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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®) code4
4. Sites of Service
• Provider office, community based provider: CMS-1500
claim form5
• Hospital outpatient clinic: UB-04/CMS 14506 claim form
5. Braeburn Access Program
• Patient Enrollment Order Form
6. Important Safety Information for Probuphine
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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. Braeburn cannot provide specific reimbursement rates, and does
not guarantee any level of reimbursement. Braeburn 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 Braeburn 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 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 equivalent or generic equivalent.
Please see IMPORTANT SAFETY INFORMATION including BOXED
WARNING on pages 14, 15 & 16
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Coding Quick Guide
Item Code Description HCPCS1 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 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®2 Code 11981 Insertion of single non-biodegradable implant
CPT® Code 11982 Removal of single non-biodegradable implant
CPT® Code 11983 Removal and re-insertion of single non-biodegradable implant
CPT® Code 17999 Unlisted procedure, skin, mucous membrane and subcutaneous
Potential ICD-10-CM3
Codes
F11.10 Opioid Abuse Uncomplicated
F11.20 Opioid Dependence Uncomplicated
F11.21 Opioid Dependence in Remission
11 Digit NDC4 58284-0100-14
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
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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 are:
NDC Number Number Description
11 Digit NDC Number 58284-0100-14
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
CMS 1500 Claim Form – 80 Character Abbreviated Descriptor:
NDC Number Number Description
11 Digit NDC Number 58284-0100-14
Each Probuphine Kit
contains: 4 Probuphine non-
biodegradable implants rods
and one Probuphine
Applicator
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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, 2017.
This for the drug code only. The Medicare Allowable is per implant (descriptor 74.2mg) and
reimbursed at $1257.11 which is based on ASP. The 2017 ASP Drug Pricing Files can be found at the following link: https://www.cms.gov/Medicare/Medicare-Fee-for-Service-Part-B-Drugs/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
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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.
The 2017 Medicare Physician Fee Schedule can be found at the following link:
https://www.cms.gov/apps/physician-fee-schedule/license-agreement.aspx
• 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 (non-
facility 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
Type of Code Code Number Description
The 2017 Medicare Physician Fee
Schedule 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 11981 Insertion of single non-biodegradable implant $143.91#
CPT® Code 11982 Removal of single non-biodegradable implant $163.29#
CPT® Code 11983 Removal and re-insertion of single non-biodegradable implant
$230.41#
CPT® Code 17999 unlisted procedure, skin, mucous membrane and subcutaneous
Payor Specific
$239.40#
$263.16#
$454.31#
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International Classification of Diseases, 10th
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 three-
character 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-for-
service will process and not audit valid ICD-10 codes unless such codes fall in.
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Potential ICD-10-CM Codes for use when billing a claim
for Probuphine ® (buprenorphine) use most specific sub-coding possible
ICD-10-CM Code Code description
F11 Opioid related disorders
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 Opioid dependence with opioid-induced mood
disorder
F11.25 Opioid dependence with opioid-induced psychotic
disorder
F11.29 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 opioid-
induced disorder
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2017 Physician Office Sample Claim Form:
CMS-15005, 6 Item 19 - When billing HCPCS J0570, some payers may ask providers to specify Probuphine®
(subdermal buprenorphine implant) with dosage administered and NDC 58284-0100-14, 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 Braeburn Access Program at 1-844-859-6341 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 11981-11983 or the unlisted CPT code 17999 (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 Braeburn Access Program
at 1-844-859-6341 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.
https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-
MLN/MLNMattersArticles/Downloads/MM9930.pdf
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2017 HOPD Sample Claim Form:
UB-04/CMS 14507,6 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, 11983 or the unlisted CPT code 17999 (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,
2017.
NOTE: Individual payers will require documentation to adjudicate any claim billed with an
unlisted CPT code. Please consult with your local payer or The Braeburn Access Program at
1-844-859-6341 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 58284-0100-14.
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Indication and Important Safety Information 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 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.
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.
CONTRAINDICATIONS
• Hypersensitivity to buprenorphine or any other ingredients in PROBUPHINE (e.g., EVA).
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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. Incomplete insertions or
infections may lead to protrusion or 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: Significant respiratory depression and death have
occurred in association with buprenorphine particularly when taken by the intravenous
(IV) route in combination with benzodiazepines or other CNS depressants (including
alcohol). Consider dose reduction of CNS depressants when used concomitantly.
