| (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 §§168.001 - 168.202 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) Disciplinary Action.
(A) Violation of this chapter or a board rule regarding
a pain management clinic's eligibility, operation, or involvement
in dispensing, administering, or prescribing medications in a nontherapeutic
manner is grounds for disciplinary action by the Board against a certified
pain management clinic or owner or operator of a pain management clinic.
Such disciplinary action may include the temporary suspension or restriction
under §164.059, of the Act of a pain management clinic certificate,
owner or operator's license, or both.
(B) A temporary suspension or restriction hearing for
a licensee or certified pain management clinic shall be held pursuant
to the procedures of Chapter 187, Subchapter F of this title (relating
to Temporary Suspension and Restriction Proceedings). Evidence of
continuing threat to public health and welfare shall include evidence
that a pain management clinic or owner or operator of a pain management
clinic is in violation of this chapter regarding the clinic's eligibility,
operation, or involvement in dispensing, administering, or prescribing
medications in a nontherapeutic manner.
(C) Violations of this title and Chapter 168 of the
Texas Occupations Code are subject to criminal prosecution under Texas
Occupations Code §165.152.
(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. 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.
(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) A person who owns or operates a pain management
clinic is engaged in the practice of medicine. This shall include,
but is not limited to, all supervision and delegation activities related
to the pain management clinic.
(g) Pending Investigations. If an applicant for a certificate
is under investigation by the board for a violation under the Act,
board rules or other law relating to the prescribing, dispensing,
administering, supplying, or selling of a controlled substance the
board may not make a decision on the application until there is a
final disposition on the matter under investigation by the board.
(h) Cancellation of a Certificate.
(1) Voluntary Cancellation. A certificate may be cancelled
by request of the certificate holder, unless the certificate holder,
pain management clinic covered by the certificate; or the medical
director of such pain management clinic is subject of a complaint,
investigation, or disciplinary action by the Board. Requests to cancel
a certificate must be submitted to the Board in writing.
(2) Mandatory Cancellation. A certificate shall be
cancelled if the certificate holder:
(A) fails to renew the certificate before the expiration
of the grace period for renewal; or
(B) no longer meets eligibility for certification as
set forth under this chapter.
(3) Notice of Cancellation Required. Upon completing
the cancellation of a certificate, the Board will issue a notice letter
to the certificate holder. Upon receipt of the Board's notice of cancellation
letter, the certificate holder must inform all staff employed or contracted
by the clinic of the cancellation of the certificate.
(i) Voluntary Surrender of a Certificate Associated
with Disciplinary Action.
(1) A certificate may be voluntarily surrendered by
the certificate holder while the certificate holder, pain management
clinic covered by the certificate, or the medical director of such
pain management clinic is subject of a complaint, investigation, or
disciplinary action by the Board.
(2) A surrender entered by the Board under this section
shall be in lieu of a hearing or further investigation of alleged
violations of the Act and its subsequent amendments related to the
application for and/or issuance of the certificate only. A surrender
entered by the Board under this section shall be considered a surrender
associated with disciplinary action against the certificate holder
and take the form of a public order.
(3) Notwithstanding the Board's entry of a surrender
under this section, the Board retains the discretion to continue any
complaint, investigation, or disciplinary action against the holder
of the certificate surrendered, medical director of the pain management
clinic covered by the certificate surrendered, or other board licensees
for alleged violations of the Act and its subsequent amendments, including,
but not limited to the prescribing practices, supervision, and medical
record keeping at the pain management clinic covered by the certificate
surrendered.
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| 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; amended to be effective January 23, 2014, 39 TexReg 297; amended to be effective September 28, 2014, 39 TexReg 7582; amended to be effective March 15, 2016, 41 TexReg 1839 |
