Understanding Viscosupplementation
Viscosupplementation is a medical procedure widely employed in the treatment of knee osteoarthritis. To fully grasp the concept, it's crucial to delve into the purpose of viscosupplementation and understand the procedure's mechanism.
Purpose of Viscosupplementation
Viscosupplementation involves injecting hyaluronic acid into the knee joint to facilitate movement and reduce pain for individuals with osteoarthritis. This gel-like fluid acts as a lubricant and shock absorber for joint loads [1].
The primary goal of this treatment is to replace depleted or poor-quality hyaluronic acid in the knee joint, reducing cartilage breakdown. Moreover, hyaluronic acid injections have shown to provide anti-inflammatory and chondroprotective effects, increase proteoglycan and hyaluronic acid synthesis, and reduce nerve impulses and nerve sensitivity associated with osteoarthritis pain.
Procedure and Mechanism
The viscosupplementation procedure consists of injecting hyaluronic acid into the affected joints to restore the physiologic viscoelasticity in the synovial fluid. This is the fluid that surrounds the joints, providing lubrication and reducing friction. Hyaluronic acid has been shown to downregulate pro-inflammatory factors and proteases known to break down the joint matrix.
The U.S. Food and Drug Administration approved viscosupplementation in 1997 after its initial use in Europe and Asia. There are different preparations of hyaluronic acid now commercially available for this procedure.
In summary, viscosupplementation is a vital procedure in the field of knee treatment, particularly for osteoarthritis patients. By injecting hyaluronic acid into the knee joint, the procedure seeks to restore joint mobility and alleviate pain, thereby improving the quality of life for the patient. However, it's essential to consider that each patient is unique, and hence the effectiveness of viscosupplementation can vary. Hence, it's always advisable to discuss with a healthcare professional before initiating the procedure.
Conditions and Considerations
When considering viscosupplementation as a treatment option, there are several factors that must be taken into account. This includes understanding who is eligible for the procedure and being aware of any contraindications and risks.
Eligibility for Viscosupplementation
Viscosupplementation injections are primarily considered for the treatment of symptomatic knee osteoarthritis (OA). The patient must be experiencing pain that interferes with functional activities and the osteoarthritis must be confirmed through radiographic evidence. Furthermore, the patient must have tried and failed, or have a contraindication to, at least 3 months of conservative therapy. Failure of intra-articular glucocorticoid injections is also a prerequisite for eligibility.
These injections, also known as intra-articular HA injections, aim to replace depleted or poor-quality HA in the knee joint and reduce cartilage breakdown. The injections have been shown to provide anti-inflammatory and chondroprotective effects, increase proteoglycan and HA synthesis, and reduce nerve impulses and nerve sensitivity associated with OA pain [2].
Contraindications and Risks
While viscosupplementation can be an effective treatment for knee OA, it is not suitable for everyone. Contraindications include known hypersensitivity to HA products, pediatric patients, bacteremic patients, and those with active local infection in the injection site.
Adverse events associated with viscosupplementation are usually mild, local, and transient. However, risks do exist. The most common risk associated with this treatment is a temporary flare-up of arthritis symptoms post-injection, leading to short-term pain and swelling. Other less common risks include infection, allergic reactions, or ineffectiveness of the treatment [4].
Patients receiving viscosupplementation may undergo one to five shots over several weeks, depending on the product used. Swelling in the knee joint, if present, may be aspirated before injecting the hyaluronic acid. The injection process typically involves the use of only one needle.
As with any medical procedure, it's important to discuss all potential risks and benefits with your healthcare provider before proceeding with viscosupplementation.
Administration Guidelines
When it comes to viscosupplementation procedures, understanding the administration guidelines is critical. This includes the appropriate dosing and frequency, as well as the correct billing and coding protocol.
Dosing and Frequency
When reporting C, J or Q HCPCS codes for hyaluronan acid therapy, it should be noted that some codes are “per dose” and some are “per mg” as specified in the code descriptor. When reporting a “per mg” drug code, report the appropriate number of units that reflect the dosage given. Units of service are to be billed in multiples of the dosage specified in the full HCPCS descriptor. This descriptor does not always match the dose given. The units billed must correspond with the smallest dose (vial) available for purchase from the manufacturer(s) that could provide the appropriate dose for the patient. Dosing frequency of injections per series and/or dosing frequency per series as listed/supported with the FDA approved dosing/package insert must be documented in the medical record. Providers are responsible for determining the code that most accurately describes the intraarticular agent furnished.
Billing and Coding Protocol
For viscosupplementation, the correct Current Procedural Terminology (CPT) code must be used. While the article does not provide specific information about viscosupplementation CPT codes.
Furthermore, subsequent injections in a series should be billed with the EJ modifier with the HCPCS code for the drug administered. The EJ modifier should not be used for the first injection of each series [7].
