VOLUME 47, ISSUE 22
November 16, 2015 Rule Proposals
Law and Public Safety
Division of Consumer Affairs Office of the Director
Proposed New Rules: N.J.A.C. 13:45A-35
Prescription Monitoring Program
Authorized By: Steve C. Lee, 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 2015-150.
Submit comments by: January 15, 2016, to:
Steve C. Lee, Acting Director
New Jersey Division of Consumer Affairs
124 Halsey Street
PO Box 45027
Newark, New Jersey 07101
The agency proposal follows:
Summary
The Division of Consumer Affairs (the Division) is proposing new 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, which became operational in September 2011, 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 proposed PMP rules establish standards for the transmittal of prescription information by pharmacies to the Division, for the Division's collection and maintenance of such information, for access to such information by authorized users, including delegates, and the requirements for practitioners to consult the PMP, under specific limited circumstances.
The PMP is an electronic database for collecting, tracking, and monitoring information about controlled dangerous substances (CDS) that are dispensed in New Jersey by licensed pharmacists in outpatient settings, and by out-of-State pharmacies dispensing into New Jersey. The law requires pharmacists and healthcare practitioners who have a current State CDS registration to register for PMP access. The law also authorizes healthcare practitioners to designate certain individuals to act as delegates on their behalf to access prescription monitoring information about the practitioners' patients.
The purpose and scope of the new rules is set forth in proposed new N.J.A.C. 13:45A-35.1. The proposed reporting requirements do not apply to, and, therefore, do not require pharmacies to transmit information about, prescriptions filled for inpatients at hospitals, long-term care facilities, or other facilities in which patients are provided with 24-hour nursing care. In addition, the reporting requirements do not apply to the direct administration of a CDS or human growth hormone to the body of an ultimate user.
Proposed new N.J.A.C. 13:45A-35.2 sets forth the definitions for the subchapter. The following terms are defined: "abuse," "acute pain," "acute trauma," "CDS registration," "certified medical assistant," "chronic pain," "controlled dangerous substance," "current patient," "Data Collection Manual," "delegate," "dental resident," "Director," "Division," "diversion," "emergency department of a general hospital," "hospice," "licensed health care professional," "medical resident," "misuse," "new patient," "pharmacy permit holder," "practitioner," and "registered dental assistant."
For purposes of obtaining PMP access as a delegate a "certified medical assistant" (CMA), as defined by statute, must have graduated from a post-secondary medical assisting educational program accredited by the American Medical Association's Committee on Allied Health Education and Accreditation (CAHEA), the Accrediting Bureau of Health Education Schools (ABHES), or any accrediting agency recognized by the U.S. Department of Education. The educational program must include at least 600 clock-hours of instruction and the program must encompass 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. The CMA must also maintain 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 American 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.
[page=2737] A licensed health care professional is defined as a registered nurse, licensed practical nurse, or licensed dental hygienist. To provide clarity to the rules, the proposed definition also specifies when an advanced practice nurse or a physician assistant would be considered a licensed health care professional. An advanced practice nurse or a physician assistant who accesses the PMP as a delegate, instead of as a practitioner, is deemed a licensed health care professional. Each one is also defined as a practitioner because an advanced practice nurse or a physician assistant is authorized to prescribe drugs in the course of his or her professional practice. Should an individual advanced practice nurse or physician assistant's authority to prescribe drugs be restricted, each would remain eligible to be designated as a delegate for purposes of accessing the PMP.
For purposes of the PMP rules and delegate access, the definition of medical resident specifically excludes a licensed physician participating in a graduate medical education program because he or she can directly access the PMP as a practitioner.
Proposed new N.J.A.C. 13:45A-35.3 requires pharmacies to collect and electronically transmit, on a daily basis, to the Division's PMP vendor certain information about prescriptions the pharmacy fills for Schedule II, III, IV, or V CDS in an outpatient setting. A pharmacy located outside of New Jersey, but registered as an out-of-State pharmacy with the Board of Pharmacy under N.J.A.C. 13:39-4.20, must also transmit information about prescriptions the pharmacy fills for Schedule II, III, IV, or V CDS in an outpatient setting that are shipped, mailed, distributed, or delivered into New Jersey. In addition to information about CDS prescriptions, the proposed new rule requires New Jersey licensed pharmacies and registered out-of-State pharmacies to electronically transmit information to the Division about prescriptions filled for human growth hormone. Human growth hormone is defined in the proposed new rules as somatrem, somatropin, or any analogue of the two, consistent with the Federal Food and Drug Administration's definition of the term under the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 333.
The electronic transmission of prescription information to the Division's PMP vendor must be consistent with program specifications as outlined in the New Jersey Prescription Monitoring Program Data Collection Manual, which the Division is proposing to incorporate by reference in the new rules. The Data Collection Manual, which is available on the Division's website, requires information to be reported in the American Society for Automation in Pharmacy (ASAP) 4.2 format, consistent with the data transmission requirements imposed on pharmacies by prescription monitoring programs in other states. In accordance with N.J.S.A. 45:1-45, the reporting pharmacies must collect and transmit information about the patient, the drug dispensed, the prescribing practitioner, the dispensing pharmacy, the source of payment for the drug dispensed, and such other information as the Director determines necessary and that is set forth in the Data Collection Manual.
Proposed new N.J.A.C. 13:45A-35.4 requires a pharmacy that does not dispense Schedule II, III, IV, or V CDS or human growth hormone, or that dispenses the drugs only to inpatients in a hospital, long-term, or other facility in which the residents are provided with 24-hour nursing care, to apply to the Division for an exemption from the PMP reporting requirements. In addition, the rule requires a pharmacy to apply for a waiver of the PMP electronic reporting requirements upon a showing of technological limitations, financial hardship, or other good cause. Exemption and waiver application forms are available on the Division's website. An application for exemption or waiver will be valid until June 30 of the following year, and will become void if the conditions that necessitated the exemption or waiver are corrected or no longer exist. If that occurs, the pharmacy must notify the Division. If the conditions persist, a pharmacy must apply for a renewal of the exemption or waiver by June 30 of each year as part of its pharmacy permit or out-of-State pharmacy registration annual renewal application.
