(1) The board
shall operate and maintain the program.
(2) (a) The board shall adopt all rules necessary to implement the program.
(b) The rules adopted pursuant to subsection (2)(a) of this section may:
(I) Repealed.
(II) Include a data retention schedule for the information obtained and stored
by the program pursuant to this part 4 and the processes for the preservation of de-identified, aggregated data for a period of time as determined by the board.
(c) (I) Except as provided in subsection (2)(c)(II) of this section, the program
shall track all controlled substances dispensed in this state. Each pharmacy shall
upload all controlled substances dispensed in each pharmacy in accordance with
all applicable reporting requirements.
(II) The requirements of this section do not apply to a prescription for
testosterone. The division shall block archived testosterone prescriptions from
view.
(3) The program is available for query only to the following persons or
groups of persons:
(a) Board staff responsible for administering the program;
(b) A practitioner with prescriptive authority, or an individual designated by
the practitioner or a medical director to act on the practitioner's or medical
director's behalf in accordance with section 12-280-403 (2)(b), to the extent the
query relates to a current patient of the practitioner. The practitioner or the
practitioner's designee shall identify the person's area of health-care specialty or
practice upon the initial query of the program.
(c) (I) A veterinarian with statutory authority to prescribe controlled
substances, to the extent the query relates to a current patient or to a client and if
the veterinarian, in the exercise of professional judgment, has a reasonable basis to
suspect the client has a substance use disorder or has mistreated an animal.
(II) As used in this subsection (3)(c):
(A) Client has the same meaning as set forth in section 12-315-104 (4).
(B) Mistreat has the same meaning as set forth in section 35-42-103 (9).
(C) Patient has the same meaning as set forth in section 12-315-104 (13).
(d) A practitioner or medical director, or an individual designated by the
practitioner or medical director to act on the practitioner's or medical director's
behalf in accordance with section 12-280-403 (2)(b), engaged in a legitimate
program to monitor a patient's substance use disorder;
(e) The medical director, or his or her designee, at a facility that treats
substance use disorders with controlled substances, if an individual in treatment at
the facility gives permission to the facility to access his or her program records;
(f) A pharmacist, an individual designated by a pharmacist in accordance
with section 12-280-403 (2)(b) to act on the pharmacist's behalf, or a pharmacist
licensed in another state, to the extent the information requested relates
specifically to a current patient to whom the pharmacist is dispensing or
considering dispensing a controlled substance or prescription drug or a patient to
whom the pharmacist is currently providing clinical patient care services;
(g) Law enforcement officials, so long as the information released is specific
to an individual patient, pharmacy, or practitioner and is part of a bona fide
investigation and the request for information is accompanied by an official court
order or subpoena;
(h) The individual who is the recipient of a controlled substance prescription,
so long as the information released is specific to the individual;
(i) State regulatory boards within the division and the director, so long as the
information released is specific to an individual practitioner and is part of a bona
fide investigation and the request for information is accompanied by an official
court order or subpoena;
(j) A resident physician with an active physician training license issued by the
Colorado medical board pursuant to section 12-240-128 and under the supervision
of a licensed physician;
(k) The department of public health and environment for purposes of
population-level analysis, but any use of program data by the department is subject
to the federal Health Insurance Portability and Accountability Act of 1996, Pub.L.
104-191, as amended, and implementing federal regulations, including the
requirement to remove any identifying data unless exempted from the requirement;
(l) A medical examiner who is a physician licensed pursuant to article 240 of
this title 12, whose license is in good standing, and who is located and employed in
the state of Colorado; a coroner elected pursuant to section 30-10-601; or a deputy
coroner who is authorized by the coroner to act on behalf of the coroner in
accordance with subsection (3.5) of this section, if:
(I) The information released is specific to an individual who is the subject of
an autopsy or a death investigation conducted by the medical examiner, coroner, or
deputy coroner;
(II) The medical examiner, coroner, or deputy coroner has legitimate access
to the individual's medical record; and
(III) The individual's death or injury occurred under unusual, suspicious, or
unnatural circumstances;
(m) The medical director in each director's role at a medical practice or
hospital with respect to any current patient of the medical practice or hospital
under the director's supervision; and
(n) (I) The executive director of the department of health care policy and
financing or the executive director's designee, for the purposes of care
coordination, utilization review, and federally required reporting pertaining to
recipients of benefits under the Colorado Medical Assistance Act, articles 4, 5,
and 6 of title 25.5, and enrollees under the Children's Basic Health Plan Act,
article 8 of title 25.5, as long as the department's use of the program data is
consistent with the federal Health Insurance Portability and Accountability Act of
1996, Pub.L. 104-191, as amended, and any implementing regulations, including the
requirement to remove any personally identifying information unless exempted
from the requirement.
