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Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific Meeting February 22, 2020 Tyler Dougherty, PharmD Assistant Professor of Pharmacy Practice South College School of Pharmacy

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Page 1: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

Update to Federal and State Controlled Substance Laws and

Guidelines

Tennessee Radiological Society

2020 Annual Scientific Meeting

February 22, 2020

Tyler Dougherty, PharmD

Assistant Professor of Pharmacy Practice

South College School of Pharmacy

Page 2: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

I have no financial relationships to disclose and I will not discuss off label use or investigational use in my presentation.

Disclosure Information

Page 3: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• Compare and contrast chronic pain guidelines and their applications

• Discuss the role of co-prescribing naloxone in high risk patients

• Review the Tennessee buprenorphine treatment guidelines and challenges with medication-assisted treatment (MAT)

• Examine new and potential federal and state legislation affecting opioid prescribing

• Utilize the Tennessee Controlled Substance Monitoring Database in practice

Objectives

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PRESCRIBING

OPIOIDS

NALOXONE

MAT

LEGISLATION

CSMD

CURRENT

LANDSCAPE

Outline

Page 5: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

Current Landscape

Page 6: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• 70,237 drug overdose deaths in 2017• 47,600 overdose deaths related to opioids• 191,146,822 opioid prescriptions dispensed by retail

pharmacies• >17,000 people die annually from prescription opioid

overdose (46/day)• Largely remained unchanged

• Heroin overdose death rates have largely remained unchanged

• More than 28,000 deaths involving synthetic opioids in 2017• Almost a 50% relative change from 2016

National Landscape

Scholl L, Seth P, Kariisa M, et al. Drug and Opioid-Involved overdose Deaths – United States, 2013-2017. MMWR. 67 (51 & 52): 1419-1427. https://www.cdc.gov/mmwr/volumes/67/wr/pdfs/mm675152e1-H.pdf

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National Landscape

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TN Overdose Deaths

Tennessee Drug Overdose Dashboard. TN Department of Health. https://www.tn.gov/health/health-program-areas/pdo/pdo/data-dashboard.html

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• 1,818 total overdose deaths

• 1,304 deaths attributed to opioids

• Fentanyl deaths increased 70%• 43% of individuals who died from a drug overdose had a

controlled substance dispensed within the last 60 days

• Heroin deaths increased 20%

• 44% of opioid-related overdose deaths included a benzodiazepine

TN Landscape – 2018 Data

Controlled Substance Monitoring Database: 2019 Report to the 111th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

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• From 2012-2018, number of MME dispensed has decreased 43%

• 2012-2018 number of opioid prescriptions for pain have decreased by 30%

• 2012-2018 number of patients receiving >120 MME/day has decreased 48%

• First year on record for decrease in NAS cases

• Stimulant prescribing continues to increase• 51% growth from 2010-2018

TN Landscape

Controlled Substance Monitoring Database: 2019 Report to the 111th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

Page 12: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

Controlled Substance Monitoring Database: 2019 Report to the 111th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

TN Landscape

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Miller AM, McDonald M (2019). Neonatal Abstinence Syndrome Surveillance Annual Report 2018. Tennessee Department of Health, Nashville, TN. https://www.tn.gov/content/dam/tn/health/documents/nas/NAS%20Annual%20Report%202018%20FINAL.pdf

TN Landscape

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Controlled Substance Monitoring Database: 2019 Report to the 111th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

TN Landscape

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PRESCRIBING

OPIOIDS

Chronic Pain Guidelines

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Page 17: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• Assess risk factors prior to initiating opioids• Previous treatments• Co-morbidities• History (overdose, SUD)• CSMD

• Can use a therapeutic trial of opioids

• Requires informed consent and treatment agreement

• Use the lowest effective dose• 50 MME/day• 90 MME/day

CDC Chronic Pain Guidelines

CDC Checklist: https://www.cdc.gov/drugoverdose/pdf/pdo_checklist-a.pdf

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• Avoid benzodiazepines with opioid

• Must use UDT at onset and at least annually

• Check PDMP at onset and every three months

• Follow up with patient:• Change of dose: 1-4 weeks

• Stable dose: every 3 months

• Acute pain: 3 days sufficient, 7 days rarely

CDC Chronic Pain Guidelines

CDC Checklist: https://www.cdc.gov/drugoverdose/pdf/pdo_checklist-a.pdf

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Limitations to CDC Guidelines

