OFFICE BASE OPIOID TREATMENT
1.1 Definitions
1.1.1 Buprenorphine
Buprenorphine, a synthetic, FDA-approved, derivative of Thebaine, is defined as a Schedule III opioid partial
agonist that works by blocking the opioid receptors in the brain and is used for both longterm maintenance and for medically supervised detoxification from opioids.
1.1.2 Buprenorphine-Naloxone
Buprenorphine-naloxone is a synthetic, Federal Drug Administration (FDA) approved, Schedule III
opioid partial agonist combination that works by blocking opioid receptors is the
preferred formulation for non-pregnant beneficiaries.
Naloxone is included to reduce the diversion potential of the drug, it is poorly absorbed sublingually or
orally, and has no negative effects when used as directed.
1.1.3 Concomitant Conditions
Concomitant conditions are medical or psychiatric illnesses or conditions that occur simultaneously to the
substance use disorder
1.1.4 Illicit Opioid Use
Illicit opioid use is the use of an illegal substance or the use of medication for reasons other than those in
which the medication was intended or in higher doses than prescribed.
1.1.5 Induction
Induction is the initial phase of opioid treatment that may take place in the office setting or at home.
Medication is adjusted until the beneficiary attains stabilization.
1.1.6 Maintenance Treatment
Maintenance treatment means the beneficiary has reached a stable, consistent schedule of medication and
counseling that prevents the desire for opioid use while allowing for abstinence of illicit
substances.
1.1.7 Medication Assisted Treatment
Medication Assisted Treatment (MAT) is the use of medications, in combination with counseling and
behavioral therapies, to provide a whole-patient approach to the treatment of substance use
disorders.
1.1.8 Office-based Opioid Treatment
Office-based Opioid Treatment (OBOT) is treatment of opioid use disorders in the clinical setting by a
qualified provider as defined under Public Law 106-310 Section 3501(a)(G)(ii) to prescribe
buprenorphine or buprenorphine- naloxone medications. Opioid use disorder is considered a
chronic condition, and the management of this disorder is incorporated into the general care
of the beneficiary.
1.1.9 Opioid Treatment Program (OTP)
An OTP is a treatment program federally certified by the Substance Abuse and Mental Health Services
Administration (SAMHSA) according to 42 CFR § 8, to provide supervised assessment
and medication assisted treatment for beneficiaries
who have an opioid use disorder diagnosis. OTPs require registration with the US Drug Enforcement Association (DEA)
and licensure by the Division of Health Service Regulation (DHSR).
1.1.10 Opioid Withdrawal Syndrome
Opioid withdrawal syndrome is hyper-excitability caused by the absence of opioids. Symptoms of opioid
withdrawal are drug cravings, anxiety, dysphoria, sweating, yawning, excessive tearing,
rhinorrhea, insomnia, nausea, vomiting, diarrhea, cramps, muscle aches, and fever.
Symptoms may appear within 8-12 hours with resolution after 7-10 days. Long acting drug
withdrawal symptoms may appear within 1-3 days and may persist for days to weeks.
1.1.11 Qualified Provider
A physician, nurse practitioner, or physician assistant who has met the requirements and received a waiver
under the Drug Addiction Treatment Act of 2000 (DATA 2000) to prescribe or dispense
schedule III, IV, or V medications for the treatment of opioid addiction.
1.1.12 Stabilization
Stabilization is the lowest dose of buprenorphine or buprenorphine-naloxone at which the beneficiary
discontinues the use of opioids without experiencing withdrawal symptoms, significant
side effects, or uncontrollable cravings for the drug of use. The beneficiary is medically
stable, fully-supported, able to perform activities of daily living, and substance free either
with or without the assistance of medication.
2.0 Eligibility Requirements
2.1 Provisions
2.1.1 General
a) (The term “General” found throughout this policy applies to all Medicaid and
NCHC policies)
a. An eligible beneficiary shall be enrolled in either:
1. The NC Medicaid Program (Medicaid is NC Medicaid program, unless
context clearly indicates otherwise); or
2. The NC Health Choice (NCHC is NC Health Choice program, unless
context clearly indicates otherwise) Program on the date of service
and shall meet the criteria in Section 3.0 of this policy.
b. Provider(s) shall verify each Medicaid or NCHC beneficiary’s eligibility
each time a service is rendered.
c. The Medicaid beneficiary may have service restrictions due to their
eligibility category that would make them ineligible for this service.
d. Following is only one of the eligibility and other requirements for
participation in the NCHC Program under GS 108A-70.21(a): Children must
be between the ages of 6 through 18.
2.1.2 Specific
b) (The term “Specific” found throughout this policy only applies to this policy)
a. Medicaid
For office-based opioid treatment, an eligible Medicaid beneficiary who is a minor, 16
through 17 years of age, shall have a documented history of at least two prior
unsuccessful withdrawal management attempts.
Refer to NCGS § 90-21.5. Minor's consent sufficient for certain medical health
services.
b. NCHC
For office-based opioid treatment, an eligible NCHC beneficiary who is a minor, 16
through 17 years of age, shall have a documented history of at least two prior
unsuccessful withdrawal management attempts. Refer to NCGS § 90-21.5. Minor's
consent sufficient for certain medical health services.
