Treatment For Opioid Use Disorder in Opioid Treatment Programs (OTPs)

Description of Procedure or Service

According to the American Society of Addiction Medicine (ASAM, 2015), Opioid Use Disorder (OUD) is a chronic disorder characterized by a problematic pattern of opioid use resulting in addiction and leading to significant clinical, economic and public health impairment or distress.

Numerous settings exist to offer OUD treatment, including specialty sites (certified Opioid Treatment Programs, residential facilities, outpatient treatment programs and specialist physicians’ offices), as well as general primary care practices, health centers, emergency departments and inpatient medical and psychiatric units. This medical policy is specific to treatment of OUD in Opioid Treatment Programs (OTPs).

Medication-assisted treatment (MAT) is the use of medication with counseling and behavioral therapies to provide a “whole-patient” approach to the treatment of OUD, focusing on improving the quality of life of those receiving treatment. OTPs are state and federally regulated to dispense opioid agonist treatment and provide daily supervised dosing of methadone, buprenorphine or naltrexone.

Regulatory Status

OTPs are regulated by Substance Abuse and Mental Health Services Administration (SAMHSA) as well as Title 42 of the Code of Federal Regulations Part 8 (42 CFR § 8). OTPs must be accredited by a SAMHSA-approved accrediting body and certified by SAMHSA.

Related Policies

Evaluation and Management Services

***Note: This Medical Policy is complex and technical. For questions concerning the technical language and/or specific clinical indications for its use, please consult your physician.

Policy

BCBSNC will cover treatment for opioid use disorder when it is determined to be medically necessary because the medical criteria and guidelines shown below are met.

Benefits Application

This medical policy relates only to the services or supplies described herein. Please refer to the Member's Benefit Booklet for availability of benefits. Member's benefits may vary according to benefit design; therefore member benefit language should be reviewed before applying the terms of this medical policy. 

When Treatment For Opioid Use Disorder is covered

Treatment for opioid use disorder in an opioid treatment program may be considered medically necessary when members meet ALL of the criteria listed below.

1. Diagnosed with moderate or severe opioid use disorder per Diagnostic and Statistical Manual of Mental Disorders (DSM). 
2. Currently addicted to an opioid. 
3. Member is free of urgent or emergent medical or psychiatric problem(s). 
4. Member age is > 18; unless the following is present: 
   1. Member is 16 or 17 years old and has a documented history of 2 or more previous unsuccessful withdrawal management attempts in the past 12 months and obtains parental consent. 
5. Member is able to give informed consent. 
6. Member became addicted at least 1 year before admission for treatment; unless 1 of the following is present: 
   1. Member was released from penal institution within 6 months.
   2. Member is certified pregnant per program physician. 
      1. There is documentation that the member is under the care of an obstetrician. 
   3. Member previously participated in documented opioid treatment in past 2 years 
   4. Member is under 18 and meets criteria under bullet 4a. 
7. There is documentation that the provider is SAMHSA certified. 
8. The provider attests that the member cannot be treated safely or effectively in a less intensive level of care than an OTP. 

When Treatment For Opioid Use Disorder is not covered

Treatment for opioid use disorder is considered not medically necessary when members do NOT meet ALL of the criteria listed above in the When Treatment is Covered section. 

Policy Guidelines

This medical policy is based on the published guidelines from the Substance Abuse and Mental Health Services Administration (SAMHSA) and American Society of Addiction Medicine (ASAM) for opioid use disorder and opioid treatment programs.

Per the DSM-5 (American Psychiatric Association, 2013), opioid use disorder is manifested by at least two of the following diagnostic criteria, occurring within a 12-month period:

1. Opioids are often taken in larger amounts or over a longer period than was intended. 
2. There is a persistent desire or unsuccessful efforts to cut down or control opioid use. 
3. A great deal of time is spent in activities necessary to obtain the opioid, use the opioid, or recover from its effects. 
4. Craving, or a strong desire or urge to use opioids. 
5. Recurrent opioid use resulting in a failure to fulfill major role obligations at work, school, or home. 
6. Continued opioid use despite having persistent or recurrent social or interpersonal problems caused or exacerbated by the effects of opioids. 
7. Important social, occupational, or recreational activities are given up or reduced because of opioid use. 
8. Recurrent opioid use in situations in which it is physically hazardous.
9. Continued opioid use despite knowledge of having a persistent or recurrent physical or psychological problem that is likely to have been caused or exacerbated by the substance. 
10. Tolerance, as defined by either of the following: 
    1. A need for markedly increased amounts of opioids to achieve intoxication or desired effect. 
    2. A markedly diminished effect with continued use of the same amount of an opioid.
       Note: This criterion is not considered to be met for those taking opioids solely under appropriate medical supervision. 
11. Withdrawal, as manifested by either of the following: 
    1. The characteristic opioid withdrawal syndrome. 
    2. Opioids (or a closely related substance) are taken to relieve or avoid withdrawal symptoms.
       Note: This criterion is not considered to be met for those individuals taking opioids solely under appropriate medical supervision. 

OUD is considered mild, moderate or severe based on the number of criteria that are present:
Mild: Presence of 2-3 criteria
Moderate: Presence of 4-5 criteria
Severe: Presence of 6 or more symptoms

ASAM and SAMHSA recommend screening patients for urgent or emergent medical or psychiatric problems requiring immediate referral for clinical evaluation. These problems are defined as: suicide risk, danger to self or others, urgent or critical medical conditions, and immediate threats.