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• Inflexible application of recommended ceiling doses/durations as hard limits

• Abrupt opioid taper or cessation

• Limited coverage and access to multi-modal, comprehensive care

• OUD diagnosis difficulty and access barriers

• Payors applying dosage limits

Kurt Kroenke, Daniel P Alford, Charles Argoff, Bernard Canlas, Edward Covington, Joseph W Frank, Karl J Haake, Steven Hanling, W Michael Hooten, Stefan G Kertesz, Richard L Kravitz, Erin E Krebs, Steven P Stanos, Mark Sullivan, Challenges with Implementing the Centers for Disease Control and Prevention Opioid Guideline: A Consensus Panel Report, Pain Medicine, Volume 20, Issue 4, April 2019, Pages 724–735, https://doi.org/10.1093/pm/pny307

Limitations to CDC Guidelines

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Petrosky E, Harpaz R, Fowler KA, et al. Chronic Pain Among Suicide Decedents, 2003 to 2014: Findings From the National Violent Death Reporting System. Ann Intern Med. [Epub ahead of print 11 September 2018]169:448–455. doi: 10.7326/M18-0830

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Individualized, Integrative Treatment

U.S. Department of Health and Human Services (2019, May). Pain Management Best Practices Inter-Agency Task Force Report: Updates, Gaps, Inconsistencies, and Recommendations. Retrieved from U. S. Department of Health and Human Services website: https://www.hhs.gov/ash/advisory-committees/pain/reports/index.html

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Tapering: Benefits vs Risk

Dowell D, Compton WM, Giroir BP. Patient-Centered Reduction or Discontinuation of Long-term Opioid Analgesics: The HHS Guide for Clinicians. JAMA. Published online October 10, 2019. doi:10.1001/jama.2019.16409.

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• Can use a therapeutic trial of opioids

• Requires informed consent and treatment agreement

• Use the lowest effective dose, immediate release products

• Discuss and document the 5 A’s (analgesia, activities of daily living, adverse side effects, aberrant drug-taking behaviors and affects) at each visit

TN Chronic Pain Guidelines

Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

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TCA §63-1-164

“Informed consent”… at a minimum:(i) Adequate information to allow the patient or the patient's legal representative to understand:(a) The risks, effects, and characteristics of opioids, including the risks of physical dependency and addiction, misuse, and diversion;(b) What to expect when taking an opioid and how opioids should be used; and(c) Reasonable alternatives to opioids for treating or managing the patient's condition or symptoms and the benefits and risks of the alternative treatments;

A healthcare practitioner may treat a patient with more than a three-day supply of an opioid if the healthcare practitioner treats the patient with no more than one (1) prescription for an opioid per encounter and:(i) Personally conducts a thorough evaluation of the patient;(ii) Documents consideration of non-opioid and non-pharmacologic pain management strategies and why the strategies failed or were not attempted;(iii) Includes the ICD-10 code for the primary disease in the patient's chart, and on the prescription when a prescription is issued; and(iv) Obtains informed consent and documents the reason for treating with an opioid in the chart.

Acts 2018, ch. 1039, § 6; 2019, ch. 117, § 1; 2019, ch. 124, §§ 7-13.

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Informed Consent

Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

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• Primary Care Providers are encouraged to treat patients requiring <120 MME/day

• If patient requires >120 MME/day, must consult with pain medicine specialist

• If patient requires >120 MME/day for more than 6 months, must consult with a pain medicine specialist annually

TN Chronic Pain Guidelines

Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

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• Assess risk for abuse• ORT

• SOAPP-R

• Establish treatment goals• 3 item PEG Assessment Scale

• Avoid benzodiazepines with opioid

• Must use UDT at onset and at least twice yearly

• Check CSMD at least twice yearly per law

• Cannot use telemedicine

TN Chronic Pain Guidelines

Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

Page 29: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• Pain present for <90 days

• Can be spontaneous, surgical, or injury-related

• Use multi-modal care:• Nonpharmacologic therapies

• NSAIDs for 2-4 weeks

• Education

• If pain persists, can try three days or less of opioids (tramadol, if not contraindicated)