2.2 Special Provisions
2.2.1 EPSDT Special Provision: Exception to Policy Limitations for a
Medicaid Beneficiary under 21 Years of Age
a. 42 U.S.C. § 1396d(r) [1905(r) of the Social Security Act]
Early and Periodic Screening, Diagnostic, and Treatment (EPSDT) is a federal
Medicaid requirement that requires the state Medicaid agency to cover services,
products, or procedures for Medicaid beneficiary under 21 years of age if the
service is medically necessary health care to correct or ameliorate a defect,
physical or mental illness, or a condition [health problem] identified through a
screening examination (includes any evaluation by a physician or other licensed
practitioner).
This means EPSDT covers most of the medical or remedial care a child needs to
improve or maintain his or her health in the best condition possible, compensate for
a health problem, prevent it from worsening, or prevent the development of
additional health problems.
Medically necessary services will be provided in the most economic mode, as long
as the treatment made available is similarly efficacious to the service requested by
the beneficiary’s physician, therapist, or other licensed practitioner; the
determination process does not delay the delivery of the needed service; and the
determination does not limit the beneficiary’s right to a free choice of providers.
EPSDT does not require the state Medicaid agency to provide any service,
product or procedure:
1. That is unsafe, ineffective, or experimental or investigational.
2. That is not medical in nature or not generally recognized as an
accepted method of medical practice or treatment.
Service limitations on scope, amount, duration, frequency, location of service, and
other specific criteria described in clinical coverage policies may be exceeded or
may not apply as long as the provider’s documentation shows
that the requested service is medically necessary “to correct or ameliorate a defect,
physical or mental illness, or a condition” [health problem]; that is, provider
documentation shows how the service, product, or procedure meets all EPSDT
criteria, including to correct or improve or maintain the beneficiary’s health in the
best condition possible, compensate for a health problem, prevent it from worsening,
or prevent the development of additional health problems.
b. EPSDT and Prior Approval Requirements
1. If the service, product, or procedure requires prior approval, the fact that
the beneficiary is under 21 years of age does NOT eliminate the
requirement for prior approval.
2. IMPORTANT ADDITIONAL INFORMATION about EPSDT and prior
approval is found in the NCTracks Provider Claims and Billing
Assistance Guide, and on the EPSDT provider page. The Web
addresses are specified below.
NCTracks Provider Claims and Billing Assistance Guide:
https://www.nctracks.nc.gov/content/public/providers/providermanuals.html
EPSDT provider page: http://dma.ncdhhs.gov/
2.2.1 EPSDT does not apply to NCHC beneficiaries
2.2.2 Health Choice Special Provision for a Health Choice Beneficiary age 6
through 18 years of age
The Division of Medical Assistance (DMA) shall deny the claim for coverage for an
NCHC beneficiary who does not meet the criteria within Section 3.0 of this policy. Only
services included under the NCHC State Plan and the DMA clinical coverage policies,
service definitions, or billing codes are covered for an NCHC beneficiary.
3.0 When the Procedure, Product, or Service Is Covered
c) Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy Limitations for
a Medicaid Beneficiary under 21 Years of Age.
3.1 General Criteria Covered
Medicaid and NCHC shall cover the procedure, product, or service related to this policy when
medically necessary, and:
a. the procedure, product, or service is individualized, specific, and consistent with
symptoms or confirmed diagnosis of the illness or injury under treatment, and not in
excess of the beneficiary’s needs;
b. the procedure, product, or service can be safely furnished, and no equally
effective and more conservative or less costly treatment is available statewide;
and
c. The procedure, product, or service is furnished in a manner not primarily intended for
the convenience of the beneficiary, the beneficiary’s caretaker, or the provider.
3.2 Specific Criteria Covered
3.2.1 Specific criteria covered by both Medicaid and NCHC
Medicaid and NCHC shall cover OBOT services for a beneficiary when all the
following components are met: diagnosis and initial evaluation, initial laboratory testing,
psychosocial treatment modalities, informed consent, treatment plan, treatment contract,
and prescription drug monitoring.