Proposed new N.J.A.C. 13:45A-35.5 requires pharmacies to transmit prescription information to the Division's PMP vendor on a daily basis pursuant to the schedule established in the Data Collection Manual. The information must be transmitted in a manner that ensures the confidentiality of patient information, consistent with all State and Federal laws, rules, and regulations, including the Federal Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Federal health privacy rule, set forth at 45 CFR Parts 160 and 164.
Consistent with the requirements of N.J.S.A. 45:1-46, proposed new N.J.A.C. 13:45A-35.6(a) sets forth the list of persons to whom the Division will provide online access to the prescription information submitted to the PMP. Subsection (b) sets forth the list of persons to whom, upon request, the Division may provide prescription information submitted to the PMP.
All persons who are authorized to have online access to PMP information must certify to the purpose for which the requested information will be used. Specifically, proposed new N.J.A.C. 13:45A-35.6(a) provides that prescribing practitioners and pharmacists must certify 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. Delegates must certify that the request is for 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. Medical residents and dental residents of a medical or dental teaching facility must certify that the request is for providing health care to or verifying information with respect to a new or current patient at the medical or dental teaching facility, as applicable, for whom the residency program has responsibility of care, or verifying information with respect to a prescriber. Designated representatives from State prescribing boards (that is, the Board of Medical Examiners, the New Jersey State Board of Dentistry, the New Jersey Board of Nursing, the New Jersey State Board of Optometrists, the New Jersey Board of Pharmacy, and the State Board of Veterinary Medical Examiners) must certify that they are engaged in a bona fide specific investigation of a licensee of that board. A designated representative of a state Medicaid or other government program must certify that the information is sought in connection with a bona fide investigation of a designated practitioner, pharmacist, or patient. The State Medical Examiner, a county medical examiner, a deputy or assistant county medical examiner, or a qualified designated assistant of such medical examiner must certify that the request is for the purpose of investigating a death pursuant to N.J.S.A. 52:17B-78 et seq. The Division will also grant online access to authorized personnel, as determined by the Director, of the Division's Drug Control Unit.
Proposed new N.J.A.C. 13:45A-35.6(b) provides that the Division may provide access to prescription information, as opposed to online access to the system, to a properly convened grand jury pursuant to a properly issued subpoena for the records, to authorized personnel of the Division or to the PMP vendor responsible for establishing and maintaining the PMP, and to prescription monitoring programs in other states 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. In addition, the Division may provide access to prescription monitoring information to a State, Federal, or municipal law enforcement officer acting pursuant to a court order and who certifies that the officer is engaged in a bona fide specific investigation of a designated practitioner, pharmacist, or patient.
Proposed new N.J.A.C. 13:45A-35.6(c) requires all persons who are authorized to have online access to PMP information to register with the Division in accordance with proposed new N.J.A.C. 13:45A-35.7, which includes completing all required forms and statements. All persons authorized to have online access to PMP information have an obligation to notify the Division within five business days of discovering that their PMP access ID and password were compromised or used without authorization. Subsection (d) sets forth the requirement that all persons who are authorized to have online access must certify to the purpose for which the requested information will be used. The rule also provides that, prior to each look-up, the certification will be completed online in the PMP.
In addition, proposed new N.J.A.C. 13:45A-35.6(e) provides that all persons granted access to PMP information must comply with applicable State and Federal laws, rules, and regulations concerning confidentiality of patient information, including the Health Insurance Portability and Accountability Act of 1996 (HIPAA) and the Federal health privacy rule. The rule also provides that a delegate shall share PMP information with only his or her delegating practitioner. In addition, the rule provides that the designated representatives of the professional boards, Medicaid or other government program, medical examiner, or authorized personnel of [page=2738] the Division's Drug Control Unit may, as part of their professional duties, share prescription monitoring information with agency personnel. Proposed new N.J.A.C. 13:45A-35.10 provides that once the PMP information is documented in the patient's record, disclosure of such information is no longer governed by the PMP statute (N.J.S.A. 45:1-44 et seq.) but by applicable State and Federal laws, including HIPAA and the Federal health privacy rule.
Under proposed new N.J.A.C. 13:45A-35.6(f), the Division may also 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. Under proposed new N.J.A.C. 13:45A-35.6(g), the Division may obtain unsolicited automated reports from the PMP or disseminate such reports to pharmacists, practitioners, and other licensed health care professionals.
Proposed new N.J.A.C. 13:45A-35.6(h) requires the Division to maintain PMP information in a manner that ensures the privacy and confidentiality of patient information. In addition, the rule requires the Division to retain PMP information for a minimum of seven years. For record retention purposes, PMP information does not include information obtained from other states via an interoperability agreement. Pursuant to N.J.S.A. 45:1-46, and as set forth in proposed new N.J.A.C. 13:45A-35.6(i), the prescription monitoring information submitted to the Division is not subject to public disclosure under the State Open Public Records Act.
Proposed new N.J.A.C. 13:45A-35.7 sets forth the registration requirements for all persons authorized to have online access to PMP information. Such persons must provide the Division with a unique individual e-mail address, complete an online tutorial upon initial access to the PMP, as deemed necessary by the Division, and submit all documentation required by the Division to verify the person's identity and credentials. The required documentation will be listed on the State's Prescription Monitoring Program's website. For practitioners and delegates who are licensed or registered by one of the Division's professional or occupational licensing boards, the PMP vendor will be able to verify the person's identity and credentials through the Division's licensing database. As certified medical assistants are not licensed or registered by the Division, they must submit documentation to verify their identity and demonstrate that they have the required credentials to be designated a delegate. Only those certified medical assistants who have the statutorily required 600 clock-hours of instruction with the specified training in the administration of intramuscular and subcutaneous injections are authorized to be designated as a delegate for purposes of accessing the PMP and the prescription monitoring information. Under the new rule, upon issuance or renewal of a practitioner's CDS registration, the Division will register practitioners to have online access to PMP information. A practitioner may also register for online access outside of the applicable CDS issuance or renewal time period.
