New Mexico
Register / Volume XXIX, Issue 18 / September 25, 2018
This
is an amendment to 16.19.29 NMAC, Sections 6 through 10, and 12, effective 09-25-2018.
16.19.29.6 OBJECTIVE: The objective of Part
29 of Chapter 19 is to promote the public health and welfare by detecting and
preventing substance abuse and misuse, and encouraging appropriate treatment of
pain and other conditions for which controlled substances are prescribed. The
purpose of the program is to improve access to controlled substances
prescription information for legitimate medical needs by allowing a
practitioner or a pharmacist to obtain a patient's pharmaceutical history
related to controlled substances. The program's
objectives will include education of the public and health care professionals
regarding the nature and extent of the problem of drug abuse, and
appropriate prescribing and use of controlled substances. [and the medical
treatment options for abusers of controlled substances and pain management.]
[16.19.29.6
NMAC - N, 07-15-04; A, 03-22-15; A, 09-25-18]
16.19.29.7 DEFINITIONS:
A. “Audit trail information” means any query based
information resulting from an authorized prescription monitoring program user’s
request for a prescription monitoring program report, which could include the
user’s name, date and time of the query or other related information.
[A.] B. “Board” means the New Mexico board of
pharmacy, herein referred to as the board.
[B.] C. “Controlled
substance” has the meaning given such term in Section 30-31-2 NMSA 1978.
[C.] D. “Delegate”
means an individual authorized as an agent of a practitioner or pharmacist for
the purpose of obtaining data from the PMP for review by the practitioner or
pharmacist. The delegate must report
directly to said practitioner or pharmacist and the practitioner or pharmacist
shall be accountable for the delegate’s actions:
(1) a
pharmacist’s delegate must be a certified pharmacy technician or a registered
intern;
(2) a
pharmacy technician or pharmacist intern may access information to the extent
the information relates specifically to a current patient to whom the
pharmacist is dispensing or considering dispensing any controlled substance, or
for the purposes of a pharmacist providing pharmaceutical care as defined in
law.
[D.] E. “Dispenser”
means the person who delivers a schedule II - V controlled substance as
defined in Subsection F of this section to the ultimate user, but does not
include the following:
(1) a
licensed hospital pharmacy that distributes such substances for the purpose of
inpatient hospital care;
(2) a
practitioner, or other authorized person who administers such a substance; or
(3) a
practitioner who dispenses to the patient no more than 12 dosage units or 72
hours’ worth (whichever is less) of such a substance or;
(4) a
wholesale distributor of a schedule II - V controlled substance;
(5) clinics,
urgent care or emergency departments dispensing to the patient no more than 12
dosage units or 72 hours’ worth (whichever is less) of such a substance or;
(6) a
veterinarians or veterinary clinics dispensing to non-human patients.
[E.] F. “Patient”
means the ultimate user of a drug for whom a prescription is issued and for whom
a drug is dispensed.
[F.] G. “Person” means an individual,
corporation, business trust, estate, trust, partnership, limited liability
company, association, joint venture or any legal or commercial entity.
[G.] H. “PMP director”
means the individual authorized by the board to administer the prescription
monitoring program (PMP).
[H.] I. “PMP report” means a compilation of
data generated from the PMP concerning a patient, a dispenser, a practitioner,
or a schedules II - V controlled substance.
[I.] J. “Practitioner” means a person
maintaining licensure pursuant to state law that allows him or her to prescribe
controlled substance medications in accordance with that licensure.
[J.] K. “Prescription
monitoring program” (PMP) means a program as described in 16.19.29.6 NMAC
which includes a centralized system to collect, monitor, and analyze
electronically, for schedules II - V controlled substances, prescribing and
dispensing data submitted by dispensers of which the data is to be used to
support efforts in education, research, enforcement and abuse prevention.
[K.] L. “Schedule II - V controlled substance”
means a substance listed in schedules II, III, IV, and V as set forth in the
Controlled Substance Act, Sections 30-31-5 through 30-31-10 NMSA 1978 or the
federal Controlled Substances Regulation (21 U.S.C. 812).
[L.] M. “State” means the state of New Mexico.
[16.19.29.7
NMAC - N, 07-15-04; A, 06-11-11; A, 08-31-12; A, 10-24-14; A, 03-22-15; A,
11-27-16; A, 09-25-18]
16.19.29.8 MANDATORY REPORTING OF PRESCRIPTION INFORMATION TO THE
PMP:
A. The board shall
monitor the dispensing of all schedule II - V controlled substances by all
dispensers licensed to dispense such substances to patients in this state.
B. Each dispenser
shall submit to the board by electronic means information regarding each
prescription dispensed for a drug included under Subsection A of this
section. Information to be submitted for
each prescription as well as the standards for how this information shall be
formatted, not contrary to law, is defined in the PMP data reporting manual
available on the state PMP website at http://nmpmp.org shall include at a
minimum:
(1) dispenser
NPI number;
(2) dispenser
NCPDP number;
(3) dispenser
DEA number;
(4) patient
name;
(5) patient
address;
(6) patient
date of birth;
(7) patient
gender;
(8) reporting
status (new, revised, void);
(9) prescription
number;
(10) date
prescription written;
(11) refills
authorized;
(12) date
prescription filled;
(13) refill
number;
(14) product ID (NDC) + product ID qualifier;
(15) quantity
dispensed;
(16) days’
supply;
(17) drug
dosage units;
(18) transmission
form of Rx origin;
(19) payment
type;
(20) prescriber
NPI number; (except veterinarians)
(21) prescriber
DEA number.
