryland

.05 Physical Facilities and Equipment.

A. A program facility shall be sufficient to accommodate the student body, lecturers, and clinical demonstrations.

B. A program facility shall be adequately lighted, well-ventilated, and in sanitary condition at all times.

C.―D.  (text unchanged)

E. A program facility shall provide modern professional equipment and provide and maintain the following for its students:

(1)―(5) (text unchanged) 

F. A facility shall display in a conspicuous place[:

(1) A] a sign, consisting of at least 2-inch letters, that states “ALL ELECTROLOGY TREATMENTS PERFORMED IN THIS FACILITY ARE PERFORMED BY STUDENTS[; and

(2) A universal/standard precautions notice in compliance with Health Occupations Article, §1-207, Annotated Code of Maryland].

.06 Student Clinical Practice.

A.―B.  (text unchanged)

C. A program facility may charge a fee for treatment rendered by a student to cover the cost of supplies only.

D. Members of the Committee shall be permitted to inspect the program facility at any time or request the program to complete an Institutional review report at any time.

.07 Reporting.

A. [A facility] An educational program shall:

(1) Keep a record of each student’s:

(a)―(c) (text unchanged)

(d) Attendance; [and]

(e) Number of hours completed; and

(f) Grades achieved; and

(2) (text unchanged)

[B. At the end of each course, the program shall submit a report to the Board on a form required by the Board.]

[C.] B. (text unchanged)

 

10.53.12 Fees

Authority: Health Occupations Article, §§8-201, 8-205, 8-206, and 8-6B-03, Annotated Code of Maryland

.01 Fees.

A. (text unchanged)

B. The following fees are established by the Board:

(1) Application [(includes initial law book)] fee ― $100;

(2) Initial Clinical examination — $100 (An initial exam applicant shall submit to the Board the application fee, initial clinical examination, and completed application.);

(3) (text unchanged) 

[(4) Renewal for 1 year or less — $100;

(4-1) Beginning in 2013, biennial renewal―$200;]

(4) Biennial renewal — $200;

(5) Inactive status (one-time fee) — $25 (no fee required if placed on inactive status by the Board for failure to submit required CEUs);

[(6) Duplicate license — $25;

(7) Electrology law book — $25;]  

[(8)] (6)―[(9)] (7) (text unchanged)

C. (text unchanged)

ROBERT R. NEALL
Secretary of Health

 

Title 20
PUBLIC SERVICE COMMISSION

Subtitle 31 TERMINATIONS OF SERVICE

Notice of Proposed Action

[19-035-P]

The Public Service Commission proposes to amend:

(1) Regulation .02 under COMAR 20.31.01 General Regulations; and

(2) Regulation .06 under COMAR 20.31.03 Restrictions on Terminations.

This action was considered by the Public Service Commission at a scheduled rule-making (RM65) meeting held on September 4, 2018, notice of which was given under General Provisions Article, §3-302, Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to clarify the minimum required content of electricity and gas service termination notices to individuals who have a legal right to reside in master-metered buildings, whether such persons are owners, renters or occupants, including the non-customer specific content set forth in COMAR 20.31.02.06.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. Economic impact will be minimal to issuing agency, other state agencies, local governments, and the public.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

Expenditure (E+/E-)

Magnitude

 


A. On issuing agency:

(E+)

$1,200

B. On other State agencies:

(E+)

$1,200

C. On local governments:

(E+)

$2,000

 

 

Benefit (+)
Cost (-)

Magnitude

 


D. On regulated industries or trade groups:

(-)

$5,000

E. On other industries or trade groups:

NONE

None

F. Direct and indirect effects on public:

(-)

$20,000

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. The assumption for the Public Service Commission is 12 lawyer man-hours reviewing utility compliance per year, at $100 per lawyer man-hour.

 

B. The assumption for the Maryland Office of People’s Counsel is 12 lawyer man-hours reviewing utility compliance per year, at $100 per lawyer man-hour.

C. The base assumption is one incident every 3 years requiring the provision of relocation assistance to unit owners/tenants/occupants of master-metered buildings whose electric and/or gas service has been terminated. We are estimating that such an incident could create as much as 120 man-hours of work at local social service agencies, at $50 per man-hour, for a total expenditure of $6,000, or an average annual expenditure of $2,000.

