ASSEMBLY, No. 3007

STATE OF NEW JERSEY

216th LEGISLATURE

 

INTRODUCED MARCH 24, 2014

 


 

Sponsored by:

Assemblywoman  MARLENE CARIDE

District 36 (Bergen and Passaic)

Assemblyman  JOSEPH CRYAN

District 20 (Union)

Assemblyman  JOSEPH A. LAGANA

District 38 (Bergen and Passaic)

Assemblyman  JOHN F. MCKEON

District 27 (Essex and Morris)

 

 

 

 

SYNOPSIS

     Requires practitioners prescribing Schedule II drugs to check prescription monitoring program prior to issuing prescription and to report prescriptions for Schedule II drugs to program; expands access to program.

 

CURRENT VERSION OF TEXT

     As introduced.

  


An Act concerning the prescription monitoring program and amending and supplementing P.L.2007, c.244.

 

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

 

     1.    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. 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).  If the division determines that a violation of law or regulations, or a breach of the applicable standards of practice, 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, or a licensed health care professional designated by the practitioner pursuant to section 5 of P.L.      , c.      (C.        ) (pending before the Legislature as this bill), who certifies that the request is for the purpose of providing health care to a current patient of the practitioner.  [Nothing] Except as provided in section 3 of P.L.      , c.      (C.        ) (pending before the Legislature as this bill), 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 or the practitioner’s designee 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.

     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.

     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.

     g.    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)

 

     2.    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), or a practitioner required to submit data by section 4 of P.L.      , c.      (C.        ) (pending before the Legislature as this bill), 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 or practitioner, practitioner’s designee, 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, [or] practitioner, or practitioner’s designee 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).

     (3)   If a licensed health care professional designated by a practitioner to access prescription monitoring information pursuant to section 5 of P.L.      , c.      (C.        ) (pending before the Legislature as this bill) knowingly discloses or uses prescription monitoring information in violation of sections 25 through 30 of P.L.2007, c.244 (C.45:1-45 through C.45:1-50), both the practitioner and the designated licensed health care professional shall be subject to civil penalties under paragraph (1) of this subsection.  Both the practitioner and the designated licensed health care professional shall also be subject to disciplinary action as provided in paragraph (2) of this subsection.

     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.).

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

 

     3.    (New section)  a.  As used in this section, “frequent patient” means a patient who receives professional services from the practitioner three or more times within a two-month period, five or more times within a six-month period, or at such other rate of frequency as the director may establish by regulation.

     b.  Prior to prescribing a Schedule II controlled dangerous substance to a new patient or to a frequent patient, a practitioner or an authorized designee of the practitioner shall access prescription monitoring information, as provided in subsection c. in this section and as authorized pursuant to subsection d. of section 26 of P.L.2007, c.244 (C.45:1-46), to determine if the patient has received other prescriptions that indicate, in the professional judgment of the practitioner, prescription abuse or diversion. 

     c.     (1)  In the case of a new patient, the practitioner or an authorized designee shall access prescription monitoring information prior to issuing an initial prescription for a Schedule II controlled dangerous substance. 

     (2)   In the case of a frequent patient who has been issued at least one prescription for a Schedule II controlled dangerous substance by the practitioner, the practitioner shall not issue an initial prescription or a renewal prescription for a Schedule II controlled dangerous substance unless the practitioner or an authorized designee has accessed prescription monitoring information for the patient within the preceding six months.

     d.    Nothing in this section shall be construed to prohibit a practitioner or designee from accessing prescription monitoring information when, in the practitioner’s professional judgment, there is a risk of prescription abuse or diversion by the patient.        

 

     4.    (New section)  a.  A practitioner shall submit, or cause to be submitted, to the division, by electronic means in a format and at such intervals as are specified by the director, information about each prescription for a Schedule II controlled dangerous substance issued by the practitioner that includes:

     (1)   The surname, first name, and date of birth of the patient for whom the prescription is issued;

     (2)   The street address and telephone number of the patient;

     (3)   The date that the prescription is issued;

     (4)   The number or designation identifying the prescription and the National Drug Code of the drug prescribed;

     (5)   The practitioner's name and Drug Enforcement Administration registration number;

     (6)   The name, strength, and quantity of the drug prescribed, and the number of refills ordered; and

     (7)   Such other information, not inconsistent with federal law, regulation, or funding eligibility requirements, as the director determines necessary.

     The practitioner shall submit the information to the division with respect to the prescriptions issued during the reporting period not less frequently than once every business day, or according to a schedule to be determined by the director if federal law, regulation, or funding eligibility otherwise requires.

     b.    The requirements of this section shall not apply to: the direct administration of a Schedule II controlled dangerous substance to the body of an ultimate user; the administration or dispensing of a Schedule II controlled dangerous substance by a health care facility licensed pursuant to P.L.1971, c.136 (C.26:2H-1 et seq.) to a patient admitted to that facility; or 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.

