50 N.J.R. 2138(a)

VOLUME 50, ISSUE 20, OCTOBER 15, 2018
RULE PROPOSALS

Reporter
50 N.J.R. 2138(a)
NJ - New Jersey Register  >  2018  >  OCTOBER  >  OCTOBER 15, 2018  >  RULE PROPOSALS  >  LAW AND PUBLIC SAFETY -- DIVISION OF CONSUMER AFFAIRS

Interested Persons Statement

INTERESTED PERSONS

Interested persons may submit comments, information or arguments concerning any of the rule proposals in this issue until the date indicated in the proposal. Submissions and any inquiries about submissions should be addressed to the agency officer specified for a particular proposal.
The required minimum period for comment concerning a proposal is 30 days. A proposing agency may extend the 30-day comment period to accommodate public hearings or to elicit greater public response to a proposed new rule or amendment. Most notices of proposal include a 60-day comment period, in order to qualify the notice for an exception to the rulemaking calendar requirements of    N.J.S.A. 52:14B-3. An extended comment deadline will be noted in the heading of a proposal or appear in a subsequent notice in the Register.
At the close of the period for comments, the proposing agency may thereafter adopt a proposal, without change, or with changes not in violation of the rulemaking procedures at    N.J.A.C. 1:30-6.3. The adoption becomes effective upon publication in the Register of a notice of adoption, unless otherwise indicated in the adoption notice. Promulgation in the New Jersey Register establishes a new or amended rule as an official part of the New Jersey Administrative Code.
Agency


LAW AND PUBLIC SAFETY > DIVISION OF CONSUMER AFFAIRS > OFFICE OF THE DIRECTOR

Administrative Code Citation

Proposed Amendments: N.J.A.C. 13:45A-35.1, 35.2, 35.3, 35.6, 35.7, 35.8, 35.9, and 35.11

Proposed New Rules: N.J.A.C. 13:45A-35.6A and 35.12
Text

Prescription Monitoring Program

Delegate Access: Athletic Trainers and Medical Scribes Employed by a Hospital's Emergency Department; Access to Prescription Monitoring Information: Electronic Health Record System; Requirements for Mandatory Look-Up; Patient Requests to Correct Inaccurate Information

Authorized By: Paul R. Rodriguez, Acting Director, Division of Consumer Affairs.
Authority: N.J.S.A. 45:1-45 et seq. (P.L. 2007 c. 244, as amended by P.L. 2015, c. 74 and P.L. 2017, c. 341).
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2018-092.
Submit written comments by December 14, 2018, to:

   Paul R. Rodriguez, Acting Director
   New Jersey Division of Consumer Affairs
   124 Halsey Street
   PO Box 45027
   Newark, NJ 07101
   or electronically at: http://www.njconsumeraffairs.gov/Proposals/Pages/default.aspx.
The agency proposal follows:

Summary

The Division of Consumer Affairs (Division) is proposing new rules and amendments to the rules for the Prescription Monitoring Program (PMP) that was established under N.J.S.A. 45:1-45 et seq. (P.L. 2007, c. 244, as amended by P.L. 2015, c. 74 and P.L. 2017 c. 341). The PMP is intended to be used as a tool by prescribers and pharmacists, who must register with the Division to gain access to the system, to combat prescription drug abuse and diversion, and for practitioners to make the most informed choices about treatment for their patients. The PMP also allows the Division to analyze prescription information data for indications of abuse or fraud through system reports, permitting early detection of abuse and sources of diversion.

The Division proposes amendments and new rules to implement P.L. 2017, c. 341. The new law amends the PMP program to expand delegate access to include athletic trainers and medical scribes employed by a hospital's emergency department, modifies the conditions under which a prescriber is required to look up a patient's PMP records, and provides for electronic health systems to access prescription monitoring information, so that PMP information can be directly integrated into electronic medical records, making access more user friendly.

In 2015, at 47 N.J.R. 2736(a), when the Division proposed new prescription monitoring program rules to implement P.L. 2015, c. 74, the Division noted its intent to initiate a future rulemaking to promulgate rules to implement additional statutory provisions for which rules would be necessary. In accordance with N.J.S.A. 45:1-45(b), the Division proposes to amend the pharmacy reporting requirements to include identifying information for the person, other than the patient, picking up a prescription when the pharmacist has a reasonable belief that the individual may be seeking a controlled dangerous substance (CDS) for any reason other than delivering the substance to the patient for the treatment of an existing medical condition. Consistent with N.J.S.A. 45:1-46(o), the Division is also proposing rules to establish a process for a patient to correct PMP information.

