EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW. [Brackets] indicate matter deleted from existing law. Underlining indicates amendments to bill. Strike out indicates matter stricken from the bill by amendment or deleted from the law by amendment. *hb1127* HOUSE BILL 1127 J1, J3 2lr2618 CF SB 984 By: Delegate Pendergrass Introduced and read first time: February 11, 2022 Assigned to: Health and Government Operations Committee Report: Favorable with amendments House action: Adopted Read second time: March 12, 2022 CHAPTER ______ AN ACT concerning 1 Public Health – State Designated Exchange – Health Data Utility 2 FOR the purpose of requiring the State designated exchange to operate as a health data 3 utility for the State for certain purposes; requiring the Maryland Department of 4 Health, dispensers, and certain nursing homes and electronic health networks 5 dispensers to provide certain data to the State designated exchange; requiring 6 dispensers to submit certain prescription information to the State designated 7 exchange; requiring the State designated exchange to establish a certain consumer 8 advisory council; and generally relating to the State designated exchange operating 9 as a health data utility. 10 BY adding to 11 Article – Health – General 12 Section 19–145 13 Annotated Code of Maryland 14 (2019 Replacement Volume and 2021 Supplement) 15 SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 16 That the Laws of Maryland read as follows: 17 Article – Health – General 18 19–145. 19 2 HOUSE BILL 1127 (A) (1) IN THIS SECTION THE F OLLOWING WORDS HAVE THE MEANINGS 1 INDICATED. 2 (2) “DISPENSER” MEANS A PERSON AUTHO RIZED BY LAW TO 3 DISPENSE, AS DEFINED IN § 12–101 OF THE HEALTH OCCUPATIONS ARTICLE, A 4 PRESCRIPTION DRUG TO A PATIENT OR THE PAT IENT’S AGENT IN THE STATE. 5 (3) “NONCONTROLLED PRESCRI PTION DRUG ” MEANS A 6 PRESCRIPTION DRUG , AS DEFINED IN § 21–201 OF THIS TITLE, THAT IS NOT A 7 CONTROLLED DANGEROUS SUBSTANCE DESIGNATED UNDER TITLE 5, SUBTITLE 4 8 OF THE CRIMINAL LAW ARTICLE. 9 (3) (4) “STATE DESIGNATED EXCH ANGE” HAS THE MEANING 10 STATED IN § 4–302.3 OF THIS ARTICLE. 11 (B) THE STATE DESIGNATED EXCH ANGE SHALL OPERATE A S A HEALTH 12 DATA UTILITY FOR THE STATE. 13 (C) THE PURPOSES OF THE H EALTH DATA UTILITY I NCLUDE THE: 14 (1) THE COLLECTION , AGGREGATION , AND ANALYSIS OF CLIN ICAL 15 INFORMATION , PUBLIC HEALTH DATA , AND HEALTH ADMINISTR ATIVE AND 16 OPERATIONS DATA TO A SSIST HEALTH CARE AND PUBL IC HEALTH LE ADERS THE 17 DEPARTMENT , LOCAL HEALTH DEPARTM ENTS, THE COMMISSION, AND THE 18 HEALTH SERVICES COST REVIEW COMMISSION IN THE EVALUATION OF PUBLIC 19 HEALTH INTERVENTIONS AND HEALTH EQUITY ; 20 (2) THE COMMUNICATION OF DATA FROM BETWEEN PUBLIC HEALTH 21 OFFICIALS AND HEA LTH CARE PROVIDERS T O ADVANCE DISEASE CO NTROL AND 22 HEALTH EQUITY ; AND 23 (3) THE ENHANCEMENT AND A CCELERATION OF THE 24 INTEROPERABILITY OF HEALTH INFORMATION T HROUGHOUT THE STATE. 