1. Upholding Professional Accountability: What You Need to Know About Physician Licensure, Discipline, & Regulation in Texas T EXAS M EDICAL B OARD Mari Robinson, J.D. Executive Director

2. Mission Statement “Our mission is to protect and enhance the public’s health, safety and welfare by establishing and maintaining standards of excellence used in regulating the practice of medicine and ensuring quality health care for the citizens of Texas through licensure, discipline and education.”

3. Texas Medical Board Composition 12 Physician members (9 M.D. and 3 D.O.) 7 Public members (non-physicians) Appointed by the Governor for 6 year term Board members Irvin Zeitler, D.O.- President Melinda McMichael, M.D.-Vice President Paulette Southard – Secretary Michael Arambula, M.D.Manuel Guajardo, M.D. Julie AtteburyScott Holliday, D.O. David BaucomMargret McNeese, M.D. Stanley Wang, M.D.George Willeford, III, M.D. Patrick Crocker, D.O.Allan Shulkin, M.D. Patricia BlackwellWynne Snoots, M.D. John D. EllisW. Roy Smythe, M.D. Timothy WebbCarlos Gallardo

4. Pain Management Clinics Prescribing to Friends & Family Office Based Anesthesia Contacts Board Rule 170 Prescriptive Delegation Registration

5. Los Angels Times, 9/17/11 “Propelled by an increase in prescription narcotic overdoses, drug deaths now outnumber traffic fatalities in the United States, a Times analysis of government data has found. Drugs exceeded motor vehicle accidents as a cause of death in 2009, killing at least 37,485 people nationwide, according to preliminary data from the U.S. Centers for Disease Control and Prevention.”

6. SB911 In 2009, the 81 st Legislative Session, Sen. Williams filed SB 911 to address the overwhelming issue of illegitimate pain management clinics in the state of Texas by requiring registration of all pain management clinics in the state. The law has its basis in a similar law passed by Louisiana several months before.

7. Who is covered? Pain management clinic--A publicly or privately owned facility for which a majority of patients are issued, on a monthly basis, a prescription for opioids, benzodiazepines, barbiturates, or carisoprodol, but not including suboxone.

8. Who is exempted? (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 TAC §97.403 (relating to Standards Specific to Agencies Licensed to Provide Hospice Services) or defined by 42 CFR §418.3; (4) a facility maintained or operated by this state; (5) a clinic maintained or operated by the United States; (6) a nonprofit health organization certified by the board under Chapter 177 of this title (relating to Certification of Non-Profit Health Organizations); (7) a clinic owned or operated by a physician who treats patients within the physician's area of specialty who personally uses other forms of treatment, including surgery, with the issuance of a prescription for a majority of the patients; or (8) a clinic owned or operated by an advanced practice nurse licensed in this state who treats patients in the nurse's area of specialty and personally uses other forms of treatment with the issuance of a prescription for a majority of the patients.

9. Who can get certified? Must get certified & renew every 2 years Must be owned by a physician(s) with an unrestricted license No owner can be convicted of, pled nolo contendere to, or received deferred adjudication for  A felony  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 Texas Occupations Code §551.003(11). No owner/contractor/employee may have:  Been denied DEA or had DEA restricted  have been subject to disciplinary action by any licensing entity for conduct that was a result of inappropriately prescribing, dispensing, administering, supplying, or selling a controlled substance

10. Personnel Requirements The medical director of a pain management clinic must, on an annual basis, ensure that all personnel are properly licensed, if applicable, trained to include 10 hours of continuing medical education related to pain management

11. Operational Requirements The medical director 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; (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; (3) establish protocols consistent with Chapter 170 of this title (relating to Pain Management); and

12. Operational Requirements (con’t) (4) establish quality assurance procedures to include at a minimum: (A) a practice quality plan that requires the medical director to complete at least 10 hours of continuing medical education in the area of pain management; (B) documentation of the background, training, and certifications for all clinical staff; (C) a written drug screening policy and compliance plan for patients receiving chronic opioids; (D) performance of periodic quality measures of medical and procedural outcomes and complications that may include questionnaires or surveys for activities of daily living scores, pain scores, and standardized scales.

13. Billing The medical director of a pain management clinic must ensure that adequate billing records are maintained for all patients and made available to the board, upon request. Billing records shall include the amount paid, method of payment, and description of services.

14. Quick Numbers ● We have received 544 applications: ● 384 have been granted ● 21 have been denied ● 54 withdrawals ● 85 are pending ● Most denials have been issued due to: ● Current board order ● Prior board order ● Criminal conviction

15. Process Step 1:Application is downloaded from the website and sent in by licensee. Step 2:The application is reviewed by a licensure analyst, and various informational sources are reviewed. Step 3:If there are no issues, the certificate is granted. If there are issues, the case is referred to file review and could be denied or more information could be requested. Step 4:If the application is denied at file review, the licensee may appeal to the licensure committee of the board.

16. Application ● Clinic Information: ● Location ● Tax ID ● Hours ● Licensee Information ● DEA/DPS numbers ● Hours on site ● Ownership information, must provide documentation ● Criminal history questions ● Board history questions.

17. Disciplinary Actions ● Since certification has began, sixteen pain management certificates have been suspended. ● During that same period, several licenses have also been suspended in connection with pain management clinics. ● Unfortunately, it looks like we are far from done. ● What are the stories of what is going on? A few examples:.

