2018 Billing and Coding Guide for

Transcription

1 Billing and Coding Guide for

2 Table of Contents 1. Introduction 2. Coding Quick Reference Guide 3. Coding for Probuphine (buprenorphine) implant National Drug Codes (NDC) 1 Healthcare Common Procedure Coding System (HCPCS) 2 International Classification of Diseases, Clinical Modification codes (ICD-10 CM) 3 Current Procedural Terminology (CPT ) code 4 4. Sites of Service Provider office, community based provider: CMS-1500 claim form 5 Hospital outpatient clinic: UB-04/CMS claim form 5. Titan Access Program Patient Enrollment Order Form 6. Important Safety Information for Probuphine 2 PRO-18EBA006 08/2018

3 Introduction The general coding and billing information contained in this guide was compiled from public sources and is provided to help you understand the availability of reimbursement related to Probuphine (buprenorphine) implant. This guide is provided as general information only and is not intended as coverage or coding advice, nor is it intended to increase or maximize reimbursement by any payor. Titan cannot provide specific reimbursement rates, and does not guarantee any level of reimbursement. Titan makes no other representations or warranties regarding the selection of codes for procedures or compliance of the information in this guide with any other billing protocols or requirements. Similarly, all CPT, HCPCS and ICD-10-CM codes are supplied for information purposes only and represent no statement, promise or guarantee by Titan that these codes will be appropriate or that reimbursement will be made. As with all claims, individual hospitals and physicians are responsible for exercising independent clinical judgment in selecting the codes that most accurately reflect a patient s condition and the procedures performed. Laws, regulations, and policies concerning coding and payment are complex and subject to change. Physicians and hospitals should refer to current, complete, and authoritative publications, such as AMA CPT lists, Medicare transmittals, and third-party payor policies as the basis for selecting codes that describe care rendered to an individual patient, and may wish to contact individual Medicare contractors or other third-party insurers as needed. Probuphine (buprenorphine) implant for subdermal administration INDICATIONS AND USAGE PROBUPHINE contains buprenorphine, a partial opioid agonist. Probuphine is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-to-moderate doses of a transmucosal buprenorphinecontaining product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet equivalent or generic equivalent). PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support. PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet equivalent or generic equivalent. Please see IMPORTANT SAFETY INFORMATION including BOXED WARNING on pages 14 & 15 3

4 Coding Quick Guide Item Code Description HCPCS 1 Code J0570 Buprenorphine implant, 74.2 mg HCPCS Code G0516 Insertion of non-biodegradable drug delivery implants, 4 or more (services for subdermal rod implant) HCPCS Code HCPCS Code G0517 G0518 Removal of non-biodegradable drug delivery implants, 4 or more (services for subdermal implants) Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for subdermal implants) CPT Code Unlisted procedure, skin, mucous membrane and subcutaneous Potential ICD-10-CM 3 Codes F11.10 Opioid Abuse Uncomplicated F11.20 Opioid Dependence Uncomplicated F11.21 Opioid Dependence in Remission 11 Digit NDC Each Probuphine System Kit contains: 4 Probuphine non-biodegradable implantable rods (a subdermal implant containing 74.2 mg of buprenorphine which is the equivalent of 80 mg of buprenorphine hydrochloride); and one Probuphine Applicator 4

5 National Drug Codes: NDC The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. The NDC for Probuphine (buprenorphine) implant is: NDC Number Number Description 11 Digit NDC Number Each Probuphine System Kit contains: 4 Probuphine nonbiodegradable implantable rods (a subdermal implant containing 74.2 mg of buprenorphine which is the equivalent of 80 mg of buprenorphine hydrochloride); and one Probuphine Applicator CMS 1500 Claim Form 80 Character Abbreviated Descriptor: NDC Number Number Description 11 Digit NDC Number Each Probuphine Kit contains: 4 Probuphine nonbiodegradable implants rods and one Probuphine Applicator 5

