Caring for ME Lunch & Learn Webinar Opioid Prescribing Regulations Updates on Chapter 488 and Related Rules

Transcription

1 Caring for ME Lunch & Learn Webinar Opioid Prescribing Regulations Updates on Chapter 488 and Related Rules Gordon H. Smith, Esq. January 23, 2018, 12-1 pm Audio is available through your computer speakers For audio by phone, call (US Toll) and enter Webinar ID#

2 Thank You to Our Sponsor! Funding for this Caring for ME webinar series is provided by: The Maine Attorney General s Office

3 QC Staff is Working to Improve the Health of Everyone in Maine

4 QC Brings Together the People Who Give, Get and Pay for Health Care to Address Shared Priorities

5 Join Us! Become a Maine Quality Counts Member Learn About Becoming a Member: visit mainequalitycounts.org & click Membership Networking events Webinars with national experts

6 Caring for ME Be Part of the Solution! In April 2016, Maine Quality Counts (QC) and Maine Medical Association (MMA) launched Caring for ME, a collaborative effort that aims to bring together a wide set of partners to promote shared messages, educational resources, and practical tools for health care providers. Support prevention efforts Maintain a compassionate and trauma-informed approach to chronic pain management Improve the safety of opioid prescribing Appropriately diagnose addiction when it exists Improve access to effective treatments for patients with substance use disorder Join QC & MMA in Caring for Maine and be part of the solution!

7 Important Webinar Notes You are in view-only mode. Please use the Q&A function to ask questions & make comments Video screen size and location is adjustable. Tomorrow you will receive an with a link to the presentation recording and slides a link to the CME / CEU survey This webinar will be archived at

8 CME Available! CME will be available for participants who have signed into the live webinar. If you did not log into this webinar with your , submit your name and address using the Q&A feature on the tool bar at the bottom of your screen. We do not have separate CEUs for nursing staff or other healthcare professionals - but you may request a CME certificate as certificate of attendance. You must complete the survey in order to receive a certificate. Please complete the survey within 1 week. A CME certificate will be ed once the survey has closed.

9 CME Disclosure The speakers today do not have any relevant financial relationships with the manufacturers(s) of any commercial products(s) and/or provider of commercial services discussed in this activity.

10 Today s Speaker: Gordon H. Smith, Esq. Gordon Smith is Executive Vice President of the Maine Medical Association. He graduated from the University of Maine with highest distinction and from the Boston College Law School, magna cum laude. He currently serves on the Executive Committee of the AMA Advocacy Resource Center, and is a member of the Board of Directors of the Daniel Hanley Center for Health Leadership. A frequent lecturer to medical groups on various medical legal subjects, Mr. Smith has served as EVP of the Maine Medical Association since September 1993.

11 Update on Chapter 488 and Associated Rules on Prescribing Opioid Medication Gordon H. Smith, Esq. Maine Medical Association Jan.23, 2018 Caring for ME Webinar

12 Disclosure There are no significant or relevant financial relationships to disclose.

13 This presentation is funded in part by a contract with:

14 Opioids: the difficult truth We know of no other medication routinely used for a nonfatal condition that kills patients so frequently. NEJM: 374; Dosage >200 MME: Number Needed to Kill = 32

15 More than One Death per Day Maine leads nation in rate of longacting opioid prescriptions Overdose death rate in Maine increased 40% from 2015 to Mainers lost to opioid/heroin deaths in overdose deaths in 2016 (313 involving opioids) 180 overdose deaths in first six months of 2017 Contrast: During the last decade, there were 258 homicides in Maine. There were 156 traffic fatalities in Maine in 2015.

