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LCD Reference Article Billing and Coding Article

Billing and Coding: Hyaluronans Intra-articular Injections of

A52420

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Draft Article
Draft Articles are works in progress and not necessarily a reflection of the current billing and coding practices. Revisions to codes are carefully and thoroughly reviewed and are not intended to change the original intent of the LCD.

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General Information

Source Article ID
N/A
Article ID
A52420
Original ICD-9 Article ID
Not Applicable
Article Title
Billing and Coding: Hyaluronans Intra-articular Injections of
Article Type
Billing and Coding
Original Effective Date
10/01/2015
Revision Effective Date
09/01/2024
Revision Ending Date
N/A
Retirement Date
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Article Guidance

Article Text

This article contains billing and coding guidelines that complement the Local Coverage Determination (LCD) Drugs and Biologicals, Coverage of, for Label and Off-Label Uses.

Abstract:

Purified natural hyaluronans have been approved by the FDA for the treatment of pain associated with osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and simple analgesics. The synovial fluid's capacity to lubricate and absorb shock is typically reduced in joints affected by osteoarthritis. These changes are partly due to a reduction in the concentration and size of hyaluronic acid molecules that are naturally present in synovial fluid. In addition to the FDA approved use, hyalurons have been recognized as a therapeutic option in osteoarthritis of the shoulder. This article defines coverage criteria for the injection of the knee or shoulder with either sodium hyaluronate (Hyalgan®, Supartz® or Visco-3™, Euflexxa™, Monovisc™, GelSyn-3™, GenVisc® 850, Durolane®, TriVisc™, Synojoynt™, Triluron™), hylan G-F 20 (Synvisc®, Synvisc-One ™), hyaluronic acid (Gel-One®), high molecular weight hyaluronan (Orthovisc®) or high molecular weight viscoelastic hyaluronan (Hymovis®).

Documentation Requirements:

The patient's medical record should contain documentation that fully supports the medical necessity for intra-articular injections of sodium hyaluronate (Hyalgan®, Supartz® or Visco-3™, Euflexxa™, Monovisc™, GelSyn-3™, GenVisc® 850, Durolane®, TriVisc™, Synojoynt™, Triluron™), hylan G-F 20 (Synvisc®, Synvisc-One ™), hyaluronic acid (Gel-One®), high molecular weight hyaluronan (Orthovisc®) and high molecular weight viscoelastic hyaluronan (Hymovis®). This documentation includes, but is not limited to, relevant medical history, physical examination and results of pertinent diagnostic tests or procedures, and history of pharmacologic therapy. Documentation of subsequent courses of treatment must clearly establish reduction of patient symptomatology and medication usage. This documentation must be submitted upon request. Claims submitted without requested supporting evidence in the medical record will be denied as being not medically necessary.

Utilization:

The dose and frequency of administration should be consistent with the FDA approved labeling.

It is expected that an injection (Synvisc-One ™, Gel-One®, Durolane®) or course of the injections (Synvisc®, Hyalgan®, Supartz® or Visco-3™, Euflexxa™, Orthovisc®, GelSyn-3™, GenVisc® 850, Hymovis®, TriVisc™, Synojoynt™, Triluron™) will not be repeated within six months time.

A repeat series of injections may be allowed when:

  1. The indications continue to be met; and
  2. Objective improvement in pain and functional capacity from the prior series of injections is documented in the medical record; and
  3. The last injection (in a prior course) was given at least six (6) months ago.

Repeat injections for shoulder arthritis are limited to a single repeat course.

Coding information:

  1. If an aspiration and an injection procedure are performed at the same session, bill only one unit for CPT code 20610 or 20611.
  2. The appropriate site modifier (RT or LT) must be appended to CPT code 20610 or 20611 to indicate if the service was performed unilaterally and modifier (50) must be appended to indicate if the service was performed bilaterally.
  3. Use "EJ" modifier on drug codes to indicate subsequent injections of a series. Do not use this modifier for the first injection of each series. A series is defined as the set of injections for each joint and each treatment. Injection of the left knee or shoulder is a separate series from injection of the right knee or shoulder.
  4. If the drug is denied as not reasonable and necessary, the associated injection code will also be denied.

