Opioids (PG018) Form

Opioids are a class of drugs naturally found in the opium poppy plant. Some prescription opioids are made from the plant directly, and others are made by scientists in labs using the same chemical structure. Opioids are often used as medicines because they contain chemicals that relax the body and can relieve pain. Prescription opioids are used mostly to treat moderate to severe pain.

The Centers for Medicare and Medicaid Services (CMS) has issued guidance regarding reducing opioid misuse in response to the opioid epidemic. This is to be done by promoting safe and responsible pain management, making sure patients can access treatment for opioid use disorder, and using data to target prevention and treatment.

This policy addresses criteria for both immediate-acting opioid analgesics (such as tramadol, hydrocodone/acetaminophen, hydromorphone, and oxycodone) and extended-release opioid analgesics (such as Fentanyl, morphine extended release, oxymorphone extended release, and oxycodone extended release).

This policy applies to any opioid analgesic on the Plan’s Formulary that requires a prior authorization:

1. The first fill for members without claims history of prior opioid use for immediate-acting opioid analgesics is limited to:
   • 3-days for members 19 and younger; or
   • 7-days for members above the age of 19.
2. Immediate-acting opioid analgesic use is required before prescribing extended-release opioid analgesics. A prior authorization is required if claims history has no prior use of an immediate- acting opioid or if a member is not already stable on an extended-release opioid analgesic.
3. A prior authorization is also required if the member has exceeded a 90 mg per day MME (morphine milligram equivalent) limit (or 80 mg per day MME limit for Ohio).
4. Non-formulary opioid analgesics will go through the non-formulary exception process. Members who meet the non-formulary exception process will then need to also meet the opioid requirements outlined below.
5. Members being treated for pain associated with cancer, sickle cell, a terminal condition, or pain being managed through hospice or palliative care will be approved for an indefinite period of time.

Definitions

• Acute pain is defined as having a duration less than one (1) month.
• Subacute pain is defined as having a duration of one (1) to three (3) months.
• Chronic pain is defined as having a duration of greater than (>) three (3) months.
• Opioid Naive is a member who has not received opioids in the last 90 days.
• Opioid Experienced is a member who has received opioids in the last 90 days.

Immediate Acting Opioid Analgesics:

Medical Necessity Criteria for Initial Authorization

The Plan considers Immediate Acting Opioid Analgesics medically necessary when BOTH of the following criteria is met:

1. The member is being treated for ONE of the following:
   1. pain associated with cancer, sickle cell, a terminal condition, or pain being managed through hospice or palliative care; OR
   2. acute or subacute pain and BOTH of the following criteria are met:
      1. Prescriber attestation that initial treatment regimen beyond the following is medically necessary:
         1. 3-days for members 19 and younger; or
         2. 7-days for members above the age of 19; and
      2. The member’s pain is related to ONE of the following:
         1. severe traumatic injuries (including crush injuries and burns); or
         2. invasive surgeries typically associated with moderate to severe postoperative pain; or
         3. other severe pain when NSAIDs and other therapies are contraindicated or likely to be ineffective; OR
   3. chronic pain and ALL of the following criteria are met:
      • The member is unable to use, or has tried and failed ONE non-pharmacologic intervention (e.g., ice, heat, elevation, rest, immobilization, or exercise); and
      • The member is unable to use, or has tried and failed THREE non-opioid pharmacologic therapies intended to treat pain, such as:
        1. Acetaminophen; and/or
        2. Anticonvulsants such as pregabalin/gabapentin; and/or
        3. Oral NSAIDs; and/or

Serotonin and norepinephrine reuptake inhibitor (SNRI) antidepressants; and/or

5. Topical nonsteroidal anti-inflammatory drugs (NSAIDs); and/or
6. Tricyclic and tetracyclic antidepressants; and

Documentation is submitted showing BOTH of the following:

1. recent urine drug screen, to assess for prescribed medications as well as other prescribed and non-prescribed controlled substances; and
2. the member’s treatment plan (i.e., specific functional goals, how opioids will be prescribed and monitored, plan for initiating, increasing, tapering, or discontinuing opioids); and

iv. Prescriber attestation is provided indicating BOTH of the following:

1. That opioids will be prescribed in accordance with current clinical practice guidelines AND an assessment of risks, harms, and goals consistent with an opioid agreement (or similar agreement) has been undertaken; and
2. The member has been assessed for concurrent use of opioid pain medication and benzodiazepines AND the prescriber has determined ONE of the following:

1. opioid pain medications and benzodiazepines will NOT be used concomitantly; or
2. benefits outweigh risks of continuing therapy with opioids and benzodiazepines or stopping benzodiazepines can be destabilizing; AND

2. Clinical chart documentation and supporting laboratory test results are provided for review to substantiate the above listed requirements.

If the above prior authorization criteria is met for:

• Management of pain related to sickle cell disease, cancer-related pain, palliative care, or end-of-life care, the requested medication will be approved indefinitely.
• Acute and subacute pain, the requested medication will be approved for 3 months.
• Chronic pain, the requested medication will be approved for 6 months or 12 months (if the prescriber is a pain management specialist).

