SB 166
Department of Legislative Services
Maryland General Assembly
2020 Session
FISCAL AND POLICY NOTE
Third Reader - Revised
Senate Bill 166 (Senator Kelley)
Finance Health and Government Operations
Drugs and Devices - Electronic Prescriptions - Controlled Dangerous Substances
This bill requires a health practitioner to issue a prescription for a controlled dangerous
substance (CDS) electronically, except under specified circumstances. The Secretary of
Health, in collaboration with the Maryland Health Care Commission (MHCC), must adopt
regulations to establish a waiver of the electronic prescription requirement. The appropriate
health occupations board may take disciplinary action against a health practitioner who
violates the requirement. A pharmacist may dispense a drug on a written or oral
prescription for a CDS that meets the exception requirements, and a pharmacist is not
required to verify that the prescription is an authorized exception to the electronic
prescription requirement. The bill takes effect January 1, 2022.
Fiscal Summary
State Effect: General fund expenditures increase by $10,000 in FY 2022 for
one-time-only costs to establish a database and by an additional indeterminate but likely
minimal amount to issue waivers. Revenues are not affected.
Local Effect: Health care practitioners in local health departments must comply with the
bill’s requirements. Revenues are not affected.
Small Business Effect: Potential meaningful.
Analysis
Bill Summary: “Electronic prescription” means a prescription that (1) is generated on an
electronic application and transmitted as an electronic data file and (2) if the prescription
is for a CDS, complies with federal law.
Exceptions
A health practitioner may issue a written or oral prescription for a CDS only if:
electronic prescribing is not available due to temporary technological or electrical
failure;
the prescription is to be dispensed by a pharmacy located outside the State;
the prescription is issued by a health practitioner outside the State;
the health practitioner is prescribing and dispensing the CDS directly to the patient;
the prescription is being dispensed directly to the patient in accordance with State
law;
the prescription is for an individual who (1) resides in a nursing or assisted living
facility; (2) is receiving care through a hospice or palliative care program or at an
outpatient renal dialysis facility and the prescription is related to the care provided;
or (3) is detained or confined in a correctional facility;
the prescription is issued by a licensed veterinarian;
the prescription includes elements that are not supported by a specified standard;
the prescription is issued for a drug for which the U.S. Food and Drug
Administration requires the prescription to contain certain elements that cannot be
transmitted electronically;
the prescription prescribes a drug under a research protocol;
the prescription is issued by a health practitioner who has received a certain waiver;
the prescription is issued by a health practitioner who requested a certain waiver
that has neither been issued nor been rejected;
the health practitioner issuing the prescription or the drug for which the prescription
is issued falls under a certain waiver;
the prescription is issued by a heath practitioner who writes a low volume of
prescriptions for CDS, as determined by MHCC; or
the prescription is issued by a health practitioner under circumstances in which the
health practitioner reasonably determines that it would be impracticable and the
delay would adversely impact the patient’s medical condition.
Waivers Issued by the Secretary of Health
The Secretary may issue a waiver that applies generally to a group of health practitioners
or drugs that meet conditions specified by the Secretary. Any waiver issued for a group of
health practitioners must apply to a health practitioner in that group without requiring the
health practitioner to apply for a waiver. Otherwise, the regulations adopted must specify
that a waiver (1) may not exceed one year and (2) may be granted for economic hardship,
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technological limitations that are not reasonably within the control of the
health practitioner, or any other exceptional circumstances.
The Secretary may adopt regulations on which temporary technological or electrical
failures constitute an exception to the requirement to issue an electronic prescription and
the circumstances under which a health practitioner is exempt from the requirement to issue
an electronic prescription because the prescription will be dispensed by a pharmacy located
outside the State.
Current Law: A drug that is intended for use by human beings and is in any of the
following classifications may be dispensed by a pharmacist only on a written or oral
prescription from a health practitioner authorized by law to prescribe the drug: (1) a
habit-forming drug, as specified; (2) a drug that, because of its toxicity or other potentiality
for harmful effect, the method of its use, or the collateral measures necessary to its use, is
not safe for use except under the supervision of a specified health practitioner; and (3) a
drug that is limited by an approved application to use under the professional supervision
of a specified health practitioner. In general, a person may not dispense a Schedule II CDS
without a written prescription from an authorized provider, with specified exceptions.
A prescription for a CDS may not be written on a preprinted prescription form that states
the name, quantity, or strength of the CDS. When a prescription is written, a separate
prescription form is required for each CDS. If a pharmacist is otherwise satisfied that a
prescription is valid, the pharmacist may fill the prescription if the pharmacist promptly
writes out and files a prescription for each substance and also files the original prescription.
A prescription must be legible.
A pharmacist may not refill and dispense a prescription unless the refilling is authorized
by the health practitioner’s specification in the original prescription or an oral order of the
health practitioner that promptly is written out and filed by the pharmacist.
These prescription requirements do not apply to any drug that is exempted under a rule or
regulation adopted by the Secretary.
Background: Based on data from the Prescription Drug Monitoring Program, there are
more than 37,000 health care practitioners in Maryland who can prescribe and more than
5.1 million CDS prescriptions were dispensed in Maryland in 2019.
According to Surescripts, as of June 2019, more than half of all states require the use of
electronic prescribing for opioids, CDS, or all prescriptions.
By January 2021, a prescription for a covered Medicare Part D drug under a prescription
drug plan or a Medicare Advantage plan for a Schedule II through V CDS must be
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transmitted electronically in accordance with an electronic prescription drug program that
meets certain requirements, with specified exceptions.
State Expenditures: The Secretary of Health, in collaboration with MHCC, must
establish a process to issue a waiver to health care practitioners from the bill’s electronic
prescription requirements. While regulations can be promulgated using existing budgeted
resources, MDH general fund expenditures increase by $10,000 in fiscal 2022 to establish
a database to accept and process waiver applications. General fund expenditures also
increase, likely minimally, to issue waivers to health care practitioners.
Small Business Effect: Small business health care practitioners who do not currently issue
electronic prescriptions must comply with the bill’s requirements (which may result in
additional costs) or obtain a waiver from the Secretary (valid only for a year).
Additional Information
Prior Introductions: HB 409 of 2019, a similar bill, received a hearing in the
House Health and Government Operations Committee, but no further action was taken on
the bill. Its cross file, SB 469, received a hearing in the Senate Finance Committee, but no
further action was taken on the bill. HB 1416 of 2018, a similar bill, was withdrawn.
Designated Cross File: None.
Information Source(s): Maryland Department of Health; Surescripts; Department of
Legislative Services
Fiscal Note History: First Reader - February 18, 2020
rh/jc Third Reader - March 15, 2020
Revised - Amendment(s) - March 15, 2020
Analysis by: Hillary J. Cleckler Direct Inquiries to:
(410) 946-5510
(301) 970-5510
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Statutes affected: Text - First - Drugs and Devices - Electronic Prescriptions - Controlled Dangerous Substances: 5-501 Criminal Law, 5-306 Criminal Law, 5-504 Criminal Law, 5-701 Criminal Law, 21-220 Criminal Law, 21-220 Criminal Law
Text - Third - Drugs and Devices - Electronic Prescriptions - Controlled Dangerous Substances: 1-101 Correctional Services, 5-101 Correctional Services, 5-501 Correctional Services, 5-306 Correctional Services, 5-504 Correctional Services, 5-701 Correctional Services, 21-220 Correctional Services, 5-101 Correctional Services, 21-220 Correctional Services