​​​50 N.J.R. 934(a)

VOLUME 50, ISSUE 5, MARCH 5, 2018
RULE PROPOSALS

Reporter
50 N.J.R. 934(a)
NJ - New Jersey Register  >  2018  >  MARCH  >  MARCH 5, 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, 35.6, 35.10, and 35.11
Text

Prescription Monitoring Program

Purpose and Scope; Definitions; Access to Prescription Monitoring Information; Retention of Information; Recordkeeping; Professional Misconduct

Authorized By: Sharon M. Joyce, 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).
Calendar Reference: See Summary below for explanation of exception to calendar requirement.
Proposal Number: PRN 2018-026.

Submit written comments by May 4, 2018, to:

    Sharon M. Joyce, 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 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). 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.

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 are necessary. In accordance with N.J.S.A. 45:1-46.i(9), the proposed amendments expand access to the electronic database to include licensed mental health practitioners (State licensed clinical social workers, marriage and family therapists, clinical alcohol and drug counselors, professional counselors, psychologists, or psychoanalysts) who provide treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by the Department of Health. The proposed amendments also establish the standards for access to the prescription monitoring information by licensed mental health practitioners. In addition, the proposed amendments set forth the provisions for the Director to review the prescription monitoring information to identify and report to practitioners and pharmacies about suspected misuse, abuse, or diversion of a controlled dangerous substance.

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 mental health practitioner providing treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by Division of Mental Health and Addiction Services (DMHAS) in the Department of Health. N.J.S.A. 45:1-46.i(9) specifies that DMHAS is in the Department of Human Services. The proposed amendments, however, reflect that DMHAS is now located within the Department of Health pursuant to the Governor's Reorganization Plan 001-2017. The Division also proposes to amend N.J.A.C. 13:45A-35.2 to include the statutory definition for "mental health practitioner," which means a State licensed clinical social worker, marriage and family therapist, clinical alcohol and drug counselor, professional counselor, psychologist, or psychoanalyst.

N.J.A.C. 13:45A-35.6 sets forth the list of persons who have access to prescription monitoring information submitted to the PMP, the certification requirements for these individuals, and other obligations for those accessing the database. The Division proposes new N.J.A.C. 13:45A-35.6(a)9 to include 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. The licensed mental health practitioner is required to certify that the request is for the purpose of providing health care to a current patient at a residential or outpatient substance abuse treatment center licensed by the Department of Health, or verifying information with respect to a patient or practitioner. In addition, in accordance with N.J.S.A. 45:1-46.i(9), the practitioner must obtain and provide the Division with the written consent of the patient for the mental health practitioner to obtain prescription monitoring information about the patient. The patient consent shall be valid for the period of treatment at the Department of Health-licensed treatment center, not to exceed one year. If the period of treatment continues for more than one year, the mental health practitioner shall re-obtain, and re-submit to the Division, the written consent of the patient. The Division proposes to recodify existing paragraph (a)9 as 10. The Division also proposes to amend subsection (g) to include mental health practitioners as individuals to whom the Division may disseminate unsolicited reports.

Proposed new N.J.A.C. 13:45A-35.6(i) provides for the Director to review the prescription monitoring information to identify and report to practitioners and pharmacies about suspected misuse, abuse, or diversion of a controlled dangerous substance. The proposed regulation specifies reporting to pharmacies, not pharmacists as provided for in the statute, because the PMP does not capture information about the individual dispensing pharmacist. In addition, the Division believes that, from a practical perspective, because a pharmacy may employ more than one pharmacist, it is necessary for the pharmacy to receive the reports. Proposed new subsection (i) also provides that, if the Division determines that a violation of law or regulation or breach of the applicable standards of practice by any person may have occurred, including, but not limited to, diversion of a controlled dangerous substance, the Division will notify the appropriate law enforcement agency or professional licensing board, and provide the prescription monitoring information required for an investigation.

Proposed new N.J.A.C. 13:45A-35.10(d) requires licensed mental health practitioners to retain in the patient record a copy of the patient consent to obtain prescription monitoring information about the patient and any PMP information accessed for the patient.

The Division also proposes to amend N.J.A.C. 13:45A-35.11(a) to include mental health practitioners. This subsection provides that noncompliance with the rules at N.J.A.C. 13:45A may be deemed professional misconduct and subject the mental health practitioner to disciplinary action and penalties.
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 will have a positive impact on the consumers of New Jersey by helping to combat prescription drug abuse and diversion. In addition, the Division believes that the proposed amendments will have a positive impact on licensed mental health practitioners who provide treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by DMHAS by providing them with access to the electronic database to obtain prescription monitoring information for the patients they are treating for substance abuse and by establishing the requirements and obligations with respect to information access.

