NC Workers’ Comp Opioid Rules: Summary and Function

1. NC Workers’ Comp Opioid Rules: Summary and Function Scarlette Gardner, Esq., Acting Division Director NC Office of State Human Resources Safety Health & Workers’ Compensation Division February 24, 2019

2. Current NC WC Opioid Prescribing Legal Requirements 1. NCMB Position Statement: CDC Guidelines 2. NC Session Law 2017-74 “STOP” Act 3. NCIC Rules For The Utilization Of Opioids, Related Prescriptions, And Pain Management Treatment In Workers' Compensation Claims

3. NCMB Position Statement NC Medical Board Position Statement Policy for the use of opioids for the treatment of pain …”the Board has decided to adopt and endorse the CDC Guideline for Prescribing Opioids for Chronic Pain written and maintained by the Centers for Disease Control and Prevention (“CDC”). While these guidelines do not constitute regulations or necessarily state the standard of care in North Carolina in every context, the Board’s believes that these guidelines can provide useful information to licensees related to the appropriate considerations to be made prior to and during treatment plans involving opioids.”… https://www.ncmedboard.org/resources-information/professional-resources/laws-rules-position-statements/position-statements/Policy_for_the_use_of_opiates_for_the_treatment_of_pain

4. NCMB Position Statement NC Medical Board Position Statement includes the following link to the CDC Guideline 4 page summary https://www.ncmedboard.org/images/uploads/article_images/CDCguidelines_at-a-glance-a.pdf Special Note:Newly adopted NCIC Opioid Rules include many elements listed in CDC Guideline four page summary document.

5. NC STOP Act provisions Applies to outpatient prescriptions only: • No more than 5 days opioid supply upon initial consultation and treatment for acute pain. • No more than 7 days opioid supply immediately following surgery. • Upon subsequent consultation for same pain, practitioners may issue any appropriate renewal, refill, or new prescription for targeted controlled substance (TCS) i.e. Schedule 2 or 3 opioid.

6. NC STOP Act provisions Mandatory Review of NC Controlled Substances Reporting System (CSRS) by all prescribers: Prior to prescribing TCS, practitioners must review patient’s 12-month prescription history in NC CSRS. For every subsequent three-month period that TCS remains part of the patient’s medical care, practitioners must review patient’s 12-month prescription history in NC CSRS. Reviews should be documented within patient’s medical record along with any electrical or technological failure that prevents such review.

7. NC STOP Act provisions Effective Date: January 1, 2020 Mandatory electronic prescribing of all outpatient TCS unless physician dispensed. Workers’ compensation payers do not usually prefer physician dispensing due to increased drug cost vs. pharmacy (PBM) network.

8. NCIC Opioid Rules Go to NCIC website at www.ic.nc.gov to obtain: Adopted administrative rules 2. NCIC Companion Guide NCIC Chart: “Basics of the phases of treatment under the Opioid Utilization Rules (.200 Rules)

9. NCIC .200 Opioid RulesSummary Chart NCIC one page chart at: “Basic Overview of the Phases of Treatment Under the Opioid Utilization Rules”

10. NCIC Opioid Task Force Guiding Principles • Attract and retain highly skilled medical providers for WC treatment. • Give prescribers a “legal” reason for refusal to continue opioid therapy. • INCENTIVIZE short-term opioid prescribing. • DETER long-term opioid prescribing via prescribing requirements and payer authorization discretion. • Promote non-pharmacological and non-opioid treatment alternatives for pain relief.

11. IMPORTANT NOTE!!! No objection letters were filed with Rules Review Commission. Thus, Rules were not forwarded to General Assembly for review which may have resulted in long delayed implementation and enactment of new laws disadvantageous to injured employees and payers.

12. NCIC’s Stated Purposes of Rules Rules DO NOT constitute medical advice or standard of care. 2. Rules address OUTPATIENT utilization of opioids, related prescriptions, and pain management treatment for non-cancer pain. 3. Rules help ensure employees receive medical care intended by Chapter 97 and costs are contained.

13. Practical Effects of Rules What this means for individual claims? • Rules create: a. Reasonable prescriber hassle factor. b. Sufficient payer authorization roadblocks to slow down opioid therapy. • Rules allow payer flexibility: a. Payers may “pump the brakes” by refusing opioid authorization when prescribers do not adhere to Rules requirements. b. Payers may authorize opioid therapy outside Rules when they deem appropriate.

14. Applicability of Rules Rules DO NOT APPLYto prescriptions issued by non-workers’ compensationprescribers. Workers’ compensation patients may be prescribed anything by other prescribers simultaneously treating them.

