TMB Update 2020: Board Rules on Pain Management - Sherif Zaafran, MD, FASA President, TMB - Texas ...
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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
6000
5000 47194514 4869 4862
4295 4093
3994
4000 3621
3522 3436 3630 3594
3129
3000
2000
1000
0
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 26,868 27,168 28,108 28,046 27,974
Technologists
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
180,000
147,168 151,312 161,779
160,000 157,090
140,000
143,978
120,000
91,072 94,086
100,000 87,815
80,000
60,000
40,000
20,000
0
2013 2014 2015 2016 2017 2018 2019 2020
Enforcement Process
Complaints Received
FY08 – FY20
10000
9169
8955 8799
9000
8182 8114
8000 7821
7550 7510
6968 7031
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
Consumers .06 %
Insurance Companies .1 %
TMB Licensee 1.2 %
Other Govt. Agency 1.6 %
Other Health Professionals 1.7 %
Annual Registration 2.2 %
Law Enforcement
3.2 %
TMB 6%
Incarcerated Patient 6%
Friend or Family… 21 %
Patient 56.8 %
0 10 20 30 40 50 60
*TMB category includes registrations responses, CME audits, medical malpractice reviews, newspaper items,
and board discovered violations.Complaints
Unprofessional by Subject
Conduct
10%
Unlicensed
Practice of
Medicine
6% Quality of Care
Impairment 44%
2.5%
Others
5%
Non-physician Crime/Fraud/Other
investigations Rules
17% 15%Complaints FY 20
Total Complaints 9,169
Remain 60%
Jurisdictional 5,533 1st chance
Remain 35% to respond
Filed 1915 2nd chance
Remain 20% to respond
Legal 1,012 3rd chance
Remain 11% to respond
Orders: 242 4th chance
Remedial Plans: 122 to respond
Remain 4%
36 SOAH 5th chance
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 safetyAreas 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 historyAreas 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 occurringBullet 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 careCheck 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 recordPrescription 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 RulesPMC: 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 organizationPMC: 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
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-
only 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 2017Chronic 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 170Board 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 or 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 or 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) Treatment 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.170.3(3) Informed consent
• 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) Pain management contract
• 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
one physician
• the patient will only use one pharmacy to fill
prescriptions
• reasons why the drug therapy may be terminatedBoard Rule 170.3(5) Periodic review of
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) Referrals and
170.3(7) 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 reviewsContact 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 78701You can also read