6 Healthcare Common Procedure Coding System (HCPCS) 1 Codes The HCPCS Level II Code Set is one of the standard code sets used for medical claims processing of office administered drugs. The HCPCS is divided into two principal subsystems, referred to as level I and level II of the HCPCS. Level I of the HCPCS is comprised of CPT (Current Procedural Terminology), a numeric coding system maintained by the American Medical Association (AMA). The CPT is a uniform coding system consisting of descriptive terms and identifying codes that are used primarily to identify medical services and procedures furnished by physicians and other health care professionals. These health care professionals use the CPT to identify services and procedures for which they bill public or private health insurance programs. Decisions regarding the addition, deletion, or revision of CPT codes are made by the AMA. The CPT codes are republished and updated annually by the AMA. Level I of the HCPCS, the CPT codes, does not include codes needed to separately report medical items or services that are regularly billed by suppliers other than physicians. Level II of the HCPCS is a standardized coding system that is used primarily to identify products, supplies, and services not included in the CPT codes, such as ambulance services and durable medical equipment, prosthetics, orthotics, and supplies (DMEPOS) when used outside a physician's office. Because Medicare and other insurers cover a variety of services, supplies, and equipment that are not identified by CPT codes, the level II HCPCS codes were established for submitting claims for these items. The development and use of level II of the HCPCS began in the 1980's. Level II codes are also referred to as alpha-numeric codes because they consist of a single alphabetical letter followed by 4 numeric digits, while CPT codes are identified using 5 numeric digits. Level II HCPCS Codes for billing Probuphine HCPCS Code Description Use J0570 Buprenorphine implant, 74.2 mg Physician office and Outpatient Ambulatory Facilities Probuphine has been assigned a specific J-Code for Probuphine (J0570) beginning January 1, This for the drug code only. The Medicare Allowable is per implant (descriptor 74.2mg) and reimbursed at $ which is based on ASP. The 2017 ASP Drug Pricing Files can be found at the following link: McrPartBDrugAvgSalesPrice/2017ASPFiles.html. Please note that the content provided by the Center for Medicare and Medicaid Services is updated frequently and should be checked quarterly. Due to the variability of health plan design and reimbursement, the physician should contact the patient s payer provider relations representative prior to implanting Probuphine to determine reimbursement for the procedure 6

7 Potential Level I Current Procedural Terminology (CPT ) Administration Codes for billing Probuphine (buprenorphine) There are no current administration codes that describe the implantation or removal of Probuphine. Probuphine consists of 4 non-biodegradable implants. Providers should consult with their local carriers to identify the most appropriate administration coding procedures and required documentation. Type of Code Code Number Description HCPCS Code G0516 Insertion of non-biodegradable drug delivery implants, 4 or more (services for subdermal $ # rod implant) HCPCS Code G0517 Removal of non-biodegradable drug delivery implants, 4 or more (services for subdermal implants) $ # HCPCS Code G0518 Removal with reinsertion, non-biodegradable drug delivery implants, 4 or more (services for subdermal implants) $ # CPT Code Insertion of single non-biodegradable implant $ # CPT Code Removal of single non-biodegradable implant $ # The 2017 Medicare Physician Fee Schedule CPT Code Removal and re-insertion of single nonbiodegradable implant CPT Code unlisted procedure, skin, mucous membrane and subcutaneous $ # Payor Specific 7 The 2017 Medicare Physician Fee Schedule can be found at the following link: CPT Copyright 2014 American Medical Association. All rights reserved. CPT is a registered trademark of the American Medical Association. The AMA assumes no liability for data contained or not contained herein. # Represents National amounts for the CMS Physician Fees when the service is provided in the physician s office (nonfacility setting) Due to the variability of health plan design and reimbursement, the physician should contact the patient s payer provider relations representative prior to implanting Probuphine to determine reimbursement for the procedure

