PROPOSAL
Maryland Register
Issue Date: March 30, 2018
Volume 45 • Issue 7 • Pages 364—366
Title 10
MARYLAND DEPARTMENT OF HEALTH
Subtitle 47 ALCOHOL AND DRUG ABUSE ADMINISTRATION
10.47.07 Prescription Drug Monitoring Program
Authority: Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland
Notice of Proposed Action
[18-072-P]
The Secretary of Health proposes to amend Regulations .02, .03, .05, .06, .08, and .09 under COMAR 10.47.07 Prescription Drug Monitoring Program.
Statement of Purpose
The purpose of this action is to:
(1) Amend Maryland Prescription Drug Monitoring Program (PDMP) regulations to align with statutory requirements as required by Chapter 147, Acts of 2016 (HB 437).
(2) Updates obsolete definitions;
(3) Updates reporting requirements;
(4) Update prescription monitoring data retention timeline;
(5) Update redisclosure provision; and
(6) Updates list of providers that are required to request prescription monitoring data before dispensing a monitored prescription drug.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. This estimate reflects the cost of increased contractual services to provide the IT infrastructure necessary to implement mandatory registration by July 1, 2017, and the mandatory use requirement by July 1, 2018, as well as the cost to hire three personnel (one full-time grade 19 database specialist and two full-time grade 15 administrative officers) primarily to ensure data quality, enforce the mandates, and expand unsolicited reporting.
|
|
Revenue (R+/R-) |
|
|
II. Types of Economic Impact. |
Expenditure
(E+/E-) |
Magnitude |
|
|
|
|
|
|
|
A. On issuing agency: |
(E+) |
$589,743 |
|
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: |
NONE |
|
|
III. Assumptions. (Identified by Impact Letter and Number from Section II.) |
|
A. General fund expenditures for PDMP increase by an estimated $589,743 in fiscal 2017, which accounts for the bill’s October 1, 2016 effective date. |
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 Michele Phinney, 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 April 30, 2018. A public hearing has not been scheduled.
.02 Definitions.
A. (text unchanged)
B. Terms Defined.
[(1) “Authorized licensed health care practitioner” means a licensed health care practitioner who is authorized by a prescriber or dispenser to access prescription monitoring data in connection with the medical care of a patient to whom the prescriber prescribes or the dispenser dispenses a monitored prescription drug.]
[(2)] (1)—[(3)] (2) (text unchanged)
[(4)] (3) Dispenser.
(a) (text unchanged)
(b) “Dispenser” does not include:
(i) (text unchanged)
(ii) An opioid [maintenance] treatment services program;
(iii)—(v) (text unchanged)
[(5)] (4) “Licensed health care practitioner” means an individual who is [licensed]:
(a) Licensed, certified, or registered under Health Occupations Article, Annotated Code of Maryland, or the laws of the practitioner’s respective state, as appropriate, to provide health care services[.]; and
(b) Authorized by a prescriber or pharmacist to access prescription monitoring data in connection with the medical care of a patient to whom the prescriber prescribes or the pharmacist dispenses a monitored prescription drug.
[(6)] (5) “Licensing entity” means an entity authorized under Health Occupations Article, Annotated Code of Maryland, to license, regulate, or discipline a prescriber or [dispenser] pharmacist.
[(7)] (6) (text unchanged)
[(8)] (7) “Opioid [maintenance] treatment services program” means a program that:
(a) Is certified by the State under Health-General Article, [§8–404] §8–401, Annotated Code of Maryland or licensed by the State under Health-General Article, §7.5-401, Annotated Code of Maryland;
(b)—(d) (text unchanged)
[(9)] (8) “Patient” means:
(a) (text unchanged)
(b) An individual for whom a [dispenser] pharmacist has dispensed or is considering dispensing a monitored prescription drug.
(9) “Pharmacist” means an individual who is licensed under Health-Occupations Article, Title 12, Annotated Code of Maryland, to dispense a monitored prescription drug.
(10) “Pharmacist delegate” means an individual who is:
(a) Authorized by a registered pharmacist to request or access prescription monitoring data; and
(b) Employed by or under contract with the same professional practice as the registered pharmacist.
