Subject: Opioids IR - 7-Day Combo Products - Acute Pain Duration Limit 1358-E P02-2025

Drug

Immediate-Release Opioid Analgesics

acetaminophen and benzhydrocodone

acetaminophen and codeine

acetaminophen and hydrocodone

acetaminophen and oxycodone

acetaminophen and tramadol

acetaminophen, caffeine, and dihydrocodeine

aspirin and oxycodone

celecoxib and tramadol

ibuprofen and hydrocodone

Note: 7-Day Combination Products – Acute Pain Duration Limit 1358-E may be used as a stand-alone criteria OR in combination with Opioids Immediate-Release (IR) Combo Products Limit 1365-H. The Opioids IR Combo Products Limit 1365-H will be coded separately.

Policy:

Indications

FDA-approved Indications

Apadaz (benzhydrocodone/acetaminophen)

Apadaz is indicated for the short-term (no more than 14 days) management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve Apadaz for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Apadaz should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Codeine/Acetaminophen

Acetaminophen and codeine phosphate oral solution and tablets are indicated for the management of mild to moderate pain, where treatment with an opioid is appropriate and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration, reserve acetaminophen and codeine phosphate oral solution and tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not provided adequate analgesia, or are not expected to provide adequate analgesia,
• Have not been tolerated, or are not expected to be tolerated.

Acetaminophen and codeine phosphate tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Hydrocodone/Acetaminophen

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration, reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Hydrocodone/Acetaminophen 2.5 mg/325 mg

Hydrocodone bitartrate and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration, reserve hydrocodone bitartrate and acetaminophen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics or combination products):

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia or are not expected to provide adequate analgesia.

Hydrocodone bitartrate and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Hydrocodone/Acetaminophen Solution

Hydrocodone bitartrate and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration, reserve hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

• Have not been tolerated, or are not expected to be tolerated
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Hydrocodone Bitartrate and Acetaminophen Oral Solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Hydrocodone/Ibuprofen

Hydrocodone bitartrate and ibuprofen tablets are indicated for the short-term management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Carefully consider the potential benefits and risks of hydrocodone bitartrate and ibuprofen tablets and other treatment options before deciding to use hydrocodone bitartrate and ibuprofen tablets. Use the lowest effective dosage for the shortest duration consistent with individual patient treatment goals. Do not use hydrocodone bitartrate and ibuprofen tablets for the treatment of conditions such as osteoarthritis or rheumatoid arthritis.

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve hydrocodone bitartrate and ibuprofen tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Hydrocodone bitartrate and ibuprofen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Lortab Elixir (hydrocodone/acetaminophen)

Lortab Elixir is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve hydrocodone bitartrate and acetaminophen oral solution for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

• Have not been tolerated, or are not expected to be tolerated
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Nalocet, Percocet, Prolate Tablets (oxycodone/acetaminophen), Oxycodone/Acetaminophen Tablets

Oxycodone and acetaminophen tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, which can occur at any dosage or duration, reserve oxycodone and acetaminophen tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Oxycodone and acetaminophen tablets should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Oxycodone/Aspirin

Oxycodone and aspirin tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve oxycodone and aspirin tablets for use in patients for whom alternative treatment options (e.g., non-opioid analgesics):

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Oxycodone/Acetaminophen Solution

Oxycodone hydrochloride and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve oxycodone hydrochloride and acetaminophen oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Oxycodone hydrochloride and acetaminophen oral solution should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Prolate Solution (oxycodone/acetaminophen), Oxycodone/Acetaminophen Solution

Oxycodone hydrochloride and acetaminophen oral solution is indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, even at recommended doses, reserve oxycodone hydrochloride and acetaminophen oral solution for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Seglentis (tramadol/celecoxib)

Seglentis is indicated for the management of acute pain in adults that is severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve Seglentis for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated, or are not expected to be tolerated
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Seglentis should not be used for an extended period of time unless the pain remains severe enough to require an opioid analgesic and for which alternative treatment options continue to be inadequate.

Trezix Capsules (acetaminophen/caffeine/dihydrocodeine), Acetaminophen/Caffeine/Dihydrocodeine Tablets

Acetaminophen, caffeine, dihydrocodeine bitartrate capsules and tablets are indicated for the management of pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Because of the risks of addiction, abuse, and misuse, with opioids, even at recommended doses, reserve acetaminophen, caffeine, dihydrocodeine bitartrate capsules and tablets for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated, or are not expected to be tolerated
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia

Tramadol/Acetaminophen

Tramadol hydrochloride and acetaminophen tablets are indicated for the management of acute pain severe enough to require an opioid analgesic and for which alternative treatments are inadequate.