D. The base assumption is one incident every 3 years, requiring the mailing and posting of notices, follow-up notices, and utility personnel providing advice and assistance to affected unit owners/tenants/occupants. We estimate a total cost of $15,000 per incident for an affected utility, for an annual average cost of $5,000.

E. The regulations are expected to have de minimus or no effects on other industries or trade groups.

F. The base assumption is one incident every 3 years, with a total benefit to the public of $60,000, or an average annual benefit of $20,000. This benefit is achieved by having at least 2 weeks actual notice before service termination, instead of a day or two. The additional time should enable affected unit owners/tenants/occupants to make less costly arrangements for alternative accommodations and moving. As a point of reference, a settlement regarding the one incident of master metered building service termination that has occurred to date valued the impact of incomplete and untimely termination notices at $100,000.

The base assumption of one incident every 3 years is generous. To date, the Commission is aware of only one incident of the type that would invoke the new regulation having occurred.

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 an impact on individuals with disabilities as follows:

The proposed revisions to COMAR provide health and safety benefits, by outlining the types of important information about pending service terminations that utilities must provide to, among many things, allow residents and occupants of master-metered buildings to contact the customer of record about the pending termination, make alternative living arrangements, and/or notify the utility about their medical conditions. This is particularly important for residents or occupants with medical conditions, disabilities, or with limited means to locate alternate housing on short notice.

Opportunity for Public Comment

Comments may be sent to Terry J. Romine, Executive Secretary, Public Service Commission, 6 St. Paul Street, 16th Floor, Baltimore, MD 21202, or call 410-767-8067, or fax to 410-333-6495. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

 

20.31.01 General Regulations

Authority: Public Utilities Article, §§2-113, 2-121, 5-101, and 7-307, Annotated Code of Maryland

.02 Definitions.

A. (text unchanged)

B. Terms Defined.

(1)—(12) (text unchanged)

 

(13) Master-Metered Building.

(a) “Master-metered building” means, for purposes of COMAR 20.31.01, 20.31.02, and 20.31.03, a building with [a] four or more dwelling [unit or] units, [the owner or landlord of which] where the customer buys electricity or gas from the utility and provides it to the [tenant or tenants] occupants in the building either as a part of [the rent or as] a [separate] rental agreement or lease, condominium fee, or other charge, or as [charge] charged under the authority of Public Utilities Article, §7-303, Annotated Code of Maryland.

(b) “Master-metered building” does not include transient facilities.

(14) “Occupant” means any individual who [permanently] has a legal right to [resides] reside in the premises.

(15)—(23) (text unchanged)

 

20.31.03 Restrictions on Terminations

Authority: Public Utilities Article, §§2-113, 2-121, 5-101, and 7-307, Annotated Code of Maryland

.06 [Tenants] Occupants [in] of a Master-Metered Building.

A. This regulation applies to terminations of service in master-metered [premises] buildings.

B. A utility shall notify [tenants] occupants in a master-metered building of an impending termination of service by all of the following. A utility shall:

(1) Individually notify all [tenants] occupants by:

(a) [first] First-class mail, postmarked not less than 14 days prior to the proposed date of disconnection and addressed to the “occupant” of each dwelling unit subject to the loss of service if the postal address is readily available to the utility; or

(b) [by flyers] Flyers or “door stuffers”, of a proposed termination at least 14 days before the scheduled termination date; and

(2) Notify [tenants] occupants by posting termination notices in conspicuous locations in the building, such as near mailboxes, entrances, and exits at least 14 days before the scheduled termination date.

C. In a situation where the utility is unable to comply with §B(1) and/or §B(2) of this regulation despite reasonable, documented efforts to do so, the utility may seek a waiver from the Commission of its obligations under §B(1) and/or §B(2) of this regulation pursuant to COMAR 20.07.01.01-1. If a waiver from §B(1) and/or §B(2) of this regulation is requested, the utility shall not terminate service to the master-metered building until the Commission rules on the utility’s requested waiver or the utility shall have complied with §B(1) and §B(2) of this regulation, provided that the waiver request shall be deemed approved if the Commission has not acted upon it within 30 days of filing.