• Avoid extended-release formulations in acute setting

• Evaluate for OUD and check CSMD

TN Chronic Pain Guidelines – Acute Pain

Tennessee Chronic Pain Guidelines. https://www.tn.gov/content/dam/tn/health/healthprofboards/pain-management-clinic/ChronicPainGuidelines.pdf

Page 30: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• Walmart: 7 day supply with up to 50 MME/day limit for opioids for acute pain• Requiring e-prescribing for opioids in 2020

• CVS/Caremark: 7 day supply with up to 90 MME/day limit for opioid prescriptions for acute pain• PA required for: day supply increase, MME increase, or ER

therapy

https://www.caremark.com/portal/asset/Opioid_Reference_Guide.pdfhttps://corporate.walmart.com/newsroom/2018/05/07/walmart-introduces-additional-measures-to-help-curb-opioid-abuse-and-misuse

Discrepancies Across Corporations

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• Express Scripts: “Initial fill days’ supply rule for adults initiating opioid therapy are limited to a 7-days’ supply for members’ first 4 fills, requiring a prior authorization to exceed 28-days’ supply in a 60-day period”

• TennCare: “up to 15 days in a 180-day period at a maximum dosage of 60 MME per day. After the first-fill prescription (less than or equal to 5 days), a member can receive up to an additional 10 days of opioid treatment with prior authorization.”

https://lab.express-scripts.com/lab/insights/drug-safety-and-abuse/our-focus-opioid-recovery-and-abuse-preventionhttps://oig.hhs.gov/oas/reports/region4/41800124_Factsheet.pdf

Discrepancies Across Corporations

Page 32: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• “Red Flags”• Distance between doctor, pharmacy, and residence

• Multiple pharmacies being used

• “Cocktails”

• Pre-printed/stamped pads

• OBRA’ 90 Requirements• Duplicate therapies

• Drug-disease contraindications

• Counseling requirements

• Insurance

Why does the Pharmacist call?

Page 33: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

“A prescription for a controlled substance to be effective must be issued for a legitimate medical purpose by an individual practitioner acting in the usual course of his professional practice. The responsibility for the proper prescribing and dispensing of controlled substances is upon the prescribing practitioner, but a corresponding responsibility rests with the pharmacist who fills the prescription. An order purporting to be a prescription issued not in the usual course of professional treatment or in legitimate and authorized research is not a prescription within the meaning and intent of Section 309 of the Act (21 U.S.C. §829) and the person knowingly filling such a purported prescription, as well as the person issuing it, shall be subject to the penalties provided for violations of the provisions of law relating to controlled substances (21 C.F.R. §1306.04(a)).”

Corresponding Responsibility Doctrine

Food and Drugs, 21 C.F.R. § 1306.04. https://www.deadiversion.usdoj.gov/21cfr/cfr/1306/1306_04.htm

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NALOXONE

Co-Prescribing Naloxone

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Davis C. Legal interventions to reduce overdose mortality: naloxone access and overdose good Samaritan laws. The Network for Public Health Law. December 2018. https://www.networkforphl.org/_asset/qz5pvn/legal-interventions-to-reduce-overdose.pdf

Current State Naloxone Access

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Abouk R, Pacula RL, Powell D. Association Between State Laws Facilitating Pharmacy Distribution of Naloxone and Risk of Fatal Overdose. JAMA Intern Med. 2019; 179: 805-11.

• States have various levels of naloxone access laws

• Naloxone access has implications for fatal and non-fatal opioid overdoses

Impact of NALs on Fatal Opioid Overdose

Type of NAL Δ Fatal OD Rate 95% CI P-Value

Direct Authority* -0.387 -0.119 to -0.656 0.007

Indirect Authority 0.121 -0.014 to 0.257 0.09

Weak NAL 0.094 -0.040 to 0.227 0.17

*Opioid related ER visits increased 15% relative other states

Does Which State You Live in Matter?

