82R24735 YDB-D
By: Truitt H.B. No. 1621
Substitute the following for H.B. No. 1621:
By: Kolkhorst C.S.H.B. No. 1621
A BILL TO BE ENTITLED
AN ACT
relating to the licensing and regulation of diagnostic imaging
facilities and fluoroscopy-guided pain management procedure
centers; providing penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle B, Title 4, Health and Safety Code, is
amended by adding Chapter 260A to read as follows:
CHAPTER 260A. DIAGNOSTIC IMAGING FACILITIES AND FLUOROSCOPY-GUIDED
PAIN MANAGEMENT PROCEDURE CENTERS
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 260A.001. SHORT TITLE. This chapter may be cited as
the Texas Diagnostic Imaging Facilities and Fluoroscopy-Guided
Pain Management Procedure Centers Licensing Act.
Sec. 260A.002. DEFINITIONS. In this chapter:
(1) "C-arm fluoroscope" means a fluoroscopic x-ray
system that connects or coordinates the image receptor and the
x-ray tube housing assembly to maintain a spatial relationship and
that allows a change in the direction of the beam axis with respect
to a patient without moving the patient.
(2) "Commissioner" means the commissioner of state
health services.
(3) "Department" means the Department of State Health
Services.
(4) "Diagnostic imaging facility" means a facility at
which a diagnostic imaging service is provided to a patient by a
diagnostic imaging provider.
(5) "Diagnostic imaging provider" means any person
that provides a diagnostic imaging service to a patient for a fee.
(6) "Diagnostic imaging service" means magnetic
resonance imaging, computed tomography, positron emission
tomography, or any hybrid technology that combines any of those
imaging modalities.
(7) "Executive commissioner" means the executive
commissioner of the Health and Human Services Commission.
(8) "Facility" means a diagnostic imaging facility or
fluoroscopy-guided pain management procedure center.
(9) "Fluoroscope" means a radiologic instrument
equipped with a fluorescent screen on which opaque internal
structures can be viewed as moving shadow images formed by the
differential transmission of x-rays throughout the body or a
similar radiologic or other instrument, as defined by executive
commissioner rule.
(10) "Fluoroscopy-guided pain management procedure
center" means a facility at which a majority of patients at the
facility are provided a fluoroscopy-guided pain management service
by a pain management provider.
(11) "Fluoroscopy-guided pain management service"
means the diagnosis and treatment of chronic pain through the use of
a fluoroscope or C-arm fluoroscope and interventional techniques,
including:
(A) ablation of targeted nerves; and
(B) percutaneous precision needle placement
within the spinal column with placement of drugs such as local
anesthetics, steroids, or analgesics in targeted areas of the
spinal column.
(12) "Pain management provider" means any person that
provides a fluoroscopy-guided pain management service to a patient
for a fee.
(13) "Person" means an individual, firm, partnership,
corporation, or association.
Sec. 260A.003. DIAGNOSTIC IMAGING AND FLUOROSCOPY-GUIDED
PAIN MANAGEMENT PROCEDURE FACILITY LICENSING FUND. All licensing
fees collected under this chapter shall be deposited in the state
treasury to the credit of the diagnostic imaging and
fluoroscopy-guided pain management procedure facility licensing
fund and shall be appropriated to the department only to administer
and enforce this chapter.
[Sections 260A.004-260A.050 reserved for expansion]
SUBCHAPTER B. FACILITY LICENSING AND REGULATION
Sec. 260A.051. LICENSE REQUIRED. (a) Except as provided by
Section 260A.052, a person may not establish or operate a
diagnostic imaging facility in this state unless the person holds a
diagnostic imaging facility license issued under this chapter.
(b) Except as provided by Section 260A.053, a person may not
establish or operate a fluoroscopy-guided pain management
procedure center in this state unless the person holds a
fluoroscopy-guided pain management procedure center license issued
under this chapter.
(c) Each separate facility location must have a separate
license.
(d) A license issued under this chapter is not transferable
or assignable.