The Division proposes to amend N.J.A.C. 13:45A-35.1(a) to reference P.L. 2017, c. 341. In addition, the Division proposes to amend N.J.A.C. 13:45A-35.1 to specify that the rules at N.J.A.C. 13:45A apply to a licensed athletic trainer and a medical scribe.

The Division proposes to amend, at N.J.A.C. 13:45A-35.2, the definitions of "certified medical assistant" and "chronic pain," and to include the statutory definitions for "licensed athletic trainer" and "medical scribe." Consistent with P.L. 2017, c. 341, the Division proposes to amend the term "certified medical assistant" to update the name of the American Medical Association's Committee to the Commission on Allied Health Education and Accreditation, reduce the number of clock-hours of instruction for the required educational program from 600 to 330, and to recognize certification or registration as a medical assistant from the National Healthcareer Association (NHA), the American Medical Certification Association (AMCA), and the National Certification Medical Association (NCMA). In addition, the Division is proposing to amend the definition of "chronic pain" to be consistent with the statutory definition at N.J.S.A. 24:21-15.2(g), such that chronic pain means pain that persists or recurs for more than three months.

P.L. 2017, c. 341 permits the Division to make prescription monitoring information available on certain electronic health systems to enhance patient care by facilitating access to this information by practitioners as they make treatment care decisions. To implement this statutory provision, in accordance with N.J.S.A. 45:1-46.h(7) and o, the Division proposes new N.J.A.C. 13:45A-35.6A and proposes to amend N.J.A.C. 13:45A-35.6(d). The proposed amendments to N.J.A.C. 13:45A-35.6(d) allow for the required certification to be furnished through the electronic system when the PMP information is accessed through such a system. Proposed new N.J.A.C. 13:45A-35.6A(a) specifies that the Division must determine that the electronic system has appropriate security protections in place. Subsection (b) provides that those practitioners who are required to look up prescription monitoring information pursuant to N.J.A.C. 13:45A-35.9 may satisfy this obligation by accessing the information through an authorized electronic system.

The Division proposes to amend N.J.A.C. 13:45A-35.7(b) to reflect the statutory change by placing the obligation on the practitioner to register with the PMP upon the initial application or renewal of the practitioner's CDS registration.
Proposed new N.J.A.C. 13:45A-35.8(c)5 provides that a practitioner practicing in a hospital's emergency department may designate as a delegate, a medical scribe (that is, an individual trained in medical documentation) who is working in that hospital's emergency department. Subparagraph (c)5i provides that a medical scribe who is no longer employed at the hospital's emergency department at which the practitioner is employed ceases to be eligible to access the PMP on behalf of that practitioner. Proposed new subparagraph (c)5ii provides that the medical director of a hospital's emergency department may designate medical scribes working in the emergency department as delegates. In recognition of the workflow in an emergency department, the Division is allowing the director of a hospital's emergency department to designate medical scribes as delegates. In such circumstances, the medical director is responsible for compliance with subsections (d), to confirm the education, training, and licensure or certification requirements of each delegate, and (e), which sets forth the responsibilities associated with ensuring the proper use by his or her delegate of the PMP and the prescription monitoring information.

Proposed new N.J.A.C. 13:45A-35.8(c)6 sets forth that a practitioner may designate as a delegate, an athletic trainer who is employed at a clinical practice setting. A clinical practice setting is defined as the setting at which the supervising physician practices. The Division notes that, in accordance with the athletic trainer rules set forth at N.J.A.C. 13:35-10, an athletic trainer must be supervised by a physician. Notwithstanding this supervision requirement, any practitioner employed in the same clinical practice setting, as that of the supervising physician and athletic trainer, may designate as a delegate the athletic trainer.

Consistent with the amended definition of "certified medical assistant," which conforms to the statutory amendments and changes to the State Board of Medical Examiners rule at N.J.A.C. 13:35-6.4, the Division proposes to amend N.J.A.C. 13:45A-35.8(d) to change from 600 to 330, [page=2139] the number of clock hours of instruction that the certified medical assistant must complete.