Page 38: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• Vermont mandated when opioids prescribed >90 MEE/day OR with a concomitant benzodiazepine

• Virginia mandated when opioids prescribed >120 MME/day or concomitant benzodiazepine

• Tennessee currently has a statewide pharmacy practice agreement• Naloxone can be dispensed to patients at risk of

overdose, to a family member or friend

• Pharmacist is required to complete training course

• Good Samaritan Law

Vermont Department of Health. Rule governing the prescribing of opioids for pain. http://www.healthvermont.gov/sites/default/files/documents/pdf/REG_ opioids-prescribing-for-pain.pdf. Published March 2019. Accessed April 28, 2019Virginia Department of Health Professions, Board of Medicine. Board of Medicine regulations on opioid prescribing and buprenorphine. https://www.dhp.virginia.gov/medicine/newsletters/ OpioidPrescribingBuprenorphine03142017.pdf. Published 2017. Accessed April28, 2019.

Co-Prescribing Naloxone

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Consider in patients who:

• >50 MME opioid dose with:• Co-morbidities making the patient more

susceptible to overdose

• Concomitant benzodiazepine use

• History of SUD

• Polypharmacy

• Good Samaritan or family member

Co-Prescribing Naloxone

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MAT

Medication Assisted Treatment

Page 42: Update to Federal and State Controlled Substance Laws and … · Update to Federal and State Controlled Substance Laws and Guidelines Tennessee Radiological Society 2020 Annual Scientific

• Enacted in 2000 with intent of allowing addicts to be treated for addiction in office-based settings (outside of OTPs)

• Only permitted drugs are buprenorphine SL and buprenorphine-naloxone tablets/films

• Treatment must be by a “qualifying physician”

• Qualifying physician may not treat more than 100 patients and must obtain special DEA number• CARA 2016 increased the number of patients

• Special DEA Identification number (DATA 2000 Waiver ID or “X” number)

Drug Addiction Treatment Act (DATA)

DEA Requirements for DATA Waived Physicians. https://www.deadiversion.usdoj.gov/pubs/docs/dwp_buprenorphine.htm

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3705143903 45525

48035 50741

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Patients Receiving Buprenorphine in TN

Tennessee Drug Overdose Dashboard. TN Department of Health. https://www.tn.gov/health/health-program-areas/pdo/pdo/data-dashboard.html

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• Buprenorphine products may only be prescribed for a use recognized by the FDA

• Buprenorphine without naloxone shall only be prescribed for patients who are:• Pregnant

• Nursing*

• Documented allergy to naloxone (< 5%)

• Licensed physicians are the only healthcare provider authorized to prescribe for MAT

TN Buprenorphine Guidelines

Tennessee Nonresidential Buprenorphine Treatment Guidelines. TN Department of Mental Health and Substance Abuse Services. 2018. https://www.tn.gov/content/dam/tn/health/documents/2018%20Buprenorphine%20Tx%20Guidelines.PDF

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Name Dosage Form Strength (mg) Manufacturer

Zubsolv SL Tablet 0.7/0.18, 1.4/0.36, 2.9/0.71, 5.7/1.4,

8.6/2.1, 11.4/2.9 mg

Orexo

Bunavail(Buprenorphine/Naloxone

Buccal Film 2.1/0.3, 4.2/0.7, 6.3/1.0 mg

BioDelivery Sciences International

Suboxone (Buprenorphine/Naloxone

SL Film 2.0/0.5, 4.0/1.0, 8.0/2.0, 12.0/3.0 mg

Indivior, Sandoz, Mylan, Dr. Reddy’s

Suboxone (Buprenorphine/Naloxone)

SL Tablet 2.0/0.5, 8.0/2.0 mg Actavis, Amneal, Ethypharm, TEVA

Subutex (Buprenorphine/Naloxone)

SL Tablet 2, 8 mg Actavis, Barr, Mylan, Sun, Rhodes

Sublocade SQ Injection (monthly)

100 mg/0.5ml, 300 mg/1.5ml

Indivior

Probuphine Implant (6 months)

74.2 mg (4 implants) Braeburn

Buprenorphine Approved for OUD

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• Insurance coverage• SUPPORT ACT

• Accessible providers• 83,000 MDs nation wide with DATA waiver• 1,900 MDs in TN with DATA waiver

• Accessible pharmacies• Choosing to stock MAT• Buprenorphine without rx?*

• Continuity of care• ER discharge• Confidentiality: HHS 42 CFR Part 2

• Diversion: brand street value

*Roy PJ, Stein MD. Offering Emergency Buprenorphine Without a Prescription. JAMA. 322(6): 501-502. 13 August 2019.

