Response to Comments: Hyaluronan Acid Therapies for Osteoarthritis of the Knee

A comment was received indicating concerns about having to meet “ALL” elements for coverage.

Thank you for your comment. The conditions for coverage that must be met in order for hyaluronan acid (HA) therapies for osteoarthritis(OA) of the knee to be considered medically reasonable and necessary are based on the HA preparation package insert intended-use criteria, evidence supported by peer-reviewed scientific literature, and recommendations from society guidelines. The conditions for coverage as stated have been determined to meet the Medicare reasonable and necessary requirements for these services as well as considered to be the standard of care for use of HA treatment among health care professionals in the community. It is not unusual for Medicare Contractors to include therapeutic prerequisites before a service should be considered. Please refer to the CMS Medicare Program Integrity Manual IOM Publication 100-08, Chapter 13, Section 13.5.4 Reasonable and Necessary Provision in an LCD. Should a patient’s medical record documentation be requested in a review, there is an expectation that the documentation will support the LCD requirements or include mitigating conditions. The conditions of coverage are not considered overly burdensome and are supported by society guidelines. Therefore, all elements in the “Covered Indications” section must be met for these services to be considered medically reasonable and necessary by Medicare.

A comment was received stating that it is cumbersome to have to supply documentation every time to support a clinical decision.

Thank you for your comment. Medicare does not require providers to “supply documentation every time” to support a clinical decision. However, if requested, all documentation to support the medical necessity of the services rendered must be maintained in the patient's medical record and made available to the contractor. Per Title XVIII of the Social Security Act, Section 1833(e), no payment shall be made to any provider for any claim that lacks the necessary information to process the claim. Medicare is cognizant of administrative provider burden. The requests for medical record documentation will be limited to those instances that necessitate medical review.

A comment was received indicating concern about possible recoupment of payment after the service was rendered.

Recoupment of payment is necessary in some situations such as billing and coding errors or when medical record documentation fails to support the medical necessity of the services as stated in the National or Local Coverage Determinations (NCDs or LCDs). Medicare NCDs and LCDs are used by multiple entities, such as the Unified Program Integrity Contractor (UPIC), Recovery Audit Contractors (RACs), and the U.S. Department of Justice (DOJ) who can request recoupment of funds through local contractors. NCDs and LCDs outline expectations, and if followed, there should be less recoupment. The NCDs and LCDs are posted in the CMS Medicare Coverage Database (MCD) and accessible to the public. Thank you for your comment.

A couple of comments were received regarding documentation of corticosteroid contraindications (such as a Diabetic) or the reason(s) requiring the use of corticosteroids during HA treatment (such as for an adverse reaction) are not easily available.

Documentation of a medical condition such as Diabetes should be available in the patient’s medical record. Prior to the administration of any therapeutic agent, as a part of the decision-making process, it would be expected that any contraindications to the agent/treatment be noted. Also, if the patient experienced an adverse reaction to HA injection necessitating additional treatment for that reaction, it would be expected to be noted and available in the patient’s medical record. Thank you for your comments.

A couple of comments were received stating that HA availability for Medicare is appropriate and does not require change.

The contractor agrees that HA availability for Medicare is appropriate as it is shown to be beneficial in some patients and Novitas will continue to provide coverage for osteoarthritis of the knee. The policy required revision to include imaging procedures that may be used with these intra-articular injections. Upon review of current literature, guidelines, and other contractor policies, additional policy updates were made in order to reflect current information. Thank you for your comment.

There is evidence that HA products can delay joint replacement, especially for persons that cannot undergo replacement. Full text literature was not submitted, but an abstract was referenced.

The 2015 technology assessment summarized in the policy, systematically reviewed the available evidence to determine if intraarticular injections of HA in individuals with osteoarthritis would delay or prevent a total knee replacement (TKR), specifically for individuals age 65 and over. They reported that no conclusions can be drawn from the available literature on delay or avoidance of TKR through the use of HA. Studies that can compare large numbers of treated and untreated individuals, preferably with a randomized design, are needed to answer this question. Review of the submitted link to an abstract article did not show a large number of treated individuals (per the abstract, most knee arthroplasty [KA] patients did not use HA). From the abstract, it cannot be determined if the patients are generalizable to the Medicare population. No changes are warranted to the LCD at this time. Thank you for your comment.