Lastly, providers are required to use the JW modifier for claims with unused drugs or biologicals from single use vials or single use packages that are appropriately discarded. Documentation of the discarded drug or biological is required in the patient's medical record [7].
Understanding these guidelines is crucial for accurate billing and coding of the viscosupplementation procedure.
Effectiveness and Results
To measure the effectiveness of viscosupplementation, several factors are considered including symptomatic relief, duration, and necessary follow-up treatments. The outcomes can vary depending on the individual patient's condition and the specific treatment protocol used.
Symptomatic Relief
Viscosupplementation injections provide a moderate symptomatic benefit to knee osteoarthritis patients and have a good safety profile. The therapeutic goal of administration of intraarticular hyaluronate, a type of viscosupplementation, is to provide and maintain intraarticular lubrication, which increases the viscoelastic properties of synovial fluid.
Intra-articular HA injections, also known as viscosupplementation, aim to replace depleted or poor-quality HA in the knee joint and reduce cartilage breakdown. These injections have been shown to provide anti-inflammatory and chondroprotective effects, increase proteoglycan and HA synthesis, and reduce nerve impulses and nerve sensitivity associated with OA pain.
According to Maheu et al. (2019), viscosupplementation may offer one of the best benefit/risk ratios among pharmacologic options for knee OA, as measured by improvements in knee OA health outcomes and delays in time to total knee replacement.
Duration and Follow-Up
The duration of the symptomatic relief and the need for follow-up treatments can vary depending on the severity of the knee osteoarthritis and the patient's response to the initial treatment.
Repeat treatments are considered medically necessary for patients being treated for osteoarthritis of the knee, who meet both of the following criteria: The Medicare program covers drugs that are furnished “incident to” a physician’s service provided, that the drugs are not usually self-administered by the patients.
Moreover, repeated courses of intra-articular HA injections are an effective and safe treatment for knee OA, with pain reduction and improved function reported throughout the initial treatment cycle and subsequent courses of treatment. There is no increased safety risk associated with repeated courses of HA injections [8].
Understanding the expected results and follow-up treatment needs can help patients and healthcare providers make informed decisions about using viscosupplementation as a treatment for knee osteoarthritis.
Resources and References
In this section, we'll look into the FDA approval and regulations regarding viscosupplementation and delve into research studies and recommendations that provide further insights into this treatment.
FDA Approval and Regulations
Purified natural hyaluronates, used in viscosupplementation, are approved by the FDA for the treatment of symptomatic osteoarthritis of the knee. This approval is specific to patients who have failed to respond to simple analgesics or conservative nonpharmacologic therapy.
The therapeutic goal of administering intraarticular hyaluronate is to provide and maintain intraarticular lubrication, which enhances the viscoelastic properties of synovial fluid. Consequently, this form of therapy is termed "viscosupplementation".
Repeat treatments are considered medically necessary for patients being treated for osteoarthritis of the knee, who meet both of the following criteria: The Medicare program covers drugs that are furnished "incident to" a physician’s service provided, that the drugs are not usually self-administered by the patients [5].
When reporting C, J or Q HCPCS codes for hyaluronan acid therapy, it should be noted that some codes are “per dose” and some are “per mg” as specified in the code descriptor. The units billed must correspond with the smallest dose available for purchase from the manufacturer(s) that could provide the appropriate dose for the patient.
Effective 01/01/2017, the use of the JW modifier to identify unused drugs or biologicals from single use vials or single use packages that are appropriately discarded is required. The discarded amount shall be billed on a separate claim line using the JW modifier. Providers are required to document the discarded drug or biological in the patient’s medical record.
Research Studies and Recommendations
Research is integral to understanding and improving medical procedures. It's important for providers to stay updated on current studies and recommendations regarding viscosupplementation. This can help guide treatment plans and provide the best care for patients.
While there are no specific studies or recommendations provided in the context for this article, providers are encouraged to seek out and review relevant research in order to enhance their understanding of viscosupplementation and its implications. This may include studies on patient outcomes, the effectiveness of different hyaluronates, and advancements in application techniques.
In conclusion, understanding FDA regulations and staying informed about research studies and recommendations is crucial in the field of viscosupplementation. This knowledge can ensure adherence to guidelines, enhance patient care, and contribute to the overall success of viscosupplementation treatments.
References
[1]: https://orthoinfo.aaos.org/en/treatment/viscosupplementation-treatment-for-knee-arthritis/
[2]: https://www.cms.gov/medicare-coverage-database/view/lcd.aspx?lcdId=39260&ver=5
[3]: https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8567800/
[4]: https://www.hopkinsmedicine.org/health/conditions-and-diseases/arthritis/viscosupplementation-treatment-for-arthritis
[5]: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=56157&ver=13
[6]: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleid=52420
[7]: https://www.cms.gov/medicare-coverage-database/view/article.aspx?articleId=59030&ver=6
[8]: https://pubmed.ncbi.nlm.nih.gov/29384776/