P.L. 2017, c. 341 modifies the mandatory prescriber look-up requirements to: expand it to include the first time a prescriber prescribes any opioid, not solely those that are a Schedule II CDS, for acute or chronic pain or a benzodiazepine drug that is a Schedule III or Schedule IV CDS, or the first time the practitioner or other person prescribes a non-opioid drug if the practitioner has a reasonable belief that the person may be seeking a CDS, in whole or in part, for any purpose other than the treatment of an existing medical condition, such as for purposes of misuse, abuse, or diversion. In addition, the law amends the exemption for prescribers in the emergency department of a general hospital and mandates the mandatory look-up for prescribers in an emergency department who prescribe a Schedule II CDS for acute or chronic pain. In addition, the law expands the conditions for quarterly look-up requirements to include when a patient continues to receive a prescription for any opioid drug for acute or chronic pain, or for a benzodiazepine that is a Schedule III or Schedule IV controlled dangerous substance. In accordance with these statutory changes, the Division proposes to amend N.J.A.C. 13:45A-35.9.

In accordance with P.L. 2017, c. 341, the Division proposes to delete N.J.A.C. 13:45A-35.9(c)5, which set forth an exemption from the mandatory look-up requirements for a practitioner prescribing a CDS in the emergency department of a general hospital, provided that the quantity prescribed did not exceed a five-day supply of the substance. Accordingly, emergency room practitioners must now comply with the mandatory look-up requirements for a patient's prescription monitoring information. In addition, the Division proposes to amend paragraph (c)11, which currently provides for an exemption from the mandatory look-up requirements for a practitioner prescribing less than a 30-day supply of a CDS to a patient immediately, but no more than 24 hours, after the patient has undergone an operation, procedure, or treatment for acute trauma, for which a CDS is recognized in the customary treatment of pain following such operation, procedure, or acute trauma. Consistent with the statutory changes, the Division proposes to amend this provision to limit to a five-day supply of a CDS that is provided immediately to a patient, after the patient has undergone an operation or treatment for acute trauma in a general hospital or a licensed ambulatory care facility. The operation or treatment may not be part of the care or treatment in an emergency department of a hospital. In addition, the proposed changes eliminate the exemption from mandatory look-up when the CDS is prescribed to a patient immediately after the patient has an undergone a procedure that is not an operation. Prescription monitoring information provides practitioners with information to make informed treatment care decisions for their patients. As such, the Legislature determined to limit the circumstances under which practitioners are exempt from the mandatory look-up requirements.
The Division proposes to amend the professional misconduct provisions at N.J.A.C. 13:45A-35.11 to include a licensed athletic trainer and medical scribe.

Pursuant to N.J.S.A. 45:1-46(o), the Division is proposing new N.J.A.C. 13:45A-35.12 to establish a process for patients to request to correct inaccurate information in the PMP. A patient, or the parent or legal guardian of an unemancipated minor who is a patient, may request a pharmacy permit holder that submitted the prescription monitoring information concerning a prescription for CDS that the patient believes was inaccurately entered into his or her pharmacy prescription profile and uploaded to the PMP. Such a request must be submitted in writing and be submitted in accordance with the pharmacy permit holder's procedures for processing. Subsection (b) sets forth the requirement for a pharmacy permit holder to establish written policies and procedures for processing, evaluating, reviewing, and handling patient requests to correct the prescription monitoring information. At a minimum, the policies and procedures must include a statement explaining in detail the basis for the requested correction; the precise change requested; documentation of the error and of the correct information; and the requester's name, address, telephone number, and original signature. Subsection (c) sets forth the timeframes for the pharmacy permit holder to review the request, verify whether the information is incorrect, and to notify the patient when the information is corrected or when a correction is deemed not appropriate or justified. A patient may request that the Board of Pharmacy review the disputed request for correction.
The Division has provided a 60-day comment period for this notice of proposal. Therefore, this notice is excepted from the rulemaking calendar requirement pursuant to N.J.A.C. 1:30-3.3(a)5.

Social Impact

The Division believes that the proposed amendments and new rules will have a positive impact on the consumers of New Jersey by helping to combat prescription drug abuse and diversion. In addition, expanding the category of eligible delegates who can look up the prescription monitoring information on behalf of practitioners enables practitioners to spend more time with their patients and make treatment care decisions.

