12 th Annual Scientific Virtual Meeting Legislative Updates November 7, 2020 CM SCHADE, MD, PHD, PE, FIPP Advanced Pain Solutions TMA Behavioral Health Committee Member TMA Delegate for 20 Years Past President Texas Pain Society 1
CM Schade, MD, PhD, PE CM Schade, MD, PhD, PE has 41 years of experience in the treatment of chronic pain. He is practicing Pain Medicine full time in Mesquite (the Dallas Metroplex ), Texas. He is ABA Board Certified in Pain Management, a Fellow of Interventional Pain Practice and a Diplomate of the American Board of Anesthesiology, American Board of Pain Medicine, American Academy of Pain Management and American Board of Interventional Pain Physicians. Dr. Schade has a PhD in Electrical Engineering and Computer Science from Stanford University and is a Licensed Professional Engineer. Colonel Schade also served 10 years with the US Air Force as a Flight Surgeon and served as the Air Force Surgeon General’s Consultant in Chemical Warfare. He is a pioneer in the field of spinal cord stimulation and has made multiple contributions that have advanced spinal cord stimulation and pain therapies and has gained national recognition for his work. Dr. Schade is also a strong supporter of patient rights and is a Director Emeritus of the Texas Pain Society, Past-President of the Greater North Texas Pain Society, a Texas Medical Association Delegate and represents Pain Medicine on the Texas Medical Association’s Interspecialty Society, is the Pain Medicine Delegate on the Medicare Carrier Advisory Committee and has served as president of the Texas Pain Society. 2
NO RELEVANT FINANCIAL DISCLOSURES 3
The Horns of a True Dilemma “We often struggle to balance reducing our patients’ pain with increasing their risk of opioid addiction.” - Vivek Murthy, United States Surgeon General, August 2016 “The benefit of tolerable pain levels and functional lives may outweigh the risk of opioid use for these patients.” - CMS Opioid Misuse Strategy 1-5-2017 4
The Opioid Pendulum 2020 5
Regulation Time Line 1981 Texas Triplicate Prescription for CII 2015 Sunset of Texas Controlled Substances registration 1989 Texas Intractable Pain Treatment Act 2016 Texas PMP moved to TSBP PMP 2005 NASPER-National all Schedules Aware Prescription Electronic Reporting Act 2018 TMB Audits: Service Area, 2007 TMB Pain Management, Rule 170 Top 50, Potentiator Drugs 2010 TMB Registration of Pain Management Clinics Rule, 195 2018 CMS Call Letter- POS Edits 2011 Opioid prescribing peaked 2019 Mandatory PMP Checks 2011 Texas PMP-Prescription Access Texas 2019 CMS POS Soft and Hard Rejects Pilot 2019 HHS MED Limit 90 2020 Telehealth Exception for COT 6
The Texas Legislature meets in less than 100 days. Nobody knows how the session will look. With the coronavirus pandemic continuing to affect everyday life, Texas legislators know that it won't be business as usual at the Capitol during the 2021 legislative session. But how different things will be is still an issue they're working to resolve . Cassandra Pollock, Oct. 6, 2020 Texas Tribune 7
DUTY TO RELIEVE PAIN The duty to relieve pain and suffering is central to the physician’s role as healer and is an obligation physicians have to their patients. Existential pain should be addressed through appropriate social, psychological, or spiritual support. Code of Medicaid Ethics of the AMA 2017 Five Dimensions of Pain; Physical Psychological Financial Religious Existential 8
The United Nations Says Untreated Pain is “Inhumane and Cruel” “The issue remains equally compelling closer to home. Surprisingly, the UN report states that over a third of patients in the United States are not adequately treated.” United Nations General Assembly. Report of the Special Rapporteur on torture and other cruel, inhuman, or degrading treatment or punishment Juan E. Mendez. New York, New York; Human Rights Council. 2013:51-56 9