a. Diagnosis and Initial Evaluation
A diagnosis of moderate or severe opioid use disorder supported by a
comprehensive assessment signed and dated by the qualified provider completing
the assessment is necessary. The assessment must address and document all of
the following elements:
1. Screening for concomitant conditions that can necessitate a higher
level of care or emergent care;
2. Substance use history consisting of the following: age of first use,
substances used, change in effects over time, history of tolerance,
history of overdose, history of withdrawal, attempts to quit, current legal
issues due to drug use, and current problems with compulsivity or drug
cravings;
3. Addiction treatment history consisting of the following: previous
treatments for addiction, types of treatments tried, and outcomes
of treatment;
4. Psychiatric history consisting of the following: diagnosis or diagnoses,
psychiatric treatments recommended or tried, and outcomes of
treatment attempts;
5. Family history consisting of the following: substance use disorders in the
family, family medical history, and family psychiatric history;
6. Medical history consisting of the following: a detailed review of systems,
past medical and surgical history, sexual history, likelihood of pregnancy
for female beneficiaries, current and past medications, current
medication (prescription and over the counter) doses, allergies, and pain
history;
7. Social history consisting of the following: quality of recovery, family,
and living environments, and substance use by other members of the
support network;
8. Readiness for change consisting of the following: the beneficiary’s
understanding of their substance use disorder, the beneficiary’s
interest in treatment now, and whether treatment is voluntary or
coerced;
9. A complete physical examination focusing on physical findings related
to addiction and any current signs of opioid intoxication, withdrawal, or
overdose;
10. A mental status examination evaluating the following: general
appearance, behavior and interaction, speech and voice, motor activity,
mood and affect, perceptions or hallucinations, thought process and
content, insight, judgement, motivation and readiness for change,
beneficiary’s stated goals and expectations, cognitive function,
personality, coping skills, and defense mechanisms. If the
beneficiary’s psychiatric disorder is beyond the provider’s
expertise andcomfort
level, referral to an addiction psychiatrist or psychologist for a
full mental health evaluation or formal diagnosis is indicated
prior to starting treatment;
11. The qualified provider shall document the benefits outweigh risks when
prescribing buprenorphine and buprenorphine-naloxone combination
product when the beneficiary is currently prescribed and taking
antiretrovirals, hepatitis medication, benzodiazepines, sedatives,
tranquilizers, antidepressants, or any other central nervous system
depressant; and
12. The qualified provider shall document that office-based opioid treatment
and the required counseling is an appropriate level of care for a
beneficiary 16 through 17 years of age who meets eligibility
requirements in Subsection 2.1.2.
*Note: Steps 1, 2, 3, 4, 5, 7, 8, and 10 may be performed by a
physician extender or behavioral health professional trained in
substance use disorders and signed off by the prescribing provider*
*Note: The 12 components (listed in subsection 3.2.1.a) of the comprehensive
assessment are essential for the thorough care of a beneficiary with a
substance use disorder diagnosis; however, completion of the full initial
evaluation need not delay the initiation of treatment. Prompt treatment is a
priority and completion of the 12 components over two or three visits is
permissible at the discretion of the provider.
b. Initial Lab Testing
Initial laboratory testing is an important aspect of the initial evaluation and
placement assessment. A urine pregnancy test must be performed on female
beneficiaries of child bearing age unless known to be positive. Toxicology tests for
drugs of abuse must be performed on all beneficiaries considered for OBOT services.
Baseline labs consisting of serum electrolytes, blood urea nitrogen (BUN) and
creatinine, complete blood count (CBC) with differential and platelet count, liver
function tests, and lipid profile, may be collected during initial evaluation if deemed
necessary by the OBOT provider to aide in determination of appropriateness for
buprenorphine or buprenorphine- naloxone therapy. The following tests may be
offered according to Centers for Disease Control (CDC) guidelines during the initial
evaluation unless known to be positive:
1. Human Immunodeficiency Virus (HIV);
2. Hepatitis B and C;
3. Syphilis; and
4. Purified protein derivative (PPD)
c. Psychosocial Treatment Modalities
Evidence has demonstrated that greater success is achieved when combining
medication assisted treatment with education and counseling for opioid dependence
when compared to pharmacotherapy alone.
Medicaid and NCHC shall require a minimum of once monthly individual or group
therapy sessions during the induction and stabilization phases of treatment
conducted by a behavioral health professional licensed to treat substance use
disorders and trained in the use of the American Society of Addiction Medicine
(ASAM) Treatment Criteria for Addictive, Substance- Related, and Co-Occurring
Conditions. Counseling sessions needed beyond induction and stabilization shall be
at the discretion of the practitioner and beneficiary, based on the beneficiary’s
ongoing needs and treatment goals.
The provider shall inquire whether the beneficiary is in counseling for their opioid
use disorder and other co-occurring diagnoses, as applicable. If the beneficiary is not
currently in counseling, the provider shall promptly refer the beneficiary to a
licensed, North Carolina Local Management Entity- Managed Care Organization
(MCO) enrolled, behavioral health professional. Optimally, counseling should begin
within 48 hours of induction if urgent need is indicted.
Note: Urgent need for substance abuse counseling is defined as a condition in which
the person is not imminently at risk of harm to self or others or unable to adequately
care for self, but, by virtue of their substance use, is in need of prompt assistance to
avoid further deterioration in the person’s condition which could require emergency
assistance. The initial appointment for an urgent need must be within 48 hours.
If the beneficiary has already initiated counseling for substance use disorder, the
qualified provider shall request ASAM placement recommendations from the
behavioral health professional to ensure the beneficiary's needs do not exceed early
intervention or outpatient service capability and document the results in the health
record within ten (10) calendar days of induction.
If the beneficiary has not yet begun counseling for substance use disorder, the
placement recommendations supplied by the behavioral health professional shall
be documented in the health record within ten (10) calendar days of counseling
initiation.
Alcoholics Anonymous (AA), Narcotics Anonymous (NA), Self- Management and
Recovery Training (SMART) recovery and other self-help or guided recovery
groups are not required by NC Medicaid or NCHC for continued service, however
the OBOT provider can have additional requirements based on the beneficiary’s
needs
If the beneficiary was identified by the behavioral health professional as requiring
intensive outpatient services or higher, it does not preclude Office- based Opioid
Treatment in addition to the higher level of care required.