Sec. 260A.052. EXEMPTIONS FROM DIAGNOSTIC IMAGING FACILITY
LICENSING REQUIREMENT. The following facilities and offices are
not required to hold a diagnostic imaging facility license issued
under this chapter:
(1) an institution licensed under Chapter 242;
(2) a hospital licensed under Chapter 241 or Chapter
577, or an outpatient clinic or facility of a hospital that meets
the requirements for provider-based status as prescribed by the
Centers for Medicare and Medicaid Services;
(3) an ambulatory surgical center licensed under
Chapter 243;
(4) a medical or dental school or an outpatient clinic
associated with a medical or dental school;
(5) a health facility, including a hospital,
maintained or operated by this state or by a hospital district
created under general or special law;
(6) a clinic or hospital maintained or operated by the
United States;
(7) an office of or clinic owned or operated by:
(A) a physician licensed under Subtitle B, Title
3, Occupations Code; or
(B) a dentist licensed under Subtitle D, Title 3,
Occupations Code; or
(8) a diagnostic imaging facility that uses only
dental diagnostic technology, which may include cone-beam computed
tomography, to obtain images of the maxillofacial region.
Sec. 260A.053. EXEMPTIONS FROM FLUOROSCOPY-GUIDED PAIN
MANAGEMENT PROCEDURE CENTER LICENSING REQUIREMENT. The following
facilities and offices are not required to hold a
fluoroscopy-guided pain management procedure center license issued
under this chapter:
(1) a pain management clinic that is certified under
Subtitle B, Title 3, Occupations Code;
(2) an institution licensed under Chapter 242;
(3) a hospital licensed under Chapter 241 or Chapter
577, or an outpatient clinic or facility of a hospital that meets
the requirements for provider-based status as prescribed by the
Centers for Medicare and Medicaid Services;
(4) an ambulatory surgical center licensed under
Chapter 243;
(5) a medical or dental school or an outpatient clinic
associated with a medical or dental school;
(6) a hospice licensed under Chapter 142 to provide
hospice services in this state or a hospice as defined by 42 C.F.R.
Section 418.3;
(7) a health facility, including a hospital,
maintained or operated by this state or by a hospital district
created under general or special law;
(8) a clinic or hospital maintained or operated by the
United States;
(9) an office of or clinic owned or operated by:
(A) a physician licensed under Subtitle B, Title
3, Occupations Code; or
(B) a dentist licensed under Subtitle D, Title 3,
Occupations Code; or
(10) a fluoroscopy-guided pain management procedure
center that uses only dental diagnostic technology, which may
include cone-beam computed tomography, to obtain images of the
maxillofacial region.
Sec. 260A.054. LICENSE APPLICATION AND ISSUANCE. (a) An
applicant for a license under this chapter must submit to the
department an application on a form prescribed by the department.
(b) The application must contain evidence that the facility
has on staff at least one physician licensed under Subtitle B, Title
3, Occupations Code.
(c) Each application must be accompanied by a nonrefundable
license fee in an amount set by the department.
(d) The department shall issue a license for a facility
under this chapter if, after inspection and investigation of the
facility, the department determines the applicant and the facility
meet the requirements of this chapter and the rules and standards
adopted for that type of facility by the executive commissioner
under this chapter.
Sec. 260A.055. LICENSE RENEWAL. (a) A license issued under
this chapter expires on the third anniversary of the date of
issuance. A person may apply to renew a facility license by:
(1) submitting a renewal application to the department
on the form prescribed by the department before expiration of the
license;
(2) submitting the renewal fee in the amount required
by the department; and
(3) complying with any other requirements specified by
executive commissioner rule.
(b) The owner or operator of a facility whose license has
expired may not continue to operate the facility until the license
is renewed.
