Opioid and Opioid Combination Medications

POLICY NUMBER

L.5.01.506

Please perform a formulary drug search on your patient’s member ID to ensure the prescription drug requested is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member’s benefit plan.

DESCRIPTION

Principles of quality medical practice dictate that patients have access to appropriate and effective pain relief. The appropriate application of current knowledge and treatment modalities can serve to improve the quality of life for those patients who suffer from pain as well as reduce the morbidity and costs associated with untreated or inappropriately treated pain. The diagnosis and treatment of pain is integral to the practice of medicine. Pain management is a part of quality medical practice for all patients with pain, acute or chronic, and it is especially urgent for patients who experience pain as a result of terminal illness. All physicians should become knowledgeable about assessing patients’ pain and effective methods of pain treatment. Accordingly, this policy was developed to support the best practices of pain management.

Pain should be assessed, and its cause diagnosed as clearly as possible using history and physical examination and appropriate testing. The medical management of pain should consider current clinical knowledge and medical research and the use of pharmacologic and non-pharmacologic modalities according to the judgment of the Provider. Pain should be promptly treated with non-pharmacologic therapy and non-opioid pharmacologic therapy, without acceptable results before opioids are considered, if the pain is not due to a surgical condition or cancer. Controlled substances, including opioid analgesics, may be essential in the treatment of acute pain due to trauma or surgery and chronic pain, whether due to cancer or non-cancer origins. Opioids are powerful tools in the relief of pain, which are associated with the risks of substance use disorder, overdose and diversion for non-medical purposes. Assessment of risk of substance misuse or diversion, substance use disorder and a benefit to harm evaluation should be a part of the history.

Tolerance and physical dependence are consequences of opioid use in patients who are not at risk for substance use disorder. Providers should recognize that 20% of the population is at risk to develop a substance use disorder, a chronic neurological condition. Informing patients of this risk is an important activity in the evidence based use of opioids. Ideally this informed consent, with a risk assessment of substance use disorder potential, is given and obtained prior to an initial prescription for any opioid. A treatment plan including a clear diagnosis, explicit goals, and exploration of other treatment options should exist. If members are to receive opioids chronically, a written/signed agreement between prescriber and patient addressing issues of prescription management, diversion, and the concurrent use of other substances should exist. In conjunction with treatment of chronic pain, certain prescription drugs, for a reasonable period of time due to Medical Necessity and/or medical policy, will be subject to Care Management.

POLICY

Dsuvia is not currently covered on any BCBSMS formulary.

Opioid medications will be considered medically necessary without prior authorization when ONE of the following criteria is met:

1. The individual is prescribed one initial 7-day supply of immediate-release/short-acting opioid <50 MME/dayOR an additional 7-day supply of <50 MME/day within 60 days of the original prescription;

2. The individual has a diagnosis of chronic cancer pain due to an active malignancy and the prescribed dosage does not exceed 50 MME/day; OR

3. Opioids are a part of an end of life treatment plan.

 Prior authorization is required for all other clinical scenarios. The requested opioid medication may be considered medically necessary when ALL of the following criteria are met:

1. ONE of the following:

   1. The request does not exceed 50 MME per day and ALL of the following:

      1. A formal, consultative evaluation was conducted and includes BOTH of the following:

         1. Diagnosis and etiology of pain (e.g. radiology reports); AND

         2. A complete medical history including previous and current non-opioid pharmacological (e.g., topical diclofenac, non-steroidal anti-inflammatory drugs [NSAIDs], muscle relaxers, gabapentin, pregabalin, etc.) and non-pharmacological therapies (e.g., physical therapy, exercise, weight loss, cognitive behavioral therapy); AND

         3. An active pain management treatment plan is provided and includes a specific treatment objective, duration of therapy, and the use of non-opioid analgesics and non-pharmacological therapies for pain relief, as appropriate, etc.; OR