Documentation must be placed in the health record that a referral has been made,
where the beneficiary was referred to, and whether the beneficiary was accepted. If
there is a delay in treatment at the appropriate level of care due to space availability,
OBOT services may continue. The OBOT provider shall document in the health
records that the beneficiary is awaiting an opening in the higher level of care and
when placement availability is expected. This documentation must be updated
weekly until the beneficiary is placed in the higher level of care or no longer requires
advanced services.
Counseling attendance records signed by the behavioral health professional shall
be obtained by the OBOT provider and placed in the health record.
d. Informed Consent
Before induction is initiated, the beneficiary shall be made aware of all treatment
options available to them as well as the risks and benefits of office- based opioid
treatment. Informed consent for office-based buprenorphine or buprenorphinenaloxone treatment must consist of all of the following information:
1. What buprenorphine or buprenorphine-naloxone is, how it works, how
to administer, potential side effects, and signs of allergic reaction;
2. The importance of being in withdrawal for induction and consequences
of not being in a state of withdrawal;
3. Buprenorphine or buprenorphine-naloxone maintains physical
dependence and a sudden discontinuation may precipitate
withdrawal;
4. A description of induction, stabilization, maintenance, and tapering
phases of treatment and expected or estimated timeframes for each
phase;
5. Counseling requirements specific to this policy and any additional
requirements as directed by the OBOT qualified provider;
6. Signs and symptoms of overdose and withdrawal due to
inadequate dosing during the induction phase of treatment;
7. Possible interaction between buprenorphine or buprenorphinenaloxone and other prescription medications, such as HIV and hepatitis
medications;
8. Risk of using buprenorphine or buprenorphine-naloxone while taking
benzodiazepines, alcohol, or other central nervous system
depressants. It must be noted that deaths have occurred when
buprenorphine was taken concurrently with benzodiazepines;
9. Obstetrical risks for pregnant women with continued substance use.
Risks to the pregnancy, mother, and fetus include preeclampsia,
miscarriage, premature delivery, intrauterine growth restriction(IUGR),
Neonatal Abstinence Syndrome (NAS) and fetal death; and
10. Any other information deemed necessary by the qualified provider.
e. Treatment Plan
A documented, individualized treatment plan must be kept in the beneficiary’s
health record and updated as goals, beneficiary condition, expectations
change. Topics to be addressed in the treatment plan are:
1. All current medications and doses;
2. Contact information for ancillary service providers for coordination of
care;
3. Current medical and psychological diagnoses;
4. Short and long term goals with expected timeframes for meetinggoals;
5. Interventions or treatment modifications based on subjective
and objective findings;
6. Contingency plan for non-compliance with treatment;
7. Signed release of information and notice of privacy practices; and
8. Any other information deemed necessary by the qualified provider.
f. Treatment Contract
Medicaid and NCHC shall delegate the decision to obtain a signed treatment
contract to the qualified provider. If the provider elects to obtain a signed treatment
contract, the following elements may be addressed in the treatment contract:
1. Agreement to keep all scheduled appointments;
2. Agreement to adhere to all office policies;
3. Agreement not to sell, share, or give any medications to another person;
4. Agreement to store medication in a secure location;
5. Understanding that mixing buprenorphine or buprenorphine-naloxone
with benzodiazepines, alcohol, and other central nervous system
depressants can lead to respiratory distress and deaths have been
reported;
6. Agreement to take all medication as prescribed and to inform the OBOT
provider when any medication is changed, discontinued, or prescribed
by another provider;
7. Agreement to use an effective form of birth control during the entire
course of treatment and to inform the OBOT provider immediately if
pregnancy is suspected;
8. Timeframe in which to return to the office for urine drug screens and
pill counts;
9. Specific stepwise consequences for unanticipated drug test results,
sample tampering, diversion, lost or stolen medications, missed
appointment, discrepancies between beneficiary supplied medication
list and the North Carolina Controlled Substance Reporting System and
any other violation of the treatment contract or non-compliance with the
treatment plan;
10. An explanation of how requests for early refills or reports of lost, stolen,
or damaged medication are handled; or
11. Any other information deemed necessary by the qualified provider.
g. Prescription Drug Monitoring
A check of the North Carolina Controlled Substance Reporting System (CSRS)
must be performed and the results documented in the health record prior to
beginning induction to ensure a beneficiary is not currently receiving
buprenorphine or buprenorphine-naloxone from another provider. Any
prescriptions found in this query, particularly opioids and benzodiazepines, must
be confirmed with the beneficiary.
CSRS inquiries must also be conducted and documented with any buprenorphine
or buprenorphine-naloxone dose change, any exceptions (signs or symptoms of
withdrawal, reported loss of medication, unexpected result on urine drug test,
admission of using illicit substances); or every six months at a minimum if the
beneficiary is stable. If undisclosed prescriptions are discovered, patients shall be
asked to sign a release of information (ROI) form allowing their treatment status to
be communicated to the prescribers; signing the ROI is requisite for remaining in
treatment.
3.2.2 Phases of Treatment
3.2.2.1 Induction
Induction usually takes place over the course of one (1) week either at home
or in the office setting. Office visits may be as frequently as daily or
infrequently as weekly based on clinical findings and the needs of the
beneficiary. The goal of induction is to find the lowest dose of buprenorphine
or buprenorphine-naloxone combination at which the beneficiary discontinues
use of other opioids and experiences no withdrawal symptoms, minimal or no
side effects, and no uncontrollable cravings for drugs of abuse. Induction
protocol will depend on the opioids of abuse and whether the beneficiary is in
a state of withdrawal at time of induction.