15. Applicability of .200 Rules Date of first TCS prescription (Targeted Controlled Substance - Schedule 2 or 3 opioid) MUST BE May 1, 2018 or after for .200 Rules to apply.

16. Applicability of .200 Rules EXEMPTION: WC patients who received TCS treatment more than 12 consecutive weeks immediately before May 1, 2018 i.e. first TCS prescription on or before February 5, 2018.

17. Payer Options REMEMBER: Rules address prescribing requirements for medical providers, not payers. Payers may or may not authorize TCS prescriptions that do not meet the Rules’ prescribing requirements. Payers requiring adherence to all Rules provides ability to put the brakes on TCS treatment.

18. .200 Rules - 2 Pain “Phases” Acute Phase: 12 weeks of treatment for pain following an injury by accident, occupational disease, surgery for an injury, or subsequent aggravation of an injury. There may be multiple “acute phases” during a claim. Chronic Phase: Continued treatment for pain immediately following a 12 week period of treatment using a targeted controlled substance “TCS”. DIFFERENT RULES APPLY TO TCS PRESCRIPTIONS IN EACH PHASE.

19. Applicability of .300, .400, .500 Rules .300, .400, .500 Rules apply to ALL TCS prescriptions: Co-prescribing naloxone. Referral for non-pharmacological treatment. 3. Referral for opioid tapering/ substance abuse disorder assessment/treatment.

20. What is the role of Nurse Case Managers? Nurse case managers may provide general, non patient specific information to medical providers regarding existence and content of the Rules. Nurse case managers may give medical providers and employees documents published on NCIC website: ic.nc.gov Nurse case managers may not provide opinions to medical providers regarding whether TCS treatment does or does not comply with the Rules. Nurse may give notice to prescriber and employee of potential issues with payer authorization of prescription.

21. Payer Options Payer Prescription Denial Options Payer may immediately authorize retail pharmacy dispensing of dosages up to the Rules’ limits so that patient goes home with some pain relief medication. Payer may authorize treatment outside of Rules based on medical documentation and communication with prescriber.

22. Payer Options Other Payer Options To Combat Noncompliant Opioid Prescribing Request written “medication review” i.e. a peer review of all WC related medications prescribed by all authorized treating physicians. Exercise NCGS §97-25 right to direct medical treatment elsewhere i.e. change authorized treating physicians if unhappy with prescriber’s nonadherence to the Rules.

23. What happens if a payer refuses to authorize a prescription? IMPORTANT POINTS!!! Medical providers will ALWAYS get paid for services rendered. Payers MAY NOT refuse to pay for a medical visit/treatment if medical provider writes a prescription that is not authorized by payer.

24. What happens if a payer refuses to authorize a prescription? Parties are encouraged to request information, communicate in detail, and reach agreement on an alternate course of treatment. IF THAT DOES NOT WORK....

25. What if employee files a medical motion related to the Rules? Rules allow employee to file NCGS §97-25 medical motion if disputes cannot be resolved by the parties: NCIC will rule based upon the following factors: (1) The necessity of a waiver; The party's responsibility for the conditions creating the need for a waiver; (3) The party's prior requests for a waiver; (4) The precedential value of such a waiver; (5) Notice to and opposition by the opposing parties; and (6) The harm to the party if the waiver is not granted.

26. 2 prongs of evidence supporting opioid therapy denial Legal Arguments • TCS prescription exceeds MED limit. • Medical records fail to show prescriber compliance with .200 Rules: • Periodic urinary drug testing (UDT). • Use of Opioid Risk Assessment Tool. • No documentation of NC CSRS checks (effective 11/1/2018 or sooner). • No documentation non-opioid, non-pharmacological therapy is not appropriate. • Type/number of TCS (short and long-acting). • Payer has attempted to compromise with patient regarding pain treatment.

27. 2 prongs of evidence supporting opioid therapy denial Patient Safety & Well-Being Arguments Non-opioid meds or therapies have not been tried. Long-term opioid therapy has not improved function. Overall pharmacy risk due to potential interaction with other drugs. Limited or no objective physical findings supporting subjective pain reports. History of opioid overdose/naloxone use. Prior attempt(s) to change authorized treating physician (ATP) were rejected. Prior attempt(s) to obtain medication review were rejected or results ignored.

28. Important Legal Distinction!!! Chronic pain is not a separate injury/ condition that must be accepted or denied, it is merely treatment for already accepted body parts/conditions. Chronic pain treatment with any provider type does not create a presumption that a separate mental injury/condition exists.