16 1,024 Maine Babies Drug Affected in ,013 in 2015 but Fewer than 1000 in 2017 Maine s infant mortality rate (7.1/1000) exceeds the national average 1 out of every 11 babies in Maine was born drug-affected in 2016 Modest reduction in 2017 but still more than 3 drug affected babies born each day

17 Prescribing of Opioid Medication for Pain Continues to Decline Has declined since 2011 Number of high dose prescriptions (greater than 90 MME) fell 41.4% 2010 to 2015 Maine saw a 20% decline in the number of scripts from first half of 2016 to first half of 2017 Maine s prescribing declined 21.5% , the 4 th largest drop in the nation

18 Opioid Use Disorder It is estimated that 28,000 Mainers have Opioid Use Disorder with capacity to treat only 3500 to 7000

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20 Maine Leads the Nation Maine leads the nation in prescribing long acting opioids at 21.8 Rx/100 people based on 2012 data published by CDC in to 65 pills prescribed for every man, woman and child in Maine annually.

21 Evidence of Over-Prescribing C-Section patients 1 53% report taking no or very few (<5) opioid pills prescribed postoperatively 83% report taking half or fewer Thoracic surgery patients 1 45% report taking no or very few (<5) opioid pills prescribed postoperatively 71% report taking half or fewer 1: PLoS One ;11(1); e Epub 2016 Jan

22 Growing Evidence of Over-Prescribing General surgery patients 2 75% partial mastectomy pts did not take any of their prescribed opioids 34% lap choly pts took no prescribed opioids 45% lap inguinal hernia pts took no prescribed opioids Pts reported having 67% to 85% opioid pills remaining Wisdom tooth extraction patients 3 On average, received 28 pills but used <50% of amount prescribed Extrapolates to >100 million opioid pills unused nationally! 2: Ann Surg, Hill et al, Sept 14, : Drug Alcohol Depend Nov 1; Epub 2016 Sep 20.

23 Maine Opiate Collaborative

24 Civics 101: A Refresher Levels of authority: 1. Statutes: Passed by Legislature, signed by Governor Identified as P.L. 2015, c. 508 or 22 MRSA 2353 (2015) Major policy directives 2. Rules/Regulations Drafted by Departments (DHHS) or Boards (BOLIM) Adopted after public comment More detailed than statutes, explanatory Identified as C.M.R. ch.11, 4 (2017) Rules are subordinate to statutes

25 Overview of P.L. 2015, Chapter 488 Effective 90 days after adjournment of the Second Regular Session of the 127 th Maine Legislature, though some provisions have other timeframes specified (July 29, 2016) As Amended by P.L. 2017, Chapter 213 As further described by OSAMHS Rule Chapter 11, Rules Governing the Controlled Substances Prescription Monitoring Program and Prescription Opioid Medications Components include: Required PMP check for prescribers and dispensers (1/1/2017) Prescribing limits on MMEs per day (7/29/2016) Prescribing limits on length of scripts (1/1/2017) Exception for emergency rooms, inpatient hospitals, long-term care facilities, or residential care facilities or in connection with a surgical procedure. Exception for medication-assisted treatment for substance use disorder Exceptions for active and aftercare cancer treatment, palliative care, and end-of-life and hospice care Other exceptions may be determined by rule Mandatory CME (12/31/2017) Mandatory electronic prescribing (7/01/2017) Partial filling of prescriptions at patient request (7/29/2016)

26 Key Definitions Acute pain Normal, predicted physiological response to a noxious chemical or thermal or mechanical stimulus Typically associated with invasive procedures, trauma or disease and is usually time-limited Chronic pain Persists beyond the usual course of an acute disease or healing of an injury May or may not be associated with an acute or chronic pathologic process that causes continuous or intermittent pain over months or years

27 Opioid medication Key Definitions A controlled substance containing an opioid; includes tramadol, does not include loperamide Prescriber Licensed health care professional with authority to prescribe controlled substances Includes MDs, DOs, PAs, NPs, podiatrists, dentists, and veterinarians Administer Action to apply prescription drug directly to a person by any route by a licensed or certified health care professional (the statute and rule do not define order, as in ordering a medication to be administered by an RN) Does not include delivery, dispensing, or distribution of a prescription drug for later use