Several comments were received pertaining to the proposed LCD Limitation #8 which states "Viscosupplementation is considered not medically reasonable and necessary following prior knee surgery." Commenters generally agreed that you would not perform viscosupplements after a patient has had a joint replacement. However, patients who have had other knee surgeries such as ACL and meniscus surgery will likely continue to have arthritis symptoms after their surgery. Their arthritis may not even develop until after the knee surgery is performed. Viscosupplements allow providers to treat arthritic symptoms in patients who are not ready or are not a candidate for joint replacement. Also, there is no time frame discussed in the Limitation as to when the previous surgery was performed. This needs to be clarified because it is unreasonable to eliminate this permanently as a treatment option. For example, if a patient has a knee arthroscopic surgery and 20 years later, has symptomatic arthritis, as the policy is written, Medicare would not allow us to treat them with viscosupplements. There was no literature submitted for review.

Thank you for all of your comments. They were helpful in revising the final policy. After review, the contractor agrees to revise this surgical limitation to add clarification. Available literature evaluated the use of HA injection in the early post-operative after an anterior cruciate ligament (ACL) reconstruction or at the end of the surgical procedure arthroscopic meniscectomy to assess effects on pain control and functional recovery. These studies did not support symptomatic improvement or faster recovery from using HA injection in this manner. The policy will be revised to clarify that the limitation applies to a post-operative timeframe so as not to preclude someone with osteoarthritic component from ever being eligible to receive a HA intra-articular injection. There was no specific post-operative timeframe agreed upon in the Contractor Advisory Committee (CAC) meetings or in the comments submitted. HA injections remain to be considered not reasonable and necessary for patients who have had prior total or partial knee arthroplasty surgery.

A commenter suggested adding a non-exclusive list of what is meant by "standardized assessment tool" for the repeat series of therapy. This could include visual analogue scale (VAS) pain scores as well as other outcomes measures.

Thank you for your comment. It is recognized that there are many measurement scales available and that different patients may best be monitored by different measurement scales. This policy allows the treating physician to utilize the best objective measurement scale to document both the patient’s baseline and response to treatment. It is expected that the same objective measurement scale will be used for both baseline and response to treatment. The policy will not specify which measurement scale to use. Medical records should describe the assessment tool utilized.

Regarding the proposed LCD Limitation #2, some patients occasionally need a steroid injection during the course of therapy, especially when there has been an allergic reaction and the material needs to be withdrawn from the joint. Presumably, the steroid injections would be on different days than the hyaluronan injections, and while the claims might be subjected to post-payment reviews, there would be no pre-payment denials/rejections unless the claim had both the steroid and the hyaluronan acid “J” codes (HCPCS codes) on the same day of service.

Thank you for your comment. It is expected that consideration be given to the precautions noted in the prescribing information (PI) for these HA products. Many HA product PI precautions note that the safety and effectiveness of the use of the HA concomitantly with other intra-articular injectables have not been established. The policy provides coverage for exceptions. Other therapeutic agents such as corticosteroids during the course of viscosupplementation therapy would be covered in the event of a documented reaction.

Regarding the proposed LCD Limitation # 6, uncommonly, patients experience an allergic reaction and the hyaluronan acid needs to be withdrawn with a simultaneous steroid injection. That first course of therapy is halted/truncated. A second course with a different hyaluronan acid could be started with less than 6 months transpiring, since the first agent was withdrawn.

It would be contraindicated to administer any HA product to a patient with a known allergic reaction to HA. Per the prescribing information for all sodium hyaluronate preparations, it is contraindicated to administer HA to patients with known hypersensitivity (allergy) to sodium hyaluronate preparations. Therefore, administration of a different HA preparation after a patient experiences an allergic reaction to HA would be considered not medically reasonable and necessary. Thank you for your comment.

