| (a) The board may conduct inspections to enforce these
rules, including inspections of a pain management clinic and documents
and records of a physician(s) and mid-level practitioner(s) practicing
at such a clinic, as set out in subsections (b) and (c) of this section.
(b) The board may inspect a pain management clinic
certified under this chapter, including the documents of a physician
practicing at the clinic, to determine if the clinic is being operated
in compliance with applicable laws and rules. If violations of the
Medical Practice Act or board rules are found during an inspection,
the board may bring an enforcement action for such violations. The
board may utilize the services of another state or local agency, as
needed, in carrying out inspections under this section.
(c) The board may inspect a clinic or facility that
is not certified under this chapter, including the documents of a
physician practicing at the clinic or facility, to determine whether
the clinic or facility is required to be certified under §168.101
of the Medical Practice Act. After an inspection, the Board may bring
a disciplinary action for failure to certify the clinic as required
by Chapter 168 of the medical practice act and board rules. In addition,
to certification violations, if any, the Board may bring a disciplinary
action for any other violation of the Medical Practice Act or board
rules found during the inspection.
(d) The following criteria will be reviewed and evaluated
in determining whether an inspection of a clinic or facility pursuant
to subsection (c) of this section should be conducted. If, after evaluation
of the criteria described below, the board reasonably believes that
a clinic or facility has not been properly certified under §168.101
of the Act, the board may inspect such clinic or facility.
(1) the patient population of a clinic or facility
includes multiple patients from outside the geographical area of service
for which the clinic or facility provides service, based on a review
of the Texas Prescription Monitoring Program (PMP) reports;
(2) the patient population of the clinic or facility
includes several patients at the same address who are all being treated
for chronic pain;
(3) data from the PMP indicating that the volume of
prescribing of a physician, or mid-level provider(s )supervised by
the physician at a clinic or facility, who has not been subject to
an inspection under subsection (c) in the previous 12 months, places
them in the top 50 prescribers in the state at any time in the preceding
12 months for prescriptions of opioids, benzodiazepines, barbiturates,
or carisoprodol, excluding prescribers at certified pain management
clinics, clinics or facilities engaged in treating cancer patients,
and certified hospice facilities;
(4) information from the PMP that a physician or mid-evel
provider(s) supervised by the physician is prescribing to multiple
patients, opioids in combination with one, or all of the following:
benzodiazepines, barbiturates, or carisoprodol in a clinic or facility;
(5) complaints and/or information, from non-anonymous
complainants related to inappropriate prescribing practices, including
those from law enforcement agencies or health care regulators, regarding
a clinic or facility, or a physician or midlevel provider(s) supervised
by the physician, working at the clinic or facility;
(6) A patient overdose death related to controlled
substances opioids, benzodiazepines, barbiturates, or carisoprodol,
prescribed by a specific physician or a physician's mid-level provider(s);
(7) arrest of a physician or a mid-level provider related
to improper or fraudulent prescribing of controlled substances;
(8) information developed during the course of a board
investigation of a physician or a physician's mid-level provider indicating
that the physician or mid-level provider is prescribing to a majority
of patients opioids, benzodiazepines, barbiturates, or carisprodol
in a clinic or facility.
(e) Unless it would jeopardize an ongoing investigation,
the board shall provide at least five business days' notice before
conducting an on-site inspection under subsection (b) of this section.
(f) When inspecting clinics or facilities that are
not certified, the board may utilize a subpoena instanter requiring
immediate production, inspection and copying of medical and billing
records. Board staff will consult with the board's medical director
prior to utilizing a subpoena instanter. If immediate production is
not made in compliance with the subpoena, the board, acting through
the attorney general, may file suit to enforce the subpoena in a district
court in Travis County.
(g) This section does not require the board to make
an on-site inspection of a physician's office.
(h) The board shall conduct inspections of pain management
clinics certified under this chapter if the board suspects that the
ownership or physician supervision is not in compliance with board
rules.
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