   2. The request exceeds 50 MME per day and ONE of the following:

      1. The individual has a diagnosis of chronic cancer pain due to an active malignancy;

      2. The individual is eligible for hospice or palliative care;

      3. The individual has a diagnosis of sickle cell disease;

      4. The individual is undergoing treatment of chronic non-cancer pain and ALL of the following:

         1. The prescriber has provided documentation to support use of opioids at a dose greater than 50 MME/day;

         2. A formal, consultative evaluation was conducted and includes BOTH of the following:

            1. Diagnosis and etiology of pain (e.g. radiology reports); AND

            2. A complete medical history is provided and includes previous and current non-opioid pharmacological (e.g., topical diclofenac, non-steroidal anti-inflammatory drugs [NSAIDs], muscle relaxers, gabapentin, pregabalin, etc.) and non-pharmacological therapies (e.g., physical therapy, exercise, weight loss, cognitive behavioral therapy);

         3. An active pain management treatment plan is provided and includes a specific treatment objective, duration of therapy, and the use of non-opioid analgesics and non-pharmacological therapies for pain relief, as appropriate, etc.; AND

         4. The prescriber is or has consulted with a pain management specialist if the request exceeds 100 MME/day;

2. If the request is for an extended-release/long-acting opioid, ALL of the following:

   1. The individual has chronic pain severe enough to require daily, around-the-clock opioid treatment;

   2. The individual has tried and failed an immediate-release/short-acting opioid within the previous 60 days; AND

   3. The requested agent is not prescribed on an as-needed (prn) basis;

3. If the requested agent contains tramadol, dihydrocodeine, or codeine, then ONE of the following:

   1. The individual is 18 years of age or older; OR

   2. The individual is 12 to less than 18 years of age, and the requested agent will NOT be used for post-operative pain management following a tonsillectomy and/or adenoidectomy;

4. Urine Drug Screening (UDS) has been completed prior to the prescribing of the requested opioid medication, and the results are consistent with current treatment;

5. The prescriber has reviewed the individual’s records in the state’s prescription drug monitoring program (PDMP) and has determined the individual is not at high risk of overdose;

6. ALL of the following:

   1. The individual is NOT concurrently using buprenorphine or buprenorphine/naloxone for opioid dependence treatment;

   2. The individual is NOT currently taking and will not be prescribed concurrent therapy with benzodiazepines (i.e. alprazolam, clonazepam, clorazepate, diazepam, lorazepam, oxazepam, temazepam, etc.);

   3. The individual is NOT currently taking and will not be prescribed dual therapy with immediate-release opioid analgesic(s); AND

   4. If the request is for an opioid combination containing acetaminophen, the individual’s cumulative dose does not exceed 3 grams/day of acetaminophen;

7. The prescriber has provided BOTH of the following:

   1. Substance use disorder risk assessment (see Policy Guidelines); AND

   2. A written/signed agreement (see Policy Guidelines) between prescriber and individual addressing issues of prescription management, diversion, and the use of other substances, including but not limited to benzodiazepines, alcohol and sedatives;

   3. The Provider certifies that he/she is the single designated Network Provider and a single designated Community Plus Pharmacy has been agreed upon by the Provider and the individual; AND

   4. The individual does not have any contraindication(s) to therapy with the requested agent.

Refer to the Clinical Best Practice Guidelines for Common Pain Conditions .

Length of Approval: Duration of therapy specified per treatment plan (up to 12 months)

Renewal Evaluation

The requested opioid medication may be approved for RENEWAL when ALL of the following criteria are met:

1. The individual has been previously approved for the requested agent through the BCBSMS PA process;

2. The individual has documented clinical improvement (i.e., improved function, decreased pain level) with the requested agent;

3. BOTH of the following:

   1. The written/signed agreement remains in place with the provider; AND

   2. The individual’s treatment plan has been evaluated for abuse, misuse, addiction, and overdose (e.g., pill counts, PDMP review, UDS evaluation, adherence);

4. ALL of the following:

   1. The individual is not currently taking and will not be prescribed dual therapy with benzodiazepines (i.e. alprazolam, clonazepam, clorazepate, diazepam, lorazepam, oxazepam, temazepam, etc.);