A few comments were received regarding the proposed LCD Limitation # 7, for some patients, hyaluronan acid therapy is attempted as a final therapeutic trial, hoping to forestall/delay arthroplasty. The language should be clarified as “consideration” and rejection of arthroplasty at one point in time should not preclude a therapeutic trial of hyaluronan acid therapy.

Thank you for your comments. There is a lack of evidence to support that the use of HA would delay or prevent knee arthroplasty. See Comment and Response #6. Therefore, it is considered not medically reasonable and necessary to use HA for that purpose.

One commenter states the proposed LCD will result in patient access issues and potential harm to patients. Specifically, the coding decisions and limitations placed on fluoroscopic guidance and confirmation of needle placement will result in physicians not making viscosupplementation available to their patients, and some physicians electing to do the procedure through blind injections.

The proposed LCD does not exclude fluoroscopic guidance for needle placement when it is medically reasonable and necessary. The policy excludes the use of imaging such as arthrography, CT scan or MRI for the purposes of needle guidance for viscosupplementation of the knee. The proposed LCD does not require blind injections; however, it would not be expected for needle guidance to be necessary for every patient. As stated in the Proposed LCD Limitation #4, fluoroscopy or ultrasound may be used for needle guidance with viscosupplementation of the knee when presentation of the patient’s affected knee on the day of the procedure makes needle insertion problematic. The presentation of the knee is expected to be documented to support the medical necessity of using imaging. Please refer to LCD Limitation #4 for this information. Thank you for your comment.

One commenter stated that current guidance from Novitas relative to other large joint injections confirms that fluoroscopic guidance and confirmation of needle placement through the appropriate use of contrast material is not only appropriate, but necessary to adequately perform this type of procedure. Specifically, facet joint interventions done without CT or fluoroscopic guidance are not considered reasonable and necessary (Other Novitas LCDs referenced). There is no logical medical or coding rationale for requiring this guidance for one large joint, e.g., the sacroiliac joint, and actively deterring and effectively prohibiting it for another, e.g. the knee. While the proposed LCD does not explicitly prohibit fluoroscopic guidance, it effectively does so.

The LCDs referenced by this commenter for facet joint injection and SI joint injection are for CPT codes that include parenthetical notes that the code is only to be used with fluoroscopy or CT per code descriptor. There is an obligation to follow correct coding guidelines. That is the “coding rationale” for requiring the guidance. That is not the case with the CPT code (20610) for injection of major joint that would be applicable to this policy for viscosupplementation of the knee. The use of fluoroscopic guidance with viscosupplementation would require the add-on CPT code 77002 if fluoroscopic guidance was used. Therefore, from a “coding rationale” perspective, the guidance is not required as it is not included in the code descriptor. From a “medical rationale” standpoint, the policy makes provisions for needle guidance with viscosupplementation of the knee when presentation of the patient’s affected knee on the day of the procedure makes needle insertion problematic. See comment and response # 12 for additional information. Thank you for your comment.

One commenter stated that the decision to exclude the CPT code 27370 is nonsensical. CPT code 77002, which is properly reported for purposes of needle placement during a fluoroscopic examination is appropriately reported with CPT code 27370.

Thank you for your comment. CPT code 77002 is appropriately reported with CPT code 27370 when a knee arthrography is performed under fluoroscopic guidance. However, CPT code 27370 (injection of contrast for knee arthrography) is not the correct CPT code for reporting an intra-articular injection of therapeutic agent with fluoroscopic guidance for needle placement. For arthrocentesis of the knee or injection under fluoroscopic guidance, the proper CPT code is 20610 for the major joint injection and the add-on CPT code 77002 for the use of the fluoroscope for needle guidance. This is applicable when performing an aspiration using fluoroscopic guidance or when injecting any therapeutic agent such as steroid or anesthetic, as well as hyaluronan acid using fluoroscopic guidance. There was coding clarification provided in the AMA CPT Assistant, June 2012, Volume 22, Issue 6, page 14 which states not to confuse an injection under fluoroscopic guidance with arthrography. It is the intent that defines the service. If the intent is to inject contrast only to confirm needle position within the joint, then it is not appropriate to report arthrography.

