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.

James “JD” Distefano, D.O.,

Satish Nayak, M.D. 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

3621 3129 3522 3436 3630 3594 3994 4295 4093 47194514 4869 4862

1000 2000 3000 4000 5000 6000 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Licensee Demographics

FY09 FY10 FY11 FY12 FY13 FY14 FY15 FY16 FY 17 FY18 FY2019

FY2020

Licensed Physicians 69,133 72,948 75,132 77,421 79,613 82,230 84,792 85,987 89,007 92,036 96,168

100,014

Acupuncturists 875 961 1,019 1,052 1,107 1,188 1,214 1,241 1,260 1,275 1312

1,318

Medical Physicists 671 649 653 655

608

Medical Radiologic Technologists 26,868 27,168 28,108 28,046

27,974

Non-certified Technicians 4,764 4,008 3,738 3790

4,306

Perfusionists 397 400 399 420

431

Physician Assistants 4,854 5,633 6,066 6,323 6,736 7,278 7,662 8,058 8,556 9,089 9791

10,482

Respiratory Therapists 15,540 15,649 15,494 15,330

15,869

Surgical Assistants 269 314 314 345 359 376 418 452 469 520 604

662

Total Licensees

87,815 91,072 94,086 143,978 147,168 151,312 157,090 161,779

20,000 40,000 60,000 80,000 100,000 120,000 140,000 160,000 180,000

2013 2014 2015 2016 2017 2018 2019 2020

Enforcement Process

Complaints R Recei ceived ed FY08 – FY2 FY20

6514 6968 6849 8182 7550 7031 6847 7510 7821 8114 8955 8799 9169 1000 2000 3000 4000 5000 6000 7000 8000 9000 10000 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020

Complaint Sources

56.8 % 21 % 6 % 6% 3.2 %

2.2 %

1.7 % 1.6 % 1.2 % .1 % .06 %

10 20 30 40 50 60

Patient Friend or Family… Incarcerated Patient TMB Law Enforcement Annual Registration Other Health Professionals Other Govt. Agency TMB Licensee Insurance Companies Consumers *TMB category includes registrations responses, CME audits, medical malpractice reviews, newspaper items, and board discovered violations.

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

Complaints by Subject

Complaints FY 20

Total Complaints 9,169 Jurisdictional 5,533 Filed 1915 Legal 1,012 Orders: 242 Remedial Plans: 122

1st chance to respond 3rd chance to respond 2nd chance to respond 4th chance to respond 36 SOAH Cases 5th chance to respond

Remain 4% Remain 11%

Remain 60%

Remain 20% Remain 35% 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
• r 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
• f 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
• ne 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
• utpatient 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

• ther 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

• pioid 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
• n pain management

PMC Director Responsibilities

• 10 hours pain management CME Cat I
• Document the background and training of staff
• Written drug screening policy
• Periodic quality measures of outcomes
• Maintain billing records for 7 years since last visit
• Establish protocols that comply w/ Board Rules 170

Telemedicine Pre-COVID

• No Rx of Scheduled drugs for chronic pain
• Allowed in some circumstances, rule updated
• Nov. 2, 2020
• Ryan Haight Act: in-person visit before

prescribing a controlled substance.

• As of Nov 2, 2020: Fed waiver of some

requirements

• Establish physician/patient relationship

w/video, store and forward technology

• Phone-only ok, but still

must follow federal law.

Telemedicine during COVID-19 Disaster Declaration

• Telemedicine maintained.
• Traditional currently allowed via phone-only

encounter.

• Standard of care still must be met.
• MR still must be telemedicine and phone-
• nly COVID-19 telemedicine isn’t always

possible:

• It depends on the patient complaint/care

needed.

• Billed at the same rate is in-person visits.

Telemedicine Requirements Unchanged Pre vs. Post-COVID

• Must provide follow-up care options
• Provide MR to the patient’s PCP within 72 hours
• Health insurance carriers cannot exclude telehealth

care from in-network providers

• No telehealth prescription or providing of abortives
• No chronic pain management
• Allowed in some circumstances per COVID-19 disaster

declaration

• TMB updated rules in October 2017

Chronic Pain via Telemedicine during COVID-19 Disaster Declaration

Current through Jan.2, 2021

• Providers may prescribe controlled substances via

telemedicine for chronic pain patients if:

• Patient is an established chronic pain patient, and
• Patient is seeking a refill for an existing prescription.
• The physician must have seen the patient in the last

90 days, either:

• In person, or
• Via telemedicine with live video and audio

communication.

This must be documented.

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.

E-prescribing

• Beginning in 2021, you must e-prescribe all

your controlled substances

• Exceptions for economic hardship,

technological limitations, other exceptional circumstances

• Waivers granted by the TMB for up to a one-

year period.

• You may delegate someone to do this on

your behalf, but you remain responsible for their actions.

Board Rules for Treating Pain

Chapter 170

Board Rule 170.3

A physician’s treatment of a patient’s pain will be evaluated by considering:

• whether it meets the generally accepted

standard of care, and

• whether the minimum requirements of

170.3 have been met.

Board Rule 170.2: Definitions

• (2) "Acute pain"--the normal, predicted, physiological response to a

stimulus such as trauma, disease, and operative procedures. Acute pain is time limited to no later than 30 days from the date of the initial prescription for opioids during a period of treatment related to the acute condition or injury. The term does not include:

• (A) chronic pain;
• (B) pain being treated as part of cancer care;
• (C) pain being treated as part of hospice or other end-of-life

care;

• (D) pain being treated as part of palliative care; or
• (E) post-surgical, post-procedure, or persistent non-chronic

pain.

