Medication Assisted Treatment: Buprenorphine Clinical Coverage Policy 8A-3 Amended Date: 10/1/2015 DRAFT Table of Contents

Transcription

1 Medication Assisted Treatment: Buprenorphine Clinical Coverage Policy 8A-3 10/1/2015 Table of Contents 1.0 Description of the Procedure, Product, or Service Definitions Eligibility Requirements Provisions General Specific Special Provisions EPSDT Special Provision: Exception to Policy Limitations for a Medicaid Beneficiary under 21 Years of Age EPSDT does not apply to NCHC beneficiaries Health Choice Special Provision for a Health Choice Beneficiary age 6 through 18 years of age When the Procedure, Product, or Service Is Covered General Criteria Covered Specific Criteria Covered Specific criteria covered by both Medicaid and NCHC Medicaid Additional Criteria Covered NCHC Additional Criteria Covered When the Procedure, Product, or Service Is Not Covered General Criteria Not Covered Specific Criteria Not Covered Specific Criteria Not Covered by both Medicaid and NCHC Medicaid Additional Criteria Not Covered NCHC Additional Criteria Not Covered Requirements for and Limitations on Coverage Prior Approval Prior Approval Requirements General Specific Additional Limitations or Requirements Provider(s) Eligible to Bill for the Procedure, Product, or Service Provider Qualifications and Occupational Licensing Entity Regulations Provider Certifications Additional Requirements Compliance Policy Implementation and History Attachment A: Claims-Related Information A. Claim Type K17 i

2 Medication Assisted Treatment: Buprenorphine Clinical Coverage Policy 8A-3 10/1/2015 B. International Classification of Diseases, Ninth Revisions, Clinical Modification (ICD-9- CM) and Procedures Codes C. Code(s) D. Modifiers E. Billing Units F. Place of Service G. Co-payments H. Reimbursement K17 ii

3 Related Clinical Coverage Policies Refer to for the related coverage policies listed below: Description of the Procedure, Product, or Service Federal statute, the Drug Addiction Treatment Act of 2000 (DATA 2000), established a new paradigm for the medication-assisted treatment of opioid addiction in the United States (Drug Addiction Treatment Act of 2000). Prior to the enactment of DATA 2000, the use of opioid medications to treat opioid addiction was permissible only in federally approved Opioid Treatment Programs (OTPs) (i.e., methadone clinics), and only with the Schedule II opioid medications methadone and levo-alpha-acetyl-methadol (LAAM), which could only be dispensed, not prescribed. Now, under the provisions of DATA 2000, qualifying physicians in the medical office and other appropriate settings outside the OTP system may prescribe and/or dispense Schedule III, IV, and V opioid medications for the treatment of opioid addiction if such medications have been specifically approved by the Food and Drug Administration (FDA) for that indication. In October 2002, FDA approved two sublingual formulations of the Schedule III opioid partial agonist medication buprenorphine for the treatment of opioid addiction. These medications, Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone), have received FDA approval and, thus, to be eligible for use under DATA Physicians who consider providing office-based treatment of opioid addiction must be able to recognize opioid use disorders and be knowledgeable about the appropriate use of opioid agonist, antagonist, and partial agonist medications. Physicians must also demonstrate required qualifications in accordance with DATA 2000 and obtain a waiver from the Substance Abuse and Mental Health Services Administration (SAMHSA). Buprenorphine is a partial agonist and research suggests that lethal overdoses are less likely than with full agonists such as methadone. However, this ceiling effect is diminished if combined with other drugs such as alcohol and benzodiazepines. Buprenorphine is used for both long-term maintenance and for medically supervised detoxification from opioids. Buprenorphine serves as an alternative to methadone as an evidence-based treatment of beneficiaries with opioid use disorders. 1.1 Definitions Buprenorphine An opioid partial agonist that is a synthetic derivative of thebaine. Two sublingual formulations of buprenorphine, the Schedule III pharmaceuticals Subutex (buprenorphine) and Suboxone (buprenorphine/naloxone), received Food and Drug Administration (FDA) approval in October 2000 for use in the treatment of opioid addiction. Buprenex, an injectable formulation of buprenorphine, has previously been available in the United States and is approved for use as a parenteral analgesic. 14K17 3

