Title 10
DEPARTMENT OF HEALTH AND MENTAL HYGIENE
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
[12-153-P]The Secretary of Health and Mental Hygiene proposes to adopt new Regulations .01—.08 under a new chapter, COMAR 10.47.07 Prescription Drug Monitoring Program.
Statement of Purpose
The purpose of this action is to establish regulations for the Prescription Drug Monitoring Program (PDMP). The PDMP will electronically monitor the prescribing and dispensing of controlled dangerous substances and make this information available to controlled substance prescribers and dispensers, law enforcement, health professional licensing boards, public health regulatory agencies, patients, and researchers in an effort to stem the rise of prescription drug abuse and diversion.
Comparison to Federal Standards
There is no corresponding federal standard to this proposed action.
Estimate of Economic Impact
I. Summary of Economic Impact. The primary economic impact of the PDMP will fall on the ADAA, including program costs associated with personnel and contractual IT support services. Dispensers of controlled substances may incur minimal costs associated with reconfiguration of practice management systems for electronic reporting to the PDMP. Primary benefits of the program include: the improved ability of healthcare providers and institutions to identify and treat patients with pain and prescription drug abuse problems; increased efficiencies for government agencies responsible for regulating the prescribing and dispensing of controlled substances; and cost savings for healthcare service payers from improved identification of controlled substance-related fraud.
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Revenue (R+/R-) |
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II. Types of Economic Impact. |
Expenditure (E+/E-) |
Magnitude |
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A. On issuing agency: |
(E+) |
$1.3 million FY12 & FY13 |
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B. On other State agencies: |
(E-) |
Unquantifiable |
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C. On local governments: |
(E-) |
Unquantifiable |
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Benefit (+) |
Magnitude | |
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D. On regulated industries or trade groups: |
(-) |
Minimal |
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(+) |
Unquantifiable | |
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E. On other industries or trade groups: |
(+) |
Unquantifiable |
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F. Direct and indirect effects on public: |
(+) |
Unquantifiable |
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III. Assumptions. (Identified by Impact Letter and Number from Section II.) | ||
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A. ADAA has currently secured $900,000 in funding from 2 federal grants administered by the Governor's Office of Crime Control and Prevention, including a $500,000 Byrne Justice Assistance Grant (BJAG) and a $400,000 Harold Rogers Prescription Drug Monitoring Grant (HRPDMP). Funding from both grants is made available to ADAA on a quarterly reimbursement basis. In May, 2012, ADAA will apply for another $400,000 HRPDMP grant with an estimated awarded date of October 1, 2012. Award would give ADAA a total of $1.3 million to fund all PDMP implementation costs between July 1, 2011, and June 30, 2013. See table below for estimated cost breakdown for this period: Category Cost (FY12 & FY13) | ||
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B. State licensing boards, law enforcement and regulatory agencies that conduct investigations related to the prescribing and dispensing of controlled dangerous substances should see a reduction in the amount of time and resources necessary to devote to investigations, as aggregated dispensing data will be available directly through the PDMP. The current costs associated with investigations are not known, though costs likely vary by agency and agency type. Public payers for healthcare services (including Medical Assistance) may see cost savings as providers and regulatory agencies use the PDMP to better identify and reduce controlled substance-related healthcare fraud. | ||
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C. Local law enforcement agencies that conduct investigations related to the prescribing and dispensing of controlled dangerous substances should see a reduction in the amount of time and resources devoted to investigations, as aggregated dispensing data will be available directly through the PDMP. | ||
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D. Dispensers of controlled substances (including pharmacies and dispensing clinics/practitioners) may incur minimal costs related to reconfiguring practice management systems for PDMP reporting, though system vendors may absorb most of these costs. Dispensers and prescribers of controlled substances may see a benefit from increasing their ability to maintain compliance with laws, regulations and practice standards and improve the quality of diagnosis and treatment services by utilizing data provided by the PDMP in patient care. | ||
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E. Private-sector payers for healthcare services may see cost savings as providers and regulatory agencies use the PDMP to better identify and reduce controlled substance-related healthcare fraud. | ||
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F. The general public will benefit through improved treatment quality in the areas of substance abuse and pain management. | ||
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, Department of Health and Mental Hygiene, 201 W. Preston Street, Baltimore, Maryland 21201, or call 410-767-6400 (TTY 800-735-2258), or email to regs@dhmh.state.md.us, or fax to 410-767-6483. Comments will be accepted through July 30, 2012. A public hearing has not been scheduled.