3.2.2.2 Stabilization
Stabilization usually takes place over the course of one to three months with
office visits being weekly or bi-weekly until full stabilization has occurred as
evidenced by stable buprenorphine or buprenorphine- naloxone dose, no
reported cravings or withdrawal, and urine drug screen is negative for opioids
and positive for buprenorphine or buprenorphine-naloxone.
3.2.2.3 Maintenance
The beneficiary is opioid free without signs of withdrawal, no increase in
buprenorphine or buprenorphine-naloxone has been required, there have been
no irregularities with urine drug screens or drug registry inquiries, and the
beneficiary is making progress towards or meeting desired goals. Once
maintenance stage has been achieved, visits may be as frequent as once (1)
monthly if deemed necessary by the qualified provider. Maintenance
treatment may continue as long as the beneficiary meets the continued service
criteria in Subsection 3.2.4 or they meet discharge criteria in Subsection
3.2.5 and the tapering process begins. Extenuating circumstance may arise
that necessitate
visits more frequently that once per month and medical justification for more
frequent visits must be documented in the beneficiary’s health record.
3.2.3 Urine Drug Screens
Presumptive urine drug testing (UDT) may be ordered by the qualified provider caring
for a beneficiary when it is necessary to rapidly obtain or integrate results into clinical
assessment and treatment decisions.
Definitive UDT may be ordered by the qualified provider caring for a beneficiary
when it is necessary to confirm any one of the following when making clinical
treatment decisions:
a. Identify a specific substance or metabolite that is inadequately detected by
a presumptive UDT;
b. Definitively identify specific drugs in a large family of drugs;
c. Identify a specific substance or metabolite that is not detected by
presumptive UDT such as fentanyl, meperidine, synthetic cannabinoids
and other synthetic or analog drugs;
d. Identify drugs when a definitive concentration of a drug is needed to guide
management
e. Identify a negative, or confirm a positive, presumptive UDT result that is
inconsistent with a beneficiary’s self-report, presentation, medical history,
or current prescribed pain medication plan;
f. Rule out an error as the cause of a presumptive UDT result;
g. Identify non-prescribed medication or illicit use for ongoing safe
prescribing of controlled substances; or
h. Use in a differential assessment of medication efficacy, side effects,
or drug-drug interactions.
The clinician’s rationale for the presumptive and definitive UDT and the
tests ordered must be documented in the patient’s medical record.
3.2.4 Continued Service Criteria
The beneficiary shall meet the following criteria for continued service:
a. The beneficiary is attending office visits and counseling as required,
but the desired outcome or level of functioning has not been
restored, improved, or sustained over the timeframe outlined in the
beneficiary’s treatment plan; or
b. The beneficiary has attended office visits and counseling as
required, has achieved current treatment plan goals, and additional
goals are indicated as evidenced by documented symptoms.
3.2.5 Discharge Criteria
Any ONE of the following criteria must be met:
a. The beneficiary or legally responsible person no longer wishes to
receive these services; or
b. The beneficiary, based on presentation and failure to show
improvement, despite modifications in the treatment plan, requires
a more appropriate level of care; or
c. The beneficiary has achieved current treatment plan goals and
the desired outcome or level of functioning has been restored,
improved, or sustained over the timeframe outlined in the
beneficiary’s treatment plan.
3.2.6 Telemedicine
Telemedicine and telepsychiatry services may be used for the medical
or counseling portions of OBOT services providing they are in
accordance with DMA policy 1H, Telemedicine and Telepsychiatry. If
telemedicine is utilized for the medical management portion of OBOT
services, the beneficiary shall be located at a facility where a physical
exam can be conducted by a nurse practitioner, physician assistant, or
MD at the time of the telemedicine visit.
3.2.7 Medicaid Additional Criteria Covered
In addition to the specific criteria covered in Section 3.2 of this policy,
Medicaid shall cover OBOT when the following criteria are met for the
following special populations:
a. Pregnant Women: If it is determined by the OBOT provider that a
higher level of care is not required and the beneficiary meets criteria
for Office-based Opioid Therapy in subsection 3.2, the beneficiary
shall be referred for prenatal care, encouraged to remain in a
substance use treatment program, and be considered for a licensed
Opioid Treatment Program if office-based treatment compliance
cannot be guaranteed.
Note: Providers shall refer pregnant beneficiaries to another provider if they
do not have the skill set or comfort level to care for a pregnant beneficiary
with a substance use disorder
b. Women of Childbearing Age: Shall be encouraged to use
effective birth control methods and referred for family planning
services. In the event of pregnancy, the beneficiary shall inform the
qualified provider immediately as a change in the treatment plan
and medication may be required if the beneficiary is currently taking
buprenorphine combined with naloxone.
c. Breastfeeding mothers: shall be encouraged to remain in OBOT
services for the duration of their breastfeeding. Buprenorphine
metabolite levels secreted in breastmilk is thought to be low.
Mothers with HIV, or with active alcohol, cocaine, oramphetamine
substance use require special consideration when encouraging
breastfeeding.
