EXPLANATION: CAPITALS INDICATE MAT TER ADDED TO EXISTIN G LAW.
[Brackets] indicate matter deleted from existing law.
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SENATE BILL 200
J1 2lr0057
(PRE–FILED)
By: Chair, Finance Committee (By Request – Departmental – Health)
Requested: October 5, 2021
Introduced and read first time: January 12, 2022
Assigned to: Finance
A BILL ENTITLED
AN ACT concerning 1
Public Health – Prescription Drug Monitoring Program – Naloxone Medication 2
Data 3
FOR the purpose of altering the requirements of the Prescription Drug Monitoring Program 4
to require the Program to monitor the dispensing of naloxone medication by all 5
prescribers and dispensers in the State and to require dispensers to report naloxone 6
medication data to the Program; and generally relating to the Prescription Drug 7
Monitoring Program and naloxone medication data. 8
BY repealing and reenacting, with amendments, 9
Article – Health – General 10
Section 21–2A–01 through 21–2A–04, 21–2A–08, and 21–2A–09 11
Annotated Code of Maryland 12
(2019 Replacement Volume and 2021 Supplement) 13
BY adding to 14
Article – Health – General 15
Section 21–2A–06.1 16
Annotated Code of Maryland 17
(2019 Replacement Volume and 2021 Supplement) 18
SECTION 1. BE IT ENACTED BY THE GENERAL ASSEMBLY OF MARYLAND, 19
That the Laws of Maryland read as follows: 20
Article – Health – General 21
21–2A–01. 22
(a) In this subtitle the following words have the meanings indicated. 23
2 SENATE BILL 200
(b) “Board” means the Advisory Board on Prescription Drug Monitoring. 1
(c) (1) “Dispense” has the meaning stated in § 12 –101 of the Health 2
Occupations Article. 3
(2) “Dispense” does not include: 4
(i) Directly administering a monitored prescription drug to a 5
patient; or 6
(ii) Giving out prescription drug samples. 7
(d) (1) “Dispenser” means a person authorized by law to dispense a monitored 8
prescription drug to a patient or the patient’s agent in the State. 9
(2) “Dispenser” includes a nonresident pharmacy. 10
(3) “Dispenser” does not include: 11
(i) A licensed hospital pharmacy that only dispenses a monitored 12
prescription drug for direct administration to an inpatient of the hospital; 13
(ii) An opioid treatment services program; 14
(iii) A veterinarian licensed under Title 2, Subtitle 3 of the 15
Agriculture Article when prescribing controlled substances for animals in the usual course 16
of providing professional services; 17
(iv) A pharmacy issued a waiver permit under COMAR 10.34.17.03 18
that provides pharmaceutical specialty services exclusively to persons living in assisted 19
living facilities, comprehensive care facilities, and developmental disabilities facilities; and 20
(v) A pharmacy that: 21
1. Dispenses medications to an inpatient hospice; and 22
2. Has been granted a waiver under § 21–2A–03(f) of this 23
subtitle. 24
(e) “Licensing entity” means an entity authorized under the Health Occupations 25
Article to license, regulate, or discipline a prescriber or dispenser. 26
(f) (1) “Monitored prescription drug” means a prescription drug that contains 27
a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance 28
designated under Title 5, Subtitle 4 of the Criminal Law Article. 29
SENATE BILL 200 3
(2) “MONITORED PRESCRIPTIO N DRUG” DOES NOT INCLUDE 1
NALOXONE MEDICATION . 2
(G) “NALOXONE MEDICATION ” MEANS AN OPIOID ANTA GONIST APPROVED 3
BY THE FEDERAL FOOD AND DRUG ADMINISTRATION FOR TH E REVERSAL OF AN 4
OPIOID OVERDOSE . 5
(H) “NALOXONE MEDICATION D ATA” MEANS THE INFORMATIO N SUBMITTED 6
TO THE PROGRAM FOR NALOXONE MEDICATION. 7
[(g)] (I) “Office” means the Office of Controlled Substances Administration in 8
the Department. 9
[(h)] (J) “Opioid treatment services program” means a program that: 10
(1) Is certified in accordance with § 8–401 of this article or licensed by the 11
State under § 7.5–401 of this article; 12
(2) Is authorized to treat patients with opioid dependence with a 13
medication approved by the federal Food and Drug Administration for opioid dependence; 14
(3) Complies with: 15
(i) The Code of Federal Regulations 42, Part 8; 16
(ii) COMAR 10.47.02.11; and 17
(iii) Requirements for the secure storage and accounting of opioid 18
medication imposed by the federal Drug Enforcement Administration and the Office; and 19
(4) Has been granted a certification for operation by the Department, the 20
federal Substance Abuse and Mental Health Services Administration, and the federal 21
Center for Substance Abuse Treatment. 22
[(i)] (K) “Pharmacist” means an individual who is licensed under Title 12 of the 23
Health Occupations Article, or by another state, to dispense a monitored prescription drug. 24
[(j)] (L) “Pharmacist delegate” means an individual who is: 25
(1) Authorized by a registered pharmacist to request or access prescription 26
monitoring data; and 27
(2) Employed by or under contract with the same professional practice as 28
the registered pharmacist. 29