   2. The individual is not currently taking and will not be prescribed dual therapy with immediate-release opioid analgesic(s);

   3. The individual is not concurrently using buprenorphine or buprenorphine/naloxone for opioid dependence treatment; AND

   4. If the request is for an opioid combination containing acetaminophen, the individual’s cumulative dose does not exceed 3 grams/day of acetaminophen;

5. The prescriber is or has consulted with a pain management specialist if the request exceeds 100 MME/day; AND

6. The individual does not have any contraindication(s) to therapy with the requested agent.

POLICY EXCEPTIONS

State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

POLICY GUIDELINES

Standardized risk assessment tools, such as the Opioid Risk Tool (ORT) https://www.drugabuse.gov/sites/default/files/files/OpioidRiskTool.pdf , are available to assess risk for opioid abuse among individuals prescribed opioids for treatment of chronic pain.

The purpose of a written/signed agreement between the prescriber and patient is to ensure patients understand their role and responsibilities regarding their treatment with opioids. Sample patient agreement forms are available at https://www.fda.gov/files/drugs/published/Opioid-Patient-Prescriber-Agreement-(PPA).pdf

The coverage guidelines outlined in the Medical Policy Manual should not be used in lieu of the Member's specific benefit plan language.

Medically Necessary is defined as those services, treatments, procedures, equipment, drugs, devices, items or supplies furnished by a covered Provider that are required to identify or treat a Member's illness, injury or Mental Health Disorders, and which Company determines are covered under this Benefit Plan based on the criteria as follows in A through D:

A.  consistent with the symptoms or diagnosis and treatment of the Member's condition, illness, or injury; and

B.  appropriate with regard to standards of good medical practice; and

C.  not solely for the convenience of the Member, his or her Provider; and

D.  the most appropriate supply or level of care which can safely be provided to Member. When applied to the care of an Inpatient, it further means that services for the Member's medical symptoms or conditions require that the services cannot be safely provided to the Member as an Outpatient.

For the definition of medical necessity, “standards of good medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. BCBSMS makes no payment for services, treatments, procedures, equipment, drugs, devices, items or supplies which are not documented to be Medically Necessary. The fact that a Physician or other Provider has prescribed, ordered, recommended, or approved a service or supply does not in itself, make it Medically Necessary.

Investigative is defined as the use of any treatment procedure, facility, equipment, drug, device, or supply not yet recognized  as a generally accepted standard of good medical practice for the treatment of the condition being treated and; therefore, is not considered medically necessary. For the definition of Investigative, “generally accepted standards of medical practice” means standards that are based on credible scientific evidence published in peer-reviewed medical literature generally recognized by the relevant medical community, and physician specialty society recommendations, and the views of medical practitioners practicing in relevant clinical areas and any other relevant factors. In order for equipment, devices, drugs or supplies [i.e, technologies], to be considered not investigative, the technology must have final approval from the appropriate governmental bodies, and scientific evidence must permit conclusions concerning the effect of the technology on health outcomes, and the technology must improve the net health outcome, and the technology must be as beneficial as any established alternative and the improvement must be attainable outside the testing/investigational setting.

POLICY HISTORY

11/08/2016: New policy added. Approved by Medical Policy Advisory Committee. Policy number L.5.01.506. Effective 03/01/2017.

02/22/2017: Policy Guidelines updated to provide links to a sample substance use disorder risk assessment tool and sample patient agreement forms.03/01/2017: Policy statement updated to add link to Clinical Best Practice Guidelines for Common Pain Conditions.

04/05/2017: Policy description updated to add Morphine/Naltrexone to the list of extended release/long-acting opioids.

10/05/2017: Policy statement updated to state that immediate release/short-acting opioid medications are limited to less than 50 MME/day for all pain conditions except end of life care and that prior authorization is required for immediate release/short-acting opioid medications if the dosage exceeds 50 MME/day for all pain conditions except end of life care. Changed "diagnosed cancer" to "diagnosed active cancer" throughout the policy.

11/14/2017: Policy reviewed and approved by Pharmacy & Therapeutics (P&T) Committee.

