Article - Billing and Coding: Hyaluronans Intra-articular Injections of (A52420)

CMS National Coverage PolicyN/AArticle TextThis 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:The indicationscontinue to be met; andSignificant improvement in pain and functional capacity from the prior series of injections is documented in the medical record; andThe 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:If an aspiration and an injection procedure are performed at the same session, bill only one unit for CPT code 20610 or 20611.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.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.If the drug is denied as not reasonable and necessary, the associated injection code will also be denied.FDA and Compendia Review:American Society of Health-System Pharmacists, Inc.AHFS Drug Information.Bethesda, MD: 2007.Clinical Pharmacology Web site. http://www.clinicalpharmacology.com/. Accessed 07/06/2021.FDA approval letter and manufacturer's insert.Full Prescibing Information for ORTHOVISC Date: 01/04.Lexi-Drugs Web site. http://online.lexi.com. Accessed 07/06/2021.Micromedix DrugDex Thomson Web site. http://www.thomsonhc.com/home/dispatch. Accessed 07/06/2021.National Comprehensive Cancer Network Web site. http://www.nccn.org/index.asp. Accessed 07/06/2021.Product Information for EUFLEXXA Issue Date: 10/05.Product information for Synvisc-One, FDA Web site: http://www.fda.gov/MedicalDevices/default.htm. Accessed 06/02/2009.United States Pharmacopoeia (USP), Volume I; Drug Information for the Health Care Professional, 2007.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.pdfHymovis P150010. Silver Spring, MD.FDA. August 28, 2015. Available at http://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfTopic/pma/pma.cfm?num=p150010Monovisc. P090031. Bedford, MA: FDA. February 25, 2014. Available at: http://www.accessdata.fda.gov/cdrh_docs/pdf9/P090031a.pdfOrthovisc. 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.pdfSynvisc-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=402834Trivisc - 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.