Proposed new N.J.A.C. 13:45A-35.8 sets forth the standards for designating delegates and the responsibilities of the delegates and the delegating practitioners. Subsection (a) provides that, consistent with the requirements of the subchapter, practitioners or a faculty member authorized by a medical or dental teaching facility may designate an unlimited number of delegates for the purpose of accessing PMP information. Irrespective of the number of delegates designated by a practitioner or an authorized faculty member of a medical or dental teaching facility, the rule provides that for each delegate, the delegating practitioner or faculty member is responsible for the use or misuse by the delegate of the PMP and the prescription monitoring information, ensuring compliance by the delegate with the recordkeeping requirements, conducting a bi-annual audit of each delegate's use, and verifying the education, training, licensure, or certification requirements for each delegate. In addition, the rule provides that the same delegate may be designated as a delegate by more than one practitioner.
Subsection (b) sets forth the requirement for the director of the medical or dental residency program to designate the faculty members who are authorized to designate medical or dental residents, as applicable, as delegates. The rule also requires the program director to comply with the subchapter's recordkeeping provisions.
Subsection (c) identifies the class of individuals who practitioners or authorized faculty members of medical or dental teaching facilities may designate as a delegate. Specifically, a practitioner may designate as a delegate a licensed health care professional or a certified medical assistant who is employed at the practice setting at which the practitioner practices. A licensed dentist is also able to designate as a delegate a registered dental assistant who is employed at the practice setting at which the licensed dentist practices dentistry. Authorized faculty members, as designated by the program director of a medical or dental residency program, may designate a medical or dental resident, as applicable. An individual who is terminated or withdraws from, or completes the graduate medical education program, is no longer authorized to be a delegate or to access the PMP. In addition, a medical resident whose program includes training outside the medical teaching facility shall not be designated as a delegate in that setting unless the delegating practitioner has been designated as an authorized faculty member and the residency program retains responsibility of care for the patient for whom healthcare is provided or information is requested.
Prior to designating an individual as a delegate, subsection (d) requires a practitioner or authorized faculty member of a medical or dental teaching facility to confirm the education, training, licensure, or certification requirements of each delegate. This includes ensuring that the delegate understands the limitations on disclosure of the prescription monitoring information and the Federal and State laws, rules, and regulations concerning the confidentiality of patient information, including HIPAA and the Federal health privacy rule. Prior to designating a certified medical assistant as a delegate, a practitioner must also confirm that the certified medical assistant has completed a minimum of 600 clock-hours of instruction, 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. In accordance with N.J.S.A. 45:1-44, only those who meet the requirements of the statutory definition of a "certified medical assistant" are eligible to be designated as a delegate for purpose of accessing the PMP and prescription monitoring information.
Subsection (e) sets forth that a practitioner or authorized faculty member of a medical or dental teaching facility who designates a delegate is responsible for the use or misuse by his or her delegate of the PMP and the prescription monitoring information. As part of this responsibility, the practitioner or authorized faculty member must terminate the delegate's access when, for any reason, the delegate is no longer authorized to be a delegate. Notification is required when a practitioner or authorized faculty member learns of any potential unauthorized use by a delegate of the PMP or prescription monitoring information. In addition, a practitioner or authorized faculty member must conduct, at least once every six months, an audit of the delegate's use of the PMP to monitor for potential misuse of the PMP or the prescription monitoring information. A practitioner or authorized faculty member must also ensure that the delegate follows the recordkeeping procedures established in accordance with proposed new N.J.A.C. 13:45A-35.10(a).
Subsection (f) provides that all persons authorized to have online access to PMP information shall not share access to the PMP with any other person or entity. Each authorized person is required to use his or her own unique ID and password to access the PMP and this information may not be shared with any other individual or entity. It is noted that subsection (f) addresses only the preclusion to sharing one's individual access to the system; there are separate provisions governing the sharing and disclosure of the PMP information. For audit purposes and monitoring compliance with the provisions of the subchapter, delegates are required to identify the practitioner on whose behalf they are accessing the prescription monitoring information.
Proposed new N.J.A.C. 13:45A-35.9(a) sets forth the limited circumstances for which practitioners, or their delegates, are required to access the PMP for a new or current patient. There is a mandatory look-up requirement the first time the practitioner prescribes a Schedule II controlled dangerous substance to a new or current patient for acute or chronic pain. If a practitioner or practitioner's delegate accesses the PMP for a new patient in advance of a scheduled appointment, the practitioner [page=2739] or delegate must document the new patient's request for professional services. In addition, practitioners are required to access the prescription monitoring information on a quarterly basis during the period of time a current patient continues to receive a prescription for a Schedule II controlled dangerous substance for acute or chronic pain. Quarterly is defined as every three months from the date the initial prescription is issued. In addition, under subsection (b), if the pharmacist has a reasonable belief that the person may be seeking a CDS for any purpose other than the treatment of an existing medical condition, before dispensing a Schedule II CDS, a pharmacist must access the prescription monitoring information to determine if the person has received other prescriptions that indicate misuse, abuse, or diversion.