Limitations of Use

Tramadol hydrochloride and acetaminophen tablets are indicated for short-term use of five days or less.

Because of the risks of addiction, abuse, and misuse with opioids, which can occur at any dosage or duration, reserve Tramadol hydrochloride and acetaminophen for use in patients for whom alternative treatment options [e.g., non-opioid analgesics]:

• Have not been tolerated, or are not expected to be tolerated,
• Have not provided adequate analgesia, or are not expected to provide adequate analgesia.

Tramadol hydrochloride and acetaminophen tablets should not be used for an extended period of time.

Screen out Logic

If the patient has filled a prescription for at least a 1-day supply of a drug indicating the patient is being treated for cancer or sickle cell disease within the past 365 days under a prescription benefit administered by CVS Caremark, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

If a claim is submitted with an ICD 10 diagnosis code indicating cancer, sickle cell disease, or palliative care under a prescription benefit administered by CVS Caremark, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

If the patient has an ICD 10 diagnosis code indicating cancer or palliative care in their member health profile in the past 365 days, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

If the patient has any history of an ICD 10 diagnosis code indicating sickle cell disease in their member health profile, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

If a claim is submitted using a hospice patient residence code under a prescription benefit administered by CVS Caremark, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

For patients with no prescription claims of a cancer drug or a sickle cell disease drug in the past 365 days, no ICD 10 diagnosis code indicating cancer, sickle cell disease, or palliative care submitted with their prescription claim, no ICD 10 diagnosis code indicating cancer or palliative care in their member health profile in the past 365 days, no history of an ICD 10 diagnosis code indicating sickle cell disease in their member health profile, or no hospice patient residence code submitted with their prescription claim:

If the patient has filled a prescription for at least an 8-day supply of an immediate-release (IR) or extended-release (ER) opioid agent indicated for the management of pain within prescription claim history in the past 90 days under a prescription benefit administered by CVS Caremark, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

If the patient does not have at least an 8-day supply of an IR or ER opioid agent indicated for the management of pain within prescription claim history in the past 90 days (i.e., this is the patient’s first fill of an opioid), and the incoming prescription drug is being filled for more than a 7-day supply, then the claim will reject with a message indicating that the patient can receive a 7-day supply (until 7-days of therapy in a 90-day period have been filled) or submit a prior authorization (PA). The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit. If using this program in combination with Opioids IR Combo Products Limit 1365-H, then subsequent initial quantity limits would apply. If the incoming prescription drug is being filled for less than a 7-day supply, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

Limit Criteria (Day Supply)

1358-E may be used as a stand-alone criteria OR in combination with Opioids IR Combo Products Limit 1365-H. The Opioids IR Combo Products Limit 1365-H will be coded separately.

Acute pain duration limits do not apply if the patient has a drug in claims history in the past year that indicates the patient is being treated for cancer or sickle cell disease. In addition, acute pain duration limits will not apply if a prescription claim is submitted with an ICD 10 diagnosis code indicating cancer, sickle cell disease, or palliative care, if the patient has an ICD 10 diagnosis code indicating cancer or palliative care in their member health profile in the past 365 days, if the patient has a history of an ICD 10 diagnosis code indicating sickle cell disease in their member health profile, or if a prescription claim is submitted using a hospice patient residence code. When using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

If the patient has filled a prescription for at least an 8-day supply of an immediate-release (IR) or extended-release (ER) opioid agent indicated for the management of pain within prescription claim history in the past 90 days under a prescription benefit administered by CVS Caremark, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

If the patient does not have at least an 8-day supply of an IR or ER opioid agent indicated for the management of pain within prescription claim history in the past 90 days (i.e., this is the patient’s first fill of an opioid), and the incoming prescription drug is being filled for more than a 7-day supply, then the claim will reject with a message indicating that the patient can receive a 7-day supply (until 7-days of therapy in a 90-day period have been filled) or submit a prior authorization (PA) for additional days supply. The prior authorization criteria would then be applied to requests submitted for evaluation to the PA unit. If using this program in combination with Opioids IR Combo Products Limit 1365-H, then subsequent initial quantity limits would apply. If the incoming prescription drug is being filled for less than a 7-day supply, then 1) when using this program in combination with Opioids IR Combo Products Limit 1365-H, the claim will proceed to the subsequent initial quantity limit criteria (1365-H) OR 2) when using this as a stand-alone program, the requested drug will be paid under that prescription benefit.