According to the American College of Radiology (ACR), injection of contrast for knee arthrography, CPT code 27370, was identified by the Relativity Assessment Workgroup (RAW) as a potentially misvalued service. The high volume growth for this procedure was likely due to it being reported incorrectly as arthrocentesis or aspiration. As a result, the RAW recommended that code 27370 be referred to the CPT Editorial Panel for deletion and be replaced with a new code to report the injection procedure for knee arthrography or CT/MRI knee arthrography.

The CPT code 27370 has been deleted per the 2019 annual CPT/HCPCS code update and will not be included in the final policy; however, the replacement CPT code 27369, will be added to the Group 2 non-covered CPT codes at finalization. Please refer to the article Billing and Coding: Hyaluronan Acid Therapies for Osteoarthritis of the Knee, A55036 for coding information. The final policy will continue to allow hyaluronan acid intra-articular injection with fluoroscopic guidance (if medically necessary) and appropriately reported with CPT codes 20610 and 77002.

A couple of comments were received regarding documentation requirements. If a patient has a different physician for part of the therapy, what documentation would be required? For example, would the new physician be required to pull records from the original physician if some conservative treatment was completed prior to the referral? Or would a summary of what the patient told the current physician be adequate?

The provider who renders the service is responsible to maintain the medical record documentation to support medical necessity as outlined in the policy. If a patient changes to a different physician mid-treatment, it would be the responsibility of the current treating provider to ensure the patient met medical necessity prior to continuation of treatment. The Title XVIII of the Social Security Act, 1833 (e) requires the provider of services to furnish information as may be necessary for a determination of payment. Information regarding prior conservative treatment as defined in the policy (non-pharmacologic therapy and type of analgesics attempted) would usually be obtained from the patient or a historian. Some of the other documentation requirements may be necessary to obtain from the initiating provider, such as the radiographic confirmation of osteoarthritis of the knee. Obtaining this information would be the standard of care prior to continuation of any therapy. Edits associated with this LCD follow beneficiary claims and a denial would occur should a product or frequency edit be surpassed.

The proposed LCD recognizes osteoarthritis (OA) as the only valid diagnosis in order for a patient to receive an HA therapy. However, some patients have multiple injuries or conditions. Therefore, would a patient with OA who experiences an injury that requires a meniscectomy no longer be able to receive an HA injection as a result?

The meniscectomy limitation will be revised to clarify a post-operative timeframe so as not to preclude someone with osteoarthritic component from ever being eligible to receive a HA intra-articular injection. Some patients may have multiple injuries or conditions, but osteoarthritis is the only condition that is covered for viscosupplementation of the knee. Thank you for your comment.

The policy would approve a repeat series of HA therapies when “there was significant improvement in pain and functional capacity achieved with the prior series of injections using a standardized assessment tool.” The policy fails to outline how “significant improvement and pain and functional capacity” would be defined. In addition, the policy does not outline how it would be documented.

Thank you for your comment. Significant improvement would be variable per patient depending on their pain level and functional capacity at baseline. The policy includes examples of presenting symptoms such as pain which interferes with the activities of daily living (e.g., ambulation, prolonged standing, or pain interrupting sleep). It is expected that those presenting symptoms as well as a baseline pain score would be reevaluated after treatment to determine if the treatment was beneficial. That information would be expected to be maintained as appropriate patient follow-up and used in decision making processes. If the patient had minimal to no improvement, it would not be considered reasonable and necessary to repeat a series in six months.

The response to treatment would be documented using a standardized assessment tool. Please refer to comment and response # 8 for additional information.

The proposed LCD would require a patient to meet five conditions in order to qualify for a HA therapy, and one of those includes three months of conservative therapy, such as home exercise and weight loss. Regarding weight loss, what criteria would be used to document a successful effort at a weight loss program? Would the patient have to self-report? Would the weight loss program have to be a medical program? What if the joint pain was in itself restricting the ability to exercise?