Challenges with MAT

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LEGISLATION

Federal and State Legislation

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SUPPORT ACTTitle/Section Regulation

Title I – Medicaid Provisions to Address Opioid Crisis

State Medicaid programs establish DUR requirements for at-risk beneficiaries

Title II – Medicare Provisions to Address Opioid Crisis

Initial examination for new Medicare enrollees must include an OUD screening and

prescription history review

Title VI – Medicare Opioid Safety Education Act

CMS must provide Medicare beneficiaries with education resources about opioid use

and pain management, and covered nonopioid treatments

Title VI – Opioid Addiction Action Plan CMS must develop an action plan on changes to Medicare/Medicaid programs to enhance treatment/prevention OUD and coverage of

MAT

Title VI – Combatting Opioid Abuse for Care in Hospitals

CMS must publish guidance for hospitals on pain management and SUD. Recommend

quality measures for OUD, reduction in opioid use in surgical setting, and pain-management

strategies

The SUPPORT for Patients and Communities Act (H.R. 6). American Society of Addiction Medicine. https://www.asam.org/advocacy/the-support-for-patients-and-communities-act-(h.r.-6)

SUPPORT Act

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• Encourage increased training on addiction/pain in medical school and residency

• New DATA 2000 waiver pathway for recent medical school graduates who have completed DATA 2000 waiver training elements

• Established loan repayment program for SUD providers in high-need areas

• Board-certified physicians in addiction medicine or addiction psychiatry can immediately treat up to 100 patients (in stead of only 30)

Teach It

The SUPPORT for Patients and Communities Act (H.R. 6). American Society of Addiction Medicine. https://www.asam.org/advocacy/the-support-for-patients-and-communities-act-(h.r.-6)

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• Authorizes $10M grant for hospitals to develop protocols on discharging patients who presented with opioid overdose

• Protocols should include:• Provision of an overdose medication at discharge

• Connection with peer-support specialists

• Referral to treatment and other services that best fit the needs of the patient

Standardize It

The SUPPORT for Patients and Communities Act (H.R. 6). American Society of Addiction Medicine. https://www.asam.org/advocacy/the-support-for-patients-and-communities-act-(h.r.-6)

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• Creates an outpatient OUD treatment demo in Medicare• Increases reimbursement and accountability metrics

• Focuses on care coordination using bio-psycho-social model

• Medicare will begin covering OTP’s (01/01/20)• Bundles payments for holistic services and methadone

coverage

• Starting October 2020, Medicaid must cover OUD treatment medication

• Starting January 1, 2021, C-II-V controlled substances must be e-prescribed for Medicare patients

Cover It

The SUPPORT for Patients and Communities Act (H.R. 6). American Society of Addiction Medicine. https://www.asam.org/advocacy/the-support-for-patients-and-communities-act-(h.r.-6)

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• Enacted in 1975 to address concerns about patient information used in non-treatment settings

• Part 2 programs are federally assisted: methadone and buprenorphine OTP’s

• Part 2 prohibits disclosure of patient records from federally assisted programs that could identify the patient as having or had SUD• Patient can consent to release of info• Consent must include name of patient, name of entity

disclosing and receiving info, amount/kind of info

• The Protecting Jessica Grubb’s Legacy Act

Disclosure of Substance Use Disorder Patient Records: How do I exchange part 2 data? The Office of the National Coordinator for Health Information Technology and SAMHSA. https://www.samhsa.gov/sites/default/files/how-do-i-exchange-part2.pdf

42 CFR Part 2 – Protecting Jessica Grubb’s Legacy Act. http://opiodcrisisstg.wpengine.com/wp-content/uploads/2017/09/42-CFR-Part-2-One-Pager.pdf

HHS 42 CFR Part 2: Confidentiality

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• SAMSHA is proposing revision to help facilitate better coordination of care for SUD

• Non-OTP providers will be able to query a central registry to determine if patient is receiving treatment

• OTP’s will be able to enroll in state PDMP and report to PDMP C II-V that are prescribed or dispensed

• Continue to prohibit law enforcement use of SUD records in prosecution

HHS 42 CFR Part 2 Proposed Rule Fact Sheet. U.S. Department of Health and Human Services. 22 August 2019: https://www.hhs.gov/about/news/2019/08/22/hhs-42-cfr-part-2-proposed-rule-fact-sheet.html

