SENATE, No. 364

STATE OF NEW JERSEY

216th LEGISLATURE

 

PRE-FILED FOR INTRODUCTION IN THE 2014 SESSION

 


 

Sponsored by:

Senator  STEVEN V. OROHO

District 24 (Morris, Sussex and Warren)

Senator  JAMES W. HOLZAPFEL

District 10 (Ocean)

 

Co-Sponsored by:

Senators Kyrillos and A.R.Bucco

 

 

 

 

SYNOPSIS

     Concerns access to information maintained by Prescription Monitoring Program.

 

CURRENT VERSION OF TEXT

     Introduced Pending Technical Review by Legislative Counsel

  


An Act concerning access to prescription monitoring information, amending P.L.1970, c.226 and P.L.2007, c.244, and repealing section 39 of P.L.1970, c.226.

 

     Be It Enacted by the Senate and General Assembly of the State of New Jersey:

 

     1.    Section 34 of P.L.1970, c.226 (C.24:21-34) is amended to read as follows:

     34.  Cooperative arrangements.  a.  The director may cooperate with federal and other State agencies in discharging his responsibilities concerning traffic in dangerous substances and in suppressing the abuse of dangerous substances.  To this end, [he] the director is authorized to:

     (1)   Except as otherwise provided by law, arrange for the exchange of information between government officials concerning the use and abuse of dangerous substances; provided, however, that in no case shall any officer having knowledge by virtue of [his] that individual’s office of any such prescription, order, or record divulge such knowledge, except in connection with a prosecution or proceeding in court or before a licensing board or officer to which prosecution or proceeding the person to whom the records relate, is a party;

     (2)   Coordinate and cooperate in training programs on dangerous substances law enforcement at the local and State levels; and

     (3)   Conduct educational programs [of eradication aimed at destroying wild or illicit growth of plant species from which controlled dangerous substances may be extracted] for:  members of the general public; pharmacy permit holders and pharmacists; and mental health practitioners, licensed health care professionals, and practitioners as defined in section 24 of P.L.2007, c.244 (C.45:1-44).

     b.    Results, information, and evidence received from the Drug Enforcement Administration relating to the regulatory functions of P.L.1970, c.226 (C.24:21-1 et seq.), as amended and supplemented, including results of inspections conducted by that agency, may be relied upon and acted upon by the director in conformance with his regulatory functions under P.L.1970, c.226, as amended and supplemented.

(cf: P.L.2007, c.244, s.18)


     2.    Section 24 of P.L.2007, c.244 (C.45:1-44) is amended to read as follows:

     24.  Definitions.  As used in sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50):

     "Controlled dangerous substance" means any substance that is listed in Schedules II, III, and IV of the schedules provided under the "New Jersey Controlled Dangerous Substances Act," P.L.1970, c.226 (C.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.

     "Director" means the Director of the Division of Consumer Affairs in the Department of Law and Public Safety.

     "Division" means the Division of Consumer Affairs in the Department of Law and Public Safety.

     “Licensed health care professional” means a registered nurse, licensed practical nurse, advanced practice nurse, physician assistant, or dental hygienist licensed pursuant to Title 45 of the Revised Statutes.

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

     "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.

     "Ultimate user" means a person who has obtained from a dispenser and possesses for his own use, or for the use of a member of his household or an animal owned by him or by a member of his household, a controlled dangerous substance.

(cf: P.L.2007, c.244, s.24)

 

     3.    Section 26 of P.L.2007, c.244 (C.45:1-46) is amended to read as follows:

     26.  Access to prescription information. 

     a.    The division shall maintain procedures to ensure privacy and confidentiality of patients and that patient information collected, recorded, transmitted and maintained is not disclosed, except as permitted in this section, including, but not limited to, the use of a password-protected system for maintaining this information and permitting access thereto as authorized under sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50), and a requirement that a person as listed in [subsection d.] subsections h. or i. of this section provide on-line affirmation of the person's intent to comply with the provisions of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) as a condition of accessing the information.

     b.    The prescription monitoring information submitted to the division shall be confidential and not be subject to public disclosure under P.L.1963, c.73 (C.47:1A-1 et seq.), or P.L.2001, c.404 (C.47:1A-5 et al.).

     c.    The division shall review the prescription monitoring information provided by a pharmacy permit holder pursuant to sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50).  The review shall include, but not be limited to:

     (1)   A review to identify whether any person is obtaining prescriptions in a manner that may be indicative of misuse, abuse, or diversion of controlled dangerous substances.  When evaluation of the information indicates that a person is obtaining prescriptions in a manner that appears to represent such misuse, abuse, or diversion by obtaining prescriptions for the same or similar drugs from multiple practitioners and pharmacists during the same time period, the division may provide prescription monitoring information about the person to practitioners and pharmacists; and