8 International Classification of Diseases, 10 th Revision, Clinical Modification (ICD-10-CM) 6 Codes that may be appropriate for use when billing a claim for Probuphine (buprenorphine) The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is a system used by physicians and other healthcare providers to classify and code all diagnoses, symptoms and procedures recorded in conjunction with hospital care in the United States. ICD-10-CM is composed of codes with 3, 4, 5, 6 or 7 characters. Codes with three characters are included in ICD-10-CM as the heading of a category of codes that may be further subdivided by the use of fourth, fifth, sixth or seventh characters to provide greater specificity. A threecharacter code is to be used only if it is not further subdivided. While diagnosis coding to the correct level of specificity is the goal for all claims, for 12 months after ICD-10 implementation, if a valid ICD- 10 code from the right family (see question 5) is submitted, Medicare fee-forservice will process and not audit valid ICD-10 codes unless such codes fall in. 8

9 Potential ICD-10-CM Codes for use when billing a claim for Probuphine (buprenorphine) use most specific sub-coding possible ICD-10-CM Code F11 Opioid related disorders Code description F11.1 Opioid abuse F11.10 Opioid abuse uncomplicated F11.2 Opioid dependence F11.20 Opioid dependence uncomplicated F11.21 Opioid dependence in remission F11.24 F11.25 F11.29 Opioid dependence with opioid-induced mood disorder Opioid dependence with opioid-induced psychotic disorder Opioid dependence with other opioid-induced disorder with unspecified opioid-induced disorder F11.9 Opioid use, unspecified F11.90 Opioid use, unspecified uncomplicated F11.99 Opioid use, unspecified with unspecified opioidinduced disorder 9

10 2017 Physician Office Sample Claim Form: CMS , 6 Item 19 - When billing HCPCS J0570, some payers may ask providers to specify Probuphine (subdermal buprenorphine implant) with dosage administered and NDC , Kit or number of units, e.g. 4 Buprenorphine Implants 74.2mg NOTE: Some payers require alternate product codes (i.e., Medicaid claims). Please consult with your local payers or contact the Titan Access Program at for further information. Item 21 - Indicate diagnosis/diagnoses using appropriate ICD-10-CM codes, such as F11.10 (Opioid Abuse Uncomplicated), F11.20 (Opioid dependence, uncomplicated) or F11.21 (Opioid Dependence in Remission). Item 24D - Indicate appropriate HCPCS and CPT codes and modifiers if required. Be sure to enter either the procedure HCPCS codes of G0516-G0518 or the procedure CPT codes of or the unlisted CPT code (unlisted procedure, skin, mucous membrane and subcutaneous). NOTE: Individual payers will require documentation to adjudicate any claim billed with an unlisted CPT code. Please consult with your local payer or contact the Titan Access Program at for further information. Additional information on the procedure may be placed in Item 19. Item 24E - Refer to the diagnosis for this service (see box 21). Enter only one diagnosis pointer per line. Item 24G One Probuphine kit contains 4 subdermal implants (74.2 mg of Buprenorphine or 80 mg Buprenorphine HCL each). CMS has designated each Buprenorphine implant to represent 1 unit. For all payers, whether performed in the outpatient clinic or a physician s office, the entity should code for 4 units of J0570 unless otherwise directed by the payer. MLN/MLNMattersArticles/Downloads/MM9930.pdf 10

11 11 Sample CMS-1500 claim form (physician office billing)

12 2017 HOPD Sample Claim Form: UB-04/CMS ,6 Locator Box 42 Enter appropriate revenue code, such as: For Medicare, revenue code 0636 (drugs that require detailed coding) For non-medicare payers, revenue code 0250 (general pharmacy) Injection services may be reported with revenue code 0510 (clinic, general service) Locator Box 43 - Describe the implant procedure Locator Box 44 - indicate appropriate CPT and HCPCS codes and modifiers if required. The HCPCS codes G0516, G0517, or G0518 may be considered for documenting the procedural service. The following CPT codes may be considered for documenting the procedural service: 11981, 11982, or the unlisted CPT code (unlisted procedure, skin, mucous membrane and subcutaneous). Additional information on the procedure may be placed in Locator Box 80. Medicare and Private Payer claims will require HCPCS J0570 as of January 1, NOTE: Individual payers will require documentation to adjudicate any claim billed with an unlisted CPT code. Please consult with your local payer or The Titan Access Program at to confirm payer requirements. Locator Box 46 - Enter 1 unit for the kit of 4 Probuphine subdermal implants (296.8 mg of Buprenorphine or 320 mg Buprenorphine HCL). Locator Box 47 - indicate total charges. Locator Box 67 - Indicate diagnosis/diagnoses using appropriate ICD-10-CM codes, either F11.10 (Opioid Abuse Uncomplicated), F11.20 (Opioid dependence, uncomplicated) or F11.21 (Opioid Dependence in Remission). Locator Box 80 - When billing a not-otherwise-classified HCPCS code like J3490, some payers may ask providers to specify Probuphine (subdermal buprenorphine implant) with dosage administered and NDC