28 Key Definitions Palliative care Patient-centered, family-focused medical care that optimizes quality of life by anticipating, preventing, and treating suffering caused by serious medical illness or physical injury or condition that substantially affects quality of life Addresses physical, emotional, social, and spiritual needs Facilitates patient autonomy and choice of care Provides access to information Discusses patient s goals for treatment and treatment options, including hospice care, when appropriate Manages pain and symptoms comprehensively Palliative care does not always include a requirement for hospice care or attention to spiritual needs. (new) Note: Does not require a terminal condition

29 Key Definitions Serious illness Medical illness or physical injury or condition that substantially affects quality of life for more than a short period of time Includes, but is not limited to, Alzheimer s disease and related dementias, lung disease, cancer and heart, renal or liver failure and chronic, unremitting or intractable pain such as neuropathic pain. (new)

30 Prescriber Responsibilities Required PMP check Upon initial prescription of benzodiazepine or opioid medication Every 90 days following Delegation of PMP check Prescribers may delegate PMP check to any staff member duly authorized by prescriber/practice and PMP Office Despite delegation, prescriber must review patient s aggregate MME (including new prescription); number of prescribers currently prescribing controlled substances to patient; and number of pharmacies currently dispensing

31 Exception to PMP Check No PMP check is required for benzodiazepine or opioid medication directly administered in an emergency room setting, an inpatient hospital setting, a long-term care facility (assisted living or nursing home), or a residential care facility, or in connection with a surgical procedure. No PMP check is required for hospice or end-oflife patients.

32 Prescriber Responsibilities Required notations on opioid prescriptions DEA number Acute or Chronic for all prescriptions (including suboxone) under 100 MME and Exemptions F and H For acute on chronic pain (Exemption Code F), use Acute For palliative care (Exemption Code B), note the diagnosis (ICD-10) code Where an exemption is claimed, the exemption code (A through H) must be noted New: Pharmacists may contact prescribers by telephone to verify and document missing information on the script.

33 Exceptions to limits on opioid medication prescribing By Statute 1. Pain associated with active and aftercare cancer treatment. Providers must document in the medical record that the pain experienced by the individual is directly related to the individual s cancer or cancer treatment. Exemption Code A 2. Palliative care in conjunction with a serious illness (includes injury). Code B, (ICD 10 Code must be included on script as well as Code B ) 3. End-of-life and hospice care. Code C 4. Medication-Assisted Treatment for substance use disorder. Code D

34 Exceptions to limits on opioid medication prescribing By Rule 5. A pregnant individual with a pre-existing prescription for opioids in excess of the 100 Morphine Milligram Equivalent aggregate daily limit. Exemption applies only during the duration of the pregnancy. Code E 6. Acute pain over an existing opioid prescription for chronic pain. The acute pain must be postoperative or new onset. Seven day prescription limit applies. Code F 7. Active taper of opioid medications, maximum taper period of six months, after which time the opioid limitations will apply, unless one of the additional exceptions in this subsection apply. Code G 8. Prescription of a second opioid after proving intolerant to a first opioid, thereby exceeding the 100 MME limit. Neither prescription may exceed 100 MME. Code H

35 Prescriber Responsibilities Continuing Education Every prescriber must complete 3 hours of CME on the prescription of opioid medication every 2 years as a condition of prescribing opioid medication First 3 hours must be completed by 12/31/2017. Electronic Prescribing Prescribers with the capability to electronically prescribe must prescribe all opioid medication electronically A waiver may be available in some circumstances: Written waiver application required Penalties for failure to comply

36 E-prescribing Mandate MMA relationship with Dr. First. Contact is Eric Landry at or No exceptions for any specialties, locations Long term care facilities may use fax per DEA rules For homeless patients, use address of shelter, street name, if possible; if no address, may prescribe on paper Exemption from limits/pmp checks is NOT exemption from E-prescribing requirement