     (2)   A review to identify whether a violation of law or regulations or a breach of the applicable standards of practice by any person may have occurred.  If the division determines that such a violation [of law or regulations, or a breach of the applicable standards of practice,] 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.

     d.    [The division may provide prescription monitoring information to the following persons:

     (1)   a practitioner authorized to prescribe, dispense, or administer controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient of the practitioner.  Nothing in sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) shall be construed to require or obligate a practitioner to access or check the prescription monitoring information prior to prescribing, dispensing, or administering medications beyond that which may be required as part of the practitioner's professional practice;

     (2)   a pharmacist authorized to dispense controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient.  Nothing in sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) shall be construed to require or obligate a pharmacist to access or check the prescription monitoring information prior to dispensing medications beyond that which may be required as part of the pharmacist's professional practice;

     (3)   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, as applicable, who certifies that he is engaged in a bona fide specific investigation of a designated practitioner whose professional practice was or is regulated by that board;

     (4)   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 or patient;

     (5)   a designated representative of a state Medicaid or other program who certifies that he is engaged in a bona fide investigation of a designated practitioner or patient;

     (6)   a properly convened grand jury pursuant to a subpoena properly issued for the records;

     (7)   authorized personnel of the division or vendor or contractor responsible for establishing and maintaining the program; and

     (8)   the controlled dangerous substance monitoring program in another state with which the division has established an interoperability agreement.] (Deleted by amendment, P.L.  , c.   ) (pending before the Legislature as this bill)

     e.    [A person listed in subsection d. of this section, as a condition of obtaining prescription monitoring information pursuant thereto, shall certify, by means of entering an on-line statement in a form and manner prescribed by regulation of the director, the reasons for seeking to obtain that information.] (Deleted by amendment, P.L.  , c.   ) (pending before the Legislature as this bill)

     f.     [The division shall offer an on-line tutorial for those persons listed in subsection d. of this section, which shall, at a minimum, include:  how to access prescription monitoring information; the rights and responsibilities of persons who are the subject of or access this information and the other provisions of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) and the regulations adopted pursuant thereto, regarding the permitted uses of that information and penalties for violations thereof; and a summary of the requirements of the federal health privacy rule set forth at 45 CFR Parts 160 and 164 and a hypertext link to the federal Department of Health and Human Services website for further information about the specific provisions of the privacy rule.] (Deleted by amendment, P.L.  , c.   ) (pending before the Legislature as this bill)

     g.    [The director may provide nonidentifying prescription drug monitoring information to public or private entities for statistical, research or educational purposes.] (Deleted by amendment, P.L.  , c.   ) (pending before the Legislature as this bill)

     h.    The division may provide online access to prescription monitoring information to the following persons:

     (1)   a practitioner authorized to prescribe, dispense, or administer controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient of the practitioner.  The division shall grant access to prescription monitoring information to as many licensed health care professionals as are authorized by a practitioner to access that information and for whom the practitioner is responsible for the use or misuse of that information, subject to a limit on the number of such health care professionals as deemed appropriate by the division for that particular type and size of professional practice, in order to minimize the burden to practitioners to the extent practicable while protecting the confidentiality of the prescription monitoring information obtained.  The director shall establish, by regulation, the terms and conditions under which a practitioner may delegate that authorization, including procedures for authorization and termination of authorization, provisions for maintaining confidentiality, and such other matters as the division may deem appropriate.  Nothing in sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) shall be construed to require or obligate a practitioner to access or check the prescription monitoring information prior to prescribing, dispensing, or administering medications beyond that which may be required as part of the practitioner's professional practice;

     (2)   a pharmacist authorized to dispense controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient.  Nothing in sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) shall be construed to require or obligate a pharmacist to access or check the prescription monitoring information prior to dispensing medications beyond that which may be required as part of the pharmacist's professional practice;

     (3)   authorized personnel of the division or a vendor or contractor responsible for maintaining the Prescription Monitoring Program;

     (4)   authorized personnel of the division responsible for administration and enforcement of the provisions of P.L.1970, c.226 (C.24:21-1 et seq.), as amended and supplemented;

     (5)   the State Medical Examiner, a county medical examiner, or a deputy or assistant county medical examiner who certifies that the request is for the purpose of investigating a death pursuant to P.L.1967, c.234 (C.52:17B-78 et seq.); and

     (6)   the controlled dangerous substance 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.

     i.     The division may provide prescription monitoring information to the following persons:

     (1)   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, as applicable, who certifies that he is engaged in a bona fide specific investigation of a designated practitioner whose professional practice was or is regulated by that board;

     (2)   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 or patient;

     (3)   a designated representative of a state Medicaid or other program who certifies that he is engaged in a bona fide investigation of a designated practitioner or patient;