Proposed new N.J.A.C. 13:45A-35.9(c) sets forth the exceptions to the mandatory look-up requirements for a practitioner or pharmacist. The mandatory look-up requirements of subsection (a) do not apply to: a veterinarian, a practitioner or practitioner's agent administering methadone as interim treatment for a patient on a waiting list for admission to an authorized substance abuse treatment program, a practitioner directly administering CDS to a patient, a practitioner prescribing a CDS that is to be dispensed by an institutional pharmacy, or a practitioner prescribing a CDS to a patient under the care of a hospice. In addition, the mandatory look-up requirements do not apply to a practitioner prescribing a CDS in an emergency department, if the prescription is for less than a five-day supply of the substance.
If there is a situation in which it is not reasonably possible for the practitioner or pharmacist to access the PMP in a timely manner, no other individual authorized to access the PMP is reasonably available, and the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance, the mandatory look-up requirements do not apply. In addition, the provisions do not apply in a situation under which consultation of the PMP would result in a patient's inability to obtain a prescription in a timely manner, thereby, in the clinical judgment of the practitioner or pharmacist, adversely impacting the medical condition of the patient. In such a situation, the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance. There is also an exception when the PMP is not operational as determined by the Division or where it cannot be accessed by the practitioner or the pharmacist due to a temporary technological or electrical failure, provided that the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance.
In addition, there is an exception for a pharmacist who is employed by a pharmacy that has been granted a waiver due to technological limitations or other exceptional circumstances, in accordance with N.J.A.C. 13:45A-35.4.
The mandatory look-up requirements also do not apply when a practitioner is 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. For purposes of the exception to the mandatory look-up requirements, a procedure is defined as an invasive procedure that requires anesthesia.
Proposed new N.J.A.C. 13:45A-35.9(d) provides that prescribing or dispensing of Schedule II CDS after accessing the prescription monitoring information shall be undertaken, as long as it is consistent with the professional practice of the practitioner or pharmacist, as applicable, as set forth in the rules of the individual's professional licensing board.
Proposed new N.J.A.C. 13:45A-35.10 sets forth recordkeeping requirements. Each practitioner and each authorized faculty member of a medical or dental teaching facility who designates a delegate is required to establish, retain, and follow written procedures to document, as part of the patient record, the mandatory PMP look-up, as required in N.J.A.C. 13:45A-35.9, and any PMP information accessed for the patient. Delegates are required to follow the documentation procedures established by their delegating practitioner. Although not an exhaustive list, examples of documentation include adding to the patient's record a summary notation of the information reviewed by the practitioner or the printed PMP report. The rule further provides that, once PMP information is documented in the patient record, disclosure of such information is governed by applicable State laws, other than the PMP law, and Federal laws, including HIPAA.
The rule also requires a practitioner or authorized faculty member of a medical or dental teaching facility who designates a delegate to establish, retain, and follow written procedures documenting verification of the delegate's education, training, and licensure or certification requirements, as required in N.J.A.C. 13:45A-35.8(c), and the bi-annual audit, as required in N.J.A.C. 13:45A-35.8(e)3. In addition, under subsection (c), the program director of the medical or dental residency program shall retain records of the faculty members who are authorized to designate a medical or dental resident, as applicable, as a delegate. Subsection (d) sets forth the requirement that the records required to be maintained in the subchapter shall be made available to the Division upon request.
Proposed N.J.A.C. 13:45A-35.11 sets forth the provisions for professional misconduct due to noncompliance with the rules in the subchapter. Subsection (a) provides that, for a pharmacy permit holder, out-of-State pharmacy that is subject to N.J.A.C. 13:45A-35, pharmacist, practitioner, licensed health care professional, or registered dental assistant, noncompliance with the rules may be deemed professional misconduct and may subject them to disciplinary action and penalties. Subsection (b) provides that a practitioner may be subject to disciplinary action for professional misconduct as a result of the noncompliance with the rules by the practitioner's delegate. Under subsection (c), noncompliance by a medical or dental resident may provide a basis for the withdrawal of the authorization of the registered resident to engage in the practice of medicine or dentistry, as applicable. Upon notice of a proposed withdrawal of such authorization, the registered resident may request a hearing. Under subsection (d), noncompliance may provide a basis for the withdrawal of the authorization to a certified medical assistant to access the PMP. Upon receipt of the notice of proposed withdrawal, the certified medical assistant will have an opportunity to provide a written explanation for the noncompliance. Subsection (e) provides that the Division will refer noncompliance with the rules in the subchapter to the appropriate licensing board. In accordance with subsection (f), the Division may also refer to law enforcement, which may result in a criminal conviction and a civil penalty, anyone authorized to access the PMP who knowingly discloses prescription monitoring information in violation of the PMP law, who uses the information in the course of committing, attempting to commit, or conspiring to commit any criminal offense, or a person who is not authorized to obtain prescription monitoring information from the PMP who knowingly obtains or attempts to obtain such information in violation of the PMP law. Subsection (g) further provides that, regardless of the person's CDS registration status or employment status, the Division shall retain the right to take action for noncompliance with the rules or violations of the law.
The Division notes that the proposed new rules focus on the time critical provisions of the new law, which are anticipated to have the most impact on patient health, that is, mandatory look-up and designation of delegates. The Division intends to initiate a future rulemaking to promulgate rules to implement the remaining statutory provisions for which rules are necessary.
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 PMP law will have a positive impact on the consumers of New Jersey by helping to combat prescription drug abuse and diversion, and having the best choices of treatment made for them. The Division believes that the proposed new rules will have a positive impact on licensed pharmacies in New Jersey and registered out-of-State pharmacies by clarifying the pharmacies' data submission obligations under the PMP law. In addition, the Division believes that the proposed new rules will have a positive impact on prescribers, pharmacists, and others authorized to obtain prescription drug information under the PMP by clarifying their obligations with respect to information access.
