82R23747 YDB-F
By: Thompson, et al. H.B. No. 1809
Substitute the following for H.B. No. 1809:
By: Kuempel C.S.H.B. No. 1809
A BILL TO BE ENTITLED
AN ACT
relating to the registration of diagnostic imaging equipment, the
accreditation of diagnostic imaging facilities, and the regulation
of diagnostic imaging providers; providing penalties.
BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS:
SECTION 1. Subtitle A, Title 3, Occupations Code, is
amended by adding Chapter 113 to read as follows:
CHAPTER 113. DIAGNOSTIC IMAGING
SUBCHAPTER A. GENERAL PROVISIONS
Sec. 113.001. DEFINITIONS. In this chapter:
(1) "Department" means the Department of State Health
Services.
(2) "Diagnostic imaging equipment" means a machine or
equipment used to provide a diagnostic imaging service to a
patient.
(3) "Diagnostic imaging facility" means any facility,
office, clinic, imaging center, hospital, or other location where a
diagnostic imaging service is provided to a patient for a fee.
(4) "Diagnostic imaging provider" means a health care
provider who performs a diagnostic imaging service on a patient for
a fee at a diagnostic imaging facility.
(5) "Diagnostic imaging service" means magnetic
resonance imaging, computed tomography, positron emission
tomography, or any hybrid technology that combines any of those
imaging modalities.
(6) "Health care provider" means a physician licensed
under Subtitle B, Title 3, or a nurse licensed under Subtitle E,
Title 3.
(7) "Patient" means a person who receives a physical
examination, evaluation, diagnosis, or treatment from a health care
provider.
(8) "Referral" means a health care provider's request
for or ordering of a diagnostic imaging service for a patient. The
term does not include a request for or ordering of nondiagnostic
imaging obtained for the sole purpose of direct incorporation into
treatment planning systems in the delivery of radiation therapy.
Sec. 113.002. RULES. The executive commissioner of the
Health and Human Services Commission, on behalf of the department
and as necessary to protect the public health and safety, shall
adopt rules specifying the procedures health care providers and
diagnostic imaging providers must use to comply with this chapter.
Sec. 113.003. SAFETY STANDARDS. Notwithstanding any other
law, a person who operates a diagnostic imaging facility that is
registered under this chapter or is exempt from registration under
this chapter may adopt and enforce safety standards that conform to
the recommendations of the American College of Radiology's ACR
Guidance Document for Safe MR Practices as the document existed on
January 1, 2011, or a more current version of the document approved
by the department.
[Sections 113.004-113.050 reserved for expansion]
SUBCHAPTER B. REGISTRATION OF FACILITIES
Sec. 113.051. REGISTRATION REQUIRED. Except as provided by
Section 113.052, a person may not operate a diagnostic imaging
facility in this state without a diagnostic imaging facility
certificate of registration issued under this subchapter.
Sec. 113.052. EXEMPTIONS FROM REGISTRATION REQUIREMENT.
The following facilities are not required to be registered under
this chapter:
(1) a birthing center licensed under Chapter 244,
Health and Safety Code;
(2) a hospital licensed under Chapter 241, Health and
Safety Code;
(3) a hospital owned and operated by this state;
(4) a diagnostic imaging facility located within or
connected to a hospital described by Subdivision (2) or (3);
(5) a diagnostic imaging facility owned or operated by
a hospital described by Subdivision (2) or (3) that is:
(A) surveyed as a service of the hospital by an
organization that has been granted deeming authority as a national
accreditation program for hospitals by the Centers for Medicare and
Medicaid Services; or
(B) granted provider-based status by the Centers
for Medicare and Medicaid Services; and
(6) a diagnostic imaging facility that uses only
dedicated dental diagnostic technology, which may include
cone-beam computed tomography used only to obtain images of the
maxillofacial region.
Sec. 113.053. APPLICATION; ISSUANCE. (a) An applicant for
a diagnostic imaging facility certificate of registration shall
submit to the department an application on the form prescribed by
the department.
(b) The department shall issue a diagnostic imaging
facility certificate of registration to an applicant if:
(1) the applicant pays any required fee; and
(2) the department determines the applicant's facility
meets the accreditation requirements under Section 113.054 and
department rule.
Sec. 113.054. ACCREDITATION OF FACILITIES. (a) The
department may not issue a diagnostic imaging facility certificate
of registration to a person unless the person's diagnostic imaging
facility has been accredited by a nationally recognized
accreditation organization approved by the department.