4 1.1.2 Opioid Treatment Program Opioid treatment programs provide medication-assisted treatment for persons diagnosed with opioid-use disorder. Medication assisted treatment 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. Research shows that when treating substance-use disorders, a combination of medication and behavioral therapies is most successful. The duration of treatment should be based on the needs of the persons served. The medications used to achieve treatment goals include methadone and buprenorphine, which are approved by the Food and Drug Administration (FDA) for the use in the treatment of opioiduse disorder Methadone A Schedule II synthetic opioid with pharmacologic actions similar to morphine and heroin; almost equally addictive. Approved for use in the treatment of opioid addiction in federally regulated Opioid Treatment Programs. May be administered orally, intramuscularly, and subcutaneously. Eligibility Requirements 2.1 Provisions General (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 Specific (The term Specific found throughout this policy only applies to this policy) a. Medicaid An eligible beneficiary should be 18 years of age or older. Adolescents (under 18) shall not be admitted for buprenorphine treatment without the written consent of the parent or other legally responsible person and all of the entrance criteria in section shall be met. 14K17 4

5 b. NCHC None apply 2.2 Special Provisions 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. 14K17 5

6 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: EPSDT provider page: EPSDT does not apply to NCHC beneficiaries 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. When the Procedure, Product, or Service Is Covered Note: Refer to Subsection 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 Specific criteria covered by both Medicaid and NCHC Entrance Criteria All of the following criteria are necessary for admission to a buprenorphine treatment program. a. A comprehensive clinical assessment to support a DSM-5 (or its successor) diagnosis of opioid use disorder moderate or severe. b. ASAM criteria are met for Office-Based Opioid Treatment (OBOT). c. The beneficiary must be assessed to be: 1. motivated for treatment 2. expected to be compliant with treatment 3. no contraindications that preclude the beneficiary from being a candidate for buprenorphine treatment. 14K17 6

7 d. The beneficiary must be in counseling or other treatment for their opioid use disorder and other co-occurring diagnoses as applicable or be scheduled to start treatment. e. Toxicology screen must be completed on admission. f. The beneficiary does not require a higher level of care. g. The beneficiary is capable of developing skills to manage symptoms, make behavioral changes, and respond favorably to therapeutic interventions. h. There is no evidence to support that alternative interventions would be more effective, based on North Carolina community practice standards (e.g., Best Practice Guidelines of the American Academy of Child and Adolescent Psychiatry, American Psychiatric Association, American Board of Addiction Medicine) Continued Services Criteria The criteria for continued service must meet both a. b. and c below: a. Any ONE of the following criteria: 1. The desired outcome or level of functioning has not been restored, improved, or sustained over the timeframe outlined in the beneficiary s treatment plan; 2. The beneficiary continues to be at risk for relapse based on current clinical assessment, and history: or 3. Tenuous nature of the functional gains; b. Any ONE of the following criteria (in addition to a.) 1. The beneficiary has achieved current treatment plan goals, and additional goals are indicated as evidenced by documented symptoms; or 2. The beneficiary is making satisfactory progress toward meeting goals and there is documentation that supports that continuation of this service is expected to be effective in addressing the goals outlined in the treatment plan. c. The beneficiary must be actively engaged in counseling or other treatment for their opioid use disorder and other co-occurring diagnoses as applicable 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 best practice or evidence-based treatment modality based on North Carolina community practice standards (for example, National Institute of Drug Abuse, American Psychiatric Association). c. The beneficiary has achieved current treatment plan goals and the desired outcome or level of functioning has been restored, 14K17 7