 

     5.    (New section)  a.  A practitioner authorized to access prescription monitoring information as provided in paragraph (1) of subsection d. of section 26 of P.L.2007, c.244 (C.45:1-46) may designate a licensed health care professional under the practitioner’s direct control and supervision who shall be granted access to prescription monitoring information by the division.  The practitioner may designate as many licensed health care professionals to access prescription monitoring information as the practitioner deems appropriate, subject to any limit on the number of such health care professionals established 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. 

     b.    A practitioner shall be responsible for the use or misuse of prescription monitoring information by any licensed health care professional designated by the practitioner as having authorization to access the information.

     c.     The director shall establish, by regulation, the terms and conditions under which a practitioner may designate a licensed health care professional to access prescription monitoring information, including procedures for authorization and termination of authorization, provisions for maintaining confidentiality, and such other matters as the division may deem appropriate.

 

     6.    The Director of the Division of Consumer Affairs, pursuant to the “Administrative Procedure Act,” P.L.1968, c.410 (C.52:14B-1 et seq.), shall adopt rules and regulations to effectuate the purposes of this act.

 

     7.    This act shall take effect on the first day of the seventh 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 would require practitioners to check the prescription monitoring program prior to issuing prescriptions for Schedule II controlled dangerous substances to certain patients and would require practitioners to submit to the prescription monitoring program certain information concerning all prescriptions issued for Schedule II controlled dangerous substances.  The bill would also expand access to prescription monitoring information.

     Specifically, a practitioner would be required to check prescription monitoring information prior to issuing a prescription for a Schedule II controlled dangerous substance to a new patient and to certain frequent patients to determine if the patient has received other prescriptions that indicate, in the professional judgment of the practitioner, prescription abuse or diversion.  The bill would define “frequent patient” to mean a patient who receives professional services from the practitioner three or more times within a two-month period, five or more times within a six-month period, or at such other rate of frequency as the Director of Consumer Affairs may establish by regulation.

     For a new patient, the check would occur prior to issuing an initial prescription for a Schedule II controlled dangerous substance.  For a frequent patient who was previously issued a prescription for a Schedule II controlled dangerous substance by the practitioner, the practitioner would be required to have checked prescription monitoring information within the preceding six months prior to issuing an initial or renewal prescription for a Schedule II controlled dangerous substance.  Nothing in the bill would prohibit a practitioner from checking prescription monitoring information for any patient when, in the practitioner’s professional judgment, there is a risk of prescription abuse or diversion by the patient.

     The bill would additionally require a practitioner to submit, or cause to be submitted, to the Division of Consumer Affairs in the Department of Law and Public Safety, by electronic means in a format and at such intervals as are specified by the Director of Consumer Affairs, information about each prescription for a Schedule II controlled dangerous substance issued by the practitioner that includes:

     (1)   The surname, first name, and date of birth of the patient for whom the prescription is issued;

     (2)   The street address and telephone number of the patient;

     (3)   The date that the prescription is issued;

     (4)   The number or designation identifying the prescription and the National Drug Code of the drug prescribed;

     (5)   The practitioner's name and Drug Enforcement Administration registration number;

     (6)   The name, strength, and quantity of the drug prescribed, and the number of refills ordered; and

     (7)   Such other information, not inconsistent with federal law, regulation, or funding eligibility requirements, as the director determines necessary.

     The practitioner would be required submit this information to the division at least once every business day, or according to a schedule to be determined by the director if federal law, regulation, or funding eligibility otherwise requires.

     The requirement to check and report prescription monitoring information would not apply to: the direct administration of a Schedule II controlled dangerous substance to the body of an ultimate user; the administration or dispensing of a Schedule II controlled dangerous substance by a licensed health care facility to a patient admitted to that facility; or 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.

     The bill would additionally permit a practitioner to designate a licensed health care professional under the practitioner’s direct control and supervision to have access to prescription monitoring information.  The practitioner would be responsible for the use or misuse of prescription monitoring information by the designee, and both the practitioner and the designee would be subject to any penalties or disciplinary action imposed for the unauthorized disclosure of prescription monitoring information by a designee. 

     Practitioners would be permitted to designate as many licensed health care professionals to have access as they deem appropriate, subject to any limits imposed by the Division of Consumer Affairs based on the type and size of the professional practice, in order to minimize the burden to practitioners to the extent practicable while protecting the confidentiality of the prescription monitoring information obtained.  Practitioners and designees would also be subject to any regulations promulgated by the Division of Consumer Affairs regarding procedures for authorization and termination of authorization, provisions for maintaining confidentiality, and such other matters as the division may deem appropriate.