.01 Scope.
This chapter sets forth the requirements for monitoring the prescribing and dispensing of controlled dangerous substances under the Prescription Drug Monitoring Program.
.02 Definitions.
A. In this chapter, the following terms have the meanings indicated.
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) "Business day" means any day except Saturday, Sunday, or a holiday on which State offices are closed.
(3) "Dispense" has the meaning stated in Health Occupations Article, §12–101, Annotated Code of Maryland, but does not include:
(a) Directly administering a monitored prescription drug to a patient; or
(b) Giving a patient prescription drug samples in accordance with Health Occupations Article, §12-102(d), Annotated Code of Maryland.
(4) Dispenser.
(a) "Dispenser" means person authorized by law to dispense a monitored prescription drug to a patient or a patient's agent in the State, including a nonresident pharmacy so authorized.
(b) "Dispenser" does not include:
(i) A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;
(ii) An opioid maintenance program;
(iii) A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services;
(iv) A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; or
(v) A pharmacy issued a waiver from reporting dispensing of monitored prescription drugs to hospice inpatients under Regulation .03G of this chapter.
(5) "Licensed health care practitioner" means an individual who is 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.
(6) "Licensing entity" means an entity authorized under Health Occupations Article, Annotated Code of Maryland, to license, regulate, or discipline a prescriber or dispenser.
(7) "Monitored prescription drug" means a prescription drug that contains a Schedule II, Schedule III, Schedule IV, or Schedule V controlled dangerous substance designated under Criminal Law Article, Title 5, Subtitle 4, Annotated Code of Maryland.
(8) "Opioid maintenance program" means a program that:
(a) Is certified by the State under Health-General Article, §8–404, Annotated Code of Maryland;
(b) Is authorized to treat patients with opioid dependence with a medication approved by the federal Food and Drug Administration for opioid dependence;
(c) Complies with:
(i) The Code of Federal Regulations 42, Part 8;
(ii) COMAR 10.47.02.11; and
(iii) Requirements for the secure storage and accounting of opioid medication imposed by the federal Drug Enforcement Administration and the State Division of Drug Control; and
(d) Has been granted a certification for operation by the Department, the federal Substance Abuse and Mental Health Services Administration, and the Federal Center for Substance Abuse Treatment.
(9) "Patient" means:
(a) An individual for whom a prescriber has prescribed or is considering prescribing a monitored prescription drug; or
(b) An individual for whom a dispenser has dispensed or is considering dispensing a monitored prescription drug.
(10) "Prescriber" means a practitioner:
(a) Lawfully authorized to prescribe a monitored prescription drug; and
(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.
(11) "Prescription drug" has the meaning stated in Health-General Article, §21–201, Annotated Code of Maryland.
(12) "Prescription monitoring data" means the information submitted to the program for a monitored prescription drug.
(13) "Program" means the Prescription Drug Monitoring Program established under Health-General Article, Title 21, Subtitle 2A, Annotated Code of Maryland.
(14) "Rehabilitation program under a health occupations board" means a group, committee, or program recognized by a licensing entity that provides assistance to a licensed health care practitioner in need of treatment and rehabilitation for alcoholism, drug abuse, chemical dependency, or other physical, emotional, or mental condition.
(15) "Technical Advisory Committee" means the Technical Advisory Committee established by Health-General Article, §21-2A-07, Annotated Code of Maryland.
.03 Dispenser Reporting.