29. NCIC Opioid Rules Details 11 NCAC Chapter 23M NCIC Rules for the Utilization of Opioids, Related Prescriptions, and Pain Management Treatment in Workers’ Compensation Claims

30. “Acute Phase” Prescriptions What a prescriber CANNOT do in any “Acute Phase” prescription: NO Fentanyl. NO transcutaneous, transdermal, transmucosal, or buccal opioid preparations without documentation in the medical record that oral opioid dosing is medically contraindicated. NO benzodiazepines for pain or as muscle relaxers. NO Carisoprodol and a TCS in an acute phase. NO prescription given to patient in advance to be dispensed at a later date.

31. “Acute Phase” - First Prescription PRESCRIBING REQUIREMENTS: • Document non-pharmacological and non-opioid treatment is insufficient. • Review information in CSRS regarding patient for preceding 12 months. • Shortest duration necessary: no more than 7 day supply post-surgery; no more than 5 day supply for anything else. • Lowest effective dose not to exceed 50 MED/day. (Exception: Patient taking 50 MED/day before surgery). • Only one short-acting TCS.

32. “Acute Phase” – Next Prescription after Days 5-7 s PRESCRIBING REQUIREMENTS: • Document non-pharmacological and non-opioid treatment is insufficient. • Review information in CSRS regarding patient for preceding 12 months. • Shortest duration necessary not to exceed one 30- day supply at a time. • Lowest effective dose not to exceed 50 MED/day. Exception: up to 90 MED/day with documentation of medical justification. • Only one short-acting opioid.

33. “Acute Phase” – Days 35-37 through Day 84 PRESCRIBING REQUIREMENTS: • Document non-pharmacological and non-opioid treatment is insufficient. • Review information in CSRS regarding patient for preceding 12 months. • Shortest duration necessary not to exceed one 30- day supply at a time. • Lowest effective dose not to exceed 50 MED/day. Exception: up to 90 MED/day with documentation of medical justification. • Only one short-acting opioid.

34. “Acute Phase”Days 35-37 through Day 84 AND THERE’S MORE…. May continue ongoing treatment with TCS in ACUTE phase only if: 1. Urine Drug Testing (UDT): a. Administer presumptive urine drug test (UDT). b. If presumptive UDT shows nondisclosed illicit or controlled substance(s) or does not show prescribed TCS, order confirmatory UDT. 2. Administer clinically validated opioid risk tool to assess risk of opioid-related harm. 3. Document in medical record whether CSRS review, UDT, or risk tool indicates increased risk of opioid-related harm. If opioid treatment is continued where there is increased risk, document medical justification..

35. “Chronic Phase” Prescriptions What a prescriber CANNOT do in any “Chronic Phase” prescription: NO transcutaneous, transdermal, transmucosal, or buccal opioid preparations without documentation in the medical record that oral opioid dosing is medically contraindicated. NO benzodiazepines for pain or as muscle relaxers. Benzodiazepines are man-made medications that cause mild to severe depression of the nerves within the brain (central nervous system) and sedation (drowsiness). Benzodiazepene examples: Xanax, Klonopin, Valium (diazepam), Ativan (lorazepam), Halcion (triazolam)

36. “Chronic Phase” prescriptions -after 12 consecutive weeks of treatment) PRESCRIBING REQUIREMENTS: • Document non-pharmacological and non-opioid treatment is insufficient. • Review information in CSRS regarding patient at every appointment when TCS is prescribed or every 3 months, whichever is more frequent. • No more than two opioids at a time – one short-acting TCS and one long-acting TCS. • Shortest duration necessary not to exceed one 30 day supply at a time.

37. “Chronic Phase” prescriptions -after 12 consecutive weeks of treatment) AND THERE’S MORE… • Lowest effective dose not to exceed 50 MED/day. Exception:up to 90 MED/daywith documentation of medical justification. Exception: up to 120 MED/daywith documentation of medical justification and payer preauthorization. • Must have payer preauthorization for: transdermal fentanyl, methadone for pain, carisoprodol combined with a TCS.

38. “Chronic Phase” prescriptions -after 12 consecutive weeks of treatment AND THERE’S MORE…. May continue ongoing treatment with TCS in CHRONIC phase only if: 1. Urine Drug Testing (UDT): a. Administer presumptive urine drug test (UDT): minimum 2 times and maximum 4 times per year without payer preauthorization (may be random and unannounced) b. If presumptive UDT shows nondisclosed illicit or controlled substance(s) or does not show prescribed TCS, order confirmatory UDT (may prescribe limited supply of TCS while awaiting results) c. Additional UDT may be ordered for documented medical reasons.

39. “Chronic Phase” prescriptions - after 12 consecutive weeks of treatment AND THERE’S MORE…. May continue ongoing treatment with TCS in CHRONIC phase only if: 2. Document in medical record whether CSRS review, UDT, or risk tool indicates increased risk of opioid-related harm. If opioid treatment is continued where there is increased risk, document medical justification for prescribing TCS.