08/10/2018: Reference updated in Sources section.

01/25/2019: Policy description updated to add brand names.

10/14/2019: Added statement to perform a formulary drug search on the patient's member ID to ensure the prescription drug requested is covered under their benefit plan. The medication(s) in this medical policy may not be covered under a specific member's benefit plan. Policy description updated to add Hycodan and Nucynta to the list of immediate release/short-acting opioids. Removed Lorcet from the list of immediate release/short-acting opioids and Fentora and Levorphanol from the list of extended release/long-acting opioids table. Policy section updated to add that Dsuvia is not currently covered on any BCBSMS formulary. Prior authorization criteria for immediate release/short-acting and extended release/long-acting opioid medications updated. Code Reference section updated to remove the following ICD-10 diagnosis codes D37.01 - D48.9 and D49.0 - D49.9.

10/31/2019: Code Reference section updated to add HCPCS codes C9399 and J8499.

02/01/2023: Policy Exceptions updated to add the following: State Health Plan (State and School Employees): The prescription drug(s) in this medical policy may be covered under a prescription drug benefit plan administered by the State Health Plan’s Pharmacy Benefit Manager. Please perform a formulary drug search at https://www.dfa.ms.gov/cvs-caremark and submit any required Prior Authorization Requests for coverage determination to the Plan’s Pharmacy Benefit Manager. Services related to delivery and/or administration of a medication determined to be not medically necessary will also be considered not medically necessary. Services related to delivery and/or administration of a self-administered drug are not covered.

07/01/2025: Effective 09/01/2025 - Policy reviewed and approved by the Pharmacy & Therapeutics (P&T) Committee. Policy description updated to remove the immediate release/short acting and extended release/long acting opioids tables. Policy section extensively revised to create separate policy statements for opioid medications considered medically necessary without prior authorization and for opioid medications in which prior authorization is required. Added renewal evaluation criteria. Removed the Federal Employee Program (FEP) from the Policy Exceptions section. Updated link in Policy Guidelines section and changed "Nervous/Mental Conditions" to "Mental Health Disorders" and "Medically Necessary" to "medical necessity." Sources updated. Policy update effective 09/01/2025.

SOURCE(S)

1. Blue Cross and Blue Shield of Massachusetts medical policy, Opioid and Opioid Combination Medication Management and Urine Drug Testing. Original policy date 07/01/2012, revised 11/24.

2. CDC Guideline for Prescribing Opioids for Chronic Pain – United States, 2016. Recommendations and Reports/March 18, 2016/65(1);1-49.

3. Dowell D, Haegerich TM, Chou R. CDC Guideline for Prescribing Opioids for Chronic Pain — United States, 2016. MMWR Recomm Rep 2016;65(No. RR-1):1–49. DOI:  http://dx.doi.org/10.15585/mmwr.rr6501e1

4. Dowell D, Ragan KR, Jones CM, Baldwin GT, Chou R. CDC Clinical Practice Guideline for Prescribing Opioids for Pain — United States, 2022. MMWR Recomm Rep 2022;71(No. RR-3):1–95. DOI: http://dx.doi.org/10.15585/mmwr.rr7103a1 .

5. Guidelines for the Chronic Use of Opioid Analgesics; Federation of State Medical Boards of the Unites States, Inc.; https://www.fsmb.org/globalassets/advocacy/policies/opioid_guidelines_as_adopted_april-2017_final.pdf

6. Model Policy on the Appropriate Use of Opioid Analgesics in the Treatment of Chronic Pain https://www.fsmb.org/Media/Default/PDF/FSMB/Advocacy/pain_policy_july2013.pdf

7. “The Surgeon General’s Call to End the Opioid Crisis.” http://turnthetiderx.org . August 2016.

CODE REFERENCE

This may not be a comprehensive list of procedure codes applicable to this policy.

The code(s) listed below are ONLY Medically Necessary if the procedure is performed according to the "Policy" section of this document.

Medically Necessary Codes

Not Medically Necessary Codes

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