Telemedicine Occupations Code Sec. 111.004. RULES. The Texas Medical Board, in consultation with the commissioner of insurance, as appropriate, may adopt rules necessary to: (1) ensure that patients using telemedicine medical services receive appropriate, quality care; (2) prevent abuse and fraud in the use of telemedicine medical services, including rules relating to the filing of claims and records required to be maintained in connection with telemedicine medical services; (3) ensure adequate supervision of health professionals who are not physicians and who provide telemedicine medical services; and (4) establish the maximum number of health professionals who are not physicians that a physician may supervise through a telemedicine medical service. 10
Telemedicine Issuance of Prescriptions (e) Limitation on Treatment of Chronic Pain. Chronic pain is a legitimate medical condition that needs to be treated but must be balanced with concerns over patient safety and the public health crisis involving overdose deaths. The Legislature has already put into place laws regarding the treatment of pain and requirements for registration and inspection of pain management clinics. Therefore, the Board has determined clear legislative intent exists for the limitation of chronic pain treatment through a telemedicine medical service. TAC , Title 22, Part 9, Chapter 174A, Rule 174.5 11
Telemedicine Issuance of Prescriptions (A) Treatment of chronic pain with scheduled drugs through use of telemedicine medical services is prohibited , unless otherwise allowed under federal and state law. (B) Treatment of acute pain with scheduled drugs through use of telemedicine medical services is allowed, unless otherwise prohibited under federal and state law. TAC , Title 22, Part 9, Chapter 174A, Rule 174.5 12
TMB Adopts Emergency Rule Related to Issuance of Prescriptions 06.05.2020 TMB Adopts Emergency Rule Related to Issuance of Prescriptions The Texas Medical Board’s Executive Committee, with advice and direction from the Governor’s Office, today adopted rules on an emergency basis related to the issuance of certain prescriptions during the COVID-19 disaster. The Governor previously extended the waiver to temporarily suspend Title 22, Chapter 174.5 (e) (2)(A) of the Texas Administrative Code. That waiver is set to expire later today. Accordingly, emergency amendments to §174.5 are necessary to help the state’s physicians, physician assistants and other health care professionals continue to mitigate the risk of exposure to COVID-19 and provide necessary medical services related to chronic pain management with controlled substances for patients. 13
PDMP’s are being widely used for enforcement but they lack sensitivity and specificity and therefore have low credibility. On 04.11.2018, the Pain Care Coalition recommended to the HELP Committee A. Increased funding for NASPER Act of 2005 B. Adoption of a National Patient Identifier Also PDMP’s need to: Input CS data for increased accuracy (Sensitivity) 1. 2. Need to identify group practices as one provider (Specificity) Include data from military and VAH (Sens. & Spec. ) 3. Include data from methadone treatment clinics (Sens. & 4. Spec. ) 14
Improvements for Tracking The Wholesale Drug Distribution of Controlled Substances Currently Used in Texas, Florida, Ohio, Michigan & Washington 15
Prescription Drug Monitoring Programs: Evidence-based practices to optimize prescriber use Prescriber Mandates - Registration? - Use with exemptions? Source: Report from the PEW Charitable Trust, December 2016. 16
What would it take to compare the PMP dispensing quantities to the ARCOS wholesale delivery quantities? In other words, we would like to know if pharmacies are not reporting or grossly under reporting their sales. INPUT SHOULD EQUAL OUTPUT Same Old Hurdles, Texas Medicine Sept 2020, Matchgame: A proposed solution 17
STATUS of APPRISS’S ANALYSIS of CS DATA Analysis of Controlled Substance Distribution Data reported to wholesales as compared to PMP data submitted by pharmacies Basic screening tool in Minnesota and Ohio- A Wholesale Outlier Model 18
SUMMARY We have the opportunity to introduce synergistic legislation By expanding Telehealth to include chronic pain and mandating that the TSBP will monitor wholesale deliveries of controlled substances 19
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CONCLUSION IF YOU AREN’T AT THE TABLE, THEN YOU ARE ON THE MENU 22
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