Thank you for your comment. The policy clearly states “Nonpharmacologic therapy (such as but not limited to [emphasis added] home exercise program, education, weight loss, physical therapy if indicated)”. These serve as examples of nonpharmacologic therapy. There are no requirements mandating weight loss be included as stated by “such as” and if that is one of the attempted nonpharmacologic conservative measures, the policy does not state that it has to be successful. “Failed” could be failure to lose weight or failure to have an improvement in symptoms despite weight loss. If weight loss was attempted, it should be noted in the patient history prior to initiating viscosupplementation. If joint pain was restricting the ability to exercise, then it is expected for that to be documented. The prescribing information for hyaluronan products state that these products are indicated in the treatment of pain in osteoarthritis of the knee in patients who have failed to respond adequately to conservative nonpharmacologic therapy and to simple analgesics. The policy provides examples that are not all inclusive as it is not intended to direct care.

If the proposed LCD were to go into effect, patients who are in the midst of the treatment phase during the implementation would need to be addressed. For example, would those patients who had just received one injection under the old program, but before the second shot, the new LCD became effective, be grandfathered and not subject to the new guidelines, for the remaining two shots?

The covered indications in the current LCD (L35427) and the proposed version of this LCD (DL35427) are based on the prescribing information for these products (which has not changed), so it would be expected that the criteria would be met under either version of the policy. The existing LCD requires at least three months of conservative therapy. This revised proposed policy provides additional examples for a patient to meet the required nonpharmacologic conservative therapy, so this would not cause a conflict. For frequency, the number of injections allowed per series is based on the product prescribing information; therefore, that number remains the same for each product in both versions of the policy. The existing active policy (L35427) has ongoing frequency edits that are not being changed. This activity is ongoing and should be a continuation of care. There should be minimal impact to a patient who is mid-treatment. Three diagnoses were removed from previous coverage and those were for unspecified knee, but the specific laterality diagnosis code remains available and should be utilized per coding guidelines. Please refer to the article Billing and Coding: Hyaluronan Acid Therapies for Osteoarthritis of the Knee, A55036 for coding information. The final version of the LCD will be posted for notice a minimum of 45 days before becoming effective. This allows ample time for these guidelines to be utilized. Thank you for your comment.

A comment was received regarding Covered Indications #5 and the word "Inflammation". The context here is one of an effusion of the knee, not inflammation. Inflammation characteristically has swelling as well has heat and redness. Osteoarthritis frequently has an effusion but not the other characteristics and could respond to an intra-articular injection of corticosteroid. Therefore, it was recommended to replace "inflammation" with "effusion".

Thank you for your comment. The prescribing information on some of the HA products warn that increases in inflammation in the injected knee following HA injection have been reported in some patients with inflammatory osteoarthritis. Some products caution the use when signs of acute inflammation are present. Some recommend to remove joint effusion if present, prior to injection of HA. Covered Indication #5 will be revised accordingly to include the recommendations for both effusion and inflammation that may be associated with osteoarthritis.

One commenter stated that that the policy is a poorly thought out revision. A number of reviews published in recent years have confirmed the improvement in osteoarthritis (OA) symptoms in patients with knee OA. In spite of the discredited, biased position statement of the American Academy of Orthopaedic Surgeon in 2013, most insurance companies including Medicare provide coverage for this service. It would be a major disservice to patients if this coverage is no longer provided. Multiple references listed for literature by author and year only, none submitted for review.

1. It is ridiculous to deny HA to patients with previous knee surgeries (anterior cruciate ligament reconstruction, menisectomy, etc.) as they will all develop OA eventually and are symptomatically improved with delay in OA progression when treated with HA. (Proposed LCD Limitation #8).
2. It should be approved for repeat injection series even if the first series was not effective as there can be benefit in this situation whether with the same or a different HA product. (Proposed LCD Limitation #9, Altman 2016).
3. It borders on malpractice to require patients to receive intra-articular corticosteroid (ICS) before receiving HA injections. ICS are clearly associated with only short-term improvement in pain (4-6 weeks) BUT accelerated cartilage deterioration (Proposed LCD Limitation #9, McAlindon 2017).
4. It also borders on malpractice to require patients to fail use of nonsteroidal anti-inflammatory agents (NSAIDS) before approving HA. NSAID toxicity, especially in elderly patients who are often on multiple medications, is associated with 16,500 deaths per year in the US. I rarely write prescription for NSAIDS. And with the push to stop using narcotics (a policy with which I strongly agree), physicians are limited in nonoperative treatment options which will be further diluted if HA are no longer covered.
5. It is also well-documented that knee arthroscopy for osteoarthritis accelerates further deterioration. The only surgery that is effective for osteoarthritis is total knee arthroplasty (TKA), which carries a large financial burden to the health care system, and still results in 15-20% of patients being dissatisfied with their outcome. Indeed in this group, certain HA may be effective for ongoing pain and inflammation after TKA (Proposed LCD Limitation #8).

