Response to Comments: Peripheral Nerve Injections and Procedures for Chronic Pain

Standard of Care

The American Society of Pain and Neuroscience (ASPN) submitted a comment letter with concerns about denial of genicular nerve RFA and other percutaneous pain interventions. This will be responded to in the next 10 comments.

They explain that “standard of care (SOC) for the community” is a fundamental metric in LCD development and that established clinical practice constitutes valid evidence for coverage decisions. They state these procedures are not investigational and are well established.

Thank you for your comments. In order to have “standard of care” the service must be provided in a fashion in which there is consistent and reproducible standards. Section 1862(a)(1)(A) of the Social Security Act states services must be “Furnished in accordance with accepted standards of medical practice for the diagnosis or treatment of the beneficiary’s condition or to improve the function of a malformed body member”. Peripheral nerve blocks (PNBs) and denervation (usually by radiofrequency or RFA) lacks standardization, which is evident throughout the literature. Additionally, there are inconsistencies among societal guidelines. The increased utilization of a procedure does not correlate with SOC when that service is not supported by evidence or if it does not demonstrate reliable improvement in outcomes within the clinical literature. Therefore, stating these services are SOC does not provide evidentiary support for coverage.

Geographic Disparities

They express concern about geographic disparities as the policy impacts 5 out of 7 MACS, leaving different coverage guidance in different regions.

Each MAC has the autonomy to develop local coverage determinations (LCDs) to meet the needs of their jurisdictions. We cannot comment on other MACs policy determinations.

New literature

They claim that the LCD process was not followed since there is new literature being developed that was not included in the LCD.

New literature submitted during the comment period has been added to the LCD and changes have been made based on this literature throughout the policy. Only peer reviewed published literature is evaluated for policy decisions so literature in development is not considered but can be considered through the LCD reconsideration process once the LCD is finalized.

Systematic reviews and meta-analysis on knee RFA

They state that systematic reviews and meta-analysis on knee RFA consistently show improvement in knee osteoarthritis (OA). They state the ASPN STEP Guidelines (2021) graded genicular RFA as Level 1, Grade A, Consensus Strong and establishes this as standard treatment option for osteoarthritis and post-arthroplasty knee pain.

The coverage has been expanded based on submitted literature to allow diagnostic genicular nerve block and genicular nerve ablation in appropriately selected patients.

The societal guidelines are mixed with some strong support for the role of RFA or cryoneurolysis for management of knee OA and others aligning with the literature as uncertain impact. It is important to understand that a SR/MA is only as reliable as the included literature and not the basis for this coverage determination; however, the additional literature submitted did provide greater evidentiary support for the procedure which resulted in changes made to the final LCD.

Trigeminal RFA is a mainstay for trigeminal ganglion related etiologies

They explain despite low quality or limited evidence, RFA is the mainstay for trigeminal ganglion related etiologies. Additionally, they explain that occipital nerve blocks are supported by societal statements for refractory headache disorder and that corticosteroids plus local anesthetic has moderate certainty evidence for Morton neuroma. Pudendal nerve blocks have supporting evidence for refractory pelvic pain.

The policy provides coverage for Morton neuroma and no changes were made. The policy was expanded to provide limited coverage for occipital nerve blocks for headaches originating from the occipital nerve as demonstrated by positive response to a diagnostic block, based on submitted literature and societal guidelines added to the LCD. There was not sufficient evidence to add coverage for refractory pelvic pain related to pudendal neuralgia due to inconsistency in the evidence and overall low quality of the supporting evidence.

Concerns with LCD thresholds

They express concern with LCD threshold of “at least moderate certainty evidence” to justify coverage, stating it sets an unrealistically high bar, disregards the totality of available literature, and discounts the role of consensus guidelines and real-world data. They opine “conditional coverage with an evidence development framework” would be more appropriate than outright denial.

It is the MACs role to ensure access to procedures demonstrating the criteria for reasonable and necessary for Medicare beneficiaries. This requires sufficient evidence to determine the procedure is not experimental. The absence of evidence or low-quality evidence does not equate with justification for coverage. Confidence in evidence is needed to make this determination, or the service/procedure is considered investigational. Conditional coverage with evidence development cannot be offered at the jurisdictional level (LCD).

Medicare Evidence Development & Coverage Advisory Committee (MEDCAC) and National Coverage Determination (NCD)

They request withdrawal of the LCD and proceed with MEDCAC and NCD.

The MACs cannot host a MEDCAC or develop an NCD; however, a Contractor Advisory Meeting (CAC) was held on 2/3/25 and the transcripts and recordings are publicly available.

They state that denying these services will increase costs by progression to joint replacement and will increase ER visits and opioid-related complications.

There was no evidence submitted to support this comment.

Genicular and trigeminal RFA

They request to maintain coverage for genicular RFA for knee osteoarthritis and post-arthroplasty pain consistent with published evidence and ASPN guidelines, preserve access to trigeminal RFA for refractory neuralgia and other select nerve-targeted procedures where medical alternatives are lacking.

The policy has been revised with limited coverage for genicular RFA and trigeminal RFA based on submitted literature, as well as other expansions where there was supporting evidence.

Engage specialty societies such as ASPN in refining LCD criteria to balance evidence rigor with clinical realities and patient needs.

Societies were engaged throughout and included in participation or nominations for the CAC as well as the open comment period. All comments and literature received have been reviewed to ensure stakeholder feedback is considered through the various steps of the LCD development process. There is also the opportunity for future changes as new literature is published through the LCD reconsideration process.

The American Society of Interventional Pain Physicians (ASIPP) submitted a comment letter with the following concerns regarding the proposed LCD. These concerns are addressed in Comments #11-20.