8 improved, or sustained over the timeframe outlined in the beneficiary s treatment plan Medicaid Additional Criteria Covered None apply NCHC Additional Criteria Covered None apply When the Procedure, Product, or Service Is Not Covered Note: Refer to Subsection 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 Specific Criteria Not Covered by both Medicaid and NCHC a. When the focus of treatment does not address the symptoms of the opioid use disorder diagnosis. b. When the requirements and limitations in Section 5.0 are not followed Medicaid Additional Criteria Not Covered a. None apply NCHC Additional Criteria Not Covered a. In addition to the specific criteria not covered in Subsection of this policy, NCHC shall not cover b. 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: 1. No services for long-term care. 2. No nonemergency medical transportation. 3. No EPSDT. 4. Dental services shall be provided on a restricted basis in accordance with criteria adopted by the Department to implement this subsection. 14K17 8

9 Requirements for and Limitations on Coverage Note: Refer to Subsection regarding EPSDT Exception to Policy Limitations for a Medicaid Beneficiary under 21 Years of Age. 5.1 Prior Approval Prior approval is required before starting a beneficiary on buprenorphine. 5.2 Prior Approval Requirements 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 Specific Utilization management of covered services is a part of the assurance of medically necessary service provision. Authorization, which is an aspect of utilization management, validates approval to provide a medically necessary covered service to eligible beneficiaries. Initial Authorization Services are based upon a finding of medical necessity, must be directly related to the beneficiary s diagnostic and clinical needs, and are expected to achieve the specific rehabilitative goals detailed in the beneficiary s treatment plan. Medical necessity is determined by North Carolina community practice standards, as verified by the LME-MCO which will evaluate the request to determine if medical necessity supports more or less intensive services. Medically necessary services are authorized in the most cost-effective mode, as long as the treatment that is made available is similarly efficacious as services requested by the beneficiary s physician, therapist, or other licensed practitioner. Typically, the medically necessary service must be generally recognized as an accepted method of medical practice or treatment. The provider shall obtain prior authorization required on the first day of this service. Medicaid and NCHC covers 90 calendar days for the initial authorization period based on medical necessity. Reauthorization Medicaid and NCHC cover up to 180 calendar days for the reauthorization, based on the medical necessity. A reauthorization request should be submitted prior to initial or concurrent authorization expiring. 5.3 Additional Limitations or Requirements Each of the following issues must be addressed by the buprenorphine treatment program: 14K17 9

10 a. The physician must refer the beneficiary into appropriate counseling, substance use disorder treatment services, and self-help groups such as Narcotics Anonymous (NA). 1. The licensed professional receiving the referral from the prescribing physician should demonstrate the use of evidence-based practices in the treatment of substance use disorders. b. Random drug testing (blood, hair, or urine) is required either on site or in conjunction with a certified laboratory. 1. Random drug testing should be done at least weekly until there have been three consecutive negative tests. At that point monthly random drug testing should be completed if testing continues to be negative. 2. Policies shall be in place for confirmatory testing with a certified laboratory. 3. Policies shall be in place for responding to drug tests negative for buprenorphine. These policies should include timely meeting between the beneficiary and the physician (or counselor) to discuss the results to consider and manage following possibilities: the beneficiary is not taking the prescribed dose the beneficiary is not taking the buprenorphine at all the beneficiary recently ingested a large amount of water or other liquid to dilute the urine sample the beneficiary ingested the buprenorphine dose only on the date of the drug test 4. Incidents of negative tests should be handled on a case-by-case basis with the beneficiary but if there is continued suspicion of diversion then discontinuation of buprenorphine treatment should be considered so as to provide greater clinical oversight. 5. Policies shall be in place for responding to drug tests positive for other substances (e.g. opiates, cocaine, marijuana, benzodiazepine) and should include timely meeting between the beneficiary and the physician (or counselor) to discuss the positive drug test to consider and manage an appropriate treatment response. c. Call-backs for confirmation of remaining pill supply (pill counts). d. Physicians shall provide beneficiary and staff education and training. e. Physicians shall have a policy for the treatment of pregnant and breast-feeding women. f. Physicians shall utilize the North Carolina Controlled Substance Reporting System to help in preventing diversion and be aware of any other sources of controlled substances being prescribed to the beneficiary. g. Other considerations: 1. Require CSRS check on enrollment and periodically 2. require permission to communicate with other treating physicians, etc 3. Require pharmacy lock in/home 4. Set expectations for referral and coordination for MI, physical illness, family planning, etc 5. Require controlled substance use contracts 14K17 10