3.2.8 NCHC Additional Criteria Covered
In addition to the specific criteria covered in Section 3.2. of this policy,
NCHC shall cover OBOT when the following criteria are met for the
following special populations:
a. Women of Childbearing Age: Shall be encouraged to use effective birth
control methods and referred for family planning services. In the event of
pregnancy, the beneficiary shall inform the qualified provider immediately
as a change in the treatment plan and medication will be required.
4.0 When the Procedure, Product, or Service Is Not Covered
d) Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy Limitations for
a Medicaid Beneficiary under 21 Years of Age.
4.1 General Criteria Not Covered
Medicaid and NCHC shall not cover the procedure, product, or service related to this policy
when:
a. the beneficiary does not meet the eligibility requirements listed in Section 2.0;
b. the beneficiary does not meet the criteria listed in Section 3.0;
c. the procedure, product, or service duplicates another provider’s procedure,
product, or service; or
d. The procedure, product, or service is experimental, investigational, or part of a
clinical trial.
4.2 Specific Criteria Not Covered
4.2.1 Specific Criteria Not Covered by both Medicaid and NCHC
Medicaid and NCHC shall not cover Office-based Opioid Treatment services when:
a. A diagnosis of substance use disorder for opioids cannot be made or
supported by assessment or documentation;
b. The provider has not complied with the requirements and limitations in
Sections 5.0, 7.0, and subsection and 3.2;
c. Initial diagnosis and evaluation, or prescribing of buprenorphine or
buprenorphine-naloxone by physicians, nurse practitioners, physician
assistants, and locum tenens physicians without a DATA 2000 waiver;or
d. The beneficiary no longer meets the requirements in Subsection 3.2.4.
4.2.2 Medicaid Additional Criteria Not Covered
Medicaid shall not cover medical office visits beyond the annual legislative limit for
mandatory services for any the following circumstances:
a. The signed treatment contract is violated without a documented intervention
by the provider;
b. Buprenorphine or buprenorphine-naloxone is not detected by qualitative or
quantitative testing on more than two occasions in a consecutive 90
calendar day period without a documented medical cause; or
c. Failure of the provider to make and document changes to the treatment plan
based on subjective or objective data that suggests a medication dose
change or other change in treatment is required as evidenced by signs or
symptoms
of withdrawal, ongoing use of illicit substances, missed appointments, or
evidence of diversion.
4.2.3 NCHC Additional Criteria Not Covered
NCGS § 108A-70.21(b) “Except as otherwise provided for eligibility, fees,
deductibles, copayments, and other cost sharing charges, health benefits coverage
provided to children eligible under the Program shall be equivalent to coverage
provided for dependents under North Carolina Medicaid Program except for the
following:
a. No services for long-term care.
b. No nonemergency medical transportation.
c. No EPSDT.
d. Dental services shall be provided on a restricted basis in accordance
with criteria adopted by the Department to implement this subsection.”
5.0 Requirements for and Limitations on Coverage
e) Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy
Limitations for a Medicaid Beneficiary under 21 Years of Age.
5.1 Prior Approval
a. Medicaid and NCHC shall not require prior approval for initiation of Office-based Opioid
Treatment services.
b. Medicaid and NCHC shall require prior approval for office visits for Office-based Opioid
Treatment services that are in excess of the annual legislated limit for mandatory
services.
5.2 Prior Approval Requirements
5.2.1 General
The provider(s) shall submit to the Department of Health and Human Services
(DHHS) Utilization Review Contractor the following:
a. the prior approval request; and
b. All health records and any other records that support the beneficiary has
met the specific criteria in Subsection 3.2 of this policy.
5.2.2 Specific
For continued OBOT services beyond the annual legislative limit for mandatory
services, the OBOT provider shall submit all of the following:
a. current treatment plan;
b. signed treatment contract (if one was obtained);
c. behavioral health attendance records (if beneficiary is attendingcounseling);
d. any disciplinary contracts signed by the beneficiary and provider;
e. last five encounter notes (or initial evaluation through current if the
beneficiary has not had five visits); and
f. last ten urine drug screens (both presumptive and definitive) by date
of service
5.3 Additional Limitations or Requirements
None Apply.
6.0 Provider(s) Eligible to Bill for the Procedure, Product, orService
To be eligible to bill for the procedure, product, or service related to this policy, the provider(s) shall:
a. meet Medicaid or NCHC qualifications for participation and be enrolled as a North
Carolina Medicaid provider;
b. have a current and signed Department of Health and Human Services (DHHS)
Provider Administrative Participation Agreement; and
c. Bill only for procedures, products, and services that are within the scope of their clinical
practice, as defined by the appropriate licensing entity.
6.1 Provider Qualifications and Occupational Licensing Entity Regulations
Qualified providers shall complete the required specialized training, and shall be granted the
waiver authority from the Substance Abuse and Mental Health Services Administration
(SAMHSA) to prescribe and dispense buprenorphine or buprenorphine- naloxone in an officebased practice. In addition to the DATA 2000 waiver, both DEA and North Carolina Division of
Mental Health, Developmental Disabilities and Substance Abuse Services Drug Control Unit
registrations are required to operate as an Office-based Opioid Treatment Practice. Providers
working in licensed Opioid Treatment Programs (OTPs) shall dispense buprenorphine or
buprenorphine-naloxone following the federal and state OTP rules and policies. Nurses working in
licensed Opioid Treatment Programs (OTPs) shall administer buprenorphine or buprenorphinenaloxone following the federal and state OTP rules and policies.