18. Disciplinary Actions (con’t) Suspension 1- the licensee employed unlicensed individuals to pose as physicians, without his supervision or presence, and to meet with patients and provide prescriptions for controlled substances using the licensee's DEA registration number and signature

19. Disciplinary Actions Suspension 2- Under surveillance, investigators observed several vehicles, some with out-of-state license plates, dropping off and picking up small groups of patients throughout the day. The patients were directed to the Clinic and pharmacy nearby by four men who appeared to be patrolling the parking lot. The dropped-off patients would enter the clinic, exit about 20 minutes later, and then go to the pharmacy next door to fill their prescriptions. The pharmacy was not reporting the drug sales to the DPS. Most of the prescriptions were for hydrocodone, and a large number of prescriptions were for Xanax and Soma as well. The three drugs are a well-known combination commonly abused and diverted for sale to addicts..

20. Disciplinary Actions Suspension 4- The licensee admitted that the clinic is owned by someone else who pays the licensee $20,000 a month with a bonus of $5,000 "if business has been good.” The licensee saw patients only for their initial visit. The clinic employed two unlicensed foreign medical graduates who examined patients and write prescriptions which the licensee signs. In addition, the licensee charges patients $200 to $300 for monthly "follow-up visits," though the patients were not actually seen but instead receive their prescriptions for controlled substances through the mail..

21. Prescribing to Friends & Family Rule 190.8(1)(M) inappropriate prescription of dangerous drugs or controlled substances to oneself, family members, or others in which there is a close personal relationship that would include the following: (i) prescribing or administering dangerous drugs or controlled substances without taking an adequate history, performing a proper physical examination, and creating and maintaining adequate records; and (ii) prescribing controlled substances in the absence of immediate need. "Immediate need" shall be considered no more than 72 hours.

22. Prescribing for Pain Board Rule 170 Evaluation of the patient Treatment plan Informed consent Agreement for treatment of chronic pain Periodic review of the treatment Consultation and referral Medical records

23. Delegation (con’t) Nurses ■ No delegation required for acts defined as Professional Nursing by Sec. 301.002. (e.g.- assessments, evaluations, observation, administration) ■APNS— can delegate diagnosis and treatment via delegation protocols, including prescription drugs Schedules III- V. Physician Assistants ■Delegation is always required. ■ can delegate diagnosis and treatment via delegation protocols, including prescription drugs Schedules III-V.

24. Prescriptive Delegation §157.052. Sites Serving Medically Underserved Populations §157.053.Prescribing at Physician Primary Practice Sites §157.0541.Prescribin g at Alternate Sites §157.054. Facility-Based Practice Sites (*Must be director /chief/chair) FTE and Facility Maximums No limits.May not exceed four PAs or APNs or their full-time equivalent at the physician’s primary practice site or at an alternate practice site. Can seek a waiver for up to six.  Long term care: May not exceed four PAs or APNs or their full-time equivalent at two facilities.  Licensed hospital: unlimited, but may only be at one facility. Patient Relationships Not addressed.Physician must have established/will establish a physician- patient relationship, but the physician is not required to see the patient within a specific period. Not addressed.

25. Prescriptive Delegation §157.052. Sites Serving Medically Underserved Populations §157.053 Prescribing at Physician Primary Practice Sites §157.0541.Prescribing at Alternate Sites §157.054. Facility- Based Practice Sites (*Must be director /chief/chair) Supervision Requirements Delegating physician: is responsible for the formulation or approval of the orders or protocols, as well as the review is on-site 10 business days during which the APN or PA is on-site providing care; receives a daily status report on any problem or complication encountered; and is available through direct telecommunication A physician shall provide continuous supervision, but the constant physical presence of the physician is not required. Delegating physician: is on-site with the APN or PA at least 10 percent of the time; is available through direct telecommunication for consultation, patient referral, or assistance with a medical emergency; reviews at least 10 percent of the medical charts at the site; must live/have primary site within 75 miles. A physician shall provide continuous supervision, but the constant physical presence of the physician is not required. Delegation must be made under a physician’s order, standing medical order, standing delegation order, or another order or protocol approved by the facility

26. Prescriptive Delegation §157.052. Sites Serving Medically Underserved Populations §157.053.Prescrib ing at Physician Primary Practice Sites §157.0541.Prescribing at Alternate Sites §157.054. Facility- Based Practice Sites (*Must be director /chief/chair) Alternate Supervising Physicians Not addressed.Allowed on a temporary basis. Advertising Requirements Must have the name & business address of the supervising physician for the site. Not addressed.

27. Office Based Anesthesia- Rule 192 You must register with the board if: Level I services--Delivery of analgesics or anxiolytics by mouth, as prescribed for the patient on order of a physician, at a dose level low enough to allow the patient to remain ambulatory. Level II services--The administration of tumescent anesthesia or the delivery of analgesics or anxiolytics by mouth in dosages greater than allowed at Level I, as prescribed for the patient on order of a physician. Level III services--Delivery of analgesics or anxiolytics other than by mouth, including intravenously, intramuscularly, or rectally. Level IV services--Delivery of general anesthetics, including regional anesthetics and monitored anesthesia care.

28. Office Based Anesthesia Board Rule 192 You must have proper training & staff: BLS, ACLS You must provide proper equipment: Oxygen, AED, Crash cart, etc. Exemptions: hospitals, government facility, some JCAHO certified centers

29. Registrations Pain Management Clinic Prescriptive Delegation & Supervision Office Based Anesthesia DEA/DPS

30. Contact Information Pre-Licensure, Registration, and Consumer Services Verifcic@tmb.state.tx.us Phone: 512-305-7030 Fax: 512-463-9416 Mailing AddressPhysical AddressTexas Medical BoardMC-240 P.O. Box 2029 333 Guadalupe, Tower III, Suite 610 Austin, TX 78768-2029 Austin, TX 78701