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1 NCIC Opioid Prescribing Rules Practical Effects Current Status of Medical Marijuana in NC Scarlette Gardner, Esq. & Melissa K. Walker, Esq. June 16, 2018 Current NC WC Opioid Prescribing Legal Requirements 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 1. NCMB Position Statement: CDC Guidelines 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. 3

NCIC Opioid Prescribing Rules Practical Effects Current ......5. Promote non-pharmacological and non-opioid treatment alternatives for pain relief. 6 IMPORTANT NOTE!!! •No objection

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Page 1: NCIC Opioid Prescribing Rules Practical Effects Current ......5. Promote non-pharmacological and non-opioid treatment alternatives for pain relief. 6 IMPORTANT NOTE!!! •No objection

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NCIC Opioid Prescribing Rules Practical Effects

Current Status of Medical Marijuana in NC

Scarlette Gardner, Esq. & Melissa K. Walker, Esq.

June 16, 2018

Current NC WC Opioid Prescribing Legal Requirements

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

1. NCMB

Position

Statement:

CDC

Guidelines

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.

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NCIC Opioid Rules

Go to NCIC website at

www.ic.nc.gov to obtain:

1. Adopted

administrative rules

2. NCIC Companion

Guide

3. NCIC Chart: “Basics

of the phases of

treatment under the

Opioid Utilization

Rules (.200 Rules)

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NCIC Opioid Task Force Guiding Principles

1. Attract and retain highly skilled medical providers for WC treatment.

2. Give prescribers a “legal” reason for refusal to continue opioid therapy.

3. INCENTIVIZE short-term opioid prescribing.

4. DETER long-term opioid prescribing via prescribing requirements and payer authorization discretion.

5. Promote non-pharmacological and non-opioid treatment alternatives for pain relief.

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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 payers.

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NCIC’s Stated Purposes of Rules

1. 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.

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Practical Effects of Rules

What this means for individual claims?

1. Rules create:

a. Reasonable prescriber hassle factor.

b. Sufficient payer authorization roadblocks to

slow down opioid therapy.

2. 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 appopriate.

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Applicability of Rules

•Rules DO NOT APPLY to prescriptions issued

by non-workers’ compensation prescribers.

•Workers’ compensation patients may be

prescribed anything by other prescribers

simultaneously treating them.

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Applicability of .200 Rules

Date of first TCS prescription(Targeted Controlled Substance - Schedule 2 or 3 opioid)

MUST BE May 2, 2018 or after for

.200 Rules to apply.

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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.

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.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.

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Applicability of .300, .400, .500 Rules

.300, .400, .500 Rules apply to ALL TCS prescriptions:

1. Co-prescribing naloxone.2. Referral for non-pharmacological

treatment.3. Referral for opioid tapering/

substance abuse disorder assessment/treatment.

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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.

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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.

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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.

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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.

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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.

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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....

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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;

(2) 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.

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:a. Periodic urinary drug testing (UDT).b. Use of Opioid Risk Assessment Tool.c. No documentation of NC CSRS checks

(effective 11/1/2018 or sooner).d. No documentation non-opioid, non-

pharmacological therapy is not appropriate.e. Type/number of TCS (short and long-acting).

•Payer has attempted to compromise with patient regarding pain treatment.

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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.

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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.

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Cost Containment/Risk Management Strategies

1. Advise payers to require PBM implement NC STOP Act

and Rules requirements in prescription approval

algorithms.

2. Advise payers to get list of claims with >90 MED scores and closely monitor their medical records for prescriber compliance with Rules.

3. 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.

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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.

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Cost Containment/Risk Management Strategies

8. Advise payers to add more providers to PPO networks to handle potential increased demand due to Rules:

a. Physical therapy/dry needling/massage

b. Acupuncture

c. Chiropractorsd. Cognitive Behavioral Therapists experienced in

chronic pain management

e. Pain Rehabilitation/Functional Restoration

Programs

f. Opioid tapering/weaning specialists

g. Opioid dependency/addiction treatmenth. IME physicians to address whether opioids

prescribed by WC provider(s) created dependency in need of tapering/weaning/addiction treatment

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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

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“Acute Phase” Prescriptions

What a prescriber CANNOT do in any “Acute Phase” prescription:1. NO Fentanyl.