Board Rule 170.2: Definitions

• (4) "Chronic pain"--pain that is not relieved with acute, post-surgical,

post-procedure, or persistent non-chronic pain treatment parameters and persists beyond the usual course of an acute condition typically caused by, or resembling that caused by, actual or potential tissue injury

• r trauma, disease process, or operative procedure or the healing or

recovery of such condition with or without treatment. This type of pain is associated with a chronic pathological process that causes continuous

• r intermittent pain for no less than 91 days from the date of the initial

prescription for opioids.

• (10) "Post-surgical, post-procedure, persistent non-chronic pain"--pain

that occurs due to trauma caused by the surgery or procedure; or an underlying condition, disease, or injury causing persistent non-chronic

• pain. These types of pain are treated in accordance with the standard of

care and last 90 days or less, but more than 30 days, from the date of initial prescriptions for opioids during a period of treatment.

Board Rule 170.3

• Skim the rule and look at the subsections.
• What are the “following requirements” about?

(1) Evaluation of the patient (2) Treatment for chronic pain (3) Informed consent (4) Agreement for treatment of chronic pain (5) Periodic review of treatment for chronic pain (6) Consultation and referral (7) Medical records

170.3(1) Evaluation of the patient

(A) A physician is responsible for obtaining a medical history and a physical examination that includes a problem-focused exam specific to the chief presenting complaint of the patient. (B) The medical record shall document the medical history and physical examination. In the case of chronic pain, the medical record must document: (i) the nature and intensity of the pain (ii) current and past treatments for pain (iii) underlying or coexisting diseases and conditions (iv) the effect of the pain on physical and psychological function (v) any history and potential for substance abuse, and (vi) the presence of one or more recognized medical indications for the use of a dangerous or scheduled drug.

170.3(1) Evaluation of the patient

• (C) Prior to prescribing dangerous drugs or controlled substances

for the treatment of chronic pain, a physician must consider reviewing prescription data and history related to the patient, if any, contained in the Prescription Drug Monitoring Program described by §§481.075, 481.076, and 481.0761 of the Texas Health and Safety Code and consider obtaining at a minimum a baseline toxicology drug screen to determine the presence of drugs in a patient, if any.

• If a physician determines that such steps are not necessary prior

to prescribing dangerous drugs or controlled substances to the patient, the physician must document in the medical record his or her rationale for not completing such steps.

170.3(2) T Treatm tmen ent p plan

(2) The physician is responsible for a written treatment plan that is documented in the medical records. The medical record must include: (A) How the medication relates to the chief presenting complaint of chronic pain; (B) dosage and frequency of any drugs prescribed, (C) further testing and diagnostic evaluations to be ordered, (D) other treatments that are planned or considered, (E) periodic reviews planned, and (F) objectives that will be used to determine treatment success, such as pain relief and improved physical and psychosocial function.

170. 170.3(3) Informed c conse nsent

• You must discuss risks and benefits of CS
• This discussion must be documented by:
• a signed document in the MR, or
• contemporaneous notation in the medical records.
• You must discuss:
• Diagnosis and treatment plan
• anticipated therapeutic results, realistic expectations for

pain relief, functioning, also that the plan may not work

• additional or different therapies, including PT or

counseling

• potential side effects and how to manage them
• adverse effects, including the potential for dependence,

addiction, tolerance, and withdrawal, and

• potential for impairment of judgment and motor skills.

170.3(4) P Pain m managem emen ent c t contr tract ct

• When treating chronic pain, the physician must establish

and inform the patient of expectations for compliance.

• If the treatment plan includes extended drug therapy, the

physician must have a written pain management agreement that includes:

• drug testing upon physician’s request
• limits on the number and frequency of refills
• the patient can only get controlled substances (CS) from
• ne physician
• the patient will only use one pharmacy to fill

prescriptions

• reasons why the drug therapy may be terminated

Board R Rule le 1 170.3 .3(5 (5) P ) Per erio iodic r ic revie iew o

• f

treatment

You must see the patient for periodic review of the treatment.

• Is the patient reaching treatment objectives?
• Is the patient’s pain being managed effectively?
• Should the treatment plan be adjusted?
• Objectively evaluate functionality, considering

caretaker input

• Evaluate compliance with the treatment plan
• Evaluate patient for potential substance abuse or

diversion Document the visit, adjustments to treatment plan, etc.

170.3(6) R Referr rrals and 170.3(7 (7) M ) Medical Recordkeeping

• Refer patients to other providers as necessary, esp. patients with

psychiatric and addiction issues.

• The medical records must contain the rationale for the treatment

plan and rationale for prescribing, specifically:

• the medical history and the physical examination
• diagnostic, therapeutic and laboratory results
• evaluations and consultations
• treatment objectives
• discussion of risks and benefits
• informed consent
• treatments
• medications (including date, type, dosage and quantity prescribed)
• instructions and agreements, and
• periodic reviews

Contact Information

Pre-Licensure, Registration, and Consumer Services Verifcic@tmb.state.tx.us Phone: 512-305-7030 Fax: 512-463-9416 Mailing Address Physical Address Texas Medical Board Texas Medical Board MC-240 MC-240 P.O. Box 2029 333 Guadalupe, Tower III, Austin, TX 78768-2029 Suite 610 Austin, TX 78701