A. For each monitored prescription drug dispensed, the dispenser shall report the following prescription monitoring data to the Department:
(1) Identifying information for the prescription issued and drug dispensed, including:
(a) Prescription number;
(b) Date prescription was issued;
(c) Date prescription was filled;
(d) Whether the prescription was new or a refill;
(e) Number of refills ordered;
(f) Sources of payment;
(g) National Drug Code for dispensed drug;
(h) Metric quantity of drug dispensed; and
(i) Days' supply of drug dispensed;
(2) Identifying information for the patient, including:
(a) Last name;
(b) First name;
(c) Date of birth;
(d) Gender;
(e) Address, including residential house or building number, apartment number, street name, state, and zip code; and
(f) A patient identification number, which may include:
(i) A state-issued driver's license or identification card number;
(ii) A residential telephone number;
(iii) An insurance or third-party payer identification number;
(iv) A passport identification number;
(v) An employer-issued identification card number;
(vi) A student identification card number;
(vii) A United States Permanent Resident Card identification number; or
(viii) A patient or customer identification number generated by the dispenser's record management system;
(3) Identifying information for the prescriber, including:
(a) A valid Drug Enforcement Administration registration number; and
(b) Last name; and
(4) Identifying information for the dispenser, including a valid Drug Enforcement Administration registration number.
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.
(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) Notify the Department, by a communications method approved by the Department, within 24 hours of discovery of the technical failure; and
(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 following reestablishment of the means of electronic reporting.
C. Waiver from Reporting Deadline.
(1) At the Secretary's discretion, a dispenser may be granted a waiver from §B of this regulation, provided that the dispenser's waiver request:
(a) Is submitted on a form or in a method approved by the Department;
(b) Is particular to a unique problem, incident or other issue that prevents the dispenser from meeting the reporting deadline; and
(c) Describes in detail and includes any available documentation of the specific circumstances that prevent the dispenser from meeting the reporting deadline.
(2) A dispenser that receives a waiver shall comply with all the terms and conditions enumerated therein, including any new reporting deadline required.
D. Means of Data Submission and Data Format. Prescription monitoring data shall be transmitted to the Department or its agent:
(1) In accordance with any procedures and guidelines established or approved by the Department, including by use of an encrypted electronic transmission method or a secure electronic reporting form; and
(2) In a format or utilizing a data standard approved by the Department.
E. Reporting of Incomplete or Inaccurate Data. Data not accepted by the Department or its agent due to inaccuracy or incompleteness shall be corrected and resubmitted to the Department no later than 3 business days after receiving notification from the Department of receipt of incomplete or inaccurate data.
F. Reporting Exemptions. The following shall be exempt from reporting prescription monitoring data to the Program:
(1) A licensed hospital pharmacy that only dispenses a monitored prescription drug for direct administration to an inpatient of the hospital;
(2) An opioid maintenance program;
(3) A veterinarian licensed under Agriculture Article, Title 2, Subtitle 3, Annotated Code of Maryland, when prescribing controlled substances for animals in the usual course of providing professional services;
(4) A pharmacy issued a waiver permit under COMAR 10.34.17.03 that provides pharmaceutical specialty services exclusively to persons living in assisted living facilities, comprehensive care facilities, and developmental disabilities facilities; and
(5) Dispensing to hospice inpatients, provided that the dispensing pharmacy has applied for and been granted a waiver by the Department pursuant to §G of this regulation.
G. Waiver for Dispensing to Hospice Inpatients.
(1) On a form or in a manner approved by the Department, a pharmacy may apply to the Department to be granted a waiver from reporting prescription monitoring data for dispensing of monitored prescription drugs to hospice inpatients, provided that:
(a) The pharmacy demonstrates, through written application, live demonstration, or any other method required by the Department, how it will distinguish dispensing to hospice inpatients from all other dispensing of monitored prescription drugs required to be reported to the Program; and
(b) The pharmacy agrees that it will be subject to unannounced, on-site inspections by the Department to verify its reporting of prescription monitoring data on customers that are not hospice inpatients.