D. If the utility seeks a waiver under §C of this regulation, the utility shall also, no later than 1 business day after its waiver request, notify, via electronic mail and first class mail, the Commission’s Office of External Relations and the People’s Counsel of:

(1) The utility’s waiver request; and

(2) All the utility’s efforts to fully comply with §B(1) and §B(2) of this regulation and why complete compliance was not feasible.

E. The notices provided pursuant to §B(1) and §B(2) of this regulation shall, at a minimum, include the following:

(1) A statement that the utility intends to terminate utility service to the master-metered building;

(2) The name of the utility customer in whose name the account is maintained and the customer’s mailing address, email address, phone number as reflected in the records of the utility not including the account number or other confidential information without the consent of the customer of record;

(3) The address of the master-metered building where service is to be terminated not including the amount owed or other billing, payment, credit or similar information without the consent of the customer of record;

(4) The date on or after which the proposed termination will occur;

(5) The office address of the utility and the utility’s customer service phone number;

(6) A statement that the occupant has applicable rights with respect to the potential service termination subject to the provisions of COMAR 20.31.03.01, including:

(a) The right to delay termination for an initial period of up to 30 days beyond the scheduled date of service termination when the termination will aggravate an existing serious illness or prevent the use of life-support equipment of any occupant of the master-metered building;

(b) How occupants can notify the utility in such circumstances including providing the required certification to the utility; and

(c) That after the initial delay, certification may be renewed once to request an additional delay by providing another certificate to the utility;

(7) A statement that it is the responsibility of the customer to notify the utility if the customer is unable to pay for service in accordance with the requirements of the utility’s billing practices;

(8) A statement that limited-income occupants may qualify for assistance including for:

(a) Financial and/or relocation assistance through 2-1-1 Maryland, and the current contact details, including phone number and website, for 2-1-1 Maryland; and

(b) Financial assistance towards utility bill payments through the Maryland Energy Assistance Program may be available, but only to limited income individuals, upon relocation and establishment of a utility account in their own name, and the current contact details, including phone number and website, for the Maryland Department of Human Services, Office of Home Energy Programs, which administers the Maryland Home Energy Assistance Program; and 

(9) A statement that for further information the occupant can contact:

(a) The Maryland Public Service Commission’s Office of External Relations and the current phone number for the Maryland Public Service Commission’s Office of External Relations;

(b) The Maryland Office of People’s Counsel and the current phone number for the Maryland Office of People’s Counsel;

(c) The utility’s customer service division and the current phone number for the utility’s customer service division; and

(d) The Maryland Office of Attorney General, Consumer Protection Division and the current phone number for the Maryland Office of Attorney General, Consumer Protection Division.

F. The notices posted pursuant to §B(2) of this regulation may also include the information required as necessary to satisfy Public Utilities Article, §7-307.2, Annotated Code of Maryland.

G. If a utility does not terminate service within 60 days of the date of the proposed termination in the notice posted pursuant to §B(2) of this regulation, the utility shall provide additional notices pursuant to §B(2) of this regulation.

H. In addition to the notices prescribed in §B of this regulation, a utility shall, not less than 14 days prior to termination of service to a master-metered building, provide written and electronic notice of its intention to terminate to the Commission’s Office of External Relations, Maryland Office of  People’s Counsel, the Maryland Office of the Attorney General, Consumer Protection Division, and any director of the social services for the political subdivision or subdivisions in which the master-metered building is located as well as a brief description of the notice provided.

I. Each utility shall identify and maintain on its records those accounts for service to master-metered buildings to ensure that service to such premises is not terminated prior to compliance with the provisions of this section.  It shall be the responsibility of the customer to inform the utility that service is being provided to a master-metered building.  The utility shall ask the customer at the time a new service application is submitted whether service is requested at a master-metered building and publish information about how to notify the utility that service is being provided to a master-metered building in its annual consumer publication and on its website.

TERRY J. ROMINE
Executive Secretary

 

 

Subtitle 70 SERVICE SUPPLIED BY WATER COMPANIES

20.70.09 Establishing Rates for Small Water Companies

Authority: Public Utilities Article, §§ 2-113, 2-121, 4-203(c), Annotated Code of Maryland

Notice of Proposed Action

[19-033-P]

The Public Service Commission proposes to adopt new Regulations .01—.06 under a new chapter, COMAR 20.70.09 Establishing Rates for Small Water Companies. This action was considered by the Public Service Commission at a scheduled rule making (RM 66) meeting held on October 31, 2018, notice of which was given under General Provisions Article, §3-302, Annotated Code of Maryland.