Medical Necessity Criteria for Reauthorization

The Plan considers Immediate Release Opioid Analgesics medically necessary when BOTH of the following criteria are met:

1. Clinical chart documentation is submitted showing ALL of the following:

• a. The member has experienced benefit in pain or function from opioid therapy; and
• b. recent urine drug screen, to assess for prescribed medications as well as other prescribed and non-prescribed controlled substances; and
• c. the member’s treatment plan (i.e., specific functional goals, how opioids will be prescribed and monitored, plan for initiating, increasing, tapering, or discontinuing opioids); AND

2. Prescriber attestation is provided indicating BOTH of the following:

• a. That opioids will be prescribed in accordance with current clinical practice guidelines AND an assessment of risks, harms, and goals consistent with an opioid agreement (or similar agreement) has been undertaken; and
• b. The member has been assessed for concurrent use of opioid pain medication and benzodiazepines AND the prescriber has determined ONE of the following:

4. opioid pain medications and benzodiazepines will NOT be used concomitantly; or
5. benefits outweigh risks of continuing therapy with opioids and benzodiazepines or stopping benzodiazepines can be destabilizing

If the above prior authorization criteria is met for chronic pain, the requested medication will be approved for 6 months or 12 months (if the prescriber is a pain management specialist).

Extended Release Opioid Analgesics:

Medical Necessity Criteria for Initial Authorization

The Plan considers Extended Release Opioid Analgesics medically necessary when BOTH of the following criteria are met:

1. The member is being treated for ONE of the following:

1. pain associated with cancer, sickle cell, a terminal condition, or pain being managed through hospice or palliative care; or

pain severe enough to require daily, around-the-clock, long-term treatment in a member who has been taking an opioid and BOTH of the following criteria are met:

1. Clinical chart documentation is submitted showing ALL of the following:
   • the member’s prior therapies and outcomes with ALL of the following:
     1. non-pharmacologic interventions (e.g., ice, heat, elevation, rest, immobilization, or exercise); and
     2. non-opioid pharmacologic therapies (such as acetaminophen, non-steroidal anti-inflammatory drugs (NSAIDs), and selected antidepressants and anticonvulsants); and
     3. immediate release opioid therapies (such as acetaminophen w/ codeine, morphine sulfate, oxycodone); and
   • recent urine drug screen, to assess for prescribed medications as well as other prescribed and non-prescribed controlled substances; and
   • the member’s treatment plan (i.e., specific functional goals, how opioids will be prescribed and monitored, plan for initiating, increasing, tapering, or discontinuing opioids); and
2. Prescriber attestation is provided indicating BOTH of the following:
   1. That opioids will be prescribed in accordance with current clinical practice guidelines AND an assessment of risks, harms, and goals⁵ consistent with an opioid agreement (or similar agreement) has been undertaken; and
   2. The member has been assessed for concurrent use of opioid pain medication and benzodiazepines AND the prescriber has determined ONE of the following:
      1. opioid pain medications and benzodiazepines will NOT be used concomitantly; or
      2. benefits outweigh risks of continuing therapy with opioids and benzodiazepines or stopping benzodiazepines can be destabilizing; AND
3. Clinical chart documentation and supporting laboratory test results are provided for review to substantiate the above listed requirements.

If the above prior authorization criteria is met for:

• Management of pain related to sickle cell disease, cancer-related pain, palliative care, or end-of-life care, the requested medication will be approved indefinitely.
• Chronic pain, the requested medication will be approved for 6 months or 12 months (if the prescriber is a pain management specialist).

Medical Necessity Criteria for Reauthorization

Authorization may be granted for continuation of therapy when all criteria for initial authorization are met.

If the above prior authorization criteria is met for chronic pain, the requested medication will be approved for 6 months or 12 months (if the prescriber is a pain management specialist).

Experimental or Investigational / Not Medically Necessary

Opioid Analgesics for any other indication are considered not medically necessary by the Plan, as this is deemed to be experimental, investigational, or unproven.⁶

References

1. Avery, N., McNeilage, A. G., Stanaway, F., Ashton-James, C. E., Blyth, F. M., Martin, R., ... & Glare, P. (2022). Efficacy of interventions to reduce long term opioid treatment for chronic non-cancer pain: systematic review and meta-analysis. bmj, 377.
2. Bolen, J. A Legal Interpretation of the CDC Opioid Prescribing Guidelines in Opioid Prescribing and Monitoring-(Second Edition), Chapter 2: Legal Ramifications (Last updated on: April 29, 2019). Available at: https://www.practicalpainmanagement.com/resource-centers/opioid-monitoring-2nd-ed/legal-Interpretation-cdc-opioid-prescribing-guidelines. Accessed April 26, 2021.
3. Centers for Disease Control and Prevention (CDC). Common elements in guidelines for prescribing opioids for chronic pain. https://www.cdc.gov/drugoverdose/pdf/common_elements_in_guidelines_for_prescribing_opiods-a.pdf. Published 2015. Accessed May 2022.
4. CMS. Reducing Opioid Misuse. Centers for Medicare and Medicaid Services. https://www.cms.gov/ About-CMS/Story-Page/Reducing-Opioid-Misuse. Accessed May 26, 2020.
5. Currie, J. M., Schnell, M. K., Schwandt, H., & Zhang, J. (2021). Prescribing of opioid analgesics and buprenorphine for opioid use disorder during the COVID-19 pandemic. JAMA network open, 4(4), e216147-e216147.
6. DailyMed.