(2) A waiver granted to a pharmacy under this regulation shall remain in effect for 2 years.
.04 Disclosure of Prescription Monitoring Data.
A. Registration of a Prescriber, a Dispenser, or an Authorized Licensed Health Care Practitioner to Request Prescription Monitoring Data.
(1) A prescriber, a dispenser, or an authorized 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) Establish procedures to authenticate a prescriber, a dispenser, or an authorized licensed health care practitioner in accordance with Health-General Article, §21-2A-06(b)(1)-(2), Annotated Code of Maryland; and
(b) Issue credentials to a prescriber, a dispenser, or an authorized licensed health care practitioner that can be used to request disclosure of or otherwise access prescription monitoring data electronically.
(3) If the credentials issued to a registrant are lost, stolen, or otherwise compromised, the registrant shall notify the Department or its agent, by a method approved by the Department, as soon as reasonably possible.
(4) A prescriber or dispenser who authorizes the registration of a licensed health care practitioner 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 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, if the prescriber or dispenser believes that the confidentiality of prescription monitoring data or the security of the Program has been compromised by an authorized licensed health care practitioner; 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 licensed health care practitioner, including if that authorized licensed health care practitioner is no longer employed by or practicing under the authority of the prescriber or dispenser.
B. Disclosure of Prescription Monitoring Data to a Prescriber, a Dispenser, or an Authorized Licensed Health Care Practitioner.
(1) Upon request from a prescriber or a licensed health care practitioner 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) Upon request from a prescriber, the Program may provide a report containing prescription monitoring data on all monitored prescription drugs dispensed pursuant to the prescriber's prescriptions, provided that the request is submitted on a form or in a manner approved by the Department.
(3) Upon request from a dispenser or a licensed health care practitioner authorized by a dispenser, the Program shall disclose patient-specific prescription monitoring data provided that the request is made pursuant to a dispenser'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, or an authorized licensed health care practitioner may request disclosure of or otherwise access patient-specific prescription monitoring data.
C. Disclosure of Prescription Monitoring Data to a Federal, State, or Local Law Enforcement Agency. The Program shall disclose prescription monitoring data to a federal, State, or local law enforcement agency on receipt of a subpoena that:
(1) Includes information sufficient to identify the unique prescriber, dispenser, or patient about whom prescription monitoring data is requested;
(2) Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end;
(3) Includes an agency case number or other identifier sufficient to identify an existing bona fide individual investigation; and
(4) Bears the name, title, and original signature of the official under whose authority the subpoena is issued.
D. Disclosure of Prescription Monitoring Data to a Licensing Entity. The Program shall disclose prescription monitoring data to a licensing entity upon receipt of an administrative subpoena that:
(1) Includes information sufficient to identify the unique prescriber or dispenser about whom prescription monitoring data is requested;
(2) Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end;
(3) Includes a case number or other identifier sufficient to identify an existing bona fide individual investigation;
(4) Includes an attestation that the subpoena was approved by a quorum of the board of the licensing entity; and
(5) Bears the name, title, and original signature of the official under whose authority the subpoena is issued.
E. Disclosure of Prescription Monitoring Data to a Rehabilitation Program under a Health Occupations Board. The Program shall disclose prescription monitoring data to a rehabilitation program under a health occupations board upon receipt of an administrative subpoena that:
(1) Includes information sufficient to identify the unique licensed health care practitioner about whom prescription monitoring data is requested;
(2) Specifies the time frame for which prescription monitoring data is requested, including the day, month, and year the report is to begin and end; and
(3) Bears the name, title and original signature of the official under whose authority the subpoena is issued.
F. Disclosure of Prescription Monitoring Data to a Patient or a Patient's Authorized Representative.
(1) Upon request, the Program shall disclose to a patient 18 years old or older prescription monitoring data about that patient provided that the request is submitted to the Program:
(a) In person and is accompanied by:
(i) A completed form approved by the Department; and
(ii) Valid photo identification issued by a government agency of any jurisdiction of the United States verifying that the patient is 18 years old or older; or
(b) In any other manner approved by the Department.
