81R7037 SJM-D By: Hamilton H.B. No. 4334 A BILL TO BE ENTITLED AN ACT relating to the licensing and regulation of pain management clinics. BE IT ENACTED BY THE LEGISLATURE OF THE STATE OF TEXAS: SECTION 1. Subtitle B, Title 3, Occupations Code, is amended by adding Chapter 167 to read as follows: CHAPTER 167. REGULATION OF PAIN MANAGEMENT CLINICS SUBCHAPTER A. GENERAL PROVISIONS Sec. 167.001. DEFINITION. In this chapter, "pain management clinic" means a publicly or privately owned facility for which a majority of patients are issued a prescription for opioids, benzodiazepines, or barbiturates, including carisoprodol. Sec. 167.002. EXEMPTIONS. This chapter does not apply to: (1) a medical or dental school or an outpatient clinic associated with a medical or dental school; (2) a hospital, including any outpatient facility or clinic of a hospital; (3) a hospice established under 40 T.A.C. Section 97.403 or defined by 42 C.F.R. Section 418.3; (4) a facility maintained or operated by this state; (5) a clinic maintained or operated by the United States; or (6) a medical facility otherwise licensed and regulated by the board. [Sections 167.003-167.050 reserved for expansion] SUBCHAPTER B. POWERS AND DUTIES OF BOARD Sec. 167.051. ADOPTION OF RULES. (a) The board shall adopt rules necessary to implement this chapter, including rules to address, for a pain management clinic: (1) the operation of the clinic; (2) personnel requirements for the clinic, including requirements for a physician who practices at a clinic; (3) standards to ensure quality of patient care; (4) licensing application and renewal procedures and requirements; (5) inspections and complaint investigations; and (6) patient billing procedures. (b) The board by rule shall prescribe fees under this chapter in amounts sufficient to administer the requirements of this chapter. Sec. 167.052. INSPECTIONS. The board may inspect a pain management clinic, including the documents of a physician practicing at the clinic, at reasonable times as necessary to ensure compliance with this chapter. Sec. 167.053. COMPLAINTS. The board shall investigate a complaint alleging a violation of this chapter or a rule adopted under this chapter by a pain management clinic licensed under this chapter or a physician who owns or operates a clinic in the same manner as other complaints under this subtitle. [Sections 167.054-167.100 reserved for expansion] SUBCHAPTER C. LICENSING OF CLINIC Sec. 167.101. LICENSE REQUIRED. (a) A pain management clinic may not operate in this state unless the clinic is licensed under this chapter. (b) A license issued under this chapter is not transferable or assignable. Sec. 167.102. LICENSE APPLICATION AND ISSUANCE. (a) A physician who owns or operates a pain management clinic shall apply for a license for the clinic under this chapter. A pain management clinic must be owned and operated by a medical director who is a physician who practices in this state under an unrestricted license. (b) An applicant for a license under this chapter must submit an application to the board on a form prescribed by the board. (c) Each application must be accompanied by a nonrefundable license fee, not to exceed $1,000, in an amount set by the board. (d) The board shall issue a license if, after inspection and investigation, it finds that the clinic meets the requirements of this chapter and the standards adopted by the board under this chapter. [Sections 167.103-167.150 reserved for expansion] SUBCHAPTER D. LICENSE RENEWAL Sec. 167.151. EXPIRATION OF LICENSE. (a) A license issued under this chapter expires on the second anniversary of the date it is issued. (b) The board shall grant a 180-day grace period from the expiration date of a license to renew the license. (c) The owner or operator of a pain management clinic for which a license has expired may not continue to operate the clinic until the clinic's license is renewed. Sec. 167.152. REQUIREMENTS FOR RENEWAL. (a) The owner or operator of a pain management clinic may apply to renew a license issued to the clinic under this chapter by: (1) submitting a renewal application to the board on the form prescribed by the board before the expiration of the grace period under Section 167.151; (2) paying the renewal fee, not to exceed $1,000, set by the board; (3) passing an inspection of the pain management clinic to ensure compliance with this chapter; and (4) complying with any other requirements adopted by board rule. (b) The board may waive the renewal fee for a clinic if no complaints against the clinic exist in the board's records. (c) The board may waive a license renewal inspection for a clinic if no complaints against the clinic exist in the board's records. (d) If a license is not renewed before the expiration of the grace period under Section 167.151, the clinic must reapply for an original license to operate the clinic. Sec. 167.153. RENEWAL FEE FOR LATE RENEWAL. A pain management clinic with a license that has been expired for 90 days or less may renew the license by paying to the board a fee that is equal to 1-1/4 times the amount of the renewal fee for the license. If a license has been expired for more than 90 days but less than 180 days, the clinic may renew the license by paying to the board a fee that is equal to 1-1/2 times the amount of the renewal fee for the license. [Sections 167.154-167.200 reserved for expansion] SUBCHAPTER E. REGULATION OF CLINICS; ENFORCEMENT Sec. 167.201. REGULATION OF PERSON AFFILIATED WITH CLINIC. (a) 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: (1) have been denied, by any jurisdiction, a license under which the person may prescribe, dispense, administer, supply, or sell a controlled substance; (2) have held a license issued by any jurisdiction, under which the person may prescribe, dispense, administer, supply, or sell a controlled substance, that has been restricted; or (3) have been subject to disciplinary action by any licensing entity for conduct that was a result of dependency on drugs or alcohol. (b) A clinic may not be owned wholly or partly by a person who has been convicted of or pled nolo contendere to: (1) an offense that constitutes a felony; or (2) 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 Section 551.003(11). (c) The owner or operator of a pain management clinic shall: (1) be on-site at the clinic at least 33 percent of the clinic's total number of operating hours; and (2) review at least 33 percent of the total number of patient files of the clinic, including the patient files of a clinic employee or contractor to whom authority for patient care has been delegated by the clinic. Sec. 167.202. DISCIPLINARY ACTION. (a) A violation of this chapter or a rule adopted under this chapter is grounds for disciplinary action against a pain management clinic licensed under this chapter or an owner or operator of a clinic licensed under this chapter. (b) A violation of this chapter may be enforced in the same manner as any other violation of this subtitle. SECTION 2. (a) Not later than March 1, 2010, the Texas Medical Board shall adopt the rules required by Chapter 167, Occupations Code, as added by this Act. (b) Notwithstanding Section 167.101, Occupations Code, as added by this Act, a pain management clinic must obtain a license required by that section not later than September 1, 2010. SECTION 3. (a) Except as provided by Subsection (b) of this section, this Act takes effect September 1, 2009. (b) Section 167.101, Occupations Code, as added by this Act, takes effect September 1, 2010.