7. Daoust, R., Paquet, J., Marquis, M., Chauny, J. M., Williamson, D., Huard, V., ... & Cournoyer, A. (2022). Evaluation of Interventions to Reduce Opioid Prescribing for Patients Discharged From the Emergency Department: A Systematic Review and Meta-analysis. JAMA network open, 5(1), e2143425-e2143425.
8. Department of Health and Human Services. Pain management best practices inter-agency task force report: updates, gaps, inconsistencies, and recommendations. May 6, 2019 (https://www.hhs.gov/sites/default/files/pain-mgmt-best-practices-draft-final-report-05062019.pdf).
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13. Goldstick JE, Guy GP, Losby JL, Baldwin GT, Myers MG, Bohnert ASB. Patterns in nonopioid pain medication prescribing after the release of the 2016 guideline for prescribing opioids for chronic pain. JAMA Netw Open 2022;5(6):e2216475-e2216475.
14. Hwang, C. S., Kang, E. M., Ding, Y., Ocran-Appiah, J., McAninch, J. K., Staffa, J. A., ... & Meyer, T. E. (2018). Patterns of immediate-release and extended-release opioid analgesic use in the management of chronic pain, 2003-2014. JAMA network open, 1(2), e180216-e180216.7
15. Kelley-Quon, L. I., Kirkpatrick, M. G., Ricca, R. L., Baird, R., Harbaugh, C. M., Brady, A., ... & Kim, E. (2021). Guidelines for opioid prescribing in children and adolescents after surgery: an expert panel opinion. JAMA surgery, 156(1), 76-90.
16. Lawal, O. D., Gold, J., Murthy, A., Ruchi, R., Bavry, E., Hume, A. L., ... & Wen, X. (2020). Rate and risk factors associated with prolonged opioid use after surgery: a systematic review and meta- analysis. JAMA network open, 3(6), e207367-e207367.
17. Manchikanti L, Abdi S, Atluri S, Balog CC, Benyamin RM, Boswell MV, et al. American Society of Interventional Pain Physicians (ASIPP) guidelines for responsible opioid prescribing in chronic non-cancer pain: Part 2 – Guidance, Pain Physician, July 2012; 15(3 Suppl): S67-116.
18. Manchikanti, L., Kaye, A. M., Knezevic, N. N., McAnally, H., Trescot, A. M., Blank, S., ... & Hirsch, J. A. (2017). Responsible, safe, and effective prescription of opioids for chronic non-cancer pain: American Society of Interventional Pain Physicians (ASIPP) guidelines. Pain physician, 20(2), S3- S92.
19. National Institute on Drug Abuse. Prescription Opioids. National Institute on Drug Abuse. https://www.drugabuse.gov/publications/drugfacts/prescription-opioids. Published May 2020. Accessed May 26, 2020.
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Roxicodone (oxycodone) [prescribing information]. Webster Groves, MO: SpecGx LLC; January 2023.

US Department of Health and Human Services (HHS). HHS guide for clinicians on the appropriate dosage reduction or discontinuation of long-term opioid analgesics. https://www.hhs.gov/opioids/sites/default/files/2019-10/Dosage_Reduction_Discontinuation.pdf. Updated October 2019. Accessed May 2022.

US Food and Drug Administration (FDA).

24. US Food and Drug Administration (FDA). FDA drug safety communication: FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use. https://www-fda-gov.libproxy.unm.edu/drugs/drug-safety-and-availability/fda-updates-prescribing-information-all-opioid-pain-medicines-provide-additional-guidance-safe-use. Published April 13, 2023.
25. Webster LR. Risk Factors for Opioid-Use Disorder and Overdose. Anesth Analg. 2017 Nov;125(5):1741-1748.
26. WHO Guidelines for the Pharmacological and Radiotherapeutic Management of Cancer Pain in Adults and Adolescents. Geneva: World Health Organization; 2018
27. Winhusen, T., Walley, A., Fanucchi, L. C., Hunt, T., Lyons, M., Lofwall, M., ... & Chandler, R. K. (2020). The opioid-overdose reduction continuum of care approach (ORCCA): evidence-based practices in the HEALing communities study. Drug and Alcohol Dependence, 217, 108325.

Clinical Guideline Revision / History Information

Original Date: 08/06/2020
Reviewed/Revised: 06/24/2021, 12/01/2021, 06/23/2022, 12/08/2022, 12/14/2023