Thank you for your comments. As previously stated in the response to comment #5, the contractor agrees that HA availability for Medicare is appropriate as it is shown to be beneficial in some patients and Novitas will continue to provide coverage for osteoarthritis of the knee.

1. Limitation #8 for ACL and meniscectomy was previously addressed. See response to comment #7. The final policy will be revised.
2. In the study by Altman et al. 2018 (Efficacy and safety of repeated courses of hyaluronic acid injections for knee osteoarthritis: A systematic review), all studies that were evaluated reported pain reduction from baseline in the intra-articular (IA)-HA treatment group throughout the initial treatment cycle, and either sustained or further reduced pain throughout the repeated courses of treatment. The study with the longest follow-up (repeated IA-HA injection every 6 months for 25 months), reported that pain decreased after the first course and continued to decrease until the end of the study, with an approximate 55% reduction in pain compared to baseline. There are limitations and risks of bias noted in the study. None-the-less, there was a response (pain reduction) noted. The study concluded that repeat courses of IA-HA injections are effective and safe treatment for knee OA. Repeat courses were demonstrated to maintain or further improve pain reduction while introducing no increased safety risk.
   
   After review, no change will be made to this requirement. Medicare will not provide coverage for repeated therapeutic injections when there is no response to a prior series. Without a beneficial response, the service would not meet the Medicare standards to be considered reasonable and necessary as the service would not meet the patient’s needs nor provide a benefit that outweighs any risk associated with the procedure.
3. The proposed Limitation #9, referenced by the commenter, does not state a requirement for corticosteroids as it states “When failure of/or contraindication to conservative therapy and/or corticosteroid injections are not documented in the medical record”. The “and/or” means it is not required in every situation. The requirement for intra-articular corticosteroids (as stated in Covered Indication #5) is dependent on the patient’s presentation of the affected knee and whether inflammation is a significant component. The prescribing information on some of the HA products caution the use of the product when signs of acute inflammation are present.
4. The proposed policy requires failure to simple analgesics “and” NSAIDs “if not contraindicated”. After review, this will be revised to state “or” NSAIDs instead of “and” NSAIDs per hyaluronan product prescribing information because some products do not include failure to NSAIDs prior to use.
5. Viscosupplementation of the knee is indicated for the treatment of pain in osteoarthritis. After a total knee replacement, it would not be possible to have osteoarthritis in the knee that was replaced; therefore, it would not be considered reasonable and necessary.

Inflammation is not clearly defined. The existing LCD appears to exclude inflammatory arthritis. The standard definition of inflammation would be assumed to apply. However, at a recent LCD meeting, the Novitas representatives did not indicate that OA patients without inflammatory features would require corticosteroid injection (CSI) prior to HA injections.

Thank you for your comment. Per the proposed policy, patients without inflammatory features do not require CSI prior to HA injections. This is only required when inflammation is a significant component of the patient’s symptoms and intra-articular corticosteroids are not contraindicated. Per the HA product prescribing information, some products caution the use when signs of acute inflammation are present. Some state that the safety and efficacy in severely inflamed knee joints has not been established.

The course of treatment was not defined. Novitas indicated at the LCD meeting that it would likely set a six-month time course for each course of treatment before another series can be tried. However, it is unclear as to whether or not Novitas would cover a second series of injections with a different agent if the first did not provide significant benefit.