C. [Each
dispenser shall submit the information in accordance with transmission methods
and frequency established by the board; but shall report at least within one
business day of the prescription being filled.
The PMP director shall have the authority to approve submission
schedules that exceed one business day.] Dispenser reporting:
(1) each
dispenser shall submit the information required under Subsection B of this
section in accordance with transmission methods and frequency established by
the board; but shall report within one business day of the prescription being
filled.
(2) if
a dispenser pharmacy did not dispense any
schedule II – V controlled substances during an operating business day, the
dispenser shall submit a “zero report” within one business day. Information to be submitted with each zero
report as well as the standards for how this information shall be formatted,
not contrary to law, is defined in the PMP data reporting manual available on
the state PMP website at http://nmpmp.org shall include at a
minimum:
(a) dispenser
DEA number;
(b) reporting
start date; and
(c) reporting
end date.
(3) the
PMP director shall have the authority to approve submission schedules that
exceed one business day.
D. Corrections to information submitted
to the PMP must be addressed including:
(1) file
upload or “outstanding uncorrected errors” as defined in the PMP data reporting
manual;
(2) prescriptions
that were not dispensed to the patient must be voided from the PMP;
(3) incorrect
information in prescriptions records submitted to the PMP must be [corrected
as soon as possible after the dispenser has been notified.] submitted to
the PMP database within five business days once the dispenser has been notified
or becomes aware of the incorrect information.
[16.19.29.8
NMAC - N, 07-15-04; A, 06-11-11; A, 08-31-12; A, 03-22-15; A, 03-23-16; A,
09-25-18]
16.19.29.9 DISCLOSURE OF PRESCRIPTION INFORMATION:
A. Prescription
information submitted to the board shall not be subject to the Inspection of the
Public Records Act, Sections 14-2-1 through 14-2-12 NMSA 1978 and shall be
confidential except as provided in Subsections C through G of 16.19.29.9 NMAC.
B. The board shall
maintain procedures to ensure that the privacy and confidentiality of patients
and patient information collected, recorded, transmitted, and maintained in
the PMP is not disclosed to persons except as provided in Subsection C
through G of 16.19.29.9 NMAC.
C. [After
receiving a complaint, the board inspectors shall review the relevant
prescription information. If there is
reasonable cause to believe a violation of law or breach of professional
standards may have occurred, the board shall notify the appropriate law
enforcement or professional licensing, certification or regulatory agency or
entity, and provide prescription information required for an investigation.]
Board inspectors may review prescription information after receiving
complaints, and in the course of their enforcement of board administered
statutes and regulations.
D. The board shall be authorized to
provide PMP information to the following persons:
(1) persons
authorized to prescribe or dispense controlled substances, for the purpose of
providing medical or pharmaceutical care for their patients;
(2) [a
delegate designated by a practitioner; or pharmacist; who must also maintain an
active account, can designate one or more (up to four) delegates for the
purpose of requesting and receiving PMP reports for the practitioner or
pharmacist; the practitioner or pharmacist shall be responsible for notifying
the PMP within 10 days of a delegate’s authorization ending.] a
consultant pharmacist for the purpose of providing pharmaceutical care for a
facility’s patients; and in ensuring that facility records appropriately
account for controlled substance receipt, administration and disposition;
(3) [state
licensing boards, including the medical board, board of nursing, board of
veterinary medicine, board of dental health care, board of examiners in
optometry, osteopathic examiners board, acupuncture & oriental medicine
board, and podiatry board, as the PMP information relates to their licensees;]
a delegate designated by a practitioner; or pharmacist; who must also
maintain an active account, can designate one or more (up to four) delegates
for the purpose of requesting and receiving PMP reports for the practitioner or
pharmacist; the practitioner or pharmacist shall be responsible for terminating
the delegate’s access to the PMP within five business days of a delegate’s
authorization ending;
(4) [professional
licensing authorities of other states if their licensees practice in this state
or prescriptions provided by their licensees are dispensed in this state;] state
practitioner licensing boards whose licensees have prescriptive authority for
controlled substances, including the medical board, board of nursing, board of
veterinarian medicine, board of dental health care, board of examiners in
optometry, board of osteopathic medicine, board of acupuncture and oriental
medicine, and board of podiatry, as the PMP information relates to their
licensees;
(5) practitioner licensing authorities of other states if their licensees practice
in this state or prescriptions provided by their licensees are dispensed in
this state;
[(5)] (6) local, state and
federal law enforcement or prosecutorial officials engaged in an ongoing investigation of an individual in the enforcement of
the laws governing licit drugs;
[(6)] (7) the state human services department regarding
medicaid program recipients;
[(7)] (8) a state
metropolitan, magistrate and district, or federal court as required by a grand
jury subpoena or criminal court order;
[(8)] (9) state drug court
personnel as authorized by the PMP director;
[(9)] (10) personnel
of the board for purposes of administration and enforcement of this rule or of
16.19.20 NMAC;
[(10)] (11) the
prescription monitoring program of another state or group of states with whom
the state has established an interoperability agreement;
[(11)] (12) a living individual who
request’s his or her own PMP report in accordance with procedures established
under the Pharmacy Act, Subsection D of Section 61-11-2 NMSA 1978 and
Subsection H of 16.19.6.23 NMAC, or an agent authorized by the living
individual along with a valid HIPAA release form or court issued subpoena, or;
[(12)] (13) a
parent to have access to the prescription records about his or her minor child,
as his or her minor child’s personal representative when such access is not
inconsistent with state or other laws;
[(13)] (14) licensed
healthcare professionals (nurses, pharmacists and practitioners) from Medicare,
health insurers, workers compensation program/insurers and pharmacy benefit
managers for persons enrolled in or covered by their programs, as part of
patient care for those persons.