(b) In approving accreditation organizations, the
department shall consider:
(1) the ability of the organization to conduct timely
reviews of accreditation applications;
(2) the organization's process for timely integration
of new technology into accreditation programs;
(3) whether the organization's criteria for
accreditation of diagnostic imaging facilities includes all of the
following:
(A) qualifications for health care providers and
medical personnel providing health care services at the facility;
(B) qualifications for and responsibilities of
medical directors, supervising health care providers, and
interpreting health care providers providing services at the
facility;
(C) procedures for ensuring that diagnostic
imaging equipment complies with established performance
specifications, such as an independent assessment of image quality
and dose and an annual survey by a medical physicist that includes
dose measurements;
(D) procedures for ensuring that the images
produced by the equipment are of diagnostic quality, including
through direct visual evaluation of representative images by a
physician trained in medical imaging;
(E) procedures for ensuring patient safety; and
(F) quality assurance reporting; and
(4) any other factors the department considers
necessary to protect the health and safety of facility patients and
the public.
(c) Notwithstanding Subsections (a) and (b), the department
shall issue a diagnostic imaging facility certificate of
registration to a person who operates a diagnostic imaging facility
accredited by a nationally recognized accreditation organization
accepted by the Centers for Medicare and Medicaid Services if the
department determines the organization's accreditation criteria
meet all department requirements.
Sec. 113.055. TERM; RENEWAL. (a) A diagnostic imaging
facility certificate of registration expires on the second
anniversary of the date of issuance.
(b) A person may renew a diagnostic imaging facility
certificate of registration by submitting to the department on the
form prescribed by the department a renewal application and any fee
required by the department.
[Sections 113.056-113.070 reserved for expansion]
SUBCHAPTER B-1. REPORTING AND DISCLOSURE OF HEALTH CARE PROVIDER
REFERRALS
Sec. 113.071. DEFINITIONS. In this subchapter:
(1) "Immediate family member" means a person's spouse,
child, child's spouse, grandchild, grandchild's spouse, parent,
parent-in-law, or sibling.
(2) "Investment interest" means:
(A) an equity or debt security issued by a
person, including:
(i) shares of stock in a corporation;
(ii) membership or other interest in a
company, including a limited liability company;
(iii) units or other interests in a
partnership, including a limited liability partnership; and
(iv) bonds, debentures, notes, or other
equity interests or debt instruments; and
(B) the rental or time sharing of imaging
equipment and office space in which a referring health care
provider receives a portion of the billing revenue.
(3) "Investor" means a person who directly or
indirectly holds a legal, beneficial ownership, or investment
interest, including an interest held through an immediate family
member, a trust, or another person related to the investor within
the meaning of "related to the provider" as defined by 42 C.F.R.
Section 413.17.
(4) "Licensing authority" means a department, board,
office, or other agency of this state that regulates a health care
provider subject to this chapter.
Sec. 113.072. REPORTING AND DISCLOSURE OF REFERRALS. A
health care provider making a referral for diagnostic imaging
services must:
(1) disclose in writing to the provider's patients the
provider's investment interest in the diagnostic imaging facility;
(2) advise the provider's patients that the patient
may choose to have another diagnostic imaging facility provide the
diagnostic imaging services; and
(3) obtain and record the patient's written consent
after the disclosure and before the diagnostic imaging services are
provided.
[Sections 113.073-113.100 reserved for expansion]
SUBCHAPTER C. CIVIL PENALTY
Sec. 113.101. CIVIL PENALTY. (a) A person who operates a
diagnostic imaging facility or a diagnostic imaging provider that
violates this chapter or rules adopted under this chapter is
subject to a civil penalty of not more than $1,000 for each
violation.
(b) The attorney general at the request of the department
shall bring an action to collect penalties under this section. In
the suit, the department and the attorney general each may recover
reasonable expenses incurred in obtaining the penalty, including:
(1) investigation and court costs; and
(2) reasonable attorney's fees, witness fees, and
deposition expenses.
(c) Expenses recovered by the department under this section
shall be deposited in a separate account outside the state treasury
to be used by the department in the enforcement of this chapter.
SECTION 2. (a) Not later than January 1, 2012, the
executive commissioner of the Health and Human Services Commission
shall adopt the rules necessary to implement Chapter 113,
Occupations Code, as added by this Act.
(b) Notwithstanding Chapter 113, Occupations Code, as added
by this Act, a person is not required to hold a diagnostic imaging
facility certificate of registration to operate a diagnostic
imaging facility until March 1, 2012.
SECTION 3. Subchapter B-1, Chapter 113, Occupations Code,
as added by this Act, applies only to a referral or diagnostic
imaging service that occurs on or after the effective date of this
Act. A referral or service that occurs before the effective date of
this Act is governed by the law as it existed immediately before the
effective date of this Act, and that law is continued in effect for
that purpose.
SECTION 4. This Act takes effect September 1, 2011.