N.J. Admin. Code § 13:45A-35.6

Current through Register Vol. 56, No. 21, November 4, 2024

Section 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. A pharmacist who is employed by a current pharmacy permit holder and is authorized to dispense controlled dangerous substances, human growth hormone, or gabapentin who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient, or verifying information with respect to a prescriber;

2. A practitioner who has a current CDS registration and is authorized to prescribe, dispense, or administer controlled dangerous substances, human growth hormone, or gabapentin who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient of the practitioner, or verifying information with respect to a prescriber;

3. A delegate authorized by a practitioner to access the PMP information for the purpose of providing health care to a new or current patient of the delegating practitioner who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient of the delegating practitioner, or verifying information with respect to a prescriber, consistent with the requirements of this subchapter;

4. A current medical resident of a medical teaching facility who is authorized to access PMP information and who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient at the medical teaching facility for whom the residency program has responsibility of care, or verifying information with respect to a prescriber, consistent with the requirements of this subchapter;

5. A current dental resident of a dental teaching facility who is authorized to access PMP information and who certifies that the request is for the purpose of providing health care to or verifying information with respect to a new or current patient at the medical teaching facility for whom the residency program has responsibility of care, or verifying information with respect to a prescriber, consistent with the requirements of this subchapter;

6. A designated representative of the State Board of Medical Examiners, New Jersey State Board of Dentistry, New Jersey Board of Nursing, New Jersey State Board of Optometrists, New Jersey State Board of Pharmacy, State Board of Veterinary Medical Examiners, or any other board in this State or another state that regulates the practice of persons who are authorized to prescribe or dispense controlled dangerous substances, human growth hormone, or gabapentin, as applicable, who certifies that he or she is engaged in a bona fide specific investigation of a designated practitioner whose professional practice was or is regulated by that board;

7. A designated representative of a state Medicaid or other government program who certifies that he or she is engaged in a bona fide investigation of a designated practitioner, pharmacist, or patient;

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-78et seq.);

9. Effective after 30 days public notice in the New Jersey Register, 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 provided 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.

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 etseq.).

(b) The Division may provide prescription monitoring information submitted to the PMP to the following, consistent with the purpose certified to by the requester under the requirements of (c) below:

1. A properly convened grand jury pursuant to a subpoena properly issued for the records;

2. Authorized personnel, as determined by the Director of the Division or the PMP vendor responsible for establishing and maintaining the PMP;

3. A State, Federal, or municipal law enforcement officer who is acting pursuant to a court order and certifies that the officer is engaged in a bona fide specific investigation of a designated practitioner, pharmacist, or patient; and

4. A prescription monitoring program in another state with which the Division has established an interoperability agreement, or which participates with the Division in a system that facilitates the secure sharing of information between states.

(c) All persons authorized to have online access to PMP information shall, in accordance with N.J.A.C. 13:45A-35.7, register with the Division and shall receive a login ID and password. Such persons shall complete all forms and statements required by the Division.

1. 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 shall, within five business days of discovering the unauthorized access, notify the Division through the PMP and submit supporting documentation evidencing the unauthorized use.

(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. 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) All persons granted access to PMP information, either through online access or by request, shall comply with all Federal and State laws, rules, and regulations concerning the confidentiality of patient information, including the Federal Health Insurance Portability and Accountability Act of 1996, specifically the Federal health privacy rule set forth at 45 CFR Parts 160 and 164.

1. A delegate shall share PMP information with only his or her delegating practitioner.

2. A person granted access to PMP information pursuant to N.J.A.C. 13:45A-35.6(a)6, 7, 8, or 9 may, in the performance of his or her professional duties, share information with personnel from his or her agency in accordance with agency policy and procedures.

3. In accordance with N.J.A.C. 13:45A-35.8(f), all persons granted online access to the PMP shall not share their PMP login ID and password with any other person or entity.

(f) The Division may provide non-identifying PMP information to public or private entities for statistical, research, or educational purposes, provided that the confidentiality of patient information is not compromised.

(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.

(h) The Division shall maintain PMP information in such a manner as to ensure the privacy and confidentiality of patient information in compliance with all Federal and State laws, rules, and regulations, including 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. The Division shall retain PMP information for a minimum of seven years.

1. For purposes of retention in this subsection, "PMP information" shall not include data obtained from other states via an interoperability agreement.

(i) The Division shall review the prescription monitoring information provided by a pharmacy permit holder pursuant to N.J.S.A. 45:1-45et 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.

(j) Pursuant to 45:1-46, the prescription monitoring information submitted to the Division shall be confidential and not be subject to public disclosure under the State Open Public Records Act, P.L. 1963, c. 73 (47:1A-1 et seq.) or P.L. 2001, c. 404 (47:1A-5 et seq.).

N.J. Admin. Code § 13:45A-35.6

Adopted by 48 N.J.R. 2374(a), effective 11/7/2016

Amended by 50 N.J.R. 1219(a), effective 5/7/2018

Amended by 50 N.J.R. 1500(a), effective 7/2/2018

Amended by 50 N.J.R. 1534(a), effective 7/16/2018

Amended by 51 N.J.R. 624(a), effective 5/6/2019