Economic Impact
The proposed new rules may have an economic impact upon licensed pharmacies in New Jersey and registered out-of-State pharmacies to the [page=2740] extent that pharmacies incur costs to electronically transmit prescription drug information to the PMP, in the specific format and in the specific intervals, delineated in the rules and the PMP Data Collection Manual. The Division notes, however, that pharmacies may request a waiver of these electronic transmission requirements due to financial hardship or other good cause. If a waiver is granted, pharmacies must make alternate arrangements for transmission of the required information.
The proposed new rules may have an economic impact upon practitioners and pharmacists to the extent that the proposed new rules require practitioners and pharmacists to allocate additional time and/or resources to access and review the prescription monitoring information in the discharge of their professional responsibilities. There are no costs associated with registering for online PMP access or obtaining prescription monitoring information.
To the extent there is an economic impact, the Division believes that any possible costs are outweighed by the need to combat prescription drug abuse and diversion, and for practitioners to make the best choices with respect to patient treatment.
Federal Standards Statement
A Federal standards analysis is not required because the proposed new rules are governed by N.J.S.A. 45:1-44 et seq. (P.L. 2007, c. 244, as amended by P.L. 2015, c. 74). However, the proposed new rules require the Division, all pharmacies transmitting prescription drug information to the PMP, and all persons authorized to access PMP prescription drug information, to 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. In addition, the Division notes that the proposed new rules requiring pharmacies to transmit information to the PMP about prescriptions dispensed for human growth hormone are consistent with the Federal definition of that term under the Federal Food, Drug, and Cosmetic Act at 21 U.S.C. § 333.
The Division believes that the proposed new rules are consistent with the standards established under the Federal National All Schedules Prescription Electronic Reporting Act of 2005, Pub.L. 109-60 (NASPER), which created a United States Department of Health and Human Services grant program for states to implement or enhance prescription drug monitoring programs.
Jobs Impact
The Division does not believe that the proposed new rules will result in the creation or the loss of jobs in the State.
Agriculture Industry Impact
The Division does not believe that the proposed new rules will have any impact on the agriculture industry of the State.
Regulatory Flexibility Analysis
Currently, the Division licenses approximately 63,560 individuals who dispense or are eligible to prescribe CDS including: 16,315 pharmacists, 30,717 physicians, 5,082 advanced practice nurses, 7,054 dentists, 1,894 physician assistants, 554 optometrists, 1,756 veterinarians, and 188 certified nurse midwives. In addition, the Division licenses approximately 2,206 pharmacies in New Jersey and registers approximately 904 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, 7,195 advanced practice nurses who do not have a CDS registration, and 2,699 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, 114 dental residents, and 3,300 dental assistants who are eligible to be designated as delegates. If these pharmacies, practitioners, licensed health care professionals, 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.
In addition, the Division believes that there are approximately 7,400 certified medical assistants in the State. Although certified medical assistants 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 new rules will impose reporting and compliance requirements on licensed New Jersey pharmacies and registered out-of-State pharmacies. In addition, the proposed new rules will impose reporting, recordkeeping, and compliance requirements on practitioners, licensed health care professionals, medical and dental residents, registered dental assistants, and certified medical assistants who are designated as delegates. Those requirements are detailed in the Summary above.
No additional professional services will be needed to comply with the proposed new rules. The costs to comply with the proposed new rules are discussed in the Economic Impact statement above. The Division believes that the proposed new rules must be uniformly applied to all licensed pharmacies in New Jersey and all registered out-of-State pharmacies dispensing prescriptions for Schedule II, III, IV, or V CDS and for human growth hormone, in order to effectuate the purposes of the PMP law. Therefore, no differing compliance requirements for any pharmacy is provided based upon the size of the business. The Division notes, however, that the proposed new rules authorize the Division to grant a waiver of the electronic reporting requirements based on financial hardship or other good cause, and, therefore, some small businesses may qualify for a waiver. Businesses that qualify for a waiver of the electronic reporting requirements will be required to submit required information to the PMP vendor in an alternate format. To help combat prescription drug abuse and diversion, the Division also believes that the proposed new rules must be uniformly applied to all practitioners who prescribe CDS and to all licensed health care professionals, medical and dental residents, registered dental assistants, and certified medical assistants who are designated as delegates. Therefore, there are no differing compliance requirements for any licensee, registrant, or certified medical assistant based upon the size of the business.
Housing Affordability Impact Analysis
The proposed 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 new rules concern the Division's Prescription Monitoring Program, including access to and transmission of prescription drug information.
Smart Growth Development Impact Analysis
The proposed 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 new rules concern the Division's Prescription Monitoring Program, including access to and transmission of prescription drug information.
Full text of the proposed new rules follows:
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 (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. A pharmacy filling prescriptions in New Jersey in an outpatient setting for a Schedule II, III, IV, or V controlled dangerous substance or for human growth hormone.
i. For purposes of this subchapter, "human growth hormone" means somatrem, somatropin, or any analogue of either of them, consistent with 21 U.S.C. § 333(e)4;
2. An out-of-State pharmacy registered with the Board of Pharmacy pursuant to N.J.A.C. 13:39-4.20 that ships, mails, distributes, or delivers a Schedule II, III, IV, or V controlled dangerous substance or human growth hormone into New Jersey in an outpatient setting pursuant to a prescription;
3. A person authorized to receive PMP information from the Division under N.J.S.A. 45:1-46 and N.J.A.C. 13:45A-35.6;
4. A pharmacist employed by a current pharmacy permit holder;
[page=2741] 5. A practitioner who has a current State Controlled Dangerous Substance (CDS) registration;
6. A licensed health care professional authorized by a practitioner to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;
7. A medical resident authorized by a faculty member of a medical teaching facility to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;
8. A dental resident authorized by a faculty member of a dental teaching facility to access the prescription monitoring information, subject to the limitations and requirements of this subchapter;
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.