11 5.4 Referral Medicaid Beneficiaries under the Age of 21 and NCHC Beneficiaries ages six through 18 years Buprenorphine treatment services provided to Medicaid beneficiaries under the age of 21 and NCHC beneficiaries require an individual, verbal or written referral, based on the beneficiary s treatment needs by a Community Care of North Carolina/Carolina Access (CCNC/CA) primary care provider, the LME- MCO, or a Medicaid-enrolled psychiatrist prior to or on the first date of service. The verbal or written referral must be documented in the health record along with the name and NPI number of the individual or agency making the referral Medicaid Beneficiaries Aged 21 and Over Buprenorphine treatment services provided to a Medicaid beneficiary age 21 or over may be self-referred or referred by some other source. If the beneficiary is not self-referred, the referral must be documented in the health record. Provider(s) Eligible to Bill for the Procedure, Product, or Service 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 Physicians providing this service must be licensed to practice in North Carolina by the North Carolina Medical Board. Physicians must also have the training and have been granted the SAMHSA waiver to prescribe buprenorphine in an office-based practice to North Carolina Medicaid beneficiaries. Physicians working in a licensed Opioid Treatment Programs (OTPs) may dispense buprenorphine following the federal and state OTP rules and policies. Individuals providing counseling and other therapeutic services to beneficiaries in a buprenorphine treatment program must 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 beneficiaries in a buprenorphine treatment program must follow the outpatient Clinical Coverage Policy 8C. 14K17 11

12 6.2 Provider Certifications Buprenorphine Waiver The Drug Enforcement Administration (DEA) issues a special identification number for physicians who have been granted the waiver from the Substance Abuse and Mental Health Services Administration (SAMHSA) to prescribe buprenorphine. Providers of this service are required to have the SAMHSA buprenorphine waiver. Additional Requirements Note: Refer to Subsection 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). 7.2 Service Records and Documentation Consent a. At the time of the initial service, the provider shall obtain the written consent from the legally responsible person for treatment for beneficiaries of all ages Provision of Services Providers shall maintain health records that document the provision of services for which NCHC or Medicaid reimburse providers. Provider organizations shall maintain, in each beneficiary s service record, at a minimum, the following documentation: Demographic information: the beneficiary s full name, contact information, date of birth, race, gender, and admission date; The beneficiary s name must be on each page generated by the provider agency; The service record number of the beneficiary must be on each page generated by the provider agency; The Beneficiary s Identification Number for services reimbursed by Medicaid or NCHC must be on all treatment plans, service note pages, accounting of release, or disclosure logs, billing records, and other documents or forms that have a place for it; An individualized treatment plan; Documentation of entrance criteria, continued service criteria, and discharge criteria; A copy of any testing, summary and evaluation reports; Documentation of communication regarding coordination of care activities; and 14K17 12

13 All evaluations, notes and reports must contain the full date the service was provided (month, day, and year) Prior Approval Documentation The service record should contain documentation of the initial prior approval request. Continuing service requests should contain the documentation of the prior approval request as well as documentation that the Continued Services Criteria has been met Service Notes and Progress Notes There must be a progress note for each treatment encounter that documents the following information: a. Date of service; b. Name of the service provided (e.g., Outpatient Therapy Individual); c. Type of contact (face-to-face, Telepsychiatry, phone call, collateral); nonface-to-face services are not covered and not reimbursable except for clinical coverage policy 1H, Telemedicine and Telepsychiatry are considered as faceto-face services. Refer to d. Purpose of the contact (tied to the specific goals in the plan); e. Description of the treatment or interventions performed. Treatment and interventions must include active engagement of the beneficiary and relate to the goals and strategies outlined on the beneficiary s plan; f. Effectiveness of the intervention(s) and the beneficiary s response or progress toward goal(s); g. The duration of the service (e.g., length of the assessment or treatment in minutes; h. Signature, with credentials, degree, and licensure of clinician who provided the service. A handwritten note requires a handwritten signature; however, the credentials, degree, and licensure may be typed, printed, or stamped; and Note: The exception to the above service note policy is the documentation required for medical providers offering medication management and billing E/M codes. In this case, the medical provider must document the chosen E/M code with all of the necessary elements as outlined in the current edition of the American Medical Association's Current Procedural Terminology (CPT) manual Electronic Signatures 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 must be followed. 14K17 13