The ASIPP states their concern “this policy will have a devastating impact on independent medical practices. It is particularly concerning that, while CMS has publicly stated its commitment to supporting independent practices, the elimination of an entire specialty—peripheral nerve blocks and related procedures—will instead have a profoundly negative effect on their viability and sustainability.” The letter goes on to share the impact of RVU reductions on providers. They state PNB is declining in utilization and therefore should not be a priority in reducing fraud, waste and abuse.

Multiple providers also wrote comment letters with concerns that mirror those of ASIPP and are addressed in these comments as well.

The policy is not intended to harm independent providers, but ensure evidence based and appropriate utilization of procedures for Medicare beneficiaries. The data in the letter to support a decline in PNB utilization was not inclusive of all PNB codes. It excluded some of the codes with the highest trends for increasing utilization, so the data was not a full description of the current utilization patterns of these procedures.

Coverage suggestion

They request to modify coverage policies to allow 2 diagnostic blocks followed by 2 radiofrequency neurotomy procedures per year, if clinically indicated, or 4 therapeutic nerve blocks. Treatment should only be performed if patients demonstrate at least 50% improvement in pain relief and/or functional status following the first and second diagnostic blocks, with comparative local anesthetic effect, consistent with established protocols for facet joint nerve blocks, which are supported by substantial evidence OR to withdraw the LCD in its entirety.

Thank you for your proposed criteria for coverage; however, there is not sufficient evidence for many of the indications to apply coverage this broadly across all PNB and procedures. The policy has been revised with expansion of coverage for many indications based on evidence submitted during the comment period. All coverage changes are based on available evidence.

21^st Century Cures act

ASIPP states they do not feel the LCD follows the intent of the 21^st Century Cures act and “under previous policies, the process would have been more inclusive. The primary goal of the 21st Century Cures Act was to improve care through transparency, but this LCD instead imposes overly strict regulations and, in this instance, seeks to eliminate an entire specialty.”

The LCD followed the process outlined by the 21^st Century Cures Act. The CAC meeting included representatives from multiple medical societies including ASIPP. Additionally, the open meetings were public and available to all interested parties. All interested parties also had the opportunity to comment during the comment period.

GRADE

They commented the LCD was extensive and felt the criteria for coverage was too strict. They also state, “The policy relies heavily on the GRADE certainty of evidence framework, including GRADE domains. However, many general physicians do not fully understand GRADE criteria, and the assessments often reflect personal biases or limited clinical knowledge rather than practical utility”. They also express concern with challenges in conducted randomized controlled trials (RCTs).

Based on the feedback from the open comment period and literature submitted, the LCD has been expanded, demonstrating the MACs receptiveness and response to feedback throughout the LCD process. We feel using reliable standards for evaluation of evidence is critical to policy development to provide a standard for evaluation of literature that is equal and consistent. Additionally, GRADE allows upgrading for high quality observational studies to ensure that RCT is not the only means for researchers to conduct clinical trials.

Stellate ganglion blocks and pudendal nerve blocks

They express concern with non-coverage of stellate ganglion (cervical sympathetic) block (CPT^® 64510): only 17.2 cases per 100,000 Medicare beneficiaries, yet highly effective for managing reflex sympathetic dystrophy and pudendal nerve block (CPT^® 64430): rarely performed, with 9.8 cases per 100,000 Medicare beneficiaries per year, but highly effective for chronic pelvic pain.

The policy has added limited coverage based on submitted evidence for stellate ganglion block. There was not sufficient evidence to add coverage for pudendal block for chronic pain due to overall low quality and inconsistency in the evidence.

Opiates

A major concern is that the elimination of these procedures may push patients toward more invasive, costly interventions, increased opioid or THC use, or, in worst-case scenarios, street drugs. Another section of the letter elaborates on these concerns and patterns in opiate use and deaths but does not link directly to pain management procedures.

There is no evidence submitted to support these comments. However, the policy has been expanded based on the other literature submitted during the comment period.

Coding

Some codes referenced in the assessment, such as CPT^® 64510 (stellate ganglion block, cervical sympathetic) and CPT^® 62281 (injection/infusion of neurolytic substance into the epidural space, cervical or thoracic region), may not strictly fit the definition of peripheral nerve blocks, raising additional concerns about the scope and rationale of this policy.

The scope of the policy is the utilization of these codes for peripheral nerve injections and procedures for chronic pain management as described within the LCD. The title of the policy was changed to add further clarity to the scope.

Geography

“This policy is introduced across all MACs except for Novitas and First Coast Services. As a result, Medicare recipients in certain states may have access to treatments available in other states, or, in the worst-case scenario, these states may adopt the final decisions of the current MACs without independent consideration.”

See Comment and Response #2.

Diagnostic blocks

“For appropriate performance of peripheral nerve stimulation, it is essential that we provide appropriate diagnostic blocks prior to embarking on peripheral nerve blocks. Comprehensive evidence-based guidelines for implantable peripheral nerve stimulation in the management of chronic pain (Manchikanti L, et al. 2024) provides a recommendation to perform diagnostic nerve blocks.” Additionally, they state “the removal of peripheral nerve blocks also limits access to peripheral nerve stimulators (PNS), as diagnostic nerve blocks are a prerequisite for these procedures based on current clinical guidance”.

The policy was never intended to restrict diagnostic blocks which are essential to proper diagnosis and patient selection for other procedures or surgeries. The policy should not cause any barrier to access for PNS. This has been clarified in the final LCD.

Expansion of coverage

The letter expresses concerns of whether the policy aligns with the criteria for reasonable and necessary. They go on the share utilization data on the codes including the provider types that may utilize the codes demonstrating a wide variety of providers using these services. They specifically discuss utilization patterns and evidence for greater occipital nerve block, suprascapular nerve block, stellate ganglion block, pudendal nerve block, peripheral nerve block (not specified), sphenopalatine ganglion block, genicular nerve neurolysis, neurolysis of the plantar common digital nerve, neurolysis of other peripheral nerves (unspecified) and unlisted procedures.