     (4)   a properly convened grand jury pursuant to a subpoena properly issued for the records; and

     (5)   a licensed mental health practitioner providing treatment for substance abuse to patients at a residential or outpatient substance abuse treatment center licensed by the Division of Mental Health and Addiction Services in the Department of Human Services, who certifies that the request is for the purpose of providing treatment to a current patient of the mental health practitioner and furnishes the division with the written consent of the patient for the mental health practitioner to obtain prescription monitoring information about the patient.  The director shall establish, by regulation, the terms and conditions under which a mental health practitioner may request and receive prescription monitoring information.  Nothing in sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) shall be construed to require or obligate a mental health practitioner to access or check the prescription monitoring information in the course of treatment beyond that which may be required as part of the mental health practitioner’s professional practice.

     j.     A person listed in subsection h. or i. of this section, as a condition of obtaining prescription monitoring information pursuant thereto, shall furnish the required certification in a form and manner prescribed by regulation of the director.

     k.    The division shall offer an online tutorial for those persons listed in subsection h. of this section, which shall, at a minimum, include:  how to access prescription monitoring information; the rights of persons who are the subject of this information; the responsibilities of persons who access this information; a summary of the other provisions of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) and the regulations adopted pursuant thereto, regarding the permitted uses of that information and penalties for violations thereof; and a summary of the requirements of the federal health privacy rule set forth at 45 CFR Parts 160 and 164 and a hypertext link to the federal Department of Health and Human Services website for further information about the specific provisions of the privacy rule.

   l.     The division may request and receive prescription monitoring information from prescription monitoring programs in other states and may use that information for the purposes of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50).

     m.   The director may provide nonidentifying prescription drug monitoring information to public or private entities for statistical, research, or educational purposes.

(cf: P.L.2007, c.244, s.26)

 

     4.    Section 28 of P.L.2007, c.244 (C.45:1-48) is amended to read as follows:

     28.  Immunity from liability.

     a.    The division shall be immune from civil liability arising from inaccuracy of any of the information submitted to it pursuant to sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50).

     b.    A pharmacy permit holder, pharmacist, mental health practitioner, licensed health care professional, or practitioner shall be immune from civil liability arising from compliance with sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50).

(cf: P.L.2007, c.244, s.28)

 

     5.    Section 29 of P.L.2007, c.244 (C.45:1-49) is amended to read as follows:

     29.  Penalties.

     a.    A pharmacy permit holder, or a person designated by a pharmacy permit holder to be responsible for submitting data required by section 25 of P.L.2007, c.244 (C.45:1-45), who knowingly fails to submit data as required, shall be subject to disciplinary action pursuant to section 8 of P.L.1978, c.73 (C.45:1-21) and may be subject to a civil penalty in an amount not to exceed $1,000 for repeated failure to comply with sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50).

     b.    (1)  A pharmacy permit holder, pharmacist, mental health practitioner, licensed health care professional, or practitioner, or any other person or entity who knowingly discloses or uses prescription monitoring information in violation of the provisions of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50) shall be subject to a civil penalty in an amount not to exceed $10,000.

     (2)   A pharmacy permit holder, pharmacist, mental health practitioner, licensed health care professional, or practitioner who knowingly discloses or uses prescription monitoring information in violation of the provisions of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50), shall also be subject to disciplinary action pursuant to section 8 of P.L.1978, c.73 (C.45:1-21).

     c.    [A penalty imposed under this section shall be collected by the director pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).] (Deleted by amendment, P.L.  , c.   ) (pending before the Legislature as this bill)

     d.    A person not authorized to obtain prescription monitoring information from the Prescription Monitoring Program, who knowingly obtains or attempts to obtain such information in violation of the provisions of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50), shall be subject to a civil penalty in an amount not to exceed $10,000.

     e.    A civil penalty imposed under this section shall be collected by the director pursuant to the "Penalty Enforcement Law of 1999," P.L.1999, c.274 (C.2A:58-10 et seq.).

     f.     In addition to any other penalty provided by law, a person not authorized to obtain prescription monitoring information from the Prescription Monitoring Program, who purposely obtains or attempts to obtain such information in violation of the provisions of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50), shall be guilty of a crime of the third degree.

(cf: P.L.2007, c.244, s.29)

 

     6.    Section 39 of P.L.1970, c.226 (C.24:21-39) is repealed.

 

     7.    This act shall take effect on the first day of the fourth month next following the date of enactment, but the Director of the Division of Consumer Affairs may take such anticipatory administrative action in advance thereof as shall be necessary for the implementation of this act.


