82R8165 YDB-F By: Thompson 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 person licensed as a health care professional or authorized to practice in health care under Subtitle B, C, or E. (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. 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. [Sections 113.003-113.050 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 unless the person holds 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; and (2) a hospital licensed under Chapter 241, Health and Safety Code. 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. 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) In this section, "third party payor" means: (1) a person authorized to engage in business involving the payment of money or another thing of value in the event of loss resulting from disability incurred as a result of accident or sickness, as described in the Insurance Code; (2) a health plan offered by an employer under the provisions of the Employee Retirement Income Security Act of 1974 (29 U.S.C. Section 1001 et seq.); (3) a publicly funded program of health care services, including Medicaid or the state child health plan; or (4) any person, other than a patient, that pays a health care provider to provide designated health services or supplies, including an insurance company or a health maintenance organization. (b) The owner or operator of a diagnostic imaging facility that provides a diagnostic imaging service for a referring health care provider shall report to the department: (1) the identity of the referring health care provider; (2) whether the referring health care provider is an investor in the diagnostic imaging facility and the exact nature of any legal, beneficial ownership, or investment interest the referring health care provider has in the diagnostic imaging facility; (3) the total number of patients who received diagnostic imaging services at the diagnostic imaging facility and who were referred by the health care provider; and (4) the additional claims data required by the department. (c) A health care provider making a referral for diagnostic imaging services as described by this section must: (1) disclose in writing to the provider's patients and any third party payor for a patient the provider's investment interest in the diagnostic imaging facility; (2) advise the provider's patients and any third party payor for the patient 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. (d) The report required under Subsection (b) may be in the form of a bill for services provided by the diagnostic imaging facility in accordance with rules for filing a clean claim adopted by the Texas Department of Insurance (28 T.A.C. Section 21.2803), as those rules existed on September 1, 2011. (e) A report required by this section must be submitted to the department in the format or method required by the department. Sec. 113.073. PUBLIC INFORMATION. Information collected under Section 113.072(b) shall be made available to the public. Sec. 113.074. DISCIPLINARY ACTION. A diagnostic imaging facility's failure to report information required by this subchapter is grounds for disciplinary action, including the imposition of an administrative penalty, by the department. [Sections 113.075-113.100 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) The Department of State Health Services shall conduct a study of the information required to be submitted to the department under Subchapter B-1, Chapter 113, Occupations Code, as added by this Act. (b) In conducting the study, the department shall compare the rates at which diagnostic imaging services were prescribed by health care providers of the same specialty who have legal, beneficial ownership, or investment interest in the diagnostic imaging services prescribed for the patient's care and those who do not have a legal, beneficial ownership, or investment interest in the prescribed diagnostic imaging services. (c) Not later than January 1, 2013, the department shall submit a report regarding the study to the lieutenant governor and the speaker of the house of representatives. SECTION 3. (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 4. 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 5. This Act takes effect September 1, 2011.