(c) The reporting requirements of this subchapter shall not apply to the direct administration of a controlled dangerous substance or human growth hormone to the body of an ultimate user; or to the administration or dispensing of a controlled dangerous substance that is otherwise exempted as determined by the Secretary of Health and Human Services pursuant to the National All Schedules Prescription Electronic Reporting Act of 2005, Pub.L. 109-60.
(d) The reporting requirements of this subchapter shall not apply to any prescriptions filled by a pharmacy for a Schedule II, III, IV, or V controlled dangerous substance or for human growth hormone dispensed to an inpatient at a hospital, long-term care, or other facility in which the resident is provided with 24-hour nursing care.
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:
"Abuse" means a maladaptive pattern of drug use that results in harm or places the individual at risk of harm. Abuse of a prescription medication involves its use in a manner that deviates from approved medical, legal, and social standards, generally to achieve a euphoric state (high), to sustain opioid dependence (that is opioid addiction), or that is other than the purpose for which the medication was prescribed.
"Acute pain" means the normal, predicted physiological response to a noxious chemical or thermal or mechanical stimulus, typically associated with invasive procedures, trauma, or disease and is generally persistent for up to one month, but no more than three months.
"Acute trauma" means serious illness and traumatic injuries requiring immediate short-term medical care to relieve suffering and minimize morbidity and mortality risk.
"CDS registration" means registration with the Division of Consumer Affairs to manufacture, distribute, dispense, or conduct research with controlled dangerous substances issued pursuant to P.L. 1970, c. 226 § 11 (N.J.S.A. 24:21-11).
"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 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 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 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.
"Controlled dangerous substance" means any substance that is listed in Schedules II, III, and V of the schedules provided under the "New Jersey Controlled Dangerous Substances Act," P.L. 1970, c. 226 (N.J.S.A. 24:21-1 et seq.). Controlled dangerous substance also means any substance that is listed in Schedule V under the "New Jersey Controlled Dangerous Substances Act" when the Director has determined that reporting Schedule V substances is required by Federal law, regulation, or funding eligibility, consistent with N.J.A.C. 13:45H.
"Current patient" means any person who is the recipient of a professional service rendered by the practitioner for purposes of diagnosis, treatment, or a consultation related to treatment.
"Data Collection Manual" means the New Jersey Prescription Monitoring Program Data Collection Manual, Version 2.1, incorporated herein by reference, as amended and supplemented, and available on the New Jersey Prescription Monitoring Program website at www.njconsumeraffairs.gov.
"Delegate" means a person authorized to access the PMP information of the practitioner's current or new patient on behalf of a practitioner who is an authorized user of the PMP.
"Dental resident" means a person who practices dentistry as a resident pursuant to N.J.S.A. 45:6-20 and, pursuant to N.J.A.C. 13:30-1.3, is a graduate of a dental school approved by the Commission on Dental Accreditation and has passed Part I and Part II of the National Board Dental examination and obtained a resident permit from the New Jersey Board of Dentistry.
"Director" means the Director of the Division of Consumer Affairs in the Department of Law and Public Safety.
"Diversion" means the redirection of a prescription drug from its lawful purpose for illicit use.
"Division" means the Division of Consumer Affairs in the Department of Law and Public Safety.
"Emergency department of a general hospital" means an emergency department of a hospital (approved general) licensed and regulated by the Department of Health under N.J.A.C. 8:43G.
"Hospice" means a hospice as defined in N.J.A.C. 8:42C-1.2, which is licensed by the New Jersey State Department of Health.
"Licensed health care professional" means a registered nurse, licensed practical nurse, or dental hygienist licensed pursuant to Title 45 of the Revised Statutes. A "licensed health care professional" also means an advanced practice nurse or a physician assistant who access the PMP as a delegate.
"Medical resident" means a graduate physician who is authorized to practice medicine and surgery by means of a valid permit issued by the State Board of Medical Examiners to a person authorized to engage in the practice of medicine and surgery while in the second year or beyond of a graduate medical education program pursuant to N.J.A.C. 13:35-1.5. For purposes of this subchapter, a medical resident shall not include a licensed physician participating in a graduate medical education program.
"Misuse" means the use of a prescribed medication in a manner that is contrary to directions, regardless of whether a harmful outcome occurs.
"New patient" means a person who for the first time seeks from or is rendered professional services by the practitioner for purposes of diagnosis, treatment, or a consultation related to a treatment.
"Pharmacy permit holder" means an individual or business entity that holds a permit to operate a pharmacy practice site pursuant to P.L. 2003, c. 280 (N.J.S.A. 45:14-40 et seq.).
"Practitioner" means an individual currently licensed, registered, or otherwise authorized by this State or another state to prescribe drugs in the course of professional practice.
"Registered dental assistant" is a person who has fulfilled the requirements for registration established by the Dental Auxiliaries Act, P.L. 1979, c. 46 (N.J.S.A. 45:6-48 et seq.), as set forth in N.J.A.C. 13:30-2.2, and works under the direct supervision of a licensed dentist.
[page=2742] 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 or for human growth hormone, as defined in N.J.A.C. 13:45A-35.1, 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. The surname, first name, and date of birth of the patient for whom the medication is intended;
ii. The street address and telephone number of the patient;
iii. The date that the medication is dispensed;
iv. The number or designation identifying the prescription and the National Drug Code of the drug dispensed;
v. The pharmacy permit number of the dispensing pharmacy;
vi. The prescribing practitioner's name and Drug Enforcement Administration registration number;
vii. The name, strength, and quantity of the drug dispensed, the number of refills ordered, and whether the drug was dispensed as a refill or a new prescription;
viii. The date that the prescription was issued by the practitioner;
ix. The source of payment for the drug dispensed; and
x. Such other information, not inconsistent with Federal law, regulation, or funding eligibility requirements, as the Director determines necessary and that is set forth in the Data Collection Manual.