[Sections 260A.056-260A.100 reserved for expansion]
SUBCHAPTER C. POWERS AND DUTIES OF DEPARTMENT AND EXECUTIVE
COMMISSIONER
Sec. 260A.101. ADOPTION OF RULES. (a) The executive
commissioner shall adopt rules necessary to implement this chapter,
including rules to address, for each type of facility:
(1) requirements for the issuance, renewal, denial,
suspension, probation, and revocation of a license to operate a
facility;
(2) minimum standards for aspects of the operation of
the facility that the executive commissioner considers necessary to
protect the facility's patients and the public, including minimum
standards for:
(A) the qualifications for the facility's
professional staff and other personnel;
(B) the equipment, including imaging equipment,
essential to the health and welfare of the facility's patients; and
(C) the sanitary and hygienic conditions within
the premises of the facility;
(3) minimum design standards for the premises of a
facility necessary to ensure the health and safety of the
facility's patients;
(4) the establishment of a quality assurance program
for patient care; and
(5) if the facility is owned wholly or partly by a
physician or dentist, the provision of a disclosure to the
facility's patients of the physician's or dentist's ownership
interest in the facility and, at the option of the facility's
individual patients, the provision of a list of alternative service
providers for the services provided by the facility.
(b) For purposes of regulation of fluoroscopy-guided pain
management procedure centers, the executive commissioner by rule
shall adopt standards for determining whether a majority of
patients at a facility are provided a fluoroscopy-guided pain
management service by a pain management provider.
(c) In adopting the rules required under Subsection (a), the
executive commissioner may adopt different minimum standards and
requirements to reflect the different services provided and the
purposes served by each type of facility.
(d) This section does not authorize the executive
commissioner to:
(1) establish the qualifications of a licensed
practitioner; or
(2) permit a person to provide health care services
who is not authorized to provide those services under another state
law.
Sec. 260A.102. INSPECTIONS. The department may inspect a
facility at reasonable times as necessary to assure compliance with
this chapter and the rules adopted under this chapter.
Sec. 260A.103. FEES. The department shall set fees imposed
under this chapter in amounts reasonable and necessary to cover the
cost of administering and enforcing this chapter.
[Sections 260A.104-260A.150 reserved for expansion]
SUBCHAPTER D. GENERAL ENFORCEMENT
Sec. 260A.151. DENIAL, SUSPENSION, PROBATION, OR
REVOCATION OF LICENSE. (a) The department may deny, suspend, or
revoke a license issued under this chapter for a violation of this
chapter or a rule adopted under this chapter.
(b) Except as provided by Section 260A.152, the procedures
by which the department denies, suspends, or revokes a license and
by which those actions are appealed are governed by the procedures
for a contested case hearing under Chapter 2001, Government Code.
(c) If the department finds that a facility is in repeated
noncompliance with this chapter or rules adopted under this chapter
but that the noncompliance does not endanger the public health and
safety, the department may schedule the facility for probation
rather than suspending or revoking the facility's license. The
department shall provide notice to the facility of the probation
and of the items of noncompliance not later than the 10th day before
the date the probation period begins. The department shall
designate a period of not less than 30 days during which the
facility will remain under probation. During the probation period,
the facility must correct the items that were in noncompliance and
report the corrections to the department for approval.
(d) The department may suspend or revoke the license of a
facility that does not correct items that were in noncompliance or
that does not comply with this chapter or the rules adopted under
this chapter within the applicable probation period.
Sec. 260A.152. EMERGENCY SUSPENSION. (a) The department
may issue an emergency order to suspend a license issued under this
chapter if the department has reasonable cause to believe that the
conduct of a license holder creates an immediate danger to the
public health and safety. An emergency suspension is effective
immediately on notice to the license holder.
(b) On written request of the license holder, the department
shall conduct a hearing not earlier than the 10th day or later than
the 30th day after the date the hearing request is received to
determine if the emergency suspension is to be continued, modified,
or rescinded.
(c) The hearing and any appeal are governed by the
department's rules for a contested case hearing and by Chapter
2001, Government Code.
Sec. 260A.153. INJUNCTION. (a) The department may
petition a district court for a temporary restraining order to
restrain a continuing violation of this chapter or the rules
adopted under this chapter if the department finds that the
violation creates an immediate threat to the health and safety of
the patients of a facility.
(b) A district court, on petition of the department and on a
finding by the court that a person is violating this chapter or the
rules adopted under this chapter, may by injunction:
(1) prohibit the person from continuing the violation;
(2) restrain or prevent the establishment or operation
of a facility without a license issued under this chapter; or
(3) grant any other injunctive relief warranted by the
facts.