25 (D) THE FOLLOWING ENTITIE S DISPENSERS SHALL PROVIDE DATA T O THE 26 STATE DESIGN ATED EXCHANGE : 27 (1) THE DEPARTMENT ; 28 (2) NURSING HOMES REQUIRE D TO PROVIDE DATA UN DER § 4–302.3 29 OF THIS ARTICLE; 30 HOUSE BILL 1127 3 (3) ELECTRONIC HEALTH NET WORKS REQUIRED TO PR OVIDE DATA 1 UNDER § 4–302.3 OF THIS ARTICLE; AND 2 (4) DISPENSERS. 3 (E) (1) THE PURPOSE OF THIS SUBSECTION I S TO: 4 (I) AUTHORIZE INDIVIDUALS AND ORGANIZATIONS IN VOLVED 5 IN THE TREATMENT AND CARE COORDINATION OF PATIENTS TO ACCESS , AS 6 LEGALLY AUTHORIZED , A PATIENT ’S MEDICATION HISTORY , INCLUDING 7 MEDICATIONS PRESCRIB ED FOR THE PATIENT ; AND 8 (II) ASSIST HEALTH CARE PR OVIDERS, CARE MANAGERS , THE 9 DEPARTMENT , AND PUBLIC HEALTH OFFICI ALS LOCAL HEALTH DEPARTM ENTS TO 10 UNDERSTAND AND PROMO TE MATTERS OF HEALTH EQUITY AND TREATMENT 11 EFFICACY. 12 (2) AFTER DISPENSING A NONCONTROLLED PRESCRIPTION DRUG , A 13 DISPENSER SHALL SUBM IT PRESCRIPTION INFO RMATION TO THE STATE 14 DESIGNATED EXCHANGE . 15 (3) THE PRESCRIPTION INFO RMATION SHALL BE SUB MITTED: 16 (I) BY ELECTRONIC MEANS ; 17 (II) WITHOUT UNDULY INCREA SING THE WORKLOAD AN D 18 EXPENSE ON A DISPENS ER; 19 (III) IN A MANNER THAT MINIMIZES BURDE N AND DUPLICATION 20 BY BEING AS COMPATIBLE AS POS SIBLE WITH EXISTING FEDERAL STANDARDS FO R 21 DATA SUBMISSION PRAC TICES, INCLUDING TECHNOLOGY SOFTWARE OF 22 DISPENSERS; AND 23 (IV) AS OTHERWISE REQUIRED BY REGULATIONS ADOPT ED BY 24 THE COMMISSION. 25 (4) THE STATE DESIGNATED EXCH ANGE MAY NOT IMPOSE ANY FEES 26 OR OTHER ASSESSMENTS ON DISPENSERS TO SUP PORT THE OPERATION O F THE 27 EXCHANGE. 28 (5) THE STATE DESIGNATED EXCH ANGE SHALL MAKE PRES CRIPTION 29 INFORMATION SUBMITTE D UNDER THIS SUBSECT ION AVAILABLE FOR PURPOS ES OF 30 TREATMENT AND CARE C OORDINATION OF A PAT IENT. 31 4 HOUSE BILL 1127 (F) THE STATE DESIGNATED EXCH ANGE SHALL MAY PROVIDE DATA , AS 1 ALLOWED BY LAW , TO INDIVIDUALS AND O RGANIZATIONS INVOLVE D IN THE 2 TREATMENT AND CARE C OORDINATION OF PATIE NTS AND TO PUB LIC HEALTH 3 OFFICIALS TO SUPPORT PUBLIC HEALTH GOALS , FOR PUBLIC HEALTH PU RPOSES 4 THAT MAY INCLUDE : 5 (1) UNDERSTANDING AND PRO MOTING THE EQUITABLE 6 AVAILABILITY TO PATI ENTS OF IMPROVING HEALTH EQUI TY THROUGH ACCESS TO 7 PRESCRIPTION MEDICAT IONS, INCLUDING FOR THE TREATMENT OF INF ECTIOUS 8 DISEASE; 9 (2) ASSISTING PROGRAMS LED BY HEALTH CARE PROVIDER S, CARE 10 MANAGERS, AND PUBLIC HEALTH OFFICI ALS IN IDENTIFYING THE DEPARTMENT , 11 LOCAL HEALTH DEPARTM ENTS, THE COMMISSION, AND THE HEALTH SERVICES 12 COST REVIEW COMMISSION TO IDENTIFY OPPORTUNITIES TO USE TREATMENTS 13 MORE EFFECTIVELY , FOR QUALITY IMPROVEM ENT, INCLUDING FOR STEWAR DSHIP 14 OF ANTIBIOTIC MEDICA TIONS; AND 15 (3) ANY ADDITIONAL PATIEN T INTERVENTIONS AND ACTIVITIES, 16 INCLUDING CASE INVES TIGATION CONDUCTING CASE INVESTIGATIONS AND 17 RELATED ACTIVITIES . 18 (G) INFORMATION SUBMITTED TO THE STATE INFORMATION EXC HANGE OR 19 PROVIDED BY THE STATE INFORMATION EXC HANGE UNDER THIS SEC TION SHALL BE 20 SUBMITTED OR PROVIDE D, TO THE EXTENT PRACTI CABLE, IN AS NEAR TO REAL T IME 21 AS POSSIBLE. 22 (G) (H) (1) THE COMMISSION, IN CONSULTATION WITH APPROPRIATE 23 STAKEHOLDERS , SHALL ADOPT REGULATI ONS TO CARRY OUT THI S SECTION. 