Economic Impact

The proposed amendments and new rules will not have an economic impact on consumers or prescribers. There are no costs associated with registering for online PMP access or obtaining prescription monitoring information.

Federal Standards Statement

A Federal standards analysis is not required because the proposed amendments and new rules are governed by N.J.S.A. 45:1-45 et seq. (P.L. 2007, c. 244, as amended by P.L. 2015, c. 74 and P.L. 2017, c. 341). However, in accordance with existing N.J.A.C. 13:45A-35.5(h), all persons authorized to access PMP prescription drug information, including licensed athletic trainers and medical scribes, must comply with the Federal Health Insurance Portability and Accountability Act of 1996, and the Federal health privacy rule set forth at 45 CFR Parts 160 and 164.

Jobs Impact
The Division believes that the proposed amendments that require prescribers in the emergency department of a general hospital to comply with the mandatory look-up requirements may result in the creation of jobs in the State. Hospitals may increase personnel authorized to access the prescription monitoring program database to assist prescribers with the look-up requirements.

Agriculture Industry Impact

The Division does not believe that the proposed amendments and new rules will have any impact on the agriculture industry of the State.

Regulatory Flexibility Analysis

Currently, the Division licenses approximately 67,490 individuals who dispense or are eligible to prescribe CDS including: 17,340 pharmacists, 30,730 physicians, 6,400 advanced practice nurses, 6,850 dentists, 2,450 physician assistants, 540 optometrists, 1,890 veterinarians, and 220 certified nurse midwives. In addition, the Division licenses approximately 2,240 pharmacies in New Jersey and registers approximately 1,120 out-of-State pharmacies. The Division also licenses or registers 161,748 health care professionals including: 120,448 registered nurses, 23,299 licensed practical nurses, 5,904 dental hygienists, 2,726 advanced practice nurses who do not have a CDS registration, and 1,000 physician assistants who do not have a CDS registration, who are eligible to be designated as delegates. The Division also registers approximately 3,932 medical residents, 205 dental residents, and 3,760 dental assistants who are eligible to be designated as delegates. The Division also licenses approximately 1,440 athletic trainers. The Division does not regulate medical scribes and does not know how many exist in the State who work in the emergency department of a hospital. If these pharmacies, practitioners, licensed health care professionals, licensed athletic trainers, registered dental assistants, and registered residents are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis applies. Although medical scribes are not licensed or certified by the Division and, therefore, are not required to be a part of this analysis, if they are considered "small businesses" within the meaning of the Regulatory Flexibility Act, N.J.S.A. 52:14B-16 et seq., then the following analysis would also apply.

The proposed amendments and new rules will impose recordkeeping and compliance requirements on licensed athletic trainers and medical scribes who work in the emergency department of a hospital. Those requirements are detailed in the Summary above. In addition, these medical scribes and licensed athletic trainers are subject to the existing [page=2140] PMP rules that impose reporting and compliance requirements. N.J.A.C. 13:45A-35.6(c) requires all persons authorized to have online access to PMP information who become aware or suspect that their login ID and password to the PMP were compromised or used without authorization to notify the Division and submit supporting documentation evidencing the unauthorized use. N.J.A.C. 13:45A-35.6(e) requires all persons granted access to PMP information to comply with all Federal and State laws, rules, and regulations concerning the confidentiality of patient information. In addition, all persons granted online access to the PMP are precluded from sharing their PMP login ID and password with any other person or entity.
In addition, the proposed amendments and new rules will impose new reporting and compliance requirements on licensed New Jersey pharmacies and registered out-of-State pharmacies. The proposed amendments and new rules also impose new compliance requirements on practitioners. Those requirements are detailed in the Summary above.

No additional professional services will be needed to comply with the proposed amendments and new rules. The costs to comply with the proposed amendments and new rules are discussed in the Economic Impact statement above.

Housing Affordability Impact Analysis

The proposed amendments and new rules will have an insignificant impact on the affordability of housing in New Jersey and there is an extreme unlikelihood that the rules would evoke a change in the average costs associated with housing because the proposed amendments and new rules concern access to the Division's Prescription Monitoring Program prescription drug information.