HHS 42 CFR Part 2: Proposed Rule Change

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• Allows for partial filling of C-II’s• Requested by the patient or practitioner

• Total quantity dispensed in all partial fills cannot exceed total quantity prescribed

• Once a partial fill occurs, the remaining portion may be filled within 30 days of the date on the Rx• If not, the prescriber should be notified

• No further quantity can be dispensed after 30 days without a new Rx

CARA 2016: Partial Fills

Comprehensive Addiction and Recovery Act 2016. 21 USC 829; 21 CFR 1306.13

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According to TNTogether legislation, what is missing on this prescription?

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Public Chapter 124 Amended: effective 4/9/2019

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MME Conversion

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• PC 978 established a task force to define minimum disciplinary action by TN licensing boards for prescribers who treat patients with opioids

• If the licensing board/agency finds “that the healthcare practitioner engaged in a significant deviation or pattern of deviation from sound medical judgement”, then:• Minimum disciplinary action must be imposed on the

practitioner

• The minimum disciplinary action is binding on each board/agency

Minimum Disciplinary Action: Opioid Prescribing

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The minimum discipline that the board or committee assesses shall include the following:

a) Reprimand

b) Successful completion of a board/committee approved intensive CE course on opioid

c) Restriction against prescribing opioids for at least six months, and until completion of CE

d) One or more Type A civil penalties

e) Must notify all collaborative practitioners (PA, NP, etc)

f) Restricted from collaborating with NP’s or PA’s during restriction

0880-02-.25. General Rules and Regulations Governing the Practice of Medicine. Minimum Discipline for Opioid Prescribing. https://publications.tnsosfiles.com/rules_filings/05-17-19.pdf

What is Minimum Discipline?

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Minimum discipline the board assesses shall include the following:a. Probationb. Successful completion of practice monitoring

program including: quarterly reports of non-opioid prescribing practices, medical record keeping, pain management, opioid practices, additional CE

c. Restriction against opioid prescribing for 2x the amount that was assessed originally (not less than 1 year)

d. One or more Type A civil penaltiese. Notification to collaborating providers

What about Repeat Offenders?

0880-02-.25. General Rules and Regulations Governing the Practice of Medicine. Minimum Discipline for Opioid Prescribing. https://publications.tnsosfiles.com/rules_filings/05-17-19.pdf

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TN CSMD Requirements

CSMD

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• Must check CSMD before prescribing opioid or benzodiazepine as a new episode of treatment• Do not have to check when prescribing 3 days or less

• Must check every 6 months when controlled substance remains apart of treatment plan

• Best practice is to check regularly with each prescription

• Can authorize up to two delegates (“extenders”) to check for you

• Include access to your collaborating practitioners

Controlled Substance Monitoring Database (CSMD) and Prescription Safety Act: Frequently Asked Questions. https://www.tn.gov/health/health-program-areas/health-professional-boards/csmd-board/csmd-board/faq.html

Tennessee CSMD

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Controlled Substance Monitoring Database: 2019 Report to the 111th Tennessee General Assembly. March 1, 2019. https://www.tn.gov/content/dam/tn/health/healthprofboards/csmd/2019%20Comprehensive%20CSMD%20Annual%20Report.pdf

Tennessee CSMD

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Practitioner Self Lookup

Slide courtesy of Dr. Todd Bess, Tennessee Controlled Substance Monitoring Database.

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Practitioner Self Lookup with Option for APRN/PA

Slide courtesy of Dr. Todd Bess, Tennessee Controlled Substance Monitoring Database.

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Practitioner vs. Peer Report

Slide courtesy of Dr. Todd Bess, Tennessee Controlled Substance Monitoring Database.

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Multi-State Lookup

Slide courtesy of Dr. Todd Bess, Tennessee Controlled Substance Monitoring Database.

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• Number of overdose deaths continue to rise, yet the number of opioid prescriptions are decreasing

• Co-prescribing naloxone should be prescribed for high-risk patients

• Access to MAT is a problem but the SUPPORT Act will help

• Clean up of TN Together created functional changes aligning state and federal law, while also attempting to balance safety and access

• CSMD has clinical utility for patient management but also for comparing own prescribing history

Summary