(c) The attorney general shall institute and conduct a suit
authorized by this section at the request of the department. The
attorney general and the department may recover reasonable expenses
incurred in obtaining relief under this section, including court
costs, reasonable attorney's fees, investigation costs, witness
fees, and deposition expenses.
(d) Venue for a suit brought under this section is in the
county in which the facility is located or in Travis County.
Sec. 260A.154. CRIMINAL PENALTY. (a) A person commits an
offense if the person knowingly establishes or operates a facility
without the appropriate license issued under this chapter.
(b) An offense under this section is a Class C misdemeanor.
(c) Each day a violation continues constitutes a separate
offense.
Sec. 260A.155. CIVIL PENALTY. (a) A person who violates
this chapter or who fails to comply with a rule adopted by the
executive commissioner under this chapter is liable for a civil
penalty of not less than $100 or more than $500 for each violation
if the department determines the violation threatens the health and
safety of a patient of the facility.
(b) Each day a violation continues constitutes a separate
violation for the purposes of this section.
(c) The attorney general may sue to collect the penalty.
The attorney general and the department may recover reasonable
expenses incurred in obtaining relief under this section, including
court costs, reasonable attorney's fees, investigation costs,
witness fees, and deposition expenses.
(d) All penalties collected under this section shall be
deposited in the state treasury in the general revenue fund.
[Sections 260A.156-260A.200 reserved for expansion]
SUBCHAPTER E. ADMINISTRATIVE PENALTY
Sec. 260A.201. IMPOSITION OF PENALTY. The commissioner may
impose an administrative penalty on a person licensed under this
chapter who violates this chapter or a rule or order adopted under
this chapter.
Sec. 260A.202. AMOUNT OF PENALTY. (a) The amount of the
penalty may not exceed $1,000 for each violation, and each day a
violation continues or occurs is a separate violation for purposes
of imposing a penalty. The total amount of the penalty assessed for
a violation continuing or occurring on separate days under this
subsection may not exceed $5,000.
(b) The amount shall be based on:
(1) the seriousness of the violation, including the
nature, circumstances, extent, and gravity of the violation;
(2) the threat to health or safety caused by the
violation;
(3) the history of previous violations;
(4) the amount necessary to deter a future violation;
(5) whether the violator demonstrated good faith,
including when applicable whether the violator made good faith
efforts to correct the violation; and
(6) any other matter that justice may require.
Sec. 260A.203. REPORT AND NOTICE OF VIOLATION AND PENALTY.
(a) If the department initially determines that a violation
occurred, the department shall give written notice of the report by
certified mail to the person.
(b) The notice must:
(1) include a brief summary of the alleged violation;
(2) state the amount of the recommended penalty; and
(3) inform the person of the person's right to a
hearing on the occurrence of the violation, the amount of the
penalty, or both.
Sec. 260A.204. PENALTY TO BE PAID OR HEARING REQUESTED. (a)
Not later than the 20th day after the date the person receives the
notice sent under Section 260A.203, the person in writing may:
(1) accept the determination and recommended penalty
of the department; or
(2) make a request for a hearing on the occurrence of
the violation, the amount of the penalty, or both.
(b) If the person accepts the determination and recommended
penalty or if the person fails to respond to the notice, the
commissioner by order shall approve the determination and impose
the recommended penalty.
Sec. 260A.205. HEARING. (a) If the person requests a
hearing, the commissioner shall refer the matter to the State
Office of Administrative Hearings, which shall promptly set a
hearing date and give written notice of the time and place of the
hearing to the person. An administrative law judge of the State
Office of Administrative Hearings shall conduct the hearing.
(b) The administrative law judge shall make findings of fact
and conclusions of law and promptly issue to the commissioner a
proposal for a decision about the occurrence of the violation and
the amount of a proposed penalty.
Sec. 260A.206. DECISION BY COMMISSIONER. (a) Based on the
findings of fact, conclusions of law, and proposal for a decision,
the commissioner by order may:
(1) find that a violation occurred and impose a
penalty; or
(2) find that a violation did not occur.