14 7.3 Coordination of Care The physician should document coordination of care activities with other specialists and professionals as needed. The provider shall coordinate and document the following coordination of care activities: a. Communication with other prescribing providers to ensure that other providers are aware that buprenorphine is being prescribed. b. Written progress or summary reports; c. Telephone communication; d. Treatment planning processes. An individualized plan of care, service plan, treatment plan, or Person-Centered Plan (PCP), consistent with and supportive of the service provided and within professional standards of practice, is required. When the beneficiary is receiving multiple behavioral health services in addition to the services in this policy, a PCP must be developed with the beneficiary, and outpatient behavioral health services are to be incorporated into the beneficiary s PCP; e. Coordination of care with the beneficiary s CCNC/CA care manager (if applicable) and primary care or CCNC/CA physician; f. Coordination of care with the applicable LME-MCO (not applicable for NCHC beneficiaries); and g. Other activities jointly determined by the referring provider and the behavioral health provider to be necessary for the continuum of care. h. Referral to other physicians and providers as needed for management of MI, acute and chronic medical problems, family planning, etc i. Note: For coordination of care pertaining to billing, refer to Attachment A. 7.4 Expected Clinical Outcomes The expected clinical outcomes must relate to the identified goals in the beneficiary s treatment plan. The outcomes must reflect changes in symptoms and behaviors that, when met, promote increased functioning such that beneficiary may no longer meet medical necessity criteria for further treatment. Examples of expected clinical outcomes for this service are the following: a. Reduced symptomatology, abstinence from the use of opiates, abstinence or decreased use of alcohol and other drugs; b. Employment or education (getting and keeping a job); c. Crime (decreased criminality); d. Stability in housing; and e. Increased social supports. If a review of the need for ongoing treatment determines that continued treatment is medically necessary, documentation of continued stay must provide the following: a. documentation of the need for ongoing treatment; b. documentation of progress made; or c. documentation of efforts to address lack of progress. 14K17 14

15 Policy Implementation and History Original Effective Date: Month Day, Year History: Date Section or Subsection Amended Change 14K17 15

16 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. ICD-10 Code(s) ICD-10 Procedure Code(s) 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) 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. 14K17 16

17 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 G. Co-payments For Medicaid refer to Medicaid State Plan, Attachment 4.18-A, page 1, located at For NCHC refer to G.S. 108A-70.21(d), located at html. H. Reimbursement Provider(s) shall bill their usual and customary charges. For a schedule of rates, refer to: I. Coordination of Care a. Coordination of care activities are included in the administrative costs for this service and are therefore not billable. b. Coordination of Benefits for Medicaid Beneficiaries 1. Any provider who serves dually eligible beneficiaries (i.e., Medicaid and Medicare or other insurance carriers) shall be enrolled as a participating provider with each of the identified insurance carriers in order to be reimbursed. 2. For beneficiaries having both Medicaid and Medicare, the provider shall bill Medicare as primary before submitting a claim to Medicaid. If both Medicare and Medicaid allow the service, Medicaid pays the lesser of: A. the Medicare cost-sharing amount; or B. the Medicaid maximum allowable for the service less the Medicare payment. 3. For beneficiaries having both Medicaid and any other insurance coverage, the other insurance shall be billed prior to billing Medicaid, as Medicaid is considered the payor of last resort. a. Coordination of Benefits for Health Choice Beneficiaries b. Children with other insurance coverage are not eligible for NCHC coverage; therefore, there is no coordination of benefits under the NCHC Program. 14K17 17