For hydrocodone/ibuprofen tablets and tramadol/acetaminophen tablets:
A quantity of 50 tablets per month of hydrocodone/ibuprofen tablets or 40 tablets per month of tramadol/acetaminophen tablets is provided upon approval of the PA to allow coverage consistent with product labeling.

Coverage Criteria

[NOTE: These drugs should be prescribed only by health care professionals who are knowledgeable about the use of opioids and how to mitigate the associated risks.]

For benzhydrocodone/acetaminophen, codeine/acetaminophen, dihydrocodeine/caffeine/acetaminophen, hydrocodone/acetaminophen, oxycodone/acetaminophen, oxycodone/aspirin, tramadol/celecoxib:

Pain associated with Cancer, Sickle Cell Disease, a Terminal Condition, or Pain being managed through Hospice or Palliative Care

Authorization may be granted when the requested drug is being prescribed for pain associated with cancer, sickle cell disease, a terminal condition, or pain being managed through hospice or palliative care.

Acute Pain

Authorization may be granted when the patient requires treatment for ACUTE pain severe enough to require an opioid analgesic when ALL of the following criteria are met:

[NOTE: Many acute pain conditions (e.g., the pain that occurs with a number of surgical procedures or acute musculoskeletal injuries) require no more than a few days of an opioid analgesic.]

• The patient can safely take the requested dose based on their history of opioid use. [NOTE: The lowest dosage necessary to achieve adequate analgesia should be prescribed.]
• The patient has been evaluated and the patient will be monitored regularly for the development of opioid use disorder.

Chronic Pain

Authorization may be granted when the requested drug is being prescribed for CHRONIC pain severe enough to require an opioid analgesic when ALL of the following criteria are met:

[NOTE: Chronic pain is generally defined as pain that typically lasts greater than 3 months.]

• The patient can safely take the requested dose based on their history of opioid use. [NOTE: The lowest dosage necessary to achieve adequate analgesia should be prescribed.]
• The patient has been evaluated and the patient will be monitored regularly for the development of opioid use disorder.
• The patient’s pain will be reassessed in the first month after the initial prescription or any dose increase AND every 3 months thereafter to ensure that clinically meaningful improvement in pain and function outweigh risks to patient safety. [NOTE: Because the risk of overdose increases as opioid doses increase, reserve titration to higher doses for patients in whom lower doses are insufficiently effective and in whom the expected benefits of using a higher dose opioid clearly outweigh the substantial risks.]

For Hydrocodone/Ibuprofen tablets and Tramadol/Acetaminophen tablets:

Authorization may be granted for the requested drug when the following criteria is met:

• The patient will NOT require use of MORE than the plan allowance of ANY of the following: 5 tablets per day OR 50 tablets per month (quantity sufficient for a 10-day supply) of hydrocodone/IBUPROFEN tablets, 8 tablets per day OR 40 tablets per month (quantity sufficient for a 5-day supply) of tramadol/ACETAMINOPHEN tablets.

Quantity Limits may Apply

Hydrocodone/Ibuprofen: 5 tablets per day AND 50 tablets per month.

Tramadol/Acetaminophen: 8 tablets per day AND 40 tablets per month.

Duration of Approval (DOA)

• 1358-E:
  • Benzhydrocodone/acetaminophen, codeine/acetaminophen, dihydrocodeine/caffeine/acetaminophen, hydrocodone/acetaminophen, oxycodone/acetaminophen, oxycodone/aspirin, tramadol/celecoxib:
    • Pain associated with cancer, sickle cell disease, a terminal condition, or pain being managed through hospice or palliative care: DOA: 12 months
    • Chronic pain: DOA: 6 months
    • Acute pain: DOA: 1 month
  • Hydrocodone/Ibuprofen tablets and Tramadol/Acetaminophen tablets: DOA: 1 month

Place of Service:

Outpatient

The above policy is based on the following references:

1. Acetaminophen and Codeine Phosphate Solution [package insert]. Allentown, PA: Genus Lifesciences Inc.; December 2023.
2. Acetaminophen and Codeine Phosphate Tablet [package insert]. Webster Groves, MO: SpecGx LLC; November 2023.
3. Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate Tablet [package insert]. Canton, MS: Larken Laboratories, Inc.; January 2021.
4. Apadaz [package insert]. Celebration, FL: Zevra Therapeutics, Inc.; December 2023.
5. Hydrocodone Bitartrate and Acetaminophen Oral Solution 7.5 mg/325 mg per 15 mL [package insert]. Greenville, SC: Pharmaceutical Associates, Inc.; February 2024.
6. Hydrocodone Bitartrate and Acetaminophen Oral Solution 10 mg/325 mg per 15 mL [package insert]. Allentown, PA: Genus Lifesciences Inc.; December 2023.
7. Hydrocodone Bitartrate and Acetaminophen Tablets 5/300 mg, 7.5/300 mg, 10/300 mg, 5/325 mg, 7.5/325 mg, 10/325 mg [package insert]. Newtown, PA: KVK-Tech, Inc.; January 2024.
8. Hydrocodone Bitartrate and Acetaminophen Tablets 2.5/325 mg, 5/325 mg, 7.5/325 mg, 10/325 mg [package insert]. Northvale, NJ: Elite Laboratories, Inc.; August 2024.
9. Hydrocodone Bitartrate and Ibuprofen Tablet [package insert]. Brookhaven, NY: Amneal Pharmaceuticals of NY, LLC; July 2024.
10. Lortab Elixir [package insert]. Atlanta, GA: Mikart, LLC; May 2021.
11. Nalocet [package insert]. Las Vegas, NV: Forte Bio-Pharma LLC; July 2024.
12. Oxycodone and Acetaminophen Tablet [package insert]. Newtown, PA: KVK-Tech, Inc.; March 2024.
13. Oxycodone and Acetaminophen Oral Solution 5 mg/325 mg [package insert]. Newtown, PA: KVK-Tec, Inc.; March 2024.
14. Oxycodone and Acetaminophen Oral Solution 10 mg/300 mg [package insert]. Las Vegas, NV: FH2 Pharma LLC; June 2023.
15. Oxycodone and Aspirin [package insert]. Laurelton, NY: Epic Pharma, LLC; July 2020.
16. Percocet [package insert]. Malvern, PA: Endo Pharmaceuticals Inc.; June 2024.
17. Prolate Solution [package insert]. Las Vegas, NV: Forte Bio-Pharma LLC; May 2021.
18. Prolate Tablet [package insert]. Las Vegas, NV: Forte Bio-Pharma LLC; January 2024.
19. Seglentis [package insert]. Montgomery, AL: Kowa Pharmaceuticals America, Inc; December 2023.
20. Tramadol and Acetaminophen Tablets [package insert]. Glasgow, KY. Amneal Pharmaceutics LLC; January 2024.
21. Trezix [package insert]. Ridgeland, MS: WraSer Pharmaceuticals; July 2017.
22. Lexicomp Online, AHFS DI (Adult and Pediatric) Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 20, 2024
23. Lexicomp Online, Lexi-Drugs Online. Waltham, MA: UpToDate, Inc.; 2024. https://online.lexi.com. Accessed November 20, 2024.
24. Micromedex® (electronic version). Merative, Ann Arbor, Michigan, USA. Available at: https://www.micromedexsolutions.com/ (cited: 11/20/2024).
25. Dowell D, Ragan, KR, Jones, CM, et al; CDC Clinical Practice Guideline for Prescribing Opioids for Pain – United States, 2022. MMWR Recomm Rep. 2022;71:1–95. Available at: http://dx.doi.org/10.15585/mmwr.rr7103a1. Accessed November 21, 2024.
26. Palliative Care. NCCN Guidelines version 1.2025. Available at: https://www.nccn.org/professionals/physician_gls/pdf/palliative.pdf. Accessed November 21, 2024.
27. Adult Cancer Pain. NCCN Guidelines version 3.2024. Available at: https://www.nccn.org/professionals/physician_gls/pdf/pain.pdf. Accessed December 9, 2024.
28. National Heart, Lung, and Blood Institute. Evidence-Based Management of Sickle Cell Disease: Expert Panel Report, 2014. Available at: https://www.nhlbi.nih.gov/sites/default/files/media/docs/sickle-cell-disease-report%20020816_0.pdf. Accessed November 21, 2024.
29. S. Food & Drug Administration. FDA updates prescribing information for all opioid pain medicines to provide additional guidance for safe use. April 13, 2023. Available at: https://www.fda.gov/drugs/drug-safety-and-availability/fda-updates-prescribing-information-all-opioid-pain-medicines-provide-additional-guidance-safe-use. Accessed November 21, 2024.

Copyright Aetna Inc. All rights reserved. Pharmacy Clinical Policy Bulletins are developed by Aetna to assist in administering plan benefits and constitute neither offers of coverage nor medical advice. This Clinical Policy Bulletin contains only a partial, general description of plan or program benefits and does not constitute a contract. Aetna does not provide health care services and, therefore, cannot guarantee any results or outcomes. Participating providers are independent contractors in private practice and are neither employees nor agents of Aetna or its affiliates. Treating providers are solely responsible for medical advice and treatment of members. This Clinical Policy Bulletin may be updated and therefore is subject to change.

June 06, 2025