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[(k)] (M) “Prescriber” means a licensed health care professional authorized by 1
law to prescribe a monitored prescription drug. 2
[(l)] (N) “Prescriber delegate” means an individual who is: 3
(1) Authorized by a registered prescriber to request or access prescription 4
monitoring data; and 5
(2) Employed by or under contract with the same professional practice as 6
the prescriber. 7
[(m)] (O) “Prescription drug” has the meaning stated in § 21–201 of this title. 8
[(n)] (P) “Prescription monitoring data” means the information submitted to the 9
Program for a monitored prescription drug. 10
[(o)] (Q) “Program” means the Prescription Drug Monitoring Program 11
established under this subtitle. 12
[(p)] (R) “Registered” means registered with the Program to request or access 13
prescription monitoring data for clinical use. 14
[(q)] (S) “Terminal illness” means a medical condition that, within reasonable 15
medical judgment, involves a prognosis for a patient that likely will result in the patient’s 16
death within 6 months. 17
21–2A–02. 18
(a) There is a Prescription Drug Monitoring Program in the Department. 19
(b) The mission of the Program is to: 20
(1) Assist prescribers, pharmacists, and public health professionals in: 21
(i) The identification and prevention of prescription drug abuse; and 22
(ii) The identification and investigation of unlawful prescription 23
drug diversion; and 24
(2) Promote a balanced use of prescription monitoring data to assist 25
appropriate law enforcement activities while preserving the professional practice of health 26
care providers and the access of patients to optimal pharmaceutical care. 27
(c) To carry out its mission, the Program shall monitor the prescribing and 28
dispensing of all Schedule II, Schedule III, Schedule IV, and Schedule V controlled 29 SENATE BILL 200 5
dangerous substances AND THE DISPENSING O F NALOXONE MEDICATIO N by all 1
prescribers and dispensers in the State. 2
21–2A–03. 3
(a) The Department shall implement the Program, subject to the availability of 4
funds. 5
(b) The Secretary may: 6
(1) Assign responsibility for the operation of the Program to any unit in the 7
Department; 8
(2) Contract with any qualified person for the efficient and economical 9
operation of the Program; and 10
(3) Identify and publish a list of monitored prescription drugs that have a 11
low potential for abuse by individuals. 12
(c) Except as provided in subsection (d) of this section, each dispenser shall 13
submit prescription monitoring data AND NALOXONE MEDICATION DATA to the Program 14
by electronic means, in accordance with regulations adopted by the Secretary. 15
(d) The Secretary, for good cause shown, may authorize a dispenser to submit 16
prescription monitoring data OR NALOXONE MEDICATION DATA by an alternative form 17
of submission. 18
(e) The Secretary, in consultation with the Maryland Health Care Commission 19
and the Board, shall: 20
(1) Determine the appropriate technology to support the operation of the 21
Program; and 22
(2) Educate dispensers, prescribers, pharmacists, prescriber delegates, 23
pharmacist delegates, and consumers about the purpose and operation of the Program. 24
(f) (1) The Secretary shall grant a waiver to a pharmacy that dispenses 25
medications to an inpatient hospice from reporting to the Program prescription monitoring 26
data for hospice inpatients if: 27
(i) The pharmacy demonstrates how it will distinguish hospice 28
inpatients from other consumers receiving medications from the pharmacy; and 29
(ii) The pharmacy agrees that it will be subject to onsite , 30
unannounced inspections by the Department to verify its reporting of the prescription data 31
of consumers who are not hospice inpatients. 32
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(2) A waiver granted under this subsection may remain in effect for up to 1
2 years. 2
(3) The Secretary may establish an application process for a pharmacy to 3
apply for a waiver under this subsection. 4
21–2A–04. 5
(a) The Secretary, in consultation with the Board, shall adopt regulations to carry 6
out this subtitle. 7
(b) The regulations adopted by the Secretary shall: 8
(1) Specify the prescription monitoring data AND NALOXONE 9
MEDICATION DATA required to be submitted under § 21–2A–03 of this subtitle; 10
(2) Specify the electronic or other means by which information is to be 11
submitted: 12
(i) Without unduly increasing the workload and expense on 13
dispensers; and 14
(ii) In a manner as compatible as possible with existing data 15
submission practices of dispensers; 16
(3) Specify that the information be submitted by dispensers once every 24 17
hours; 18
(4) Specify that the Program: 19
(i) Shall provide the information technology software to dispensers 20
necessary to upload prescription drug monitoring data AND NALOXONE MEDICATION 21
DATA to the Program; and 22
(ii) May not impose any fees or other assessments on prescribers or 23
