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