See Comment and Response #1. Safety and effectiveness are not the primary focus of the definition of reasonable and necessary which goes beyond that to require the service is determined, based on evidence, to not be investigational and improve patient outcomes in the Medicare population.

The following procedures have limited coverage criteria in the final policy based on submitted evidence during the open comment period: stellate ganglion, lumbar sympathetic, trigeminal nerve, genicular nerve, greater occipital nerve, suprascapular nerve, trigeminal nerve and diagnostic blocks.

The following blocks and denervation procedures remain non-covered for the treatment of chronic pain based on insufficient evidence: digital nerve, thoracic nerve, posterior tibial nerve, pudendal nerve, ganglion impar, and unspecified nerve blocks and procedures.

The Federation for Pain Care Access (FPCA) submitted comments expressing concern that the policy will restrict access to necessary pain management services and force patients to more invasive options or opioids. They argue there is substantial peer-reviewed literature to support the procedures and encourage withdrawal or significant revision of the LCD. They provide several systematic review references for genicular RFA, occipital and trigeminal interventions, stellate ganglion blocks, suprascapular and pudendal nerve blocks. They state these are standard of care. They are concerned about geographic inequities and consequences of restricted access. They also state the policy does not align with several societal guidelines. They recommend that the LCD adopts a standardized utilization criterion, such as allowing up to 2 diagnostic blocks followed by up to 2 radiofrequency or cryoablation sessions annually, contingent upon documentation of at least 50% pain relief after diagnostic trials.

Thank you for your comments. There were no supporting literature or references submitted with the letter. The final policy has undergone substantial revision based on additional evidence submitted during the open comment period. Please see Comments and Responses #1, 2, 4, 5, 9, 12, 15, 16 & 20. Additional societal guidelines submitted throughout the open comment period have been added to the final LCD. We are unable to locate guidelines from ASIPP specific to PNB since 2001, which were reviewed.

The FPCA states the LCD does not align with the 2018 Pain Management Best Practices Inter-Agency Task Force Report, created by HHS, the VA, and the Department of Defense, which recommended a multimodal and multidisciplinary approach that includes interventional procedures such as peripheral nerve blocks.

We believe the final LCD aligns with the mission of this report in determining the most effective and beneficial interventions to manage chronic pain for the Medicare population aligning with the requirements for reasonable and necessary.

Multiple providers express their concern with the policy. The letters oppose the policy for largely non-covered positions on PNB. They state there is established evidence for these procedures and the procedures align with SOC. Several patient examples are provided.

The letters express concern that the LCD lacks transparent, evidence-based rationale for the exclusion of these procedures, the proposed injection limits (e.g., 2 or 3 in a lifetime, or annual limits) are arbitrary, with no clinical or outcomes-based justification, and the exclusions conflict with national educational standards, the Accreditation Council for Graduate Medical Education (ACGME) pain-medicine curriculum, and ASRA/ASIPP clinical guidelines. They request withdrawal of the LCD or substantial revisions including recommendations allowing up to 2 diagnostic peripheral nerve blocks, followed (if ≥ 50% relief is achieved) by up to at least 3 therapeutic and/or 2 radiofrequency neurotomy procedures per year.

Thank you for your comments. Please see Comments and Responses # 8, 12, 13 & 20. The analysis of evidence and rationale for determination has been expanded for each indication to ensure transparency in the interpretation of evidence and decision-making process. Policy is based on the available evidence and consideration of societal support including subject matter input from the CAC. While the national educational standards and the Accreditation Council for Graduate Medical Education (ACGME) pain-medicine curriculum may play a role in determining who is qualified to perform the procedures, they are not used in coverage determination. Additional societal guidelines submitted during the open comment period have been added to the final LCD and contributed to the expansion of coverage in the LCD. The suggested limits differ among providers, further exemplifying the lack of standardization of these procedures in current practices.

Provider letters citing opiate literature that was not supportive

Several providers oppose the policy and state these procedures improve pain while reducing risk of long-term medication or surgery. They cite 2 references as evidence for reduction in opiate use (Cohen 2020 and Manchikanti 2019). They share multiple patient stories of positive outcomes because of PNB and procedures. They request maintaining coverage when procedures are performed for clearly documented, evidence-based indications, establish reasonable frequency or diagnostic criteria to ensure appropriate utilization, and engage with specialty societies (ASIPP, ASRA, ASPN) and interventional pain experts in finalizing the LCD.

Thank you for your comments. The comments did not include the full citation or manuscript for Cohen 2020 or Manchikanti 2019. The only paper we could find by Cohen et al. published in Pain Medicine in 2020 was on pain management during the COVID epidemic and we did not locate evidence that “patients reduced opioid intake significantly following interventional treatment” in that manuscript. In a 2020 commentary by Manchikanti in Pain Physician from 2019 we could not locate the statement “multimodal pain care including nerve blocks decreased long-term opioid use by more than 40%”; therefore, these citations were not added to the final LCD.

The final LCD, based on the evidence submitted, expands coverage and ensures access. Input from individuals and societies provided supporting evidence and clinical insights for the final LCD changes. See Comments and Responses #10, 16, & 20.

National Pain Advocacy Center (NPAC)

The National Pain Advocacy Center (NPAC) opposes the LCD and asks that it is rescinded or revised. They review the challenges in pain management, efforts to reduce opiate use and the role PNBs play as part of a multidisciplinary care for chronic pain. They cite the 2022 Clinical Practice Guideline, HHS Pain Management Practices Interagency report as support stating this report “cited peripheral nerve blocks as one key tool in managing pain”.