Definitions

Opioid Treatment Programs (OTP) are federally and state-licensed to dispense opioid agonist treatment. An OTP is defined as a program or practitioner engaged in opioid treatment of individuals with an opioid agonist treatment medication registered under 21 U.S.C. 823(g)(1).

Office based opioid therapy (OBOT) provides authorization of medication via regular outpatient prescriptions filled in a retail pharmacy like any other prescription medication, and is available for buprenorphine, but not methadone. Physicians in private practices or a number of types of public sector clinics can be authorized to prescribe outpatient supplies of the partial opioid antagonist buprenorphine. There is no regulation per se of the clinic site itself, but of the individual physician who prescribes buprenorphine.

Billing/Coding/Physician Documentation Information

This policy may apply to the following codes. Inclusion of a code in this section does not guarantee that it will be reimbursed. For further information on reimbursement guidelines, please see Administrative Policies on the Blue Cross Blue Shield of North Carolina web site at www.bcbsnc.com. They are listed in the Category Search on the Medical Policy search page.

HCPCS: G1028, G2067, G2068, G2069, G2073, G2074, G2075, G2076, G2077, G2078, G2079, G2080, G2215, G2216, H0020, S0109

ICD-10 diagnosis codes: F11.x

HCPCS code G2216 is limited to being billed 10 units once per calendar month, however, exceptions to this limit are allowed in the case where the member uses the initial supply of naloxone dispensed by the OTP to the extent that it is medically reasonable and necessary to provide additional naloxone. If an additional supply of naloxone is needed within 30 days of the original supply being provided, OTPs must document in the medical record the reason for the exception.

BCBSNC may request medical records for determination of medical necessity. When medical records are requested, letters of support and/or explanation are often useful, but are not sufficient documentation unless all specific information needed to make a medical necessity determination is included.

Scientific Background and Reference Sources

American Society of Addiction Medicine. The ASAM National Practice Guideline for the Use of Medications in the Treatment of Addiction Involving Opioid Use . Chevy Chase, MD: American Society of Addiction Medicine; 2015.

Substance Abuse and Mental Health Services Administration. Federal Guidelines for Opioid Treatment Programs. HHS Publication No. (SMA) PEP15-FEDGUIDEOTP. Rockville, MD:

Substance Abuse and Mental Health Services Administration, 2015. Substance Abuse and Mental Health Services Administration. Medications for Opioid Use Disorder. Treatment Improvement Protocol (TIP) Series 63, Full Document. HHS Publication No. (SMA) 195063FULLDOC. Rockville, MD: Substance Abuse and Mental Health Services Administration, 2018.

American Psychiatric Association. Diagnostic and Statistical Manual of Mental Disorders. 5th ed. Arlington, DC: American Psychiatric Association; 2013

Specialty Matched Consultant Advisory Panel – 6/2020

Specialty Matched Consultant Advisory Panel – 6/2021

Medical Director review 6/2021

Medical Director review 2/2022

Specialty Matched Consultant Advisory Panel – 6/2022

Medical Director review 6/2022

Specialty Matched Consultant Advisory Panel – 6/2023

Medical Director review 6/2023

Specialty Matched Consultant Advisory Panel – 6/2024

Medical Director review 6/2024

Policy Implementation/Update Information

03/24/20 Notification of new policy. Notification given 3/24/2020 for effective date 5/26/2020. (eel)

08/11/20 Specialty Matched Consultant Advisory Panel review 6/17/2020. Updated When Covered section criteria 1. from “severe” to “moderate or severe”. Medical Director review. No change to policy statement. (bb)

7/13/21 Description section updated with “Related policies, Evaluation and Management Services”. Specialty Matched Consultant Advisory Panel review 6/2021. Medical Director review 6/2021. (bb)

12/30/21 The following codes were added to the Billing/Coding section: G1028, G2067 through G2080, and G2215 to G2216 effective 1/1/2022. (tt)

3/8/22 Billing/Coding section updated to include “HCPCS code G2216 is limited to being billed 10 units once per calendar month, however, exceptions to this limit are allowed in the case where the member uses the initial supply of naloxone dispensed by the OTP to the extent that it is medically reasonable and necessary to provide additional naloxone. If an additional supply of naloxone is needed within 30 days of the original supply being provided, OTPs must document in the medical record the reason for the exception”. Medical Director review 2/2022. (tt)

7/12/22 References added. Specialty Matched Consultant Advisory Panel review 6/2022. Medical Director review 6/2022. No change to policy statement. (tt)

6/30/23 References added. Specialty Matched Consultant Advisory Panel review 6/2023. Medical Director review 6/2023. No change to policy statement. (tt)

7/17/24 References added. Specialty Matched Consultant Advisory Panel review 6/2024. Medical Director review 6/2024. No change to policy statement. (tt)

12/31/24 Updated Billing/Coding section to remove code span G2067-G2080 due to deletion of HCPCS codes G2070, G2071, G2072, effective 1/1/2025. Billing/Coding section now reads as follows: G1028, G2067, G2068, G2069, G2073, G2074, G2075, G2076, G2077, G2078, G2079, G2080, G2215, G2216, H0020, S0109. (tt)