FDA and Compendia Review:

  1. American Society of Health-System Pharmacists, Inc. AHFS Drug Information®. Bethesda, MD: 2007.
  2. Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 07/06/2021.
  3. FDA approval letter and manufacturer's insert.
  4. Full Prescibing Information for ORTHOVISC® Date: 01/04.
  5. Lexi-Drugs Web site. http://online.lexi.com. Accessed 07/06/2021.
  6. Micromedix DrugDex® Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 07/06/2021.
  7. National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 07/06/2021.
  8. Product Information for EUFLEXXA™ Issue Date: 10/05.
  9. Product information for Synvisc-One™, FDA Web site: http://www.fda.gov/MedicalDevices/default.htm. Accessed 06/02/2009.
  10. United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.
  11. U.S. Food and Drug Administration Premarket Notification Database:
    • Euflexxa®. P010029. Rockville, MD: FDA. October 11, 2011. Available at:
      http://www.accessdata.fda.gov/cdrh_docs/pdf/p010029s008a.pdf.
    • Gel-One®. P080020. Rockville, MD: FDA. March 22, 2011. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf8/p080020a.pdf.
    • GelSyn-3™.  P110005. Rockville, MD: FDA. May 9, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf11/P110005b.pdf.
    • GenVisc® 850. No P140005. Silver Spring, MD: FDA September 2, 2015. Available at: http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p140005.
    • Hyalgan®. P950027. Rockville, MD: FDA. May 28, 1997. Available at http://www.accessdata.fda.gov/cdrh_docs/pdf/P950027A.pdf
    • Hymovis® P150010. Silver Spring, MD.FDA. August 28, 2015. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p150010
    • Monovisc™. P090031. Bedford, MA: FDA. February 25, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031a.pdf
    • Orthovisc®. P030019. Rockville, MD: FDA. February 4, 2004. Available at:
      http://www.accessdata.fda.gov/cdrh_docs/pdf3/p030019a.pdf.
    • Supartz® or Visco-3™. P980044. Rockville, MD: FDA. January 24, 2001. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P980044a.pdf.
    • Synvisc®. P940015. Rockville, MD: FDA August 8, 1997. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf/P940015A.pdf
    • Synvisc-One®. No. P940015. Rockville, MD: FDA. February 26, 2009. Available at:
      http://www.accessdata.fda.gov/cdrhdocs/pdf/P940015S012a.pdf.
    • Durolane - https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpma/pma.cfm?ID=402834
    • Trivisc - https://www.accessdata.fda.gov/cdrh_docs/pdf16/P160057a.pdf.
    • Synojoynt - htttps://www.fda.gov/medical-devices/recently-approved-devices/synojoynttm-p170016.
    • Triluron - https://www.fda.gov/medical-devices/recently-approved-devices/trilurontm-p180040.

Response To Comments

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Coding Information

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Group 1

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

(17 Codes)
Group 1 Paragraph

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 Group 1 Codes
Code Description
M17.0 Bilateral primary osteoarthritis of knee
M17.11 Unilateral primary osteoarthritis, right knee
M17.12 Unilateral primary osteoarthritis, left knee
M17.2 Bilateral post-traumatic osteoarthritis of knee
M17.31 Unilateral post-traumatic osteoarthritis, right knee
M17.32 Unilateral post-traumatic osteoarthritis, left knee
M17.4 Other bilateral secondary osteoarthritis of knee
M17.5 Other unilateral secondary osteoarthritis of knee
M17.9 Osteoarthritis of knee, unspecified
M19.011 Primary osteoarthritis, right shoulder
M19.012 Primary osteoarthritis, left shoulder
M19.111 Post-traumatic osteoarthritis, right shoulder
M19.112 Post-traumatic osteoarthritis, left shoulder
M19.211 Secondary osteoarthritis, right shoulder
M19.212 Secondary osteoarthritis, left shoulder
M75.41 Impingement syndrome of right shoulder
M75.42 Impingement syndrome of left shoulder
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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Bill Type Codes

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the article does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the article should be assumed to apply equally to all claims.

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Revenue Codes

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory. Unless specified in the article, services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the article should be assumed to apply equally to all Revenue Codes.

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Coding Table Information

Excluded CPT/HCPCS Codes - Table Format
Code Descriptor Generic Name Descriptor Brand Name Exclusion Effective Date Exclusion End Date Reason for Exclusion
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Non-Excluded CPT/HCPCS Ended Codes - Table Format
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Revision History Information

Revision History Date Revision History Number Revision History Explanation
09/01/2024 R18

Clarification was provided in the Article text section under Utilization by replacing the word "Significant" in #2 with the word "Objective". 
08/01/2021 R17

Based on compendia review, ICD-10 codes M75.41 and M75.42 have been added to the Group 1 ICD-10 code list effective for dates of service on or after 08/01/2021.
05/01/2021 R16

Based on Transmittal 10631 (CR 12155) - Quarterly Update to the Medicare Physician Fee Schedule Database (MPFSDB) – April 2021 Update, HCPCS code J7333 is being deleted effective for dates of service on or after 04/01/2021. The description for HCPCS code J7321 has been revised to include “Visco-3”.
08/01/2020 R15

The article has been updated to add Synojoynt™ and Triluron™ to the "Documentation and Utilization" sections of the article and the following language has been added to the Group 1 Paragraph section: 

For dates of service on or after 10/01/2019 HCPCS code J7331 should be used to report Synojoynt™.