Thank you for your comments. We agree with the importance of multidisciplinary care for chronic pain. Please see Comments and Responses #16, 19, 20, & 22 which address the expansion of coverage in the final LCD.

The referenced Clinical Practice Guidelines state, “Additional research and more specific data establishing the clinical benefits of specific interventional procedures for specific pain conditions would be beneficial and can further identify various procedures for specific clinical conditions”. It also explains that PNBs play a critical role in pain management for acute pain associated with surgery and states PNB “can also have a role in potentially diminishing or preventing the development of chronic pain syndromes”. It also reviews evidence necessary for coverage determination.

Anesthesia

The American Association of Nurse Anesthesiology (AANA) expresses concern with the proposed policy limiting access, exacerbating health disparities and increasing opioid use. They recommend a revision to allow the procedures when first line therapies fail, elimination of lifetime caps, clarification of sedation criteria for PNIs, and provision of provider templates for documentation requirements.

Thank you for your comments. Many of your concerns are addressed in Comments and Responses # 1, 5, 9, 15, 16 & 20. These comments address the expansion of coverage in the final LCD based on submitted evidence. The policy is limited to chronic pain; therefore, literature submitted for acute surgical pain was not added to the final LCD.

A section to address the role of anesthesia has been added to the LCD to provide the requested clarification. The anesthesia requirements align with the American Society for Anesthesia recommendations and other policies addressing blocks for pain management for chronic pain. Documentation requirements are outlined in the Billing and Coding article.

For Total Knee Arthroplasty (TKA)

A provider comments on their concerns with limitations for persistent post-operative pain after total knee replacement and lack of effective treatment options. They feel genicular nerve RFA is an effective option and cite Davis et al., Pain Medicine 2018; Bellini et al., Pain Physician 2017 for references. They advocate for coverage for this indication.

Thank you for your comments. Full citations or articles were not included. We identified Davis T, Loudermilk E, DePalma M, et al. Prospective, Multicenter, Randomized, Crossover Clinical Trial Comparing the Safety and Effectiveness of Cooled Radiofrequency Ablation with Corticosteroid Injection in the Management of Knee Pain From Osteoarthritis Regional Anesthesia & Pain Medicine 2018;43:84-91; however, this RCT excluded patients who had prior total knee arthroplasty and therefore, it does not provide evidence for the role of genicular nerve RFA in this population. We were unable to identify a manuscript by Bellini et al. in Pain Physicians 2017.

In a systematic review (cited in the LCD by Meiling et al.), there is limited evidence and low certainty to support the use of genicular nerve RFA for chronic knee pain post TKA. While there is some societal support for this indication, the level of evidence rating to support the recommendation was derived from the literature for osteoarthritis and largely excludes the post-TKA population, so it is not generalizable to this group. Therefore, genicular nerve RFA is not covered for this indication. If additional literature is developed, it can be submitted via the LCD reconsideration process.

Commenters write gratitude for “ending coverage on this non-FDA approved, barbaric practice!” One commenter shared their story of repetitive and failed procedures resulting in greater pain. She advocated for evidence-based decisions and limiting practices that she considers abusive of seniors. Another commenter fully supports the proposed LCD to eliminate or restrict coverage of peripheral nerve blocks and related ablation procedures for chronic pain, stating the evidence, patient experiences, and long-term data all point in one direction—these procedures are not worth the risks. The commenter feels the policy represents progress toward safer, more ethical, and more evidence-based pain management care; stating these interventions have been overused, poorly regulated, and often cause more harm than good for patients.

Thank you for your comments. We are focused on creating evidence-based policies to ensure Medicare beneficiaries have access to effective and beneficial procedures and protection from those that are not supported by quality evidence.

A comment letter from Avanos medical, a manufacturer of technologies used to treat chronic pain expresses concern about the proposed policy. They express concern about the policy increasing opiate use, state there is evidence for the role of RFA for chronic pain management and the policy will create a population of patients without reasonable treatment options. They state there is societal support for the procedures. Full text literature was provided to support the comments.

Thank you for your comments and supporting literature. Refer to Comments and Responses # 4, 9, 16 and 20 to address these concerns.

Multiple letters were received from providers in different states expressing concerns with provider burn out and burden. They overall oppose the restrictive coverage in the proposed policy and express concern it will increase opiate use and request reconsideration. Some letters shared frustration with the proposed policy overall and focused on the challenges in the management of chronic pain. Many clinical vignettes were shared.

Thank you for taking the time from your busy schedules to express your concerns. We have listened to the provider community and incorporated submitted evidence with expansion of coverage from the proposed policy where evidence can support these changes. See Comments and Responses # 10, 16 & 20.

Multiple patient letters share their story about the benefits they and their family members have received from PNI and procedures. They request continued access to these treatments.

Thank you for your comments. We have considered patient and provider input as well as additional supporting evidence submitted during the open comment period. The final policy has expanded coverage for appropriately selected indications.

A nurse practitioner in a chronic pain practice advocates for coverage for occipital nerve blocks and procedures and cites a meta-analysis by Inan et al. 2019 for support. She also supports genicular nerve blocks and shares the positive benefits she has seen in her care of these patients and cites Gupta 2022 and McCormick 2023 for support.

Thank you for your comments and providing supporting literature. Based on additional supporting literature, limited coverage has been added to the final LCD for these indications. See Comments and Responses # 4, 9, 20. Inan et al., 2019 is in the final LCD. As full citations or text were not provided, we were unable to locate Gupta 2022 or McCormick 2023 for review; but systematic reviews on genicular nerve RFA were added to the LCD. If these articles impact coverage they can be submitted in PDF format as part of the LCD reconsideration process.