dispensers to support the operation of the Program; 24
(5) Identify the mechanism by which [prescription]: 25
(I) PRESCRIPTION monitoring data are disclosed to a person, in 26
accordance with § 21–2A–06 of this subtitle; AND 27
(II) NALOXONE MEDICATION DATA ARE DISCLOSED T O A 28
PERSON, IN ACCORDANCE WITH § 21–2A–06.1 OF THIS SUBTITLE; 29
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(6) Identify the circumstances under which a person may disclose 1
prescription monitoring data OR NALOXONE MEDICATION DATA received under the 2
Program; 3
(7) Specify the process for the Program’s review of prescription monitoring 4
data AND NALOXONE MEDICAT ION DATA and reporting of: 5
(i) Possible misuse or abuse of a monitored prescription drug under 6
§ 21–2A–06(c) of this subtitle; or 7
(ii) A possible violation of law or possible breach of professional 8
standards under § 21–2A–06(d) of this subtitle; 9
(8) Establish requirements for Program retention of prescription 10
monitoring data AND NALOXONE MEDICATION DATA for 3 years; and 11
(9) Require that: 12
(i) Confidential or privileged patient information be kept 13
confidential; and 14
(ii) Records or information protected by a privilege between a health 15
care provider and a patient, or otherwise required by law to be held confidential, be filed in 16
a manner that, except as otherwise provided in [§ 21–2A–06] §§ 21–2A–06 AND 17
21–2A–06.1 of this subtitle, does not disclose the identity of the person protected. 18
21–2A–06.1. 19
(A) NALOXONE MEDICATION DATA: 20
(1) ARE CONFIDENTIAL AND PRIVILEGED, AND NOT SUBJECT TO 21
DISCOVERY, SUBPOENA, OR OTHER MEANS OF LE GAL COMPULSION IN CI VIL 22
LITIGATION; 23
(2) ARE NOT PUBLIC RECORD S; AND 24
(3) EXCEPT AS PROVIDED IN SUBSECTION (B) OF THIS SECTION OR AS 25
OTHERWISE BY LAW , MAY NOT BE DISCLOSED TO ANY PERSON . 26
(B) (1) THE PROGRAM SHALL DISCLOS E NALOXONE MEDICATION DATA, 27
IN ACCORDANCE WITH R EGULATIONS ADOPTED B Y THE SECRETARY, FOR PUBLIC 28
HEALTH SURVEILLANCE , RESEARCH, ANALYSIS, PUBLIC REPORTING, AND 29
EDUCATION AFTER REDACTION OF AL L INFORMATION THAT C OULD IDENTIFY A 30
PATIENT, PRESCRIBER, DISPENSER, OR ANY OTHER INDIVIDUAL. 31
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(2) THE SECRETARY MAY REQUIRE SUBMISSI ON OF AN ABSTRACT 1
EXPLAINING THE SCOPE AND PURPOSE OF THE R ESEARCH, ANALYSIS, PUBLIC 2
REPORTING, OR EDUCATION BEFORE DISCLOSING NALOXONE MEDICATION DATA 3
UNDER PARAGRAPH (1) OF THIS SUBSECTION . 4
21–2A–08. 5
(a) With respect to the administration and operation of the Program, the 6
Department and its agents and employees are not subject to liability arising from: 7
(1) The inaccuracy of any information submitted to the Program in 8
accordance with this subtitle; or 9
(2) The unauthorized use or disclosure of prescription monitoring data OR 10
NALOXONE MEDICATION DATA by a person to whom the Program was authorized to 11
provide prescription monitoring data OR NALOXONE MEDICATION DATA under this 12
subtitle. 13
(b) Except as provided in § 21–2A–09(b)(3) of this subtitle, a prescriber, prescriber 14
delegate, pharmacist, or pharmacist delegate, acting in good faith, is not subject to liability 15
or disciplinary action arising solely from: 16
(1) Requesting or receiving, or failing to request or receive, prescription 17
monitoring data from the Program; or 18
(2) Acting, or failing to act, on the basis of prescription monitoring data 19
provided by the Program. 20
21–2A–09. 21
(a) A dispenser who knowingly fails to submit prescription monitoring data OR 22
NALOXONE MEDICATION DATA to the Program as required under this subtitle shall be 23
subject to a civil penalty not exceeding $500 for each failure to submit required information. 24
(b) (1) A person who knowingly discloses, uses, obtains, or attempts to obtain 25
by fraud or deceit, prescription monitoring data OR NALOXONE MEDICATION DATA in 26
violation of this subtitle shall be guilty of a misdemeanor and on conviction is subject to 27
imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both. 28
(2) In addition to the penalties under paragraph (1) of this subsection, a 29
prescriber, prescriber delegate, pharmacist, or pharmacist delegate who knowingly 30
discloses or uses prescription monitoring data OR NALOXONE MEDICATI ON DATA in 31
violation of this subtitle shall be subject to disciplinary action by the appropriate licensing 32
entity. 33
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(3) A prescriber or pharmacist who violates § 21–2A–04.1 or § 21–2A–04.2 1
of this subtitle shall be subject to disciplinary action by the appropriate licensing entity. 2
(4) The release of prescription monitoring data by a prescriber, prescriber 3
delegate, pharmacist, or pharmacist delegate to a licensed health care professional solely 4
for treatment purposes in a manner otherwise consistent with State and federal law is not 5
a violation of this subtitle. 6
SECTION 2. AND BE IT FURTHER ENACTED, That this Act shall take effect 7
October 1, 2022. 8