18 Attachment B: Evidence-Based Practice Evidence-Based Practice The Substance Abuse and Mental Health Services Administration (SAMHSA) Center for Substance Abuse Treatment has published the Treatment Improvement Protocol (TIP) # 40, titled Clinical Guidelines for the Use of Buprenorphine in the Treatment of Opioid Addiction. This TIP is a comprehensive best practice guideline for the use of buprenorphine in treating opioid use disorders. Treatment with buprenorphine for opioid use disorders is considered an evidence-based best practice by SAMHSA. TIP 40 and other best practice guidelines include the following as a part of what would be considered best practice and buprenorphine treatment. a. The preferred medication would be the buprenorphine/naloxone combination (Suboxone) for induction as well is stabilization unless contraindicated (e.g. pregnancy) and then the monotherapy (Subutex) is recommended. The buprenorphine/naloxone combination serves to minimize diversion and intravenous abuse. b. Maintenance treatment three phases and approximate length 1. Induction one week; with suggested frequency of daily administration for at least the first two days. i. Goal of induction is defined minimum dose of buprenorphine at which the beneficiary discontinues the use of other opioids, experiences no withdrawal symptoms, has minimal or no side effects, and no uncontrollable cravings for drugs of abuse. ii. Induction phase occurs on site in the physician office and should be guided by written protocols. 2. Stabilization 1 to 2 months Goal is to reduce cravings and use of illicit opioids as evidenced by negative toxicology. Suggested frequency is weekly. Pill counts are recommended 3. Maintenance 12 months to indefinite; suggested frequency is monthly for beneficiaries who are stable, making progress toward treatment goals, and have negative drug tests. Attention must be maintained to issues such as: psychosocial, family, relapse prevention, cravings, psychiatric comorbidity, other alcohol or drug abuse, somatic consequences of drug use, legal consequences of drug use, and financial. c. Termination 1. Ideally, discontinuation of medication should occur when the beneficiary has achieved maximum benefit from treatment. Buprenorphrine should be tapered slowly while psychosocial services continue to be provided. Beneficiaries should be assessed for continued stability. Involuntary termination of treatment may occur under certain circumstances but abandonment should be avoided and physicians should have written policies and procedures that should be discussed with beneficiaries who should agree to comply with these policies. d. 14K17 18

19 e. Weekly random drug testing until three consecutive tests are negative and then monthly random drug testing. f. Counseling and relapse prevention treatment occur at a minimum weekly for the first 12 weeks and then monthly if the beneficiary is abstinent and compliant with treatment. g. If there is evidence of illicit use or diversion: i. Diversion could result in immediate discharge. ii. Illicit use could result in: 1. increasing clinic visits; 2. more frequent drug testing and pill counts; 3. increasing the intensity or frequency of treatment for the opioid use disorder or other substance use disorders; or 4. detoxification and referral to more intensive treatments. h. Harm reduction philosophy focuses on keeping the beneficiary in treatment. 14K17 19

20 The Policy Questions Not a Part of the Policy 1. Best practice would suggest that the physician would be able to dispense buprenorphine in the office during the induction phase as well as at other times when the individual is in the office. In addition, the physician would write a prescription and the person would take most of their doses at home. The question would be is this allowed or would there be any issues with the physician dispensing buprenorphine in the office? Would a clinic have to be an OTP to dispense buprenorphine? 2. Best practice also allows maintenance for an indefinite period as long as medical necessity criteria are met. Is this something we are, but with? 3. Who should this policy cover? Does it cover all physicians prescribing buprenorphine are only those with larger caseloads such that they are operating a opioid treatment program clinic? 4. Should we require beneficiaries receiving buprenorphine treatment to have a pharmacy home so that all prescriptions come from a single pharmacy? 5. Can an individual be on both methadone and buprenorphine at the same time? 6. Do we want to provide guidance or limitations on UDS? For instance cover on ly office screen to be followed by confirmation if Need to consider more innovative payment models. Possibly care bundles. Other? 8. Given that this service can be only provided by physicians, do we still need to have the referral requirement for under 21? 9. Section c references Telepsychiatry do we want the service to be able to be provided via Telepsychiatry? 10. The policy should be a joint policy with behavioral health and medical K17 20