Statement of Purpose

The purpose of this action is to define small water companies as those having gross revenues of $350,000 or less, and to establish procedures for conducting a staff-assisted rate case for these small water companies.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. This action authorizes a formal process by which Commission staff will assist small water companies in preparing rate cases. The Commission anticipates an increase in filings from small water companies as a result of this action. The Commission will work to absorb these efforts within existing resources.

Small water utilities often incur disproportionately high rate case expenses compared to their overall requested revenue increases. This action will allow these utilities to avoid a significant cost of filing rate cases. An increased frequency of requests for rate relief by small water companies may result in a more immediate increase in affected water rates, although those costs are eventually recoverable and, if allowed, to sit unrecovered could eventually lead to rate shock. Increased frequency of requests may also ensure that water companies remain financially healthy and able to provide safe, reliable and economically efficient water services to consumers.

Additionally, staff’s assistance minimizes the costs typically associated with filing a rate case with the Commission. This reduces the costs to small water companies and, therefore, their customers.

 

 

Revenue (R+/R-)

 

II. Types of Economic Impact.

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:

(+)

Unquantifiable

E. On other industries or trade groups:

NONE

F. Direct and indirect effects on public:

(+)

Unquantifiable

III. Assumptions. (Identified by Impact Letter and Number from Section II.)

A. The issuing agency will accomplish the enforcement of these regulations, including the assistance to requesting small water companies with existing resources. No other State agency regulations are affected by these regulations and no local governments own water companies that are regulated by the Commission.

B. The issuing agency will accomplish the enforcement of these regulations, including the assistance to requesting small water companies with existing resources. No other State agency regulations are affected by these regulations and no local governments own water companies that are regulated by the Commission.

C. The issuing agency will accomplish the enforcement of these regulations, including the assistance to requesting small water companies with existing resources. No other State agency regulations are affected by these regulations and no local governments own water companies that are regulated by the Commission.

D. A review of rate case filings from small water companies indicates that as much as 40% of an increase is consumed by rate case expense.

E. The public and industries and trade groups will be affected to the extent they are customers. Although rates may increase due to the relative ease of staff-assisted rate cases, these increases can be expected to take place only where necessary and to result in safe and reliable water service by providing the company sufficient revenue for the provision of safe and reliable water service.

F. The public and industries and trade groups will be affected to the extent they are customers. Although rates may increase due to the relative ease of staff-assisted rate cases, these increases can be expected to take place only where necessary and to result in safe and reliable water service by providing the company sufficient revenue for the provision of safe and reliable water service.

Economic Impact on Small Businesses

The proposed action has a meaningful economic impact on small business. An analysis of this economic impact follows.

To the extent that the small business is a small, regulated water company, it will benefit from the resources of staff assistance in filing a rate case. More efficient regulations will allow small water companies to recover prudently incurred costs and investments without the typical costs associated with the expertise needed for a base rate proceeding with the Commission.

Impact on Individuals with Disabilities

The proposed action has no impact on individuals with disabilities.

Opportunity for Public Comment

Comments may be sent to Terry J. Romine, Executive Secretary, Public Service Commission, 6 St. Paul Street, 16th Floor, Baltimore, MD 21202, or call 410-767-8067, or fax to 410-333-6495. Comments will be accepted through March 4, 2019. A public hearing has not been scheduled.

.01 Scope.

This chapter applies to small water companies whose gross annual revenues for the most recent calendar year do not exceed $350,000.

.02 Definitions.

A. In this chapter, the following terms have the meanings indicated.

B  Terms Defined.

(1) “Applicant” means a small water company seeking a change in rates or rate design under the provisions of this chapter.

(2) “Small water company” means a water company as defined in Public Utilities Article, §1-101, Annotated Code of Maryland eligible to seek a change in rates or rate design under the provisions of this chapter.

(3) “Staff-assisted rate case” means a proceeding by which a small water company may, under the provisions of this chapter, seek a rate increase or change in rate design.    

.03 Waiver.

