| (a) Application for Certification.
(1) Certification requirement. Effective September
1, 2010, a pain management clinic may not operate in Texas without
obtaining a certificate from the board. A physician who owns or operates
a pain management clinic shall submit an application on a form prescribed
by the board. If a clinic has more than one physician owner, then
only the medical director must file an application with the board.
Certificates issued pursuant to this subsection are not transferable
or assignable. If there is more than one physician owner of the clinic,
only the primary physician owner shall be required to register with
the board.
(2) Determination of Eligibility by the Executive Director.
The executive director shall review applications for certification
and may determine whether an applicant is eligible for certification
or refer an application to a committee of the board for review. If
an applicant is determined to be ineligible for a certificate by the
executive director pursuant to §§167.001 - 167.202 of the
Act or this chapter, the applicant may request review of that determination
by a committee of the board. The applicant must request the review
not later than the 20th day after the date the applicant receives
notice of the determination.
(3) Ineligibility Determination.
(A) If the board, upon recommendation by a committee
of the board, determines that an applicant is ineligible for certification,
the applicant shall be notified of the board's determination and given
the option of appealing the determination to State Office of Administrative
Hearings (SOAH). An applicant has 20 days from the date the applicant
receives notice of the committee's determination to appeal to SOAH.
(B) If the applicant timely requests a SOAH hearing,
the applicant must file a petition with SOAH appealing the determination
and shall comply with all other provisions relating to formal proceedings
as set out in Chapter 187, Subchapter C of this title (relating to
Formal Board Proceedings at SOAH). If an applicant subsequently withdraws
the appeal, the matter shall be referred to the full board to render
a final determination on the application.
(C) If the applicant does not timely request an appeal
to SOAH, the board's determination shall be shall become administratively
final at the next scheduled board meeting.
(D) A determination of ineligibility by the board shall
be in writing and made available to the public.
(4) Withdrawal. Applicants for certificates may withdraw
their applications at any time, unless:
(A) the executive director has made a determination
of ineligibility;
(B) the executive director has referred an application
to a committee of the board for a determination of eligibility and
the committee has determined that the applicant is not exempt from
the requirements of §195.4 of this title (relating to Operation
of Pain Management Clinics) or is ineligible for a certificate; or
(C) the applicant is under investigation by the board
for inappropriately prescribing, dispensing, administering, supplying,
or selling a controlled substance.
(5) Temporary Suspension of Certificate. A temporary
suspension hearing for a clinic shall be held pursuant to the procedures
of Chapter 187, Subchapter F of this title (relating to Temporary
Suspension Proceedings). Evidence of continuing threat to public health
and welfare shall include evidence that a clinic is in violation of
this chapter regarding eligibility or operation or that the clinic's
staff is dispensing, administering, or prescribing medications in
a nontherapeutic manner.
(6) Confidentiality of Records. All records in the
possession of or received or gathered by the board relating to an
application for or investigation of a pain clinic shall be considered
confidential under §164.007 of the Texas Occupations Code and
not subject to release under the Public Information Act, Chapter 552
of the Texas Government Code.
(7) Expiration. An application that has been filed
with the board in excess of one year will be considered expired. Any
further request for certification will require submission of a new
application. An extension to an application may be granted under certain
circumstances, including:
(A) Delay by board staff in processing an application;
(B) Application requires Licensure Committee review
after completion of all other processing and will expire prior to
the next scheduled meeting;
(C) Licensure Committee requires an applicant to meet
specific additional requirements for licensure and the application
will expire prior to deadline established by the Committee;
(D) Applicant requires a reasonable, limited additional
period of time to obtain documentation after completing all other
requirements and demonstrating diligence in attempting to provide
the required documentation;
(E) Applicant is delayed due to unanticipated military
assignments, medical reasons, or catastrophic events.
(b) Eligibility for Certification.
(1) The owner or operator of a pain management clinic,
an employee of the clinic, or a person with whom a clinic contracts
for services may not:
(A) have been denied, by any jurisdiction, a license
issued by the Drug Enforcement Agency or a state public safety agency
under which the person may prescribe, dispense, administer, supply,
or sell a controlled substance;
(B) have held a license issued by the Drug Enforcement
Agency or a state public safety agency in any jurisdiction, under
which the person may prescribe, dispense, administer, supply, or sell
a controlled substance, that has been restricted; or
(C) have been subject to disciplinary action by any
licensing entity for conduct that was a result of inappropriately
prescribing, dispensing, administering, supplying, or selling a controlled
substance.
(2) A pain management clinic may not be owned wholly
or partly by a person who has been convicted of, pled nolo contendere
to, or received deferred adjudication for:
(A) an offense that constitutes a felony; or
(B) an offense that constitutes a misdemeanor, the
facts of which relate to the distribution of illegal prescription
drugs or a controlled substance as defined by Texas Occupations Code §551.003(11).
(3) As a requirement for eligibility, a physician applying
for a pain management certificate must meet the active practice of
medicine definition as defined under §163.11 of this title (relating
to Active Practice of Medicine).
(c) Expiration of Certificate.
(1) Certificates shall be valid for two years.
(2) Certificate holders shall have a 180-day grace
period from the expiration date to renew the certificate, however,
the owner or operator of the clinic may not continue to operate the
clinic while the permit is expired.
(d) Certificate Renewal.
(1) Certificates must be timely renewed. If a certificate
is not renewed before the expiration of the grace period, the certificate
will be automatically cancelled and the owner or operator of the clinic
must reapply for original certification.
(2) A certificate may not be cancelled for nonrenewal
or by request, while a clinic is under investigation with the board.
(e) The board shall coordinate the certification required
under this section with the registration required under the Medical
Practice Act, Texas Occupations Code, Chapter 156, so that the times
of registration, payment, notice, and imposition of penalties for
late payment are similar and provide a minimum of administrative burden
to the board and to physicians.
(f) Ownership of a pain management clinic is the practice
of medicine.
(g) Pending Investigations. If an applicant is under
investigation by the board for inappropriately prescribing, dispensing,
administering, supplying, or selling a controlled substance at the
time of application or while the applicant's application is being
processed, no decision on the application shall be rendered until
resolution of the board investigation.
|
| Source Note: The provisions of this §195.2 adopted to be effective May 2, 2010, 35 TexReg 3281; amended to be effective June 28, 2011, 36 TexReg 3922; amended to be effective December 4, 2011, 36 TexReg 8033; amended to be effective May 15, 2012, 37 TexReg 3586; amended to be effective March 18, 2013, 38 TexReg 1876 |