Providers who utilize Buprenorphine or buprenorphine-naloxone in Office-based Opioid
Treatment (OBOT) shall be able to recognize opioid use disorders and be knowledgeable about
the appropriate use of opioid agonist, antagonist, and partial agonist medications. Providers shall
demonstrate required qualifications according to DATA 2000 and obtain a waiver from the
Substance Abuse and Mental Health Services Administration (SAMHSA).
Providers of counseling and other therapeutic services to a beneficiary in an Office-based Opioid
Treatment program shall be licensed to provide those services and directly enrolled with North
Carolina Division of Medical Assistance or the appropriate LME- MCO. Licensed professionals
providing outpatient treatment services to a beneficiary in an Office-based Opioid Treatment
program shall follow the outpatient Clinical Coverage Policy 8C, Outpatient Behavioral Health
Services Provided by Direct-Enrolled Providers, located on DMA’s website at
http://dma.ncdhhs.gov/.
6.2 Provider Certifications
6.2.1 SAMHSA Waiver
The Drug Enforcement Administration (DEA) issues a special identification number for
providers who have been granted the waiver from the Substance Abuse
and Mental Health Services Administration (SAMHSA) to prescribe and dispense
buprenorphine or buprenorphine-naloxone. Providers who provide this service are required
to have the SAMHSA waiver and the special DEA number.
7.0 Additional Requirements
f) Note: Refer to Subsection 2.2.1 regarding EPSDT Exception to Policy
Limitations for a Medicaid Beneficiary under 21 Years of Age.
7.1 Compliance
Provider(s) shall comply with the following in effect at the time the service is rendered:
a. All applicable agreements, federal, state and local laws and regulations including
the Health Insurance Portability and Accountability Act (HIPAA) and record retention
requirements; and
b. All DMA’s clinical coverage policies, guidelines, policies, provider manuals,
implementation updates, and bulletins published by the Centers for Medicare
and Medicaid Services (CMS), DHHS, DHHS division(s) or fiscal contractor(s).
In addition to the above, the provider shall comply with the following:
a. Policies of the North Carolina Medical Board; and
b. Center for Substance Abuse Treatment. Clinical Guidelines for the Use of
Buprenorphine in the Treatment of Opioid Addiction. Treatment Improvement
Protocol (TIP) Series 40. DHHS Publication No. (SMA) 04-3939. Rockville, MD:
Substance Abuse and Mental Health Services Administration, 2004.
7.2 Documentation
7.2.1 Health Record Documentation
Provider(s) shall document and maintain, in each beneficiary’s health record, at a
minimum, the following:
a. Demographic information: the beneficiary’s full name, contact information,
date of birth, race, gender, and admission date;
b. The beneficiary’s name and date of birth must be on each page generated
by the office;
c. The health record number of the beneficiary must be on each page
generated by the office;
d. The Beneficiary’s Identification Number for services must be on all
contracts, progress note pages, billing records, and other documents or
forms that have a place for it;
e. An individualized treatment plan and treatment contract;
f. Initial diagnosis and any tools used during the initial evaluation period;
g. Signed and dated copies of any testing, consultations, encounter notes,
and reports; and
h. Communication regarding coordination of care activities; and
7.2.2 Encounter Notes
There must be a note documenting the following information for each encounter. Notes
may be handwritten if legible, otherwise they must be dictated or in electronic health
record (EHR), reviewed, and signed within three business days of the encounter. Prefilled electronic health records must be reviewed for accuracy prior to being
electronically signed. All notes must be dated and the provider shall sign all documents
with their name and credentials.
Encounter documents must contain the following elements at a minimum:
a. Date of service;
b. Subjective response to treatment;
c. Review of Systems(ROS) which may be carried over on electronic charting
or documented in the handwritten or dictated note;
d. Documentation of physical examination and possible signs of withdrawal or
intoxication;
e. Medication list, including new and changed prescriptions, updated at
each visit;
f. Results of periodic tests and interventions such as urine drug screens, pill
counts, CSRS inquiries, and actions taken for unanticipated lab results or
missed appointments;
g. Any consults made with other providers (mental health, OB/GYN, PCP, etc.)
or family members of the beneficiary; and
h. Follow up plans.
Note: There needs to be clear documentation when a beneficiary cancels, they no show
or reschedules encounters. If there is any gap in services, there needs to be an
explanation in the health record about what the issue is. If the client has attendance
problems, that needs to be addressed with the client, and documented in the health record
with an explanation for the missed appointments.
Note: When an electronic signature is entered into the electronic record by agency
staff (employees or authorized individuals under contract with the agency), the
standards for Electronic Signatures found in the September 2011 Medicaid Bulletin
(http://dma.ncdhhs.gov/document/archived-medicaid- bulletins-2010-2013) must be
followed. In addition, electronic signatures must comply with federal guidelines
found in 45 CFR parts 160 and 162.
8.0 Policy Implementation and History
Original Effective Date: Month Day, Year
History:
Date Section or
Subsection
Amended
Change
02/01/2017 All Sections and
Attachment(s)
New policy on Buprenorphine or buprenorphine-naloxone
Treatment Services.