[(10)] (11) “Prescriber” means a practitioner:
(a) Lawfully authorized to prescribe a monitored prescription drug; [and] or
[(b) Registered with:
(i) The federal Drug Enforcement Administration in accordance with 21 USC 822 Part C and 21 CFR Part 1301; and
(ii) For those practitioners licensed to practice in the State, the State Division of Drug Control in accordance with Criminal Law Article, §5-301 et seq., Annotated Code of Maryland, and COMAR 10.19.03.03.]
(b) Legally authorized to prescribe a monitored prescription drug under an institutional DEA registration;
(12) “Prescriber delegate” means an individual who is:
(a) Authorized by a registered prescriber to request or access prescription monitoring data; and
(b) Employed by or under contract with the same professional practice as the registered prescriber.
[(11)] (13)—[(13)] (15) (text unchanged)
(16) “Registered” means a person registered with the Program to request or access prescription monitoring data for clinical use.
[(14)] (17)—[(15)] (18) (text unchanged)
(19) “Zero report” means an electronic report submitted by a dispenser to the Program to confirm that no monitored prescription drugs were dispensed during the reporting time frame.
.03 Dispenser Reporting.
A. (text unchanged)
B. Reporting Deadline.
(1) A dispenser shall report prescription monitoring data to the Department [no later than 3 business days after dispensing a monitored prescription drug] to include zero reports at least once every 24 hours and in accordance with procedures developed by the Department and approved by the Advisory Board on Prescription Drug Monitoring.
(2) A dispenser that suffers a mechanical, electrical, or other technical failure that, as a direct consequence, precludes the dispenser’s ability to report prescription monitoring data electronically shall:
(a) (text unchanged)
(b) Submit a report for each monitored prescription drug dispensed during the period of technical failure as soon as possible, but no later than [3 business days] 24 hours following reestablishment of the means of electronic reporting.
C.—E. (text unchanged)
F. Reporting Exemptions. The following shall be exempt from reporting prescription monitoring data to the Program:
(1) (text unchanged)
(2) An opioid [maintenance] treatment service program;
(3)—(5) (text unchanged)
G. (text unchanged)
.05 Disclosure of Prescription Monitoring Data.
A. Registration of a Prescriber, a Prescriber Delegate, a [Dispenser] Pharmacist, a Pharmacist Delegate, or [an Authorized] a Licensed Health Care Practitioner to Request Prescription Monitoring Data.
(1) A prescriber, a prescriber delegate, a [dispenser] pharmacist, a pharmacist delegate, or [an authorized] a licensed health care practitioner shall register with the Department or its agent, in a manner specified by the Department, in order to request disclosure of or otherwise access prescription monitoring data.
(2) The Department or its agent shall:
(a) (text unchanged)
(b) Issue credentials to a prescriber, a prescriber delegate, a [dispenser or an authorized licensed health care practitioner] pharmacist, or a pharmacist delegate that can be used to request disclosure of or otherwise access prescription monitoring data electronically.
(3) (text unchanged)
(4) A prescriber or [dispenser] pharmacist who authorizes the registration of a licensed health care practitioner, prescriber delegate, or pharmacist delegate to request disclosure of or otherwise access prescription monitoring data shall:
(a) Make every reasonable effort, including regularly reviewing and auditing any available logs of system access and use, to ensure the [authorized licensed health care practitioner,] prescriber delegate or pharmacist delegate is requesting disclosure of, redisclosing, or otherwise accessing prescription monitoring data in clear compliance with Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records;
(b) Immediately notify the Department or its agent, by a method approved by the Department, as well as the licensing entity responsible for licensing, certifying, or registering the [authorized licensed health care practitioner,] prescriber delegate, or pharmacist delegate, if applicable, if the prescriber or [dispenser] pharmacist believes that the confidentiality of prescription monitoring data or the security of the Program has been compromised by [an authorized licensed health care practitioner] that individual; and
(c) Immediately notify the Department or its agent, by a method approved by the Department, of any requested change in the registration status of [an authorized] a licensed health care practitioner, prescriber delegate, or pharmacist delegate, including if that [authorized licensed health care practitioner] individual is no longer employed by or practicing under the authority of the prescriber or [dispenser] pharmacist.