A provider comments regarding their concerns with the policy and emphasized the importance of diagnostic blocks and the benefits they have seen from therapeutic blocks. Clinical examples were provided. They express concern that the policy will increase surgery and opiate use. They suggest the following: “Continuing PNB with or without corticosteroid should continue if the patient experiences 50% or more relief for 2.5 months or more (epidural guidelines). If the PNB performed on 2 occasions does not lead to this duration of relief but does lead to significant relief with the local anesthetic component, then a discussion could be had of peripheral nerve radiofrequency ablation and/or peripheral nerve stimulation. Image-guidance should be recommended for both safety and diagnostic accuracy but not mandated.”

Thank you for comments. The policy has been revised based on feedback from providers and submitted evidence through the open comment period. We appreciate your recommendations but cannot extrapolate literature from epidural to PNB, nor can we create coverage that does not consider the evidence for the condition being treated; therefore, the policy is divided by conditions with coverage and rationale for decision making for each indication. See Comments and Responses # 1, 12, 16, & 20.

AAO-HNS

The American Academy of Otolaryngology-Head and Neck Surgery (AAO-HNS), the American Broncho-Esophagological Association (ABEA) and the American Laryngological Association (ALA) submit a joint letter and express concern that the policy does not address the treatment of neurogenic cough and disorders of the vocal cords and larynx. They explain CPT^® code 64408 is used for management of these conditions and is billed with ICD-10 codes R05 (Neurogenic cough) and J38 (disease of vocal cords and larynx) and 98% of the utilization is by Otolaryngology-Head and Neck Surgeons.

Thank you for sharing your concerns. The scope of the policy is limited to chronic pain management and should not impact access to these services. The billing and coding article has been updated accordingly.

An unsigned letter from a provider urges the policy to move forward in current form stating, “these interventions have been overused, poorly regulated, and often cause more harm than good for patients.” The writer expresses concern about the lack of evidence. While PNB and procedures are marketed as safe and effective, the provider has seen “permanent nerve injury or increased neuropathic pain, scarring, infection, or bleeding at the injection site, and exacerbation of preexisting pain conditions or the creation of new pain sources”. The writer states reliance on these procedures encourages “a cycle of trial-and-error interventions rather than addressing underlying causes of pain through comprehensive, multidisciplinary approaches such as physical therapy, behavioral health support, and noninvasive medical management. Restricting coverage will encourage providers to adopt safer, evidence-based alternatives and refocus care toward true rehabilitation and functional recovery”. The writer is not convinced limitations will increase cost or opiate use. They encourage the policy to be enforced as written and limit coverage to acute pain management such as surgical pain and prohibit long term use or use for chronic pain indications. They also encourage “requirement for full, informed consent documentation outlining risks of nerve damage and worsening pain before any covered procedure”.

Thank you for your comment and sharing your experience as a provider who is open to sharing the downsides to these procedures. Many of the concerns you share are the motivation for why this topic was selected for LCD development. While the policy has been expanded based on submitted evidence during the open comment period, we are optimistic that the improvement in patient selection and reduction in use for long term pain management for chronic pain conditions in the absence of supporting evidence addresses your concerns. We have added the importance of informed consent to the LCD.

A commenter submits a letter expressing their concern with the “quality of the evidence cited and the methodological limitations of the research used to support this determination”. They acknowledge the lack of RCT and the low quality of the RCT that have been conducted on this topic. They provide a table that demonstrates the absence or insufficient sample size challenging the current literature on these procedures. They suggest, “The current body of literature does not provide adequate certainty or clarity on the risks versus benefits of these procedures. To dismiss these procedures entirely as medically unnecessary risks denying potentially effective interventions to patients who may otherwise improve in function or quality of life”. They recommend Medicare fund high quality trials to address these questions with recommendations for study design to result in high-quality literature.

Thank you for your comments. We are in agreement with your concerns about the lack of high-quality literature and the need for more rigorous studies to address these procedures. We do not agree that lack of evidence is a rationale for continued coverage. In the absence of supporting evidence, services are experimental or investigational and not aligned with reasonable and necessary which is required for Medicare coverage. The areas in which additional evidence was submitted have been expanded for continued coverage, but higher quality research is certainly needed. The MACs cannot fund clinical trials. See Comments and Responses # 1, 4, 6, 14 & 20.

Mental health

Several providers write to share their extensive experience in managing patients with chronic pain and benefits of PNI and RFA for their conditions. They explain the pain can lead to mental health issues and even suicide. These services can provide options for non-surgical candidates and improve quality of life. They agree the evidence is mixed but do not feel it should be used to limit care which can cause patient harm and increased opioid use.

Thank you for your comments. Literature was not submitted to support these comments, especially the concern that there is a link between the policy position and suicide. The policy has been expanded based on feedback from patients, providers and additional evidence submitted during the open comment period. A multi-disciplinary approach to pain management which addresses mental health concerns is strongly encouraged.

The Illinois Society of Anesthesiologist and the Illinois Bone and Joint Institute submit similar letters on the benefits associated with the procedure and recommend withdrawal of the LCD. They discuss the challenges in medical management for pain conditions and their concern for increasing opioid therapy if the policy is implemented. They provide additional literature to support occipital nerve blocks for greater occipital neuralgia and state it is not for chronic migraine headache prevention. They say there may be a role for cluster headaches. They also provide evidence to support stellate ganglion nerve blocks, trigeminal neuralgia blocks and RFA, suprascapular nerve blocks, ganglion impar blocks and genicular nerve blocks. Full citations for 65 references were included and those not already in the LCD were reviewed and added if applicable.

Thank you for your comments. The supporting literature has been reviewed and has contributed to the expansion of coverage for the indications that the literature supports. See Comments and Responses # 3, 5, 9, 15, 16 & 20.