(b) The notice of the commissioner's order under Subsection
(a) that is sent to the person in accordance with Chapter 2001,
Government Code, must include a statement of the right of the person
to judicial review of the order.
Sec. 260A.207. OPTIONS FOLLOWING DECISION: PAY OR APPEAL.
Not later than the 30th day after the date the order of the
commissioner under Section 260A.206 that imposes an administrative
penalty becomes final, the person shall:
(1) pay the penalty; or
(2) file a petition for judicial review of the
commissioner's order contesting the occurrence of the violation,
the amount of the penalty, or both.
Sec. 260A.208. STAY OF ENFORCEMENT OF PENALTY. (a) Within
the period prescribed by Section 260A.207, a person who files a
petition for judicial review may:
(1) stay enforcement of the penalty by:
(A) paying the penalty to the court for placement
in an escrow account; or
(B) giving the court a supersedeas bond approved
by the court that:
(i) is for the amount of the penalty; and
(ii) is effective until all judicial review
of the commissioner's order is final; or
(2) request the court to stay enforcement of the
penalty by:
(A) filing with the court a sworn affidavit of
the person stating that the person is financially unable to pay the
penalty and is financially unable to give the supersedeas bond; and
(B) sending a copy of the affidavit to the
commissioner by certified mail.
(b) If the commissioner receives a copy of an affidavit
under Subsection (a)(2), the commissioner may file with the court,
not later than the fifth day after the date the copy is received, a
contest to the affidavit. The court shall hold a hearing on the
facts alleged in the affidavit as soon as practicable and shall stay
the enforcement of the penalty on finding that the alleged facts are
true. The person who files an affidavit has the burden of proving
that the person is financially unable to pay the penalty and to give
a supersedeas bond.
Sec. 260A.209. COLLECTION OF PENALTY. (a) If the person
does not pay the penalty and the enforcement of the penalty is not
stayed, the penalty may be collected.
(b) The attorney general may sue to collect the penalty and
may recover reasonable expenses, including attorney's fees,
incurred in recovering the penalty.
(c) A penalty collected under this subchapter shall be
deposited in the state treasury in the general revenue fund.
Sec. 260A.210. DECISION BY COURT. (a) If the court
sustains the finding that a violation occurred, the court may
uphold or reduce the amount of the penalty and order the person to
pay the full or reduced amount of the penalty.
(b) If the court does not sustain the finding that a
violation occurred, the court shall order that a penalty is not
owed.
Sec. 260A.211. REMITTANCE OF PENALTY AND INTEREST. (a) If
the person paid the penalty and if the amount of the penalty is
reduced or the penalty is not upheld by the court, the court shall
order, when the court's judgment becomes final, that the
appropriate amount plus accrued interest be remitted to the person
not later than the 30th day after the date that the judgment of the
court becomes final.
(b) The interest accrues at the rate charged on loans to
depository institutions by the New York Federal Reserve Bank.
(c) The interest shall be paid for the period beginning on
the date the penalty is paid and ending on the date the penalty is
remitted.
Sec. 260A.212. RELEASE OF BOND. (a) If the person gave a
supersedeas bond and the penalty is not upheld by the court, the
court shall order, when the court's judgment becomes final, the
release of the bond.
(b) If the person gave a supersedeas bond and the amount of
the penalty is reduced, the court shall order the release of the
bond after the person pays the reduced amount.
Sec. 260A.213. ADMINISTRATIVE PROCEDURE. A proceeding to
impose the penalty is considered to be a contested case under
Chapter 2001, Government Code.
SECTION 2. (a) Not later than January 1, 2012, the
executive commissioner of the Health and Human Services Commission
shall adopt the rules required by Chapter 260A, Health and Safety
Code, as added by this Act.
(b) Notwithstanding Section 260A.051, Health and Safety
Code, as added by this Act, a person is not required to hold a
diagnostic imaging facility license or a fluoroscopy-guided pain
management procedure center license until March 1, 2012.
SECTION 3. (a) Except as provided by Subsection (b) of
this section, this Act takes effect September 1, 2011.
(b) Subchapters D and E, Chapter 260A, Health and Safety
Code, as added by this Act, take effect September 1, 2012.