STATEMENT

 

     This bill revises certain provisions of statutory law concerning access to information maintained by the Prescription Monitoring Program (PMP), which was established in the Division of Consumer Affairs in the Department of Law and Public Safety pursuant to P.L.2007, c.244 (C.45:1-45) as an electronic system for monitoring controlled dangerous substances that are dispensed in or into the State by a pharmacist in an outpatient setting.

     The bill requires that the division review the prescription monitoring information provided by a pharmacy permit holder including, but not be limited to:  a review to identify whether any person is obtaining prescriptions in a manner that may be indicative of misuse, abuse, or diversion of controlled dangerous substances; and a review to identify whether a violation of law or regulations or a breach of the applicable standards of practice by any person may have occurred.  If the division determines that such a violation or breach may have occurred, the division is to notify the appropriate law enforcement agency or professional licensing board, and provide the prescription monitoring information required for an investigation.

     The bill also stipulates that when evaluation of the information reviewed by the division indicates that a person is obtaining prescriptions in a manner that appears to represent misuse, abuse, or diversion of controlled dangerous substances, by obtaining prescriptions for the same or similar drugs from multiple practitioners and pharmacists during the same time period, the division may provide prescription monitoring information about the person to practitioners and pharmacists.

     In addition, the bill differentiates between the type of access to be afforded to various parties seeking information maintained by the PMP, as follows:

     (1)   The division may provide online access to prescription monitoring information to the following persons:

     -- a practitioner authorized to prescribe, dispense, or administer controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient of the practitioner, with the division to grant access to prescription monitoring information to as many licensed health care professionals as are authorized by a practitioner to request that information on the practitioner’s behalf and for whom the practitioner is responsible for the use or misuse of that information, subject to a limit on the number of such health care professionals as deemed appropriate by the division for that particular type and size of professional practice;

     -- a pharmacist authorized to dispense controlled dangerous substances who certifies that the request is for the purpose of providing health care to a current patient;

     -- authorized personnel of the division or a vendor or contractor responsible for maintaining the PMP;

     -- authorized personnel of the division responsible for administration and enforcement of the provisions of the "New Jersey Controlled Dangerous Substances Act";

     -- the State Medical Examiner, a county medical examiner, or a deputy or assistant county medical examiner who certifies that the request is for the purpose of investigating a death pursuant to their statutory responsibilities; and

     -- the controlled dangerous substance 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.

     (2)   The division may provide prescription monitoring information to the following persons:

     -- a designated representative of any state professional licensing board that regulates the practice of persons who are authorized to prescribe or dispense controlled dangerous substances, as applicable, who certifies that he is engaged in a bona fide specific investigation of a designated practitioner whose professional practice was or is regulated by that board;

     -- 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 or patient;

     -- a designated representative of a state Medicaid or other program who certifies that he is engaged in a bona fide investigation of a designated practitioner or patient;

     -- a properly convened grand jury pursuant to a subpoena properly issued for the records; and

     -- a licensed mental health practitioner providing treatment for substance abuse to patients at a licensed residential or outpatient substance abuse treatment center, who certifies that the request is for the purpose of providing treatment to a current patient of the mental health practitioner and furnishes the division with the written consent of the patient for the mental health practitioner to obtain prescription monitoring information about the patient.  (A mental health practitioner will not be required to access or check the prescription monitoring information in the course of treatment beyond that which may be required as part of the mental health practitioner’s professional practice.)

     The bill also authorizes the division to request and receive prescription monitoring information from prescription monitoring programs in other states and to use that information for the purposes of the PMP.

     Furthermore, the bill expands the immunity and penalty provisions of the law governing the PMP to include mental health practitioners (i.e., a clinical social worker, marriage and family therapist, alcohol and drug counselor, professional counselor, psychologist, or psychoanalyst licensed or otherwise authorized to practice under State law) and other licensed health care professionals (i.e., a registered nurse, licensed practical nurse, advanced practice nurse, physician assistant, or dental hygienist licensed under State law).

     The bill expands the penalty provisions of the law governing the PMP to provide that:  a person not authorized to obtain prescription monitoring information from the PMP, who knowingly obtains or attempts to obtain such information, is subject to a civil penalty of up to $10,000; and, in addition to any other penalty provided by law, a person not authorized to obtain such information, who purposely obtains or attempts to obtain such information, is guilty of a crime of the third degree (punishable by imprisonment for a term of three to five years, or a fine of up to $15,000, or both).

     Finally, the bill repeals section of P.L.1970, c.226 (C.24:21-39), which requires that every practitioner, within 24 hours after determining that a person is a drug dependent person by reason of the use of a controlled dangerous substance for purposes other than the treatment of sickness or injury prescribed and administered as authorized by law, report that determination to the Director of the Division of Consumer Affairs.

     The bill takes effect on the first day of the fourth month following enactment, but authorizes the director to take prior administrative action as necessary for its implementation.