40. “Chronic phase” prescriptions - after 12 consecutive weeks of treatment OTHER SPECIAL CONSIDERATIONS: Whenever a different provider begins treating WC patient with TCS, that provider must administer clinically validated opioid risk assessment tool. If patient is receiving carisoprodol or benzodiazepines from another prescriber, then WC medical provider who adds opioid must inform other provider he has done so and advise employee of risk of taking such medications with an opioid.

41. Does employee need an opioid antagonist (naloxone/Narcan)? Provider shall consider prescribing opioid antagonist during “acute” or “chronic” phase if: Patient takes a benzodiazepine or carisoprodol and an opioid. Patient takes more than 50 MED/day. Patient has history of drug overdose. Patient has history of substance abuse disorder. Provider is aware patient has underlying mental health condition that poses increased risk of overdose. Patient has medical condition or co-morbidity that poses increased risk of overdose.

42. Does employee need an opioid antagonist (naloxone/Narcan)? Prescription shall be written to allow product selection by payer to include FDA-approved intranasal formulation. Payers ARE NOT required to pay for an opioid antagonist every time an opioid is prescribed…they are good for several years. Approximate retail cost two-pack: $130.00

43. How to order nonpharmacological treatment? Provider may order nonpharmacological treatment i.e. acupuncture, physical therapy, chiropractic massage therapy, biofeedback, cognitive behavior therapy, functional restoration programs, etc. just like you order anything else. Payer may request additional information from provider via any method allowed by the WC Act. (NCIC has created non-mandatory form.)

44. NCIC Forms related to Opioid Rules Provide medical provider with NCIC opioid related forms included in the NCIC Companion Guide when requested by payer to do so: • Employer/Carrier Request to Health Care Provider for Additional Information Regarding Non-Pharmacological Treatment Recommendation • Employer/Carrier Request to Health Care Provider for Additional Information Regarding Recommendation for Opioid Tapering or Discontinuation • Employer/Carrier Request to Health Care Provider for Additional Information Regarding Recommendation for Substance Use Disorder Treatment Payer fills out top block of information on ALL forms.

45. How to order evaluation for need to taper opioids or addiction? Provider may refer patient to appropriate provider for evaluation for opioid taper or addiction. Payer may request additional information from provider via any method allowed by WC Act. (NCIC has created non-mandatory form.)

46. Employee Strategies to Continue Opioid Therapy Provide medical literature and/or engage in ex parte communication with authorized treating physician per NCGS §97-25. Get an IME/second opinion from another medical provider pursuant to NCGS §97-25. Get independent IME. Get authorized treating physician to refer employee to pain management. File medical motion seeking NCIC Order for change of authorized treating physician.

47. Employee Strategies to Continue Opioid Therapy, cont. File medical motion seeking approval of specific medications based on medical records. File medical motion to remove or replace RP. Get a medication review from another authorized treating physician. Get authorized treating physician to recommend spinal cord stimulator. 10. Get employee to talk about spinal cord stimulator with authorized treating physician. 11. Get newer, more expensive brand opioid with no generic prescribed in an attempt to keep getting higher dosages of generic opioids.

48. Why does employee/legal counsel want injured employee to remain on opioids? More expensive drug = increase in claim settlement value. Increase likelihood employee will be found “disabled” from engaging in any employment due to ongoing pain. Increase likelihood employee will be approved for Social Security Disability. Increase likelihood employee cannot effectively participate in voc rehab. Increase likelihood employee will be issued additional permanent work restrictions associated with need for ongoing pain medications.

49. Cost Containment/Risk Management Strategies for Payers Advise payers to require PBM implement NC STOP Act and Rules requirements in prescription approval algorithms. Advise payers to get list of claims with >90 MED scores and closely monitor their medical records for prescriber compliance with Rules. Advise payers to direct or transfer care to physicians that comply with Rules (especially pain management) and try other pain therapies before opioids. 4. Advise payers authorizing non-pharmacological treatment in lieu of opioid therapy to initially authorize same amount of visits as usual for such therapies to avoid potential medical motions.

50. Cost Containment/Risk Management Strategies 5. Advise payers to BE FLEXIBLE and make good faith effort to confer with employee/counsel and prescriber to reach agreement on opioid therapy or alternatives instead of automatic denial. 6. Advise payers to thoroughly document all efforts to reduce opioid therapy to safe levels i.e. attempted/ completed medication reviews, communications with prescriber pursuant to NCGS §97-25.6(c)(2)(b), appropriate course of treatment. 7. Utilize nurse case management services to closely monitor and coordinate care for > 90 MED claimants, especially with multiple physicians prescribing opioids.