B. Disclosure of Prescription Monitoring Data to a Prescriber, a Prescriber Delegate, a [Dispenser] Pharmacist, or [an Authorized Licensed Health Care Practitioner] a Pharmacist Delegate.
(1) Upon request from a prescriber or a licensed health care practitioner or a prescriber delegate authorized by a prescriber, the Program shall disclose patient-specific prescription monitoring data provided that the request is made solely for the purpose of the medical care or treatment of the patient about whom prescription monitoring data is being requested.
(2) (text unchanged)
(3) Upon request from a [dispenser] pharmacist or a licensed health care practitioner or pharmacist delegate authorized by a [dispenser] pharmacist, the Program shall disclose patient-specific prescription monitoring data provided that the request is made pursuant to a [dispenser’s] pharmacist’s responsibility to perform due diligence and exercise professional judgment when presented with a prescription to dispense a monitored prescription drug for use by the patient about whom prescription monitoring data is being requested.
(4) The Department or its agent shall make available the electronic means by which a prescriber, a [dispenser] pharmacist, [an authorized licensed health care practitioner,] a prescriber delegate, or a pharmacist delegate may request disclosure of or otherwise access patient-specific prescription monitoring data.
(5) (text unchanged)
C.—J. (text unchanged)
K. Technical Advisory Committee Review.
(1) (text unchanged)
(2) Notwithstanding §K(1) of this regulation, the Program may disclose prescription monitoring data to the authorized administrator of another state’s prescription drug monitoring program for disclosure to a prescriber, a prescriber delegate, a [dispenser] pharmacist, a pharmacist delegate, a licensed health care practitioner authorized by a prescriber or a dispenser, or a patient in a manner consistent with §§B(1)—(4) and F of this regulation.
(3)—(5) (text unchanged)
(6) For all purposes, including but not limited to confidentiality, security, redisclosure, and admissibility as evidence, [the reports of the Technical Advisory Committee shall be considered as one and the same with the prescription monitoring data upon which the Committee's reports are based] Program reports based on evaluation of prescription monitoring data and that contain individual identifying information shall be considered as one and the same with the prescription monitoring data.
.06 Notice to Patients.
A. [Dispenser] Pharmacists.
(1) Any [dispenser] pharmacist who intends to request prescription monitoring data from the Program may post a sign that can be easily viewed by the public at the place where the prescription is delivered to the [dispenser] pharmacist.
(2) The sign shall disclose to the public that the [dispenser] pharmacist may access prescription monitoring data on a patient for whom a prescription for a monitored prescription drug is presented.
(3) In lieu of posting a sign, the [dispenser] pharmacist may provide such notice in written material provided to the patient.
B. (text unchanged)
.08 Penalties and Sanctions.
A.—B. (text unchanged)
C. Administrative Sanctions. A prescriber or [dispenser] pharmacist who knowingly discloses or uses prescription monitoring data in violation of Health-General Article, §21-2A, Annotated Code of Maryland shall be subject to disciplinary action by the appropriate licensing entity.
.09 General Provisions.
A.—B. (text unchanged)
C. A prescriber or [dispenser] pharmacist:
(1)—(2) (text unchanged)
D. Redisclosure of Prescription Monitoring Data.
(1) Prescription monitoring data received under Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .04 of this chapter may be redisclosed only:
(a) [To facilitate the treatment of a patient and in] In a manner consistent with the Health Insurance Portability and Accountability Act of 1996 (HIPAA), 42 U.S.C. §§1320d et seq., as amended, and all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records; or
(b) For entities to which the Program has disclosed data in accordance with Regulation .05C—E and H of this chapter, to another agency cooperating with or providing support for the original data recipient’s existing, bona fide, individual investigation[;].
[(c) To a State or local child fatality review team established under Health-General Article, Title 5, Subtitle 7, Annotated Code of Maryland; or
(d) To a local drug overdose fatality review team established under Health-General Article, Title 5, Subtitle 9, Annotated Code of Maryland.]
(2) The release of prescription monitoring data by a prescriber or [dispenser] pharmacist to a licensed health care professional solely for treatment purposes in a manner otherwise consistent with State and federal law is not a violation of Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland.
E. The Program shall retain prescription monitoring data for [3] 5 years from the date of receipt.
F. (text unchanged)
ROBERT R. NEALL
Secretary of Health