24 (2) THE REGULATIONS SHALL TAKE INTO ACCOUNT CO NSUMER 25 PERSPECTIVE AND INCLUDE: 26 (I) THE SPECIFIC DATA REQ UIRED TO BE PROVIDED UNDER 27 SUBSECTION (D) OF THIS SECTION; 28 (II) THE SPECIFIC PRESCRIP TION INFORMATION REQ UIRED TO 29 BE SUBMITTED UNDER S UBSECTION (E) OF THIS SECTION; 30 (III) THE TIME FRAME FOR SU BMITTING PRESCRIPTIO N 31 INFORMATION UNDER SU BSECTION (E) OF THIS SECTION; 32 HOUSE BILL 1127 5 (IV) THE ELECTRONIC MEANS AND MANNER BY WHICH 1 PRESCRIPTION INFORMA TION IS TO BE SUBMIT TED UNDER SUBSECTION (E) OF THIS 2 SECTION; AND 3 (V) PRESCRIPTION INFORMAT ION SUBMISSION 4 REQUIREMENTS THAT AL IGN WITH THE DATA SU BMISSION REQUIREMENT S ON 5 DISPENSERS OF MONITORED PRESCRIPTION DRUGS U NDER TITLE 21, SUBTITLE 2A 6 OF THIS ARTICLE; AND 7 (VI) IDENTIFICATION AND NE CESSARY SUPPRESSION OF 8 INFORMATION RELATED TO PROVIDERS OR MEDI CATIONS THAT ARE DET ERMINED 9 TO HAVE SIGNIFICANT POTENTIAL TO CAUSE H ARM. 10 (I) (1) THE STATE DESIGNATED EXCH ANGE SHALL ESTABLISH A 11 CONSUMER ADVISORY CO UNCIL TO BRING THE P ERSPECTIVES OF INDIV IDUALS AND 12 ORGANIZATIONS WITH A N INTEREST IN PROTEC TING CONSUMERS INTO THE 13 DELIVERY OF SERVICES PROVIDED BY THE STATE DESIGNATED EXCH ANGE. 14 (2) IN SELECTING MEMBERS , THE STATE DESIGNATED EXCH ANGE 15 SHALL CONSIDER DIVER SITY OF EXPERIENCE . 16 (3) THE CONSUMER ADVISORY COUNCIL ESTABLISHED UNDER 17 PARAGRAPH (1) OF THIS SUBSECTION S HALL: 18 (I) CONSIST OF A MINIMUM OF SIX MEMBERS , INCLUDING AT 19 LEAST FOUR CONSUMER REPRES ENTATIVES AND TWO ST AFF REPRESENTATIVES , 20 AND MAINTAIN A RATIO OF CONSUMER REPRESEN TATIVES TO NONCONSUM ER 21 REPRESENTATIVES OF A T LEAST TWO TO ONE ; 22 (II) IDENTIFY AND REPORT C ONSUMER PRIVACY CONC ERNS TO 23 SENIOR LEADERSHIP OF THE STATE DESIGNATED EXCHANGE ; 24 (III) ADVISE ON EFFORTS TO EDUCATE CONSUMERS ON DATA 25 EXCHANGE POLICIES , INCLUDING OPTIONS FO R CONSUMERS TO OPT O UT OF 26 DISCLOSURE OF PROTEC TED HEALTH INFORMATI ON; 27 (IV) MEET AT LEAST 3 TIMES EACH YEAR ; AND 28 (V) ADOPT AND MAINT AIN A CHARTER TO BE POSTED ONLINE 29 THAT INCLUDES THE PU RPOSE, MEMBERS, AND MEETING SCHEDULE OF THE 30 CONSUMER ADVISORY CO UNCIL. 31 SECTION 2. AND BE IT FURTHER ENACTED, That on or before January 1, 2024, 32 the Maryland Department of Health, the Maryland Health Care Commission, and the State 33 6 HOUSE BILL 1127 designated exchange shall submit a report to the General Assembly, in accordance with § 1 2–1257 of the State Government Article, that identifies ongoing revenue sources to fund 2 the activities required under § 19–145 of the Health – General Article, as enacted by Section 3 1 of this Act. 4 SECTION 3. AND BE IT FURTHER ENACTED, That this Act shall take effect 5 October 1, 2022. 6 Approved: ________________________________________________________________________________ Governor. ________________________________________________________________________________ Speaker of the House of Delegates. ________________________________________________________________________________ President of the Senate.