Another commenter added that there are a number of HA products on the market and it is important to note that they have many differing properties. The commenter requested that Novitas consider modifying the language in the Draft LCD to allow for a repeat series of injections after one ineffective series potentially with a differing agent.

The terms did not change from the current policy to the proposed policy. A course of treatment is referred to as a series and is defined in the policy as a set of injections for each joint and each treatment (initial or repeat). The number of injections per series is based on the full prescribing information and is located in the utilization guideline section of the policy. Repeat series may not be given more frequently than six months from the prior series of injections.

A repeat series utilizing a different agent would not be covered if the prior series did not provide significant benefit.

In Section 4 of the Draft LCD it states under limitations that:

“Imaging procedures (e.g., arthrography, CT scan, MRI) for the purpose of visualization of the knee to provide guidance for needle placement are considered not medically reasonable and necessary and will not be covered. Fluoroscopy or intra-articular injection major joint (e.g., knee) with ultrasound guidance may be medically necessary and allowed if documentation supports that the presentation of the patient’s affected knee on the day of the procedure makes needle insertion problematic."

For the knee, guidance may not be needed, but at a minimum it was suggested that the language affording the need to use ultrasound with documentation should also be extended to fluoroscopy. These knees are usually severely arthritic and it is not unusual for the needle placement to be difficult or "problematic". In those cases where the injection is optimized by using fluoroscopic guidance, that should be allowed. Many other comments were received regarding image guidance, specifically fluoroscopic guidance, requesting that it be allowed.

Regarding the use of language that talks about major joint (e.g., knee). While for the knee, fluoroscopic guidance may be beneficial, for hips it is strongly beneficial and necessary. Although this policy is about knees, major joints should not be lumped together.

Thank you for your comment. There appears to be confusion about the use of fluoroscopy, which the proposed LCD allows but would not expect to be medically necessary with every injection. The proposed LCD does not allow arthrography, CT, or MRI for needle guidance. Fluoroscopy is allowed when medically necessary and billed appropriately. When fluoroscopy is used with viscosupplementation of the knee for needle guidance, it is reported without using an arthrography CPT code. CPT coding for this procedure would require the use of an injection into a major joint. The reason for “lumping” the major joints together is because that is how the CPT code for this service (CPT code 20610) describes an injection into a major joint or bursa (e.g., shoulder, hip, knee, subacromial bursa). The example of knee was the only major joint listed in the policy language since this policy is only applicable to the knee.

The limitation on imaging will be clarified in the final policy since there seems to be confusion about the coverage of fluoroscopy. LCDs will no longer contain coding information, so please refer to coding article A55036 for a list of the noncovered imaging codes. Additional information on properly reporting image guidance for needle placement with viscosupplementation of the knee will be added to the coding article as well for provider education.

A comment was received on the Provider Qualifications section requesting to allow for the reimbursement of hyaluronan acid therapies provided by CRNAs.

Specific provider types are not included or excluded from the policy. The provider qualifications include criteria to be met for all aspects of the procedure and its related care that must be within the scope of practice of the provider’s professional licensure and the provider must have appropriate training as outlined in the policy to be considered a qualified provider. Thank you for your comment.

In reference to a statement in the History/Background and/or General Information section. It states that:

“The most recent research, however, has not found viscosupplementation to be effective at significantly reducing pain or improving function. Although some patients report pain relief with the procedure, others are not helped by the injections.”

This statement was more accurate when the American Academy of Orthopaedic Surgeons first published their treatment guidelines and meta-analysis over 4 years ago however the preponderance of data since the AAOS data was published has demonstrated a clinical benefit for the class. Additionally, over the past few years a number of guidelines and positions statements have also been issued in support of the efficacy of the class by a number of organizations such as AMSSM, ACR, OARSI and VA/DoD.

The statement in the background section of the policy is informational and has no bearing on coverage. The statement is reflective of research findings on patient-reported outcomes. Clinical practice guidelines for the treatment of knee osteoarthritis have conflicting recommendations for intra-articular hyaluronic acid treatment for knee osteoarthritis. Thank you for your comment.