Smart Growth Development Impact Analysis

The proposed amendments and new rules will have an insignificant impact on smart growth development and there is an extreme unlikelihood that the rules would evoke a change in housing production in Planning Areas 1 or 2, or within designated centers, under the State Development and Redevelopment Plan in New Jersey because the proposed amendments and new rules concern access to the Division's Prescription Monitoring Program prescription drug information.

Racial and Ethnic Community Criminal Justice and Public Safety Impact

The Division has evaluated this rulemaking and determined that it will not have an impact on pretrial detention, sentencing, probation, or parole policies concerning adults and juveniles in the State. Accordingly, no further analysis is required.

Regulations

Full text of the proposal follows (additions indicated in boldface thus; deletions indicated in brackets [thus]):

SUBCHAPTER 35.  PRESCRIPTION MONITORING PROGRAM

13:45A-35.1    Purpose and scope

(a) The rules in this subchapter implement the provisions of P.L. 2007, c. 244, as amended by P.L. 2015, c. 74 and P.L. 2017, c. 341 (N.J.S.A. 45:1-44 through 51), establishing a Prescription Monitoring Program (PMP) in the Division of Consumer Affairs.

(b) The rules in this subchapter shall apply to the following:

1.-9. (No change.)

10. A registered dental assistant authorized by a licensed dentist to access the prescription monitoring information, subject to the limitations and requirements of this subchapter; [and]

11. A licensed mental health practitioner providing treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by the Department of Health, subject to the limitations and requirements of this subchapter[.];

12. A licensed athletic trainer authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter; and

13. A medical scribe authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter.

(c)-(d) (No change.)
13:45A-35.2    Definitions

The following words and terms, when used in this subchapter, shall have the following meanings unless the context clearly indicates otherwise:

…
"Certified medical assistant" means a person who is a graduate of a post-secondary medical assisting educational program accredited by the [American Medical Association's Committee] Commission on Allied Health Education and Accreditation (CAHEA), or its successor, the Accrediting Bureau of Health Education Schools (ABHES), or its successor, or any accrediting agency recognized by the U.S. Department of Education, which educational program includes, at a minimum, [600] 330 clock-hours of instruction, and encompasses training in the administration of intramuscular and subcutaneous injections, as well as instruction and demonstration in: pertinent anatomy and physiology appropriate to injection procedures; choice of equipment; proper technique, including sterile technique; hazards and complications; and emergency procedures; and who maintains current certification or registration, as appropriate, from the Certifying Board of the American Association of Medical Assistants (AAMA), the National Center for Competency Testing (NCCT), the National Healthcareer Association (NHA), the American Medical Certification Association (AMCA), the National Certification Medical Association (NCMA), the American Medical Technologists (AMT), or any other recognized certifying body approved by the Board of Medical Examiners. A "clock-hour" shall be calculated at the rate of one hour for every 50 minutes of in-class participation.

"Chronic pain" means pain that persists [for three or more consecutive months and after reasonable medical efforts have been made to relieve the pain or its cause and that continues, either continuously or episodically] or recurs for more than three months.

…

"Licensed athletic trainer" means an individual who is licensed by the State Board of Medical Examiners to practice athletic training, pursuant to the Athletic Training Licensure Act, P.L. 1984, c. 203 (N.J.S.A. 45:9-37.35 et seq.).

…

"Medical scribe" means an individual trained in medical documentation who assists a physician or other licensed health care professional by documenting the patient's encounter with the professional in the patient's medical record and gathering data for the professional, including, but not limited to, nursing notes, patient medical records, laboratory work, and radiology tests.

…

13:45A-35.3    Pharmacy reporting requirements; electronic format

(a) A pharmacy filling a prescription for a Schedule II, III, IV, or V controlled dangerous substance, for human growth hormone, as defined in N.J.A.C. 13:45A-35.1, or for gabapentin, in an outpatient setting, shall collect and electronically transmit to the Division's PMP vendor on a daily basis information for each prescription, as specified in the New Jersey PMP Data Collection Manual.

1. For purposes of this section, in accordance with N.J.S.A. 45:1-45 and as specified in the Data Collection Manual, the following information shall be collected and transmitted to the Division:

i.-viii. (No change.)
ix. The source of payment for the drug dispensed; [and]

x.Identifying information for any individual, other than the patient for whom the prescription was written, who picks up the prescription, if the pharmacist has a reasonable belief that the person picking up the prescription may be seeking a controlled dangerous substance, in whole or in part, for any reason other than delivering the substance to the patient for the treatment of an existing medical condition.