[page=935] Economic Impact

The proposed amendments will not have an economic impact on consumers or licensed mental health practitioners who provide treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by the Department of Health. 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 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). 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 mental health practitioners, 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 does not believe that the proposed amendments will result in the creation or the loss of jobs in the State.

Agriculture Industry Impact

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

​Regulatory Flexibility Analysis

​Currently, the Division licenses 20,266 mental health care practitioners including: 2,105 clinical alcohol and drug counselors, 9,874 clinical social workers, 561 marriage and family therapists, 4,068 professional counselors, 30 psychoanalysts, and 3,628 psychologists. If these licensed mental health practitioners 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.

The proposed amendments will impose recordkeeping and compliance requirements on licensed New Jersey mental health practitioners who provide treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by the Department of Health. Those requirements are detailed in the Summary above. In addition, these mental health practitioners are subject to the existing 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.

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

To help combat prescription drug abuse and diversion, the Division also believes that the proposed amendments must be uniformly applied to all licensed mental health practitioners who provide treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by the Department of Health. Therefore, there are no differing compliance requirements for any licensee based upon the size of the business.

Housing Affordability Impact Analysis

The proposed amendments 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 concern access to the Division's Prescription Monitoring Program prescription drug information.

Smart Growth Development Impact Analysis

The proposed amendments 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 concern access to the Division's Prescription Monitoring Program prescription drug information.

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) (No change.)

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

1.-8. (No change.)

9. A certified medical assistant authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter; [and]

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.

(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:
. . .

"Mental health practitioner" means a clinical social worker, marriage and family therapist, clinical alcohol and drug counselor, professional counselor, psychologist, or psychoanalyst licensed or otherwise authorized to practice pursuant to Title 45 of the Revised Statutes.
. . .

13:45A-35.6 Access to prescription monitoring information; retention of information

(a) The Division shall provide online access to prescription monitoring information submitted to the PMP to the following:

1.-7. (No change.)

8. The State Medical Examiner, a county medical examiner, a deputy or assistant county medical examiner, or a qualified designated assistant thereof, who certifies that the request is for the purpose of investigating a death pursuant to P.L. 1967, c. 234 (N.J.S.A. 52:17B-78 et seq.); [and]

9.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 Healthprovided that the licensed mental health practitioner:

i. Certifies that the request is for the purpose of providing health care to a current patient at a residential or outpatient substance abuse treatment center licensed by the Department of Health, or verifying information with respect to a patient or practitioner; and

ii. Provides the Division with the written consent of the patient for the mental health practitioner to obtain prescription monitoring information about the patient.

(1) Patient consent shall be valid for the period of treatment by the mental health practitioner at the residential or outpatient substance abuse treatment center or for one year, whichever is less. After one year, the mental health practitioner shall re-obtain, and re-submit to the Division, the written consent of the patient; and

[9.] 10. Authorized personnel, as determined by the Director of the Division, responsible for administration of the provisions of P.L. 1970, c. 226 (N.J.S.A. 24:21-1 et seq.)[;].

(b)-(f) (No change.)

(g) Notwithstanding the provisions of this subchapter, the Division may obtain unsolicited automated reports from the PMP or disseminate such reports to pharmacists, practitioners, mental health practitioners, and other licensed health care professionals.

[page=936] (h) (No change.)

(i)The Division shall review the prescription monitoring information provided by a pharmacy permit holder pursuant to N.J.S.A. 45:1-45 et seq., and the rules of this subchapter. The review shall include, but not be limited to, a review to identify whether:

1. Any person is obtaining a prescription in a manner that may be indicative of misuse, abuse, or diversion of a controlled dangerous substance. When an evaluation of the information indicates that a person may be obtaining a prescription for the same or a similar controlled dangerous substance from multiple practitioners or pharmacies during the same period, the Division may provide prescription monitoring information about the person to practitioners and pharmacies; and

2. A violation of law or regulation or breach of the applicable standards of practice by any person may have occurred, including, but not limited to, diversion of a controlled dangerous substance. If the Division determines that such a violation or breach may have occurred, the Division shall notify the appropriate law enforcement agency or professional licensing board, and provide the prescription monitoring information required for an investigation.

[(i)] (j) (No change in text.)

​​13:45A-35.10  Recordkeeping

(a)-(c) (No change.)

(d)Each mental health practitioner shall retain in the patient record a copy of the patient consent, and any PMP information accessed for the patient.

[(d)] (e) (No change in text.)

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, [or] registered dental assistant, or mental health practitioner to disciplinary 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)-(g) (No change.)