(II) The department of health care policy and financing shall use the data
collected pursuant to subsection (3)(n)(I) of this section to review and analyze
current rules and other policies, appropriate utilization, and safe prescribing
practices.
(3.5) A coroner may authorize a deputy coroner to access the program on
behalf of the coroner if:
(a) The coroner takes reasonable steps to ensure that the deputy coroner is
sufficiently competent to use the program; and
(b) The coroner remains responsible for:
(I) Ensuring that access to the program is limited to the purposes specified in
subsection (3)(l) of this section and that the access occurs in a manner that
protects the confidentiality of program information; and
(II) Any negligent breach of the confidentiality of information obtained from
the program by the deputy coroner.
(4) (a) A practitioner, except for a veterinarian licensed pursuant to part 1 of
article 315 of this title 12, or the designee of a practitioner or medical director shall
query the program prior to prescribing an opioid unless the patient receiving the
prescription:
(I) Is receiving the opioid in a hospital, skilled nursing facility, residential
facility, or correctional facility;
(II) Has been diagnosed with cancer and is experiencing cancer-related pain;
(III) Is undergoing palliative care or hospice care;
(IV) Is experiencing post-surgical pain that, because of the nature of the
procedure, is expected to last more than fourteen days;
(V) Is receiving treatment during a natural disaster or during an incident
where mass casualties have taken place; or
(VI) Has received only a single dose to relieve pain for a single test or
procedure.
(a.5) A practitioner, except a veterinarian licensed pursuant to part 1 of
article 315 of this title 12, or the designee of a practitioner or medical director shall
query the program before prescribing a benzodiazepine to a patient unless the
benzodiazepine is prescribed to treat a patient in hospice or to treat epilepsy, a
seizure or seizure disorder, a suspected seizure disorder, spasticity, alcohol
withdrawal, or a neurological condition, including a posttraumatic brain injury or
catatonia.
(b) The program must use industry standards to allow providers or their
designees direct access to data from within an electronic health record to the
extent that the query relates to a current patient of the practitioner.
(c) A practitioner or the designee of a practitioner or of a medical director
complies with this subsection (4) if the practitioner or the practitioner's or medical
director's designee attempts to access the program before prescribing an opioid or
a benzodiazepine and the program is not available or is inaccessible due to
technical failure.
(d) A violation of this subsection (4) does not create a private right of action
or serve as the basis of a cause of action. A violation of this subsection (4) does not
constitute negligence per se or contributory negligence per se and does not alone
establish a standard of care. Compliance with this subsection (4) does not alone
establish an absolute defense to any alleged breach of the standard of care.
(e) Repealed.
(5) The board shall not charge a practitioner or pharmacy who transmits data
in compliance with the operation and maintenance of the program a fee for the
transmission of the data.
(6) The board or the department of public health and environment, pursuant
to a written agreement that ensures compliance with this part 4, may provide data
to qualified personnel of a public or private entity for the purpose of bona fide
research or education, so long as the data does not identify a recipient of, a
practitioner who prescribed, or a prescription drug outlet that dispensed a
prescription drug.
(7) (a) The board shall provide a means of sharing information about
individuals whose information is recorded in the program with out-of-state health-care practitioners and law enforcement officials that meets the requirements of
subsection (3)(b), (3)(d), or (3)(g) of this section.
(b) The board may, within existing funds available for operation of the
program, provide a means of sharing prescription information and electronic health
records through a board-approved vendor and method with the health information
organization network, as defined in section 25-3.5-103 (8.5), in order to work
collaboratively with the statewide health information exchanges designated by the
department of health care policy and financing. Use of the information made
available pursuant to this subsection (7)(b) is subject to privacy and security
protections in state law and the federal Health Insurance Portability and
Accountability Act of 1996, Pub.L.104-191, as amended, and any implementing
regulations.
(8) The board shall develop criteria for indicators of misuse, abuse, and
diversion of controlled substances and, based on those criteria, provide unsolicited
reports of dispensed controlled substances to prescribing practitioners and
dispensing pharmacies for purposes of education and intervention to prevent and
reduce occurrences of controlled substance misuse, abuse, and diversion. In
developing the criteria, the board shall consult with the Colorado dental board,
Colorado medical board, state board of nursing, state board of optometry, Colorado
podiatry board, and state board of veterinary medicine.
(9) Reports generated by the program and provided to prescribing
practitioners for purposes of information, education, and intervention to prevent
and reduce occurrences of controlled substance misuse, abuse, and diversion are:
(a) Not public records under the Colorado Open Records Act, part 2 of
article 72 of title 24;
(b) Not discoverable in any criminal or administrative proceeding against a
prescribing practitioner; and
(c) Not admissible in any civil, criminal, or administrative proceeding against
a prescribing practitioner.