Multiple providers submitted the following or similar letters: “As a clinician, I’ve seen patients regain daily function and reduce opioid use thanks to properly selected peripheral nerve blocks and percutaneous denervation. The draft LCD would curtail these options except for a narrow set of diagnoses. Please consider: (1) allowing coverage for peripheral nerve blocks and denervation when medically necessary and supported by clinical judgment and documentation; (2) aligning coverage with existing multidisciplinary guidelines; and (3) avoiding one‑size‑fits‑all exclusions that are not reflective of patient heterogeneity.”

The policy has been expanded based on feedback from patients, providers and additional evidence submitted during the open comment period. The concerns in this letter are addressed in Comments and Responses #10 & 20. The final policy provides background, evidence review, societal input and rationale for decision making for each indication to ensure there are not “one‑size‑fits‑all exclusions” and the coverage determinations are based on evidence and clinical input received.

A provider comments concern that the policy will worsen health care disparities, harm patients, undermine continuity of care, lead to loss of training opportunities for fellows and residents, restrict practice autonomy and erode the mission of the field of pain medicine. They state the selective evidence review omits high quality RCT and societal guidelines supporting these procedures and were not considered, the standards for evidence are unrealistic, the policy conflicts with CMS’s goals for opiate reduction and the terminology is confusing which may result in “unintentionally extended non-coverage to diagnostic or unrelated procedures”.

Thank you for comments. The policy has been expanded based on feedback from providers and additional evidence submitted during the open comment period. There was no literature submitted with these comments. Terminology has been improved throughout the policy based on feedback . The billing and coding article provides clarifications to alleviate confusion and ensure the scope of non-coverage is not misinterpreted. See Comments and Responses # 1, 6, 10, 11, 14, 16, & 20.

Long COVID and thoracic nerve blocks

A stakeholder urges access for PNB for chronic pain conditions like fibromyalgia, long COVID and chronic fatigue syndrome.. They state there is emerging evidence and PNBs can be cost saving. They also express concern with funding for clinical trials to explore further.

Thank you for your comments. Cost analysis is not considered for LCD development, so the reference provided for cost was not added to the LCD. The remaining submitted literature was reviewed. The coverage was expanded for stellate ganglion block for CRPS based on submitted evidence. Since long COVID is not a chronic localized neuropathic pain condition, it is not within the scope of this LCD. Patients with Long-Covid that present with localized neuropathic pain will fall within individual nerves covered in the LCD.

The article submitted (Shah 2015) supports a role for thoracic nerve block for acute operative pain management and the policy does not limit the use in this setting; however, for chronic pain management there is not sufficient evidence to support thoracic nerve block.

The Pacific Spine and Pain Society comments on opposition to the proposed policy stating that it would reduce access to non-opioid, minimally invasive treatments and reduce access to safe and effective PNB procedures. They state there is evidence demonstrating durable pain relief from PNB and RFA. The policy does not align with the goal of opiate reduction. They provide a summary of medical management of the challenges including poor adherence and tolerability. They summarize the benefits from intervention treatments and reduction in opiate use seen in a study for knee OA. They also cite few serious adverse effects from the procedures. They provide supporting literature for occipital nerve blocks and RFA, stellate ganglion blocks, genicular nerve RFA, suprascapular nerve blocks and ablation, pudendal nerve blocks, trigeminal nerve blocks and destruction, and posterior tibial and digital nerve blocks. They state the policy will increase costs, disability and increase surgeries. They encourage inclusion of patients, providers and societies in policy development. The letter included 24 full citations.

Thank you for your comments. Based on feedback from providers and additional evidence submitted during the open comment period, the final policy includes expansion of coverage for most of the indications requested in your letter. See Comments and Responses # 1, 4-6, 8-10, 15, 16, 20, 24 & 41. All submitted literature that was not already in the LCD has been reviewed and added where appropriate. Articles on medical management, cost-analysis and non-investigational papers such as reviews were not added. The final policy represents inclusion of providers and societies input during the open comment period resulting in meaningful change. The MACs will continue to align with the requirements for evidence-based policy decisions as we work together to serve the Medicare beneficiaries.

A pain management provider comments with concerns about the impact on function for seniors. He explains that chronic pain reduces mobility and participation in rehabilitation. He finds PNB and procedures to be a useful tool in multi-modality care. He cites “The American Society of Regional Anesthesia & Pain Medicine (ASRA) has stated that these proposed LCDs misclassify much evidence-based procedures as not medically necessary” and is urging rapid comment and revision. ASRA Pain Medicine and the ACR also issued a call for public comments. He requests retaining coverage, defining clear criteria for appropriate use (i.e., indication, documentation of previous therapies, measurable pain/function outcomes, provider credentialing) rather than blanket exclusion, and ensuring stakeholder engagement.

Thank you for your comments. We agree with the importance of a multi-modality approach to pain management. You will find responses to your concerns in Comments and Responses # 10, 16, 20, & 22.

A commenter who is part of a large comprehensive pain program expresses concerns with the Proposed LCD and provided several requests including:

1. Remove blanket non-coverage and replace it with indication-specific, evidence-aligned coverage criteria (i.e., diagnostic response thresholds; imaging guidance; conservative-care prerequisites; functional endpoints).
2. Permit anesthetic-only diagnostic blocks and staged therapeutic series when they demonstrate at least 50% pain reduction and clinically meaningful functional improvement on validated measures for the expected pharmacologic duration, rather than categorical bans or lifetime steroid-injection caps that lack evidentiary support in focal neuropathies.
3. Allow genicular nerve RFA/cooled RFA for knee osteoarthritis after failure of guideline-concordant nonoperative care, with image guidance, documentation of positive diagnostic blocks, and reasonable frequency limits, harmonizing with RCTs and evidence syntheses (Kwon 2024; Vallejo 2023; Toubasi 2025; Almeida 2025).
4. Cover greater occipital nerve blocks for chronic migraine/occipital neuralgia in refractory patients, with documentation of disability and attack frequency, and consider ultrasound guidance to optimize accuracy (Mustafa 2024; Chowdhury 2024; Saraçoğlu 2024; Giuliani 2025).
5. Permit suprascapular nerve blocks for adhesive capsulitis/chronic shoulder pain when conservative measures fail, using validated functional scales (e.g., SPADI, ASES), and re-treat only with documented benefit consistent with trial durability windows (Harley 2025; Schiltz 2022; Adey-Wakeling 2013; Chang 2016).
6. Retain access to stellate ganglion block for selected patients (e.g., sympathetically maintained pain; PTSD with high symptom burden) with outcome tracking and standard safety parameters (Rae Olmsted 2020).
7. Codify stewardship: image guidance; avoidance of deep sedation unless exceptional clinical need; standardized patient-reported outcomes; and maximum annual frequencies aligned to observed duration of benefit by indication.
8. Process and timing- The proposed policy is MAC-initiated, posted September 25, 2025, with public comments accepted through November 8, 2025, and an Open Meeting on October 27, 2025. Given the scope and the disconnect between the proposed restrictions and current evidence, we respectfully request the MACs defer finalization and convene subject-matter experts from interventional pain medicine, neurology, physiatry, geriatrics, and patient representatives to craft condition-specific, evidence-proportionate coverage.
9. They also provide recommendations for peripheral pain syndromes.

Thank you for your comments and submission of supporting literature with citations. As suggested, the final LCD has been revised and replaces many non-covered positions with indication-specific, evidence-aligned coverage criteria. We have incorporated submitted evidence from the open comment period and stakeholder input. The references cited are included in the LCD if applicable, but review papers and CME activities were not added as they are not determinative evidence. Comments and Responses #1, 4, 5, 9, 10, 13, 16, 20, & 26 also address your stated concerns. As explained in the LCD, there is insufficient evidence to support the use of PNB for management of peripheral pain syndromes.

Several commenters request coverage of stellate ganglion blocks for long COVID, ME/CFS and chronic pain condition management.

Thank you for your comments. The policy has been expanded to include coverage of stellate ganglion blocks for complex regional pain syndrome based on evidence submitted during the open comment period. Since long COVID is not a chronic localized neuropathic pain condition, it is not within the scope of this LCD. Patients with long-Covid that present with localized neuropathic pain will fall within individual nerves covered in the LCD. If supportive evidence is published, it can be considered through the LCD reconsideration process.

The Society of Women Innovators in Pain Management comments on concerns regarding the policy limiting access for PNB which are supported by evidence and societal guidelines for chronic pain management. They support coverage for 2 diagnostic, 2 RFAs and up to 4 therapeutic blocks annually if at least >50% improvement for PNB procedures and RFAs.

Thank you for your comments. Please see Comments and Responses # 10, 12, & 20, which address your concerns. The letter included 11 references which were reviewed. We do not use review papers, case reports or series for policy decisions; therefore, these were not added to the LCD. The societal guidance shared has been added to the LCD if not already incorporated and applicable to PNB or procedures for chronic pain management.

A provider commented that there is evidence to support clinical effectiveness of ultrasound-guided PNBs and recommends withdrawal of the proposed LCD or maintenance of outcome-based standards, such as ≥50% pain or functional improvement for continued authorization

Thank you for your comments. Five references were listed but did not include full citations or PDFs of the articles. We could not locate these manuscripts (Karmaker 2018, Dada 2014, Pingree 2017, Naja 2013). If after reviewing the final LCD and changes that have been made you believe these articles impact coverage, they can be submitted in PDF format as part of the LCD reconsideration process. See Comments and Responses # 12, 16, and 20.

The Pain Medicine Coalition, the American Society of Anesthesiologist and the Multisociety Pain Workgroup request withdrawal of the proposed LCD. They express concern that it would limit access to diagnostic and therapeutic nerve blocks and denervation procedures. Additionally, they express concern this does not align with the mission to reduce opiate use. The list of concerns include: failure to consider high-quality evidence demonstrating safety and effectiveness of nerve blocks and denervation procedures, conflict with consensus guidelines and recommendations, denial of coverage for anesthesia for denervation procedures, inclusion of incorrect information about the treatments and conditions discussed in the draft LCD, failure to consider patient access when they are without other treatment options and combining coverage for diagnostic and therapeutic block procedures which have drastically different roles. No supporting evidence was submitted with comments.

Thank you for your comments. The final policy has been revised to incorporate evidence and consideration of input received during the open comment period and are addressed in Comments and Responses # 1, 2, 10, 13, 19, 20, 26, 27 & 36.

The final policy expands coverage based on the submitted evidence; however, high-quality evidence is lacking and there is a need for further investigation to understand the role of these procedures, especially beyond short-term pain management with robust methodology to improve the understanding of these procedures. This balances the potential benefits patients may receive with the need for further investigations in this area. The policy does not deny coverage of anesthesia for denervation but does not allow for routine use for PNIs consistent with ASA Guidelines. If you believe there is mischaracterization of diseases, please provide further input and supporting evidence and if this impacts coverage this can be considered through the LCD reconsideration process. The final policy considers access for conditions without alternative treatments and if there is evidence to support the role of the procedures for these indications. The policy does not limit the role of diagnostic blocks but does limit therapeutic blocks based on the individual conditions and evidence to support their role in the treatment.

The Coalition for Interventional Pain Treatment, a group of 7 manufacturers of Radiofrequency Ablation (RFA) and Cryoneurolysis-based pain therapies, request withdrawal of the proposed LCD. They cite concerns regarding opiate use increasing and the policy not aligning with initiatives to decrease opiate use. They recommend the LCD be revised but also question if an LCD is needed for PNB and procedures since utilization is lower than for other ablation/cryoneurolysis procedures. They recommend separating nerve blocks and destruction into separate LCDs since nerve blocks are often diagnostic in nature. They cite Barreto 2025 to consider for ablation/cryoneurolysis not included in the proposed LCD since it was published after the LCD.