2. NO transcutaneous, transdermal, transmucosal, or buccal opioid preparations without documentation in the medical record that oral opioid dosing is medically contraindicated.

3. NO benzodiazepines for pain or as muscle relaxers.

4. NO Carisoprodol and a TCS in an acute phase.

5. NO prescription given to patient in advance to be dispensed at a later date.

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“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 (effective 11/1/18).

❑ 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.

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“Acute Phase” –Next Prescription after Days 5-7s

PRESCRIBING REQUIREMENTS:

❑ Document non-pharmacological and non-opioid

treatment is insufficient.

❑ Review information in CSRS regarding patient for

preceding 12 months (effective 11/1/18).

❑ 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.

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“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 (effective 11/1/18).

❑ 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.

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“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..

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“Chronic Phase” Prescriptions

What a prescriber CANNOT do in any “Chronic Phase” prescription:

1. NO transcutaneous, transdermal, transmucosal, or buccal opioid preparations without documentation in the medical record that oral opioid dosing is medically contraindicated.

2. 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)

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“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. (effective

11/1/18).

❑ 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.

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“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/day with documentation

of medical justification.

Exception: up to 120 MED/day with

documentation of medical justification and payer

preauthorization.

❑ Must have payer preauthorization for:

transdermal fentanyl, methadone for pain,

carisoprodol combined with a TCS.

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“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.

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“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.

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“Chronic phase” prescriptions -after 12 consecutive weeks of treatment

OTHER SPECIAL CONSIDERATIONS:

1. Whenever a different provider begins treating WC patient with TCS, that provider must administer clinically validated opioid risk assessment tool.

2. 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.

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Does employee need an opioid antagonist (naloxone/Narcan)?

Provider shall consider prescribing opioid antagonist during “acute” or “chronic” phase if:

1. Patient takes a benzodiazepine or carisoprodol and an opioid.

2. Patient takes more than 50 MED/day.

3. Patient has history of drug overdose.

4. Patient has history of substance abuse disorder.

5. Provider is aware patient has underlying mental health condition that poses increased risk of overdose.

6. Patient has medical condition or co-morbidity that poses increased risk of overdose.

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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

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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.)

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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.)

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Typical Workers’ Compensation Pain Cycle

Traditional pain management approach:

Step 1: Prescribe drugs/procedures

Step 2: If pain does not subside or worsens, repeat Step 1.Why: Fastest, cheapest route to close claim.

WHAT HAS BEEN IGNORED? Biopsychosocial factors

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Biopsychosocial Factors

Potential Biospsychosocial Factors

▪Lifestyle factors (e.g., diet, exercise, sleep)

▪Stressors and stress management strategies

▪Psychosocial context (e.g., family constellation, family medical/psychological, impact of illness on family)

▪Recent major life events

▪Perceived strengths

▪Job/academic activities

▪Hobbies

▪Peer supports

▪Meaning of illness

▪Functional impairment (what patient can or cannot do)

▪Cultural factors (e.g., meaning of illness, preferred treatment approaches, involvement of elders and religious leaders)

Change the Pain Paradigm

Change the chronic pain treatment cycle:

Step 1: Assess and diagnose biopsychosocial factors

driving pain early in claim and provide needed behavioral

health interventions ranging from simple to complex.

Step 2: Prescribe appropriate non-opioid therapies first and

give them time to work.

Examples: biofeedback, cognitive behavior therapy, dry

needling, acupuncture, chiropractic, physical therapy, etc.

Step 3: Use opioids as a last resort for long term pain.

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Contact Information:

Scarlette Gardner, Esq.NC Office of State Human Resources

State Workers’ Compensation Manager

116 West Jones Street

Raleigh, NC 27603

(919) 807-4858

[email protected]

OSHR Website: workerscomp.nc.gov

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