13 13 Sample UB-04 (CMS-1450) claim form (institutional billing)

14 Indication & Important Safety Information INDICATIONS AND USAGE PROBUPHINE (buprenorphine) is indicated for the maintenance treatment of opioid dependence in patients who have achieved and sustained prolonged clinical stability on low-tomoderate doses of a transmucosal buprenorphine-containing product (i.e., doses of no more than 8 mg per day of Subutex or Suboxone sublingual tablet equivalent or generic equivalent). PROBUPHINE should be used as part of a complete treatment program to include counseling and psychosocial support. PROBUPHINE is not appropriate for new entrants to treatment and patients who have not achieved and sustained prolonged clinical stability, while being maintained on buprenorphine 8 mg per day or less of a Subutex or Suboxone sublingual tablet or generic equivalent. IMPORTANT SAFETY INFORMATION WARNING: IMPLANT MIGRATION, PROTRUSION, EXPULSION and NERVE DAMAGE ASSOCIATED WITH INSERTION and REMOVAL Risk Associated with Insertion and Removal Insertion and removal of PROBUPHINE are associated with the risk of implant migration, protrusion, expulsion resulting from the procedure. Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion and expulsion. Incomplete insertions or infections may lead to protrusion or expulsion. Because of the risks associated with insertion and removal, PROBUPHINE is available only through a restricted program called the PROBUPHINE REMS Program. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified, prior to performing insertions or prescribing PROBUPHINE implants. Patients must be monitored to ensure that PROBUPHINE is removed by a healthcare provider certified to perform insertions. PROBUPHINE is contraindicated in patients with a history of hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA). 14

15 SUMMARY OF WARNINGS AND PRECAUTIONS Serious Complications from Insertion and Removal: Rare but serious complications including nerve damage and migration resulting in embolism and death may result from improper insertion of drug implants inserted in the upper arm. Additional complications may include local migration, protrusion, and expulsion. All Healthcare Providers must successfully complete a live training program on the insertion and removal procedures and become certified in the PROBUPHINE REMS program prior to performing insertions or prescribing PROBUPHINE implants. Addiction, Abuse, and Misuse: Buprenorphine can be abused in a manner similar to other opioids. Monitor patients for conditions indicative of diversion or progression of opioid dependence and addictive behaviors. Respiratory and CNS Depression: Life-threatening respiratory depression and death have occurred in association with buprenorphine use. Concomitant Use of Benzodiazepines or other CNS Depressants: concomitant use increases the risk of adverse reactions including overdose and death. Ensure that other healthcare providers prescribing benzodiazepines or other CNS depressants are aware of the patient s buprenorphine treatment and coordinate care to minimize this risk. Neonatal Opioid Withdrawal Syndrome: Neonatal opioid withdrawal syndrome(nows) is an expected and treatable outcome of prolonged use of opioids during pregnancy. Adrenal Insufficiency: If diagnosed, treat with physiologic replacement of corticosteroids, and wean patient off of the opioid. Unintentional Pediatric Exposure: In the event an implant protrudes or comes out, keep the implant away from children. Buprenorphine can cause severe, possibly fatal, respiratory depression in children. Risk of Opioid Withdrawal with Abrupt Discontinuation: If treatment with PROBUPHINE is temporarily interrupted or discontinued, monitor patients for withdrawal and treat appropriately. Risk of Hepatitis, Hepatic Events: Monitor liver function tests prior to initiation and during treatment and evaluate suspected hepatic events. Risk of Withdrawal in Patients Dependent on Full Agonist Opioids: Verify that patient is clinically stable on transmucosal buprenorphine and not dependent on full agonists before inserting PROBUPHINE. Treatment of Emergent Acute Pain: Treat pain with a non-opioid analgesic whenever possible. If opioid therapy is required, monitor patients closely because higher doses may be required for analgesic effect. Impairment of Ability to Drive and Operate Machinery: PROBUPHINE may impair the abilities required for potentially dangerous tasks such as driving a car or operating machinery, especially for the first hours following initial insertion. Adverse events commonly associated with PROBUPHINE administration (>10% of subjects) were implant-site pain, pruritus, and erythema, as well as non-implant-site related events ( 5%) of headache, depression, constipation, nausea, vomiting, back pain, toothache, and oropharyngeal pain. To report SUSPECTED ADVERSE REACTIONS, contact Titan at or FDA at FDA-1088 or 15 Please see FULL PRESCRIBING INFORMATION, including BOXED WARNING and MEDICATION GUIDE.