Thank you for your comments. The policy does not restrict the role of diagnostic blocks, and this has been clarified in the final LCD. Since diagnostic, therapeutic blocks and neurodestructive procedures overlap in their role we feel that a single LCD is best to address this. The final LCD is divided into sections based on indications with background, evidence, coverage and rationale for each indication separately to ensure thorough consideration of the literature for each indication. Barreto 2025 was added to the Genicular nerve section. Comments and Responses #16, 19, 20 further address your concerns.

The U.S. Association for the Study of Pain (USASP), a member organization of approximately 1,000 pain researchers and clinicians, states concern that low-quality evidence as justification for non-coverage underestimates clinical experience and higher-quality studies to support these procedures. They state the evidence for occipital nerve block is high-quality. They discuss the heterogenicity in the systematic reviews that they feel lowers the overall impact of the procedure since it is included with other headache types. They also cite a recent SR/MA for genicular nerve (Kanjanapanang 2025) which was not included in the LCD. They state the importance of diagnostic pudendal nerve blocks, which can also be therapeutic, but can help patients participate in pelvic physical therapy. They cite Andiman 2025 systematic review for pudendal nerve blocks. No full text articles or full citations were included.

Thank you for your comments. The final policy has been revised to incorporate evidence and consideration of input received during the open comment period and your concerns are addressed in Comments and Responses # 1, 4, 6, 9, 10, 13, 14, 15, 19, 20 & 36. While we agree that the heterogeneity of the systematic reviews limits the reliability of their conclusions, we do not agree with the assessment that there is high quality evidence to support occipital nerve, but coverage has been expanded based on moderate certainty evidence. Future investigations to better understand patient selection, standardization of procedures and long-term outcomes are needed. The remaining submitted literature has been added to the LCD. We did not feel that Andiman et al. supports coverage for RFA based on only 7 total subjects receiving RFA in the review as well as the methodological concerns with the included literature (see Pudendal Section of the LCD).

The American College of Radiology submitted a comment letter expressing concern that the restricted access in the proposed policy to PNB and procedures may contribute to the opiate epidemic. They recommend coverage is based on response to diagnostic nerve blocks. They encourage continuation of RFA for the medial branch nerve of the spine for chronic neck and back pain. They support coverage for genicular nerve blocks for chronic knee pain for patients who are not candidates for surgery or post- TKA pain. They cite Barreto 2025 and Kanjanapanang 2025 as supporting evidence. They support covering pudendal nerve interventions including RFA with supporting literature.

Thank you for your comments and for submitting PDFs of the supporting literature. Most concerns are addressed in Comments and Responses # 12, 16 & 20. This policy does not address RFA for medial nerves of the spine. The supporting literature for pudendal nerve interventions has been reviewed and added to the policy; however, there is not sufficient literature to understand the potential role of these procedures for this indication (see Pudendal Section of the LCD).

A letter signed by the Multi-society Pain Workgroup recommends rescinding the LCD or postponing in order to collaborate with the undersigned societies. They explain the burden of chronic pain, challenges to reduce opiate use and limitations of conservative management options alone. They state nerve blocks provide target-specific diagnostic information and therapeutic effects. They state some of the conditions treated with PNB and procedures are too rare to conduct RCTs, but without access can worsen outcomes for these patients. They state, “The proposed LCD does not meet the evidentiary standards necessary to justify a noncoverage determination for all PNB procedures” highlighting the wide variability in systematic reviews. They express concern that the LCD does not align with societal recommendations. They state terminology used for thoracic nerve blocks is confusing as it is non-specific. They do not believe the policy will reduce waste.

For trigeminal neuralgia (TN) they express concern with 6-months wait before interventional treatment, they also consider RFA a surgical procedure, and they explain challenges in distinguishing TN from other facial pain conditions.

For other procedures they recommend removal of microvascular decompression (MVD) which is not percutaneous and they do not feel that percutaneous trigeminal glycerol rhizotomy falls into the scope of the LCD. They explain that anesthesia is used for RFAs and should not be restricted. They provide an evidence summary for genicular nerve blocks and RFA and provide 2 new systematic reviews that help in addressing the flaws of previous reports. They offer to engage with the MACs to develop collaborative recommendations.

Thank you for your detailed comments and supporting literature. Most of your concerns are addressed in Comments and Responses # 1, 4-6, 9-10, 13-16, 19-20, 26-27 & 36. In response to additional concerns brought up in the letter, the policy does not require RCTs and the final LCD provides coverage for rare conditions when there is evidence to support the procedures are not harmful and can improve outcomes. Thoracic nerve block has been defined. For the 6 months wait prior to TN treatment, this is supported by literature. If new literature provides alternative standards, it can be submitted through the LCD reconsideration process. For the purpose of the policy, we consider percutaneous interventions to be procedures, while surgical interventions require a significant incision, tissue manipulation and are generally higher risk. This classifies RFA as a minimally invasive procedure. While trigeminal neuralgia is considered a diagnosis of exclusion, we believe there are criteria to allow a diagnosis which is necessary for patient selection for interventional procedures. We agree MVD and rhizotomy are classified as ablative procedures and they have been removed from the LCD except where they are being compared to RFA in the studies.

The MACs have followed the LCD process, which included a CAC meeting and open comment period, to ensure societal and stakeholders had the opportunity to provide input in the LCD development. The output of this engagement has resulted in evidence-based changes to the final LCD that considered the input from societies to better align with the needs of the population. There are areas in which there is insufficient evidence, and the intervention does not align with reasonable and necessary. The reconsideration process can be used to expand coverage as evidence develops in the future.