For dates of service on or after 10/01/2019 HCPCS code J7332 should be used to report Triluron™.

This information was inadvertently removed when the article was converted to the new Billing and Coding format. 
08/01/2020 R14

Based on Transmittal 10165 (CR 11792 - July 2020 Integrated Outpatient Code Editor (I/OCE) Specifications Version 21.2), the article has been updated to add HCPCS code J7333 for Visco-3™. The terminology for HCPCS code J7321 has been revised.
11/07/2019 R13

This article was converted to the new Billing and Coding Article format. The Article Text section has been revised to remove the indications which can be found on the FDA Web site and in the approved compendia. The limitations have been added to the coding information. The “Sources of Information” has been revised to “FDA and Compendia Review.” Sources of information other than the FDA and compendia have been moved to a PDF file attached to LCD L33394.
10/01/2019 R12

Based on Transmittal 4367 (CR 11422 - Quarterly Healthcare Common Procedure Coding System (HCPCS) Drug/Biological Code Changes - October 2019 Update), HCPC codes J7331 has been added for Synojoynt™ and J7332 has been added for Triluron™ to the CPT/HCPC paragraph section of the article. Synojoynt™ and Triluron™ have been added throughout the article.
01/01/2019 R11

Based on the 2019 annual HCPCS update, HCPC code C9465 has been deleted and HCPCS code J7318 has been added for Durolane® and HCPCS code J7329 has been added for TriVisc™ to the “CPT/HCPCS Codes” section of the article. TriVisc™ has been added throughout the article.
04/01/2018 R10

CPT code 20611 has been added to the "Coding Information" section guidelines 1 and 2.
04/01/2018 R9

Based on Transmittal 3988 - April 2018 Update of the Hospital Outpatient Prospective Payment System (OPPS), HCPCS code C9465 has been added effective for dates of service on or after 04/01/2018. HCPCS code J3490 should be used to report Durolane® when billed to the Part B MAC. Durolane® has been added throughout the article.

 

 
01/01/2018 R8

Based on the 2018 annual HCPCS update, the description for HCPCS codes J7321 and J7328 have been revised. GelSyn-3™ and Visco-3™ have been added throughout the article. Outdated information has been removed from the CPT/HCPCS Group 1 paragraph section.
01/01/2017 R7 Based on the 2017 annual HCPCS update, HCPCS code Q9980 has been deleted and replaced with HCPCS code J7320 for GenVisc® 850 and HCPCS code C9471 has been deleted and replaced with HCPCS code J7322 for Hymovis®. Based on provider request, CPT codes 20610 and 20611 have been removed from the CPT/HCPCS Group 1 code list and have been added to the CPT/HCPCS Group 2 code list.
08/01/2016 R6 The article has been revised to clarify repeat courses of injections. A new section, “Indications for Repeat Courses of Injections:” has been added to the article and the “Limitations” section of the article has been revised.
05/17/2016 R5 The CPT/HCPCS Codes paragraph section has been clarified to indicate that HCPCS code C9471 should be used to report Hymovis® when billed to the Part A MAC and that HCPCS code J3490 should be used to report Hymovis® when billed to the Part B MAC.
04/01/2016 R4 Based on Transmittal 3471, April 2016 Update of the Hospital Outpatient Prospective Payment System (OPPS), HCPCS code C9471 has been added for Hymovis® effective for dates of service on or after 04/01/2016. Hymovis® has been added throughout the article. The information in the Group 1: Paragraph in the “CPT/HCPCS Codes” section has been revised to state:
    For dates of service on or after 04/01/2016, HCPCS code C9471 should be used to report Hymovis®. For dates of service prior to 04/01/2016, HCPCS code J3490 should be used.
Lexi-Drugs compendium has been added to the “Abstract” section of the article and Lexi-Drugs Web site has been added to the “Sources of Information” section.
01/01/2016 R3 Based on the annual 2016 HCPCS update, HCPCS code J7328 has been added for Gel-Syn™ and HCPCS code Q9980 has been added for GenVisc® 850. GenVisc® 850 has been added throughout the article. The information in the Group 1: Paragraph in the “CPT/HCPCS Codes” section has been revised to state:
    For dates of service on or after 01/01/2016, HCPCS code J7328 should be used to report Gel-Syn™. For dates of service prior to 01/01/2016, HCPCS code J3490 should be used to report Gel-Syn™.
10/01/2015 R2 The place of service guideline for the Part B MAC has been removed.
10/01/2015 R1 Updated to include revisions made since April 2014.
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