02/21/2017 Attachment A (C) Typographical error fixed; 99213 changed to 99203 on first line of
CPT Codes.
03/15/2017 Subsection 3.2.1 (c) Clarified counseling requirements as follows:
Medicaid and NCHC shall require a minimum of once monthly
individual or group therapy sessions during the induction and
stabilization phases of treatment conducted by a behavioral health
professional licensed to treat substance use disorders and trained in the
use of the American Society of Addiction Medicine (ASAM)
Treatment Criteria for Addictive, Substance- Related, and CoOccurring Conditions. Counseling sessions needed beyond induction
and stabilization shall be at the discretion of the practitioner and
beneficiary, based on the beneficiary’s ongoing needs and treatment
goals.
The provider shall confirm the beneficiary is in counseling for their
opioid use disorder and other co-occurring diagnoses, as applicable. If
the beneficiary is not currently in counseling, the provider shall
promptly refer the beneficiary to a licensed, North Carolina Local
Management Entity-Managed Care Organization (MCO) enrolled,
behavioral health professional. Optimally, counseling should begin
within 48 hours of induction if urgent need is indicted.
03/15/2017 Subsection 5.2.2 (c) Added “if beneficiary is attending counseling”
08/01/2017 Subsection 3.2.1 (a) Added clarifying statement:
**Note: The 12 components (listed in subsection 3.2.1.a) of the
comprehensive assessment are essential for the thorough care of a
beneficiary with a substance use disorder diagnosis; however,
completion of the full initial evaluation need not delay the
initiation of treatment. Prompt treatment is a priority and
completion of the 12 components over two
or three visits is permissible at the discretion of the provider.
Date Section or
Subsection
Amended
Change
08/01/2017 Subsection 3.2.1 (c) Clarified counseling requirements as follows:
The provider shall inquire whether the beneficiary is in counseling for
their opioid use disorder and other co-occurring diagnoses, as
applicable. If the beneficiary is not currently in counseling, the
provider shall promptly refer the beneficiary to a licensed, North
Carolina Local Management Entity-Managed Care Organization
(MCO) enrolled, behavioral health professional. Optimally, counseling
should begin within 48 hours of induction if urgent need is indicted.
01/01/2018 Subsection 5.1 (b) Removed the following:
Medicaid and NCHC shall require Pharmacy Prior Authorization for
use of buprenorphine or buprenorphine-naloxone combination
medication (refer to pharmacy prior approval and
renewal criteria located at https://www.nctracks.nc.gov/)
Attachment A: Claims-Related Information
Provider(s) shall comply with the, NCTracks Provider Claims and Billing Assistance Guide, Medicaid bulletins,
fee schedules, DMA’s clinical coverage policies and any other relevant documents for specific coverage and
reimbursement for Medicaid and NCHC:
A. Claim Type
Professional (CMS-1500/837P transaction)
B. International Classification of Diseases, Tenth Revision (ICD-10) and Procedures
Provider(s) shall report the ICD-10 and procedures code(s) to the highest level of specificity that supports
medical necessity. Provider(s) shall use the current ICD-10 edition and any subsequent editions in effect
at the time of service. Provider(s) shall refer to the applicable edition for code description, as it is no
longer documented in the policy.
C. Code(s)
Provider(s) shall report the most specific billing code that accurately and completely describes the
procedure, product or service provided. Provider(s) shall use the Current Procedural Terminology (CPT),
Health Care Procedure Coding System (HCPCS), and UB-04 Data Specifications Manual (for a complete
listing of valid revenue codes) and any subsequent editions in effect at the time of service. Provider(s) shall
refer to the applicable edition for the code description, as it is no longer documented in the policy.
If no such specific CPT or HCPCS code exists, then the provider(s) shall report the procedure, product
or service using the appropriate unlisted procedure or service code.
CPT Code(s)
99201 99202 99203 99204
99205 99211 99212 99213
99214 99215 99241 99242
99243 99244 99245 T1015
Unlisted Procedure or Service
CPT: The provider(s) shall refer to and comply with the Instructions for Use of the CPT Codebook, Unlisted
Procedure or Service, and Special Report as documented in the current CPT in effect at the time of service.
HCPCS: The provider(s) shall refer to and comply with the Instructions For Use of HCPCS National
Level II codes, Unlisted Procedure or Service and Special Report as documented in the current HCPCS
edition in effect at the time of service.
D. Modifiers
Provider(s) shall follow applicable modifier guidelines.
E. Billing Units
Provider(s) shall report the appropriate code(s) used which determines the billing unit(s).
F. Place of Service
Office, clinics, and Federally Qualified Health Centers
G. Co-payments
For Medicaid refer to Medicaid State Plan, Attachment 4.18-A, page 1, located at
http://dma.ncdhhs.gov/.
For NCHC refer to G.S. 108A-70.21(d),
H. Reimbursement
Provider(s) shall bill their usual and customary charges. For a
schedule of rates, refer to: http://dma.ncdhhs.gov
Was this article helpful?
That’s Great!
Thank you for your feedback
Sorry! We couldn't be helpful
Thank you for your feedback
Feedback sent
We appreciate your effort and will try to fix the article