(1) For purposes of this subparagraph, "identifying information" includes the individual's first and last name, relationship to the patient, and, if available, the type of, and identification number on, a state or Federal government identification; and

[x.] xi. (No change in text.)

2. (No change.)

[page=2141] 13:45A-35.6    Access to prescription monitoring information; retention of information
(a)-(c) (No change.)
(d) All persons authorized to have online access to PMP information shall, in accordance with (a) above, prior to each look-up certify to the purpose for which the requested information will be used. [The] Except as provided in (d)1 below, certification shall be completed online in the PMP system.

1.If the PMP information is being accessed using an electronic system authorized pursuant to N.J.A.C. 13:45A-35.6A(a), the certification may be furnished through the electronic system.

(e)-(j) (No change.)

13:45A-35.6A   Access to prescription monitoring information: electronic health record system

(a) The Division may make prescription monitoring information available on electronic systems that collect and display health information, such as an electronic system that connects hospital emergency departments for the purpose of transmitting and obtaining patient health data from multiple sources, or an electronic system that notifies practitioners of information pertaining to the treatment of overdoses, provided that the Division determines that any such electronic system has appropriate security protections in place.

(b) Practitioners who are required to access prescription monitoring information pursuant to N.J.A.C. 13:45A-35.9, may discharge that responsibility by accessing one or more authorized electronic systems into which the prescription monitoring information maintained by the Division has been integrated.
13:45A-35.7    Registration

(a) (No change.)

(b) [The Division] A practitioner shall register [a practitioner] to have online access to PMP information upon [issuance] initial application for, or renewal of, the practitioner's CDS registration.
1. (No change.)
13:45A-35.8    Delegates
(a)-(b) (No change.)
(c) Delegates may be designated as follows:
1.-4. (No change.)

5.A practitioner practicing in a hospital's emergency department may designate as a delegate, a medical scribe who is working in a hospital's emergency department.

i. An individual who is no longer employed at the hospital's emergency department at which the practitioner practices is no longer authorized to be a delegate or to access the PMP on behalf of that practitioner.

ii. For purposes of (c)5 above, the medical director of a hospital's emergency department may designate medical scribes working in the emergency department as delegatesfor a practitioner practicing in a hospital's emergency department. In such cases, the medical director shall be responsible for compliance with (d) and (e) below.

6. A practitioner may designate as a delegate, an athletic trainer who is employed at a clinical practice setting. For purposes of this paragraph, "clinical practice setting" shall mean the setting at which the supervising physician practices.

i. An individual who is no longer employed at the clinical practice setting at which the practitioner practices is no longer authorized to be a delegate or to access the PMP on behalf of that practitioner.

(d) Prior to designating a delegate, a practitioner or an authorized faculty member of a medical or dental teaching facility shall confirm the education, training, and licensure or certification requirements of each delegate.

1. (No change.)

2. Prior to designating a certified medical assistant as a delegate, a practitioner shall confirm that that the certified medical assistant has completed a minimum of [600] 330 clock-hours of instruction, and which encompasses training in the administration of intramuscular and subcutaneous injections, as well as instruction and demonstration in: pertinent anatomy and physiology appropriate to injection procedures; choice of equipment; proper technique, including sterile technique; hazards and complications; and emergency procedures.

(e)-(f) (No change.)

13:45A-35.9    Mandatory look-up

(a) Except as provided in (c) below, a practitioner or the practitioner's delegate shall access prescription monitoring information for a new or current patient consistent with the following:

1. The first time the practitioner prescribes a Schedule II controlled dangerous substance or any opioid to a new or current patient for acute or chronic pain;

i. When the practitioner or the practitioner's delegate accesses the prescription monitoring information for a new patient in advance of the scheduled appointment, the practitioner or delegate shall document the new patient's request for professional services; [and]

2.The first time the practitioner prescribes a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance;

3. If the practitioner has a reasonable belief that the person may be seeking a controlled dangerous substance, in whole or in part, for any purpose other than the treatment of an existing medical condition, such as for purposes of misuse, abuse, or diversion, the first time the practitioner or other person prescribes a non-opioid drug other than a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance;

