TMB Update 2020: Board Rules on Pain Management Sherif Zaafran, - PowerPoint PPT Presentation

TMB Update 2020: Board Rules on Pain Management Sherif Zaafran, MD, FASA President, TMB

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.”

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 Sherif Zaafran, M.D.- President Kandace B. Farmer, D.O. -Vice President Michael Cokinos– Secretary Arun Agarwal Roberto D. Martinez, M.D. Sharon Barnes Linda Molina J.D. Devinder S. Bhatia, M.D. LuAnn R. Morgan George L. De Loach, D.O. Jayaram B. Naidu, M.D. Satish Nayak, M.D. James “JD” Distefano, D.O., Kandace B. Farmer, D.O. Manuel “Manny” Quinones, Jr., M.D. Robert Gracia Jason K. Tibbels, M.D. Tomeka M. Herod David G. Vanderweide, M.D. Jeffrey L. Luna, M.D.

What We Will Cover • The enforcement process generally • Statutes and rules on pain management • The Prescription Monitoring Program • PMC inspections

Physician Licenses Issued 6000 4869 4862 5000 47194514 4295 4093 3994 3621 4000 3522 3436 3630 3594 3129 3000 2000 1000 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Licensee Demographics FY2020 FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY 17 FY18 FY2019 Licensed 100,014 69,133 72,948 75,132 77,421 79,613 82,230 84,792 85,987 89,007 92,036 96,168 Physicians 1,318 Acupuncturists 875 961 1,019 1,052 1,107 1,188 1,214 1,241 1,260 1,275 1312 Medical 608 671 649 653 655 Physicists Medical 27,974 Radiologic 26,868 27,168 28,108 28,046 Technologists Non-certified 4,306 4,764 4,008 3,738 3790 Technicians 431 Perfusionists 397 400 399 420 Physician 10,482 4,854 5,633 6,066 6,323 6,736 7,278 7,662 8,058 8,556 9,089 9791 Assistants Respiratory 15,869 15,540 15,649 15,494 15,330 Therapists Surgical 662 520 604 269 314 314 345 359 376 418 452 469 Assistants

Total Licensees 180,000 147,168 151,312 161,779 157,090 160,000 140,000 143,978 120,000 94,086 87,815 91,072 100,000 80,000 60,000 40,000 20,000 0 2013 2014 2015 2016 2017 2018 2019 2020

Enforcement Process

Complaints R Recei ceived ed FY08 – FY2 FY20 10000 9169 8955 8799 9000 8182 8114 7821 8000 7550 7510 7031 6968 6849 6847 7000 6514 6000 5000 4000 3000 2000 1000 0 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Complaint Sources .06 % Consumers Insurance Companies .1 % 1.2 % TMB Licensee 1.6 % Other Govt. Agency 1.7 % Other Health Professionals 2.2 % Annual Registration Law Enforcement 3.2 % 6% TMB 6 % Incarcerated Patient 21 % Friend or Family… 56.8 % Patient 0 10 20 30 40 50 60 *TMB category includes registrations responses, CME audits, medical malpractice reviews, newspaper items, and board discovered violations.

Complaints by Subject Unprofessional Conduct 10% Unlicensed Practice of Medicine Quality of Care 6% 44% Impairment 2.5% Others 5% Crime/Fraud/Other Non-physician Rules investigations 15% 17%

Complaints FY 20 Total Complaints 9,169 Remain 60% 1 st chance Jurisdictional 5,533 to respond Remain 35% 2 nd chance Filed 1915 to respond Remain 20% Legal 1,012 3rd chance to respond Remain 11% Orders: 242 4th chance Remedial Plans: 122 to respond Remain 4% 5 th chance 36 SOAH Cases to respond Remain.4%

Remedial Plans • Non-disciplinary in nature • Not reportable to NPDB • Cannot be used in cases of • Patient death • Boundary violations • Felonies Agreed Orders • Disciplinary in nature • Reportable to NPDB • Must be used in cases of • Patient death • Boundary violations • Felonies

Areas of Concern • Outdated prescribing practices • normally not pain specialists • physicians with a small percentage of chronic pain patients • too trusting - especially with long term patients • no controls in place: • accept excuses for lost meds • early refills • no UDS • inadequate pain management contracts • not checking the PMP regularly.