16 Footnotes 1. NDC National Drug Code: The Drug Listing Act of 1972 requires registered drug establishments to provide the Food and Drug Administration (FDA) with a current list of all drugs manufactured, prepared, propagated, compounded, or processed by it for commercial distribution. (See Section 510 of the Federal Food, Drug, and Cosmetic Act (Act) (21 U.S.C. 360)). Drug products are identified and reported using a unique, three-segment number, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDA publishes the listed NDC numbers and the information submitted as part of the listing information in the NDC Directory which is updated daily. The information submitted as part of the listing process, the NDC number, and the NDC Directory are used in the implementation and enforcement of the Act. 2. HCPCS Level II Coding Process & Criteria: The Centers for Medicare and Medicaid (CMS) published on August 17, 2000 (45 CFR ) to implement the HIPAA requirement for standardized coding systems established the HCPCS level II codes as the standardized coding system for describing and identifying health care equipment and supplies in health care transactions that are not identified by the HCPCS level I, CPT codes. The HCPCS level II coding system was selected as the standardized coding system because of its wide acceptance among both public and private insurers. Public and private insurers were required to be in compliance with the August 2000 regulation by October 1, The HCPCS Level II Coding Process/Criteria document describes HCPCS level II coding procedures and coding criteria. 3. ICD-10-CM: The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is a system used by physicians and other healthcare providers to classify and code all diagnoses, symptoms and procedures recorded in conjunction with hospital care in the United States. The Centers for Disease Control developed and maintains the ICD-10-CM code set. Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational- Tool-ICN pdf 4. CPT, Current Procedural Terminology: The American Medical Association developed and maintains the official Current Procedural Terminology (CPT ) code set. Please refer to AMA website with any questions at the following link: The CPT is the most widely accepted medical nomenclature used to report medical procedures and services under public and private health insurance programs. CPT is maintained by the CPT Editorial Panel, which meets three times a year to discuss issues associated with new and emerging technologies as well as difficulties encountered with procedures and services and their relation to CPT codes. 5. CMS 1500 Form: The Form CMS-1500 is the standard paper claim form to bill Medicare Fee-For-Service (FFS) Contractors when a paper claim is allowed. In addition to billing Medicare. Form CMS-1500 may be suitable for billing various government and some private insurers. Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/form_cms-1500_fact_sheet.pdf 6. Developed by Alchemy Healthcare Solutions LLC, 5/ UB-04 (CMS-1450) Form: The Form CMS-1450, also known as the UB-04, is the standard claim form to bill Medicare Administrative Contractors (MACs) when a paper claim is allowed. In addition to billing Medicare, the 837I and Form CMS may be suitable for billing various government and some private insurers. MLN/MLNProducts/Downloads/837I-FormCMS-1450-ICN pdf 16 PRO-18EBA006 08/2018