4. Any time the practitioner prescribes a Schedule II controlled dangerous substance for acute or chronic pain to a patient receiving care or treatment in the emergency department of a general hospital;

[2.] 5. On a quarterly basis during the period of time a current patient continues to receive a prescription for a Schedule II controlled dangerous substance or for an opioid drug for acute or chronic pain, or for a benzodiazepine that is a Schedule III or Schedule IV controlled dangerous substance.

i. (No change.)
(b) Except as provided in (c) below, if the pharmacist has a reasonable belief that the person may be seeking a controlled dangerous substance, in whole or in part, for any purpose other than the treatment of an existing medical condition, such as for purposes of misuse, abuse, or diversion, a pharmacist shall not dispense a Schedule II controlled dangerous substance, any opioid, or a benzodiazepine drug that is a Schedule III or Schedule IV controlled dangerous substance to any person without first accessing the prescription monitoring information to determine if the person has received other prescriptions that indicate misuse, abuse, or diversion.

(c) The provisions of (a) and (b) above, as applicable, shall not apply to:

1.-4. (No change.)
5. [A practitioner prescribing a controlled dangerous substance in the emergency department of a general hospital, provided that the quantity prescribed does not exceed a five-day supply of the substance;] (Reserved)

6.-10. (No change.)
11. A practitioner who is prescribing [less than a 30-day] no more than a five-day supply of a controlled dangerous substance to a patient immediately, but no more than 24 hours, after the patient has undergone an operation[, procedure,] or treatment for acute trauma, [for which a controlled dangerous substance is recognized in the customary treatment of pain following such operation, procedure, or acute trauma] in a general hospital or a licensed ambulatory care facility, so long as that operation or treatment was not part of the care or treatment in the emergency department of a general hospital as provided in (a) above.

[i. For purposes of this paragraph, "procedure" means an invasive procedure that requires anesthesia.]
(d) (No change.)

13:45A-35.11             Professional misconduct

(a) Noncompliance with the rules in this subchapter may be deemed professional misconduct and may subject the pharmacy permit holder, an out-of-State pharmacy that is subject to this subchapter, pharmacist, practitioner, licensed health care professional, registered dental assistant, [or] mental health practitioner, or licensed athletic trainer to disciplinary [page=2142] action pursuant to the provisions of N.J.S.A. 45:1-21 and to the penalties set forth in N.J.S.A. 45:1-49.
(b)-(c) (No change.)

(d) Noncompliance with the rules in this subchapter may provide a basis for the withdrawal of the authorization to a certified medical assistant or medical scribe to access the PMP. Upon receipt of the notice of proposed withdrawal, the certified medical assistant or medical scribe shall have an opportunity to provide a written explanation for the noncompliance.
(e)-(g) (No change.)

13:45A-35.12    Patient requests to correct inaccurate information

(a) A patient, or the parent or legal guardian of an unemancipated minor who is a patient, may request a pharmacy permit holder that submitted prescription monitoring information concerning a prescription for controlled dangerous substances for that patient or unemancipated minor to correct information that the person believes to have been inaccurately entered into that patient's or unemancipated child's prescription profile. The request shall be in writing using the process established by the pharmacy permit holder.

(b) A pharmacy permit holder shall have written policies and procedures for processing, evaluating, reviewing, and handling patient requests to correct information submitted to the prescription monitoring program. The policies and procedures shall include, at a minimum:

1. A statement explaining in detail the basis for the requested correction;

2. The precise change requested;

3. Documentation of the error and of the correct information; and

4. The requester's name, address, telephone number, and original signature.

(c) Upon receiving notice from a patient, or the parent or legal guardian of an unemancipated minor who is a patient, that the prescription monitoring data specific to that patient's prescription history is incorrect, the pharmacy permit holder shall:

1. Verify that the information is incorrect and, if so, correct the information in both the patient profile and the PMP within 14 days of the patient notification.

i. The pharmacy permit holder shall notify the patient when the information has been corrected in the PMP.

2. If the pharmacy permit holder determines that a correction is not appropriate or justified, within 14 days of the patient request, the pharmacy permit holder shall notify the patient, and advise the patient of the process for requesting the Board of Pharmacy to review the disputed request for correction.