Areas of Concern • An “everyone else is wrong” perspective: • ideologically adverse to the prevailing standard of care • Unwilling or unable to recognize and acknowledge mistakes • Not willing to adapt to new requirements • Places monetary gain over patient health and safety

Areas of Concern • High volume prescribers may be audited: • If audit raises concerns, the Board may investigate. • Audit examines: • Whether prescriber is registered as a PMC • Whether prescriber has ABMS sub-specialty in pain management • Volume of opioids, benzos, and opioids/benzos in combination • Patient overdoses • Midlevel prescribers PMP report • Criminal and TMB disciplinary history

Areas of Concern • Pill mills • everyone pays cash • everyone gets prescription • nearly 100% get an opioid and a majority either a benzo or Soma • may or may not be records, diagnostic imaging, or UDS • pre-signed prescriptions • sometimes even discharge patients, but • no legitimate practice of medicine occurring

Bullet Proof Glass

This Receptionist had a Glock

Money counters.. Cameras

But I’m doing things right, how do I avoid investigations? • Keep up with the evolving standard of care • Follow the rules • Document that you followed the rules • You can’t prevent complaints, but treat patients correctly, think through the tough calls, and document your rationale in your medical records.

Statutes and Rules

Statutes and Rules on Pain Management • Statutes • Tex. Occ. Code, Chapter 163: Pain Management Clinics • Tex. Occ. Code § 164.051(a)(6): TMB enforcement authority • Tex. Health & Safety Code, Chapter 483: Recordkeeping requirements for prescription drugs • Tex. Health & Safety Code § 481.075(e)(1): information that must be included in prescriptions • Rules • Chapter 170: Pain Management • Chapter 195: Pain Management Clinics • Chapter 193: Standing Delegation Orders (supervision and delegation of midlevels) • 190.8(1)(A): Physicians must meet the standard of care

Check the PMP • As of March 2020, Texas law requires prescribers to check a patients prescribing history before every prescription for: • opioids • benzodiazipines • barbituates • Carisoprodol • Exception: if a patient is a cancer patient or in hospice • You must document this in their medical record

Prescription Monitoring Program (PMP) • Docs can look up patients’ prescribing history here • Monitors the prescription and dispensing of all controlled substances in TX and also shows surrounding states • Pharmacists must report Rx for Schedule II-V drugs within one business day • Docs can access the PMP through the Tex. Pharmacy Board’s website

Pain Management Clinics

Do you need to register? • You must register with TMB, if: • More than 50% of patients receive a monthly prescription for one or more of these drugs: • opioids • benzodiazepines • barbiturates • soma • And you do not qualify for an exemption • Suboxone is not included in this • Chapter 195 of the Board Rules

PMC: Exemptions from Registration • Medical or dental school or an associated outpatient clinic • Hospital, including any outpatient facility or clinic of a hospital • Hospice • Texas state or federal facility • Nonprofit health organization

PMC: Registration Exemptions 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. • Do you have an ABMS or AOA sub-board certification in pain management? • If you don’t, then you might not qualify for this exemption. • Do you personally perform other treatments on over ½ your patients? • If you don’t, then you might not qualify for this exemption.

SB315(2017): Addressing the opioid epidemic • Subpoenas for medical records are enforceable by a state judge • TMB inspection authority clarified to include registered and unregistered PMC • Opioid antagonists • TMB guidelines for prescribing and administering (170.4 through 170.8 proposed) • Physicians exempt from liability.

Criteria for inspecting clinics • Over 50% of patients get an opioid, benzo, Soma, or barbiturate • The clinic is w/out PMC registration • Patients traveling far distances to see provider • Multiple family members treated on same day • High volume prescriber of controlled substances • Prescribing the cocktail or a variant to most patients • Complaints about inappropriate prescribing • Patient overdoses/deaths • Arrests of clinic providers

PMC Employee Requirements • 10 hours of CME in pain management for any personnel with patient contact • Director on site at least 33% of time • Director reviews at least 33% of charts • Follow protocols in compliance with TMB Rule 170 on pain management