13:45A-35.4 Requests for exemption or waiver
(a) A pharmacy that does not dispense Schedule II, III, IV, or V controlled dangerous substances or human growth hormone, or that dispenses Schedule II, III, IV, or V controlled dangerous substances or human growth hormone only to inpatients in a hospital, long-term or other facility in which the residents are provided with 24-hour nursing care, shall apply to the Division for an exemption from the PMP on a form supplied by the Division and available at www.njconsumeraffairs.gov.
(b) A pharmacy may apply for a waiver of the PMP electronic reporting requirements contained in this subchapter or in the Data Collection Manual for good cause, such as technological limitations or financial hardship, by filing a written application for waiver with the Division on a form supplied by the Division and available at www.njconsumeraffairs.gov. The application for waiver shall document the reasons for the pharmacy's inability to comply with the electronic submission requirement and shall specify the format the pharmacy proposes to use to submit required information to the PMP vendor.
(c) An application for exemption or waiver request granted pursuant to this section shall be valid until June 30 of the following year unless otherwise limited by the Division. If the conditions that necessitated the exemption or waiver are corrected or no longer exist, the pharmacy shall notify the Division, and the exemption or waiver shall become void. If the reasons necessitating the exemption or waiver persist, the pharmacy shall, by June 30 of each year as part of its pharmacy permit or out-of-State pharmacy registration annual renewal application, apply to the Division for a renewal of the exemption or waiver.
13:45A-35.5 Frequency requirements for transmitting information; confidentiality
(a) A pharmacy shall transmit prescription information required by N.J.A.C. 13:45A-35.3 to the PMP vendor on a daily basis pursuant to the schedule established in the Data Collection Manual. Omissions and errors in the transmitted information shall be corrected and submitted as provided in the Data Collection Manual.
(b) A pharmacy shall transmit the required prescription information in such a manner as to ensure the 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.
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 or human growth hormone 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 or human growth hormone 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 or human growth hormone, 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-78 et seq.); and
9. 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) 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.
[page=2743] (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. The certification shall be completed online in the PMP 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, 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) Pursuant to N.J.S.A. 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 (N.J.S.A. 47:1A-1 et seq.) or P.L. 2001, c. 404 (N.J.S.A. 47:1A-5 et seq.).
13:45A-35.7 Registration
(a) All persons authorized to have online access to PMP information shall register with the Division. To register, all persons shall:
1. Provide the Division with a unique individual e-mail address.
2. Complete an online tutorial upon initial access to the PMP and as deemed necessary by the Director.
3. Submit all documentation required by the Division to verify the person's identity and credentials. The required documentation shall be listed on the New Jersey Prescription Monitoring Program website at www.njconsumeraffairs.gov.
(b) The Division shall register a practitioner to have online access to PMP information upon issuance or renewal of the practitioner's CDS registration.
1. Practitioners may also register to access prescription monitoring information outside of their applicable CDS issuance or renewal time period.
13:45A-35.8 Delegates
(a) A practitioner or a faculty member authorized by a medical or dental teaching facility may designate a delegate or delegates for the purpose of accessing PMP information for a new or current patient, or a prescriber, consistent with the requirements of this subchapter.
1. As set forth in this subsection, for each designated delegate, a practitioner or a faculty member authorized by a medical or dental teaching facility is responsible for the use or misuse of the PMP and the prescription monitoring information, ensuring compliance with the recordkeeping requirements, conducting a bi-annual audit, and verifying the education, training, and licensure or certification requirements for each delegate.
2. A delegate may be an authorized delegate for more than one practitioner.
(b) The director of the medical or dental residency program shall designate the faculty members who are authorized to designate medical or dental residents, as applicable, as delegates. The director of the medical or dental residency program shall comply with the recordkeeping provisions of N.J.A.C. 13:45A-35.10.
(c) Delegates may be designated as follows:
1. A practitioner may designate as a delegate a licensed health care professional or a certified medical assistant who is employed at the practice setting at which the practitioner practices.
2. A licensed dentist may designate as a delegate a registered dental assistant who is employed at the practice setting at which the licensed dentist practices dentistry.
3. A faculty member authorized by a medical teaching facility, in accordance with (b) above, may designate as a delegate a medical resident.
i. An individual who is terminated or withdraws from, or completes the graduate medical education program is no longer authorized to be a delegate or to access the PMP.
ii. A medical resident whose program includes training outside the medical teaching facility shall not be designated as a delegate in that setting unless the delegating practitioner has been designated as an authorized faculty member pursuant to (b) above and the residency program retains responsibility of care for the patient for whom healthcare is provided or information is requested.
4. A faculty member authorized by a dental teaching facility may designate as a delegate a dental resident.
i. An individual who is terminated or withdraws from, or completes the graduate dental education program is no longer authorized to be a delegate or to access the PMP.
(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. Prior to designating a delegate, a practitioner or an authorized faculty member of a medical or dental teaching facility shall ensure that the delegate understands the limitations on disclosure of the prescription monitoring information, and the 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.
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 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) A practitioner or an authorized faculty member of a medical or dental teaching facility who designates a delegate is responsible for the use or misuse by his or her delegate of the PMP and the prescription monitoring information. A practitioner or an authorized faculty member of a medical or dental teaching facility who designates a delegate shall:
1. Terminate the delegate's access to the PMP when a delegate, for any reason, is no longer authorized to be a delegate.
[page=2744] 2. Terminate the delegate's access and notify the PMP when a practitioner or an authorized faculty member of a medical or dental teaching facility learns of any potential unauthorized use by a delegate of the PMP or prescription monitoring information.
i. The practitioner or authorized faculty member of a medical or dental teaching facility shall, within five business days of discovering the unauthorized access, notify the Division through the PMP and submit supporting documentation evidencing the unauthorized use.