(2) Upon request, the Program shall disclose patient-specific prescription monitoring data to a patient's authorized representative who is 18 years old or older, including the parent or legal guardian of a minor, an individual with power of attorney, the personal representative of a decedent's estate, or any other person duly authorized by State law to request or otherwise access medical records on behalf of a patient, provided that the request shall be submitted to the Program:
(a) In person and accompanied by:
(i) A completed form approved by the Department;
(ii) Valid photo identification issued by a government agency of any jurisdiction of the United States verifying that the patient's authorized representative is 18 years old or older; and
(iii) An original copy of any form or documentation required by State law or regulation to verify the authority of the representative to request or otherwise access the medical records of a patient on their behalf; or
(b) In any other manner approved by the Department.
(3) If a patient, a patient's authorized representative, or a patient's prescriber believes that prescription monitoring data relating to the patient's prescription history is incorrect, the patient, authorized representative, or prescriber may request that the Program correct the data provided that the request:
(a) Is submitted to the Program in writing and on a form or in a manner approved by the Department; and
(b) Includes documentation, which may include but not be limited to, a copy of the original prescription and a signed, notarized statement from the prescriber or dispenser that demonstrates which of the specific data elements reported to the Program under Regulation .03A of this chapter are incorrect.
(4) Upon determination by the Secretary that prescription monitoring data specific to a patient's prescription history is incorrect, the Program shall issue a corrected prescription history report to the patient or the patient's authorized representative.
G. Disclosure of Prescription Monitoring Data to Another State's Prescription Drug Monitoring Program.
(1) Upon request, the Program may disclose prescription monitoring data to another state's prescription drug monitoring program provided that the request:
(a) Is submitted on a form or in a manner approved by the Department;
(b) Is under the authority of the authorized administrator of that state's program; and
(c) Includes an attestation that prescription monitoring data will only be used or redisclosed in a manner consistent with the provisions of Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .08D of this chapter.
(2) The Program may develop and implement interoperability with another state's prescription drug monitoring program to facilitate the automated exchange of prescription monitoring data provided that a written agreement has been established with the other state's program specifying that the information technology employed will:
(a) Only disclose prescription monitoring data to registered users of the other state's program in a manner consistent with the provisions of Health-General Article, §21-2A-06, Annotated Code of Maryland, and this regulation; and
(b) Operate in accordance with all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records.
H. Upon request, the Program may disclose prescription monitoring data to the Office of the Chief Medical Examiner, the Maryland Medical Assistance Program, the Office of the Inspector General of the Department, and the Office of Health Care Quality provided that the request:
(1) Includes information sufficient to identify the unique prescriber, dispenser, licensed health care practitioner, or patient about whom prescription monitoring data is requested;
(2) Specifies the time frame for which prescription monitoring data is requested, including the day, month and year the report is to begin and end;
(3) Includes a case number or other identifier sufficient to identify an existing bona fide individual investigation; and
(4) Includes an attestation that the request was approved by the Secretary.
I. Disclosure of Prescription Monitoring Data for Research, Analysis, Education, and Public Reporting.
(1) The Program may disclose prescription monitoring data for research, analysis, education, and public reporting:
(a) In response to requests determined by the Department to be consistent with institutional review board protocols and human subjects research protections;
(b) Upon approval by the Department of a written proposal or abstract explaining the purpose and scope of the research, analysis, education, and public reporting; and
(c) After redaction of all information that could identify a patient, prescriber, dispenser, or any other individual.
(2) The Secretary may waive the requirement of §I(1)(b) of this section for requests from units of the Department.