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 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.
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
mental or physical abilities required for the performance of potentially dangerous tasks
such as driving a car or operating machinery.
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Other systemic effects: PROBUPHINE may cause orthostatic hypotension in ambulatory
patients. Buprenorphine, may elevate cerebrospinal fluid pressure and should be used
with caution in patients with head injury, intracranial lesions, and other circumstances
when cerebrospinal pressure may be increased. Buprenorphine can produce miosis and
changes in the level of consciousness that may interfere with patient evaluation.
Buprenorphine has been shown to increase intracholedochal pressure, as do other
opioids, and thus should be administered with caution to patients with dysfunction of
the biliary tract.
Infection at Implant Site: Infection may occur at the site of the insertion or removal.
Excessive palpation may increase an opportunity for infection. Improper removal carries
risk of implant-site infection.
General Precautions: PROBUPHINE should be administered with caution in debilitated
patients and those with myxedema or hypothyroidism; adrenal cortical insufficiency
(e.g., Addison’s disease); CNS depression or coma; toxic psychoses; prostatic
hypertrophy or urethral stricture; acute alcoholism; delirium tremens; or kyphoscoliosis.
PROBUPHINE should also be administered with caution in patients with a history of
keloid formation, connective tissue disease, e.g., scleroderma or history of recurrent
MRSA infections.
Most common side effects of PROBUPHINE include: headache, insomnia, rhinorrhea,
upper respiratory tract infection, nausea, anxiety, back pain, depression, constipation,
and vomiting.
PLEASE SEE THE FULL PRESCRIBING INFORMATION, INCLUDING BOXED WARNING AND
MEDICATION GUIDE, which you can access at www.probuphine.com
To report SUSPECTED ADVERSE REACTIONS, contact Braeburn at 1-844- 859-6341
or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch
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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, andCosmetic Act (Act) (21 U.S.C. § 360)). Drug products are identified and reported using a unique, three-segmentnumber, called the National Drug Code (NDC), which serves as a universal product identifier for drugs. FDApublishes the listed NDC numbers and the information submitted as part of the listing information in the NDCDirectory 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 August17, 2000 (45 CFR 162.10002) to implement the HIPAA requirement for standardized coding systems establishedthe HCPCS level II codes as the standardized coding system for describing and identifying health careequipment and supplies in health care transactions that are not identified by the HCPCS level I, CPT codes. TheHCPCS level II coding system was selected as the standardized coding system because of its wide acceptanceamong both public and private insurers. Public and private insurers were required to be in compliance with theAugust 2000 regulation by October 1, 2002. The HCPCS Level II Coding Process/Criteria document describesHCPCS level II coding procedures and coding criteria.
3. ICD-10-CM: The International Classification of Diseases, Tenth Revision, Clinical Modification (ICD-10-CM) is asystem used by physicians and other healthcare providers to classify and code all diagnoses, symptoms andprocedures recorded in conjunction with hospital care in the United States. The Centers for Disease Controldeveloped and maintains the ICD-10-CM code set. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/ICD9-10CM-ICD10PCS-CPT-HCPCS-Code-Sets-Educational-Tool-ICN900943.pdf
4. CPT®, Current Procedural Terminology: The American Medical Association developed and maintains theofficial Current Procedural Terminology (CPT®) code set. Please refer to AMA website with any questions at thefollowing link: https://www.ama-assn.org/practice-management/cpt-frequently-asked-questions The CPT isthe most widely accepted medical nomenclature used to report medical procedures and services under publicand private health insurance programs. CPT is maintained by the CPT Editorial Panel, which meets three timesa year to discuss issues associated with new and emerging technologies as well as difficulties encountered withprocedures 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 forbilling various government and some private insurers. https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/downloads/form_cms-1500_fact_sheet.pdf
6. Developed by Alchemy Healthcare Solutions LLC, 5/2016
7. UB-04 (CMS-1450) Form: The Form CMS-1450, also known as the UB-04, is the standard claim form to billMedicare Administrative Contractors (MACs) when a paper claim is allowed. In addition to billing Medicare, the837I and Form CMS- 1450 may be suitable for billing various government and some private insurers.https://www.cms.gov/Outreach-and-Education/Medicare-Learning-Network-MLN/MLNProducts/Downloads/837I-FormCMS-1450-ICN006926.pdf
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