37 E-prescribing Mandate - Exceptions Exceptional circumstances allowing written prescriptions: Temporary technological or electrical failure To be dispensed by VA or Indian Health Service pharmacy, or outside Maine Prescriber reasonably determines that it would be impractical, patient could not obtain medication timely, and delay would adversely impact patient s medical condition

38 Partial fill Upon patient request, pharmacist may dispense lesser quantity of medication than is prescribed Remainder of prescription is void Pharmacist must, within 7 days, notify prescriber of quantity actually dispensed Notification may be by notation in patient s EHR, by electronic transmission or fax or telephone In cases of pharmacist shortage, lesser quantity may be dispensed. Remainder may be dispensed only if within 72 hours.

39 Penalties Civil violation Subject to fine of $250 per incident up to a maximum of $5000 per calendar year More serious concern is Licensing Board action PMP will report violations to Board, prescriber will receive 2 weeks advance notice and opportunity to comment

40 What will the Maine CDC Be Looking For? High number of prescribers in a short time High number of doses in a short time Days supply of prescriptions for the same drug overlapping by more than a few days Inappropriate combinations of controlled substances More than one method of payment within a short time More than one out-of-state prescriber for the same patient, within a short time More than one pharmacy on the same day More than one pharmacy in different public health districts within one month Dangerous levels of specific drugs

41 COMING VERY SOON Licensing Boards: Revised version of Joint Rule, Chapter 21 Universal opioid precautions (exception for medical emergency) Risk assessment tool encouraged, assessment must be documented Use measuring tools to assess level of pain, function, quality of life Random toxicological drug screens required at least annually Frequency based on patient s level of risk Random pill counts an additional tool, probably not mandatory Treatment agreement, informed consent rules detailed & mandatory These requirements mostly for chronic pain prescriptions

42 More Regulatory and Legislative Activity Licensing Boards: CME (Chapter 1) MDs: All must have 3 hours of opioid CME every 2 years, regardless of opioid prescribing, starting in 2018 Other Boards: Only as condition of prescribing opioids MaineCare rules Limit of 4 acute pain prescriptions (28 days) Legislative Task Force on the Opioid Crisis Recommendations Currently Under Discussion

43 Resources MMA s Opioid Crisis page: Opioid laws & rules, Maine Opiate Collaborative task force Reports, CDC guidelines, naloxone, Q and A, DHHS clarifications. Caring for ME page: Webinars, opioid laws & rules, information on pain management and tapering, etc.

44 Questions? Maine Medical Association 30 Association Drive, P.O. Box 190 Manchester, Maine Fax Gordon Smith, Esq. Andrew MacLean, Esq. Peter Michaud, Esq.

45 Upcoming Caring for ME Webinars Tues, February 6, 2018, 12-1 pm, Caring for ME Webinar: Alternative Treatments for Pain, Elisabeth Fowlie Mock, MD, MICIS, Register via zoom Tues, March 13, 2018, 12-1 pm, Caring for ME Webinar: Snuggle ME Guidelines: What s New?, Kelley Bowden, Zoom Registration Tues, May 15, 2018, 12-1 pm: Caring for ME Webinar: Setting up MAT Programs in the Emergency Department: Ranjiv Advani MD & Leah Bauer MD, Midcoast Hospital, Register via zoom Tues, June 12, 2018, 12-1 pm, Caring for ME Webinar: Integrated Care for Pregnant and Parenting Women with Opioid Use Disorders: Best Practice with Limited Resources, Daisy Goodman, DNP, Zoom Registration

46 QC launched 6 Online CME Modules with the Support of the Board of Licensure in Medicine (BOLIM) and the MMA in August of Compliance with Maine Prescribing Laws Safe Opioid Prescribing & Prescribing Limits Chronic Pain Management Appropriate Diagnosis and Treatment of Opioid Addiction Safe & Compassionate Opioid Tapering Maternity Care and the Snuggle ME Guidelines