J. Technical Advisory Committee Review.
(1) Before the Program discloses prescription monitoring data under COMAR 10.47.07.04C—E, G and H, the Technical Advisory Committee shall:
(a) Review the request for disclosure; and
(b) Within 10 business days of submission of the request to the Technical Advisory Committee for review, submit to the Program, in written form, clinical guidance and interpretation of the prescription monitoring data requested to:
(i) Assist the Secretary's decision on how to respond to a judicial subpoena, administrative subpoena, or other request; and
(ii) Be made available for use by the recipient of prescription monitoring data should the request for disclosure be authorized.
(2) If the Technical Advisory Committee has not provided clinical guidance and interpretation within 10 business days of submission of the request, the Department may:
(a) Proceed as if the Technical Advisory Committee does not have clinical guidance or interpretation to provide regarding the request at issue; and
(b) Respond to the original request for disclosure.
(3) The Department shall establish procedures, which may include but not be limited to secure electronic messaging, for the timely disclosure of prescription monitoring data to the Technical Advisory Committee and the receipt of responses from the Technical Advisory Committee to ensure that the review process is conducted with all possible expediency.
(4) 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.
.05 Notice to Patients.
A. Dispenser.
(1) Any dispenser 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.
(2) The sign shall disclose to the public that the dispenser 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 may provide such notice in written material provided to the patient.
B. Prescriber.
(1) Any prescriber who intends to request prescription monitoring data from the Program may post a sign that can be easily viewed by the public that discloses to the public that the prescriber may access prescription monitoring data on a patient.
(2) In lieu of posting a sign, the prescriber may provide such notice in written material provided to the patient.
.06 Confidentiality.
A. Prescription monitoring data are confidential, privileged, not subject to discovery, subpoena, or other means of legal compulsion in civil litigation, and are not public records.
B. The Program shall ensure that confidential or privileged patient information be kept confidential and that records or information protected by a privilege between a health care provider and a patient, or otherwise required by law to be held confidential, be filed in a manner that, except as otherwise provided in Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .04 of this chapter, does not disclose the identity of the person protected.
C. The Program shall periodically conduct an audit review of prescription monitoring data and disclosure requests to ensure compliance with §B of this regulation.
.07 Penalties and Sanctions.
A. Civil Penalties. A dispenser who knowingly fails to submit prescription monitoring data to the Program as required by Regulation .03 of this chapter shall be subject to a civil penalty not exceeding $500 for each failure to submit required information.
B. Criminal Penalties. A person who knowingly discloses, uses, obtains, or attempts to obtain by fraud or deceit prescription monitoring data in violation of in Health-General Article, §21-2A, Annotated Code of Maryland, shall be guilty of a misdemeanor and on conviction is subject to imprisonment not exceeding 1 year or a fine not exceeding $10,000 or both.
C. Administrative Sanctions. A prescriber or dispenser 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.
.08 General Provisions.
A. The Program shall make available the information technology necessary for dispensers to report prescription monitoring data to the Program.
B. The Program may not impose any fees or other assessments on prescribers or dispensers to support the operation of the Program.
C. A prescriber or dispenser:
(1) Is not required or obligated to access or use the prescription monitoring data available under the Program; and
(2) When acting in good faith, is not subject to liability or disciplinary action arising solely from:
(a) Requesting or receiving, or failing to request or receive, prescription monitoring data from the Program; or
(b) Acting, or failing to act, on the basis of prescription monitoring data provided by the Program.
D. Redisclosure of prescription monitoring data received under Health-General Article, §21-2A-06, Annotated Code of Maryland, and Regulation .04 of this chapter is prohibited unless intended to facilitate the treatment of a patient and is consistent with all other State and federal laws and regulations governing the security and confidentiality of protected health information and personal medical records.
E. The Program shall retain prescription monitoring data for 3 years from the date of receipt.
F. A member of the Technical Advisory Committee:
(1) Shall serve for a term of 3 years from the date of appointment; and
(2) May be reappointed at the discretion of the Secretary.
JOSHUA M. SHARFSTEIN, M.D.
Secretary of Health and Mental Hygiene