Upon application by an applicant, the Commission may waive the application of a regulation in this chapter to an applicant that demonstrates good cause.

.04 Development of a Staff–Assisted Rate Case for a Small Water Company.

A. A Staff-assisted rate case shall be developed upon the submission of the following documents to the Commission’s Executive Director:

(1) A letter requesting development of a staff-assisted rate case; and

(2) A completed staff-assisted rate case application for a small water company including all necessary attachments or exhibits.

B. Upon receipt of all completed materials listed in §A of this regulation, the Commission’s technical staff shall send the applicant and the Maryland Office of People’s Counsel written notice that the application has been received, and the staff-assisted rate case shall be deemed submitted.

C. If the application is not complete:

(1) Technical staff shall give notice to the applicant in writing of any deficiencies;

(2) The applicant shall have a reasonable opportunity, not to exceed 90 business days, after receipt of the notice to file information to remedy the indicated deficiencies; and

(3) If deficiencies are not resolved in a timely manner, the applicant shall be informed in writing that the application for a staff-assisted rate case has been rejected.

.05 Staff-Assisted Rate Case Procedures for a Small Water Company.

A. The procedures for a staff-assisted rate case are:

(1) The Commission’s Accounting Investigations Division shall audit the small water company’s books and records, including those relating to depreciation;

(2) The Commission’s Engineering Division shall inspect the small water company’s facilities, provide a description of the various system components, evaluate the condition of the various system components, and evaluate the adequacy of service being provided;

(3) The Commission’s Telecommunications, Gas and Water Division shall establish a rate of return applicable to rates to be proposed for the applicant based on the work of the Accounting Investigations Division and the Engineering Division; and

(4) The work of the Commission’s technical staff shall be coordinated by the Office of Staff Counsel which, upon completion of all required work needed to propose rates, shall compile a report containing technical staff’s work papers, findings, and recommendation as to the small water company’s revenue requirement and rates which shall be forwarded to the Executive Director.

B. Upon approval from the Executive Director, technical staff’s report shall be sent to the applicant for its review and acceptance. Following the applicant’s acceptance, the report shall be sent to the Maryland Office of People’s Counsel and any known affected community association whose members are served by the applicant for the purpose of determining whether the proposed rates contained in technical staff’s report can be agreed upon.

.06 Stipulation and Settlement.

A. The applicant, the Maryland Office of People’s Counsel, the Commission’s technical staff, and any other interested persons shall engage in negotiations for the purpose of reaching a settlement agreement.

B. If an agreement is reached, it shall be reduced to writing in the form of a stipulation and settlement with such exhibits as are appropriate.

C. A stipulation and settlement derived under §A of this regulation shall be filed with the Commission together with a summary letter from technical staff and the technical staff report.

D. Upon filing as described by §C of this regulation, the stipulation and settlement shall be assigned a case number and treated as any other case which is filed with the Commission.

E. If no agreement is reached under §A of this regulation, the applicant may file a request for a revision of its retail rates under Public Utilities Article, §§4-203(a) and 4-204, Annotated Code of Maryland.

TERRY J. ROMINE
Executive Secretary

 

Subtitle 75 SERVICE SUPPLIED BY SEWAGE DISPOSAL COMPANIES

20.75.08 Establishing Rates for Small Sewage Disposal Companies

Authority: Public Utilities Article, §§ 2-113, 2-121, 4-203(c), Annotated Code of Maryland

Notice of Proposed Action

[19-034-P]

The Public Service Commission proposes to adopt new Regulations .01—.06 under a new chapter, COMAR 20.75.08 Establishing Rates for Small Sewage Disposal Companies. This action was considered by the Public Service Commission at a scheduled rule making (RM 66) meeting held on October 31, 2018, notice of which was given under General Provisions Article, §3-302, Annotated Code of Maryland.

 

Statement of Purpose

The purpose of this action is to define small sewage disposal companies as those having gross revenues of $350,000 or less and to establish procedures for conducting a staff-assisted rate case for these small sewage disposal companies.

Comparison to Federal Standards

There is no corresponding federal standard to this proposed action.

Estimate of Economic Impact

I. Summary of Economic Impact. This action authorizes a formal process by which Commission staff will assist small sewage disposal companies in preparing rate cases. There are very few small, regulated sewage disposal companies in the State. The Commission will