E. The board shall
use de-identified data obtained from the PMP database to identify and report to
state and local public health authorities the geographic areas of the state
where anomalous prescribing dispensing or use of controlled substances is
occurring.
F. The board shall share PMP database
data with the department of health for the purpose of tracking inappropriate
prescribing and misuse of controlled substances, including drug overdose.
G. The board shall provide data to public or
private entities for statistical, research, or educational purposes after
removing information that could be used to identify individual patients and
persons who have received prescriptions from dispensers.
H. PMP information gained from other
states’ prescription monitoring programs shall not be subject to civil
subpoena, nor shall such information be disclosed, discoverable, or compelled
to be produced in any civil proceeding, nor shall such records be deemed
admissible as evidence in any civil proceeding for any reason.
[16.19.29.9
NMAC - N, 07-15-04; A, 06-11-11; A, 08-31-12; A, 03-22-15; A, 11-27-16; A,
09-25-18]
16.19.29.10 [[RESERVED]]
DISCLOSURE OF AUDIT TRAIL
INFORMATION:
A. Audit trail
information maintained by the board shall not be subject to the Inspection of
Public Records Act, Sections 14-2-1 through 14-2-12 NMSA 1978, and shall be
confidential except as provided in Subsection C and D of 16.19.29.10 NMAC.
B. The board shall
maintain procedures to ensure that the privacy and confidentiality of patients
and patient information collected, recorded, transmitted, and maintained in the
PMP is not disclosed to persons except as provided in Subsection C and D of
16.19.29.10 NMAC.
C. Board inspectors
may review audit trail information after receiving complaints, and in the
course of their enforcement of board administered statutes and regulations.
D. The board shall
be authorized to provide audit trail information to the following persons:
(1) state
practitioner licensing boards whose licensees have prescriptive authority for
controlled substances, including the medical board, board of nursing, board of
veterinary medicine, board of dental health care, board of optometry, board of
osteopathic medicine, board of acupuncture and oriental medicine, and board of
podiatry, as the audit trail information relates to their licensees for the
purposes of reviewing compliance with PMP utilization;
(2) practitioner
licensing authorities of other states if their licensees practice in this state
or prescriptions provided by their licensees are dispensed in this state as the
audit trail information relates to their licensees for the purposes of
reviewing compliance with PMP utilization requirements;
(3) personnel
of the board for purposes of administration and enforcement of this rule or of
16.19.20 NMAC;
(4) the
board shall share PMP database data with the department of health for the
purpose of tracking inappropriate prescribing and misuse of controlled
substances, including drug overdose.
E. Audit trail
information shall not be subject to civil subpoena, nor shall such information
be disclosed, discoverable, or compelled to be produced in any civil
proceeding, nor shall such records be deemed admissible as evidence in any
civil proceeding for any reason.
[16.19.29.10
NMAC - N, 07-15-04; A, 06-11-11; Repealed, 03-22-15; A, 09-25-18]
16.19.29.12 REGISTRATION FOR
ACCESS TO PRESCRIPTION INFORMATION:
A. Persons
authorized for access to PMP information as listed in [Paragraphs (1) through
(9) and (13)] Paragraphs (1) through (10) and (14) of Subsection D
of 16.19.29.9 NMAC must apply for access as described at the PMP website
located at http://nmpmp.org or as otherwise indicated. Persons granted access must maintain
individual accounts and shall not share access information with other persons.
B. All persons
authorized for access to PMP information and applying for such access to the
PMP shall successfully complete a web based training program as determined by
the PMP director.
C. Persons
reporting prescription information to the PMP, but not authorized for access to
PMP information must also apply for access as described at the PMP website
located at http://nmpmp.org or as otherwise indicated.
D. The PMP director
shall have the authority to set account access and registration renewal
requirements necessary for accounts to be considered active and shall also have
authority to cancel inactive accounts.
[16.19.29.12 NMAC - N, 07-15-04;
16.19.29.12 NMAC - N, 06-11-11; A, 08-31-12; A, 03-22-15; A, 11-27-16; A,
09-25-18]