3. Conduct, at least once every six months, audits of the delegate's use of the PMP to monitor for potential misuse of the PMP or prescription monitoring information.
4. Ensure that the delegate follows the recordkeeping procedures established by the practitioner as set forth in N.J.A.C. 13:45A-35.10(a).
(f) All persons authorized to have online access to PMP information shall not share access to the PMP with any other person or entity.
1. All persons granted access to the PMP shall access the PMP using their own unique user login ID and password. The login ID and password shall not be shared with any other person or entity.
2. All delegates shall identify the practitioner on whose behalf they are accessing the prescription monitoring information.
3. All persons authorized to have online access to PMP information may share such information as set forth in N.J.A.C. 13:45A-35.6.
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 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. On a quarterly basis during the period of time a current patient continues to receive a prescription for a Schedule II controlled dangerous substance for acute or chronic pain.
i. For purposes of this paragraph, "quarterly" means every three months from the date the initial prescription is issued.
(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 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) above shall not apply to:
1. A veterinarian;
2. A practitioner or the practitioner's agent administering methadone as interim treatment for a patient on a waiting list for admission to an authorized substance abuse treatment program;
3. A practitioner administering a controlled dangerous substance directly to a patient;
4. A practitioner prescribing a controlled dangerous substance to be dispensed by an institutional pharmacy, as defined in N.J.A.C. 13:39-9.2;
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;
6. A practitioner prescribing a controlled dangerous substance to a patient under the care of a hospice;
7. A situation in which it is not reasonably possible for the practitioner or pharmacist to access the PMP in a timely manner, no other individual authorized to access the PMP is reasonably available, and the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance;
8. A situation under which consultation of the PMP would result in a patient's inability to obtain a prescription in a timely manner, thereby, in the clinical judgment of the practitioner or pharmacist, adversely impacting the medical condition of the patient, and the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance;
9. A situation in which the PMP is not operational as determined by the Division or where it cannot be accessed by the practitioner or pharmacist due to a temporary technological or electrical failure and the quantity of CDS prescribed or dispensed does not exceed a five-day supply of the substance;
10. A pharmacist who is employed by a pharmacy that, in accordance with N.J.A.C. 13:45A-35.4, has been granted a waiver due to technological limitations that are not reasonably within the control of the pharmacist, or other exceptional circumstances demonstrated by the pharmacist; or
11. A practitioner who is prescribing less than a 30-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.
i. For purposes of this paragraph, "procedure" means an invasive procedure that requires anesthesia.
(d) Prescribing or dispensing of Schedule II CDS after accessing the prescription monitoring information in accordance with (a) or (b) above shall be undertaken if consistent with the practitioner's or pharmacist's professional practice as set forth in the rules of the individual's respective professional licensing board.
13:45A-35.10 Recordkeeping
(a) Each practitioner and each authorized faculty member of a medical or dental teaching facility who designates a delegate shall establish, retain, and follow written procedures to document, as part of the patient record, the PMP look-up as required in N.J.A.C. 13:45A-35.9 and any PMP information accessed for the patient.
1. Each delegate shall follow the documentation procedures established by his or her delegating practitioner.
2. Examples of documentation include a summary notation of the information reviewed by the practitioner or the printed PMP report in the patient record.
3. Once PMP information is documented in the patient record, disclosure of such information is governed by applicable State laws, other than N.J.S.A. 45:1-45, and Federal laws, 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.
(b) A practitioner or an authorized faculty member of a medical or dental teaching facility who designates a delegate shall establish, retain, and follow written procedures to document:
1. Verification of each delegate's education, training, and licensure or certification requirements, as required in N.J.A.C. 13:45A-35.8(d); and
2. The bi-annual audit, as required in N.J.A.C. 13:45A-35.8(e)3.
(c) The program director of the medical or dental residency program shall retain records of the faculty members authorized to designate a medical or dental resident, as applicable, as a delegate.
(d) All records required to be maintained in this subchapter shall be made available to the Division upon request.
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 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) Noncompliance with the rules in this subchapter by a delegate may be deemed professional misconduct by the practitioner and may subject the 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.
(c) Noncompliance with the rules in this subchapter may provide a basis for the withdrawal of the authorization of a registered resident to engage in the practice of medicine or the practice of dentistry, as applicable. Upon receipt of the notice of proposed withdrawal, the registered resident may request a hearing, which shall be conducted [page=2745] pursuant to the Administrative Procedure Act, N.J.S.A. 52:14B-1 et seq. and 52:14F-1 et seq.
(d) Noncompliance with the rules in this subchapter may provide a basis for the withdrawal of the authorization to a certified medical assistant to access the PMP. Upon receipt of the notice of proposed withdrawal, the certified medical assistant shall have an opportunity to provide a written explanation for the noncompliance.
(e) The Division shall refer noncompliance with the rules in this subchapter to the appropriate licensing board.
(f) The Division shall refer to law enforcement, which may result in a criminal conviction and a civil penalty in accordance with N.J.S.A. 45:1-49 the following persons:
1. A person who is authorized to obtain prescription monitoring information from the PMP who knowingly discloses such information in violation of the provisions of N.J.S.A. 45:1-45 through 50.
i. The production of a patient record in response to a lawful request by the patient, an authorized representative, or pursuant to a subpoena or other court order shall not be deemed a knowing disclosure within the meaning of the statute;
2. A person who is authorized to obtain prescription monitoring information who uses this information in the course of committing, attempting to commit, or conspiring to commit any criminal offense; and
3. A person who is not authorized to obtain prescription monitoring information from the PMP who knowingly obtains or attempts to obtain such information in violation of the provisions of N.J.S.A. 45:1-45 through 50.
(g) Notwithstanding the provisions of this subchapter and the person's CDS registration status or employment status, the Division shall retain the right to take action for noncompliance with the rules in this subchapter or violations of the provisions of N.J.S.A. 4 |
