LCD Reference Article Response To Comments Article

Response to Comments: Trigger Point Injections

A60436

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Contractor Information

Contractor Name	Contract Type	Contract Number	Jurisdiction	States
Novitas Solutions, Inc.	A and B MAC	04111 - MAC A	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04112 - MAC B	J - H	Colorado
Novitas Solutions, Inc.	A and B MAC	04211 - MAC A	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04212 - MAC B	J - H	New Mexico
Novitas Solutions, Inc.	A and B MAC	04311 - MAC A	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04312 - MAC B	J - H	Oklahoma
Novitas Solutions, Inc.	A and B MAC	04411 - MAC A	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04412 - MAC B	J - H	Texas
Novitas Solutions, Inc.	A and B MAC	04911 - MAC A	J - H	Colorado New Mexico Oklahoma Texas
Novitas Solutions, Inc.	A and B MAC	07101 - MAC A	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07102 - MAC B	J - H	Arkansas
Novitas Solutions, Inc.	A and B MAC	07201 - MAC A	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07202 - MAC B	J - H	Louisiana
Novitas Solutions, Inc.	A and B MAC	07301 - MAC A	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	07302 - MAC B	J - H	Mississippi
Novitas Solutions, Inc.	A and B MAC	12101 - MAC A	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12102 - MAC B	J - L	Delaware
Novitas Solutions, Inc.	A and B MAC	12201 - MAC A	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12202 - MAC B	J - L	District of Columbia
Novitas Solutions, Inc.	A and B MAC	12301 - MAC A	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12302 - MAC B	J - L	Maryland
Novitas Solutions, Inc.	A and B MAC	12401 - MAC A	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12402 - MAC B	J - L	New Jersey
Novitas Solutions, Inc.	A and B MAC	12501 - MAC A	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12502 - MAC B	J - L	Pennsylvania
Novitas Solutions, Inc.	A and B MAC	12901 - MAC A	J - L	Delaware District of Columbia Maryland New Jersey Pennsylvania

Article Information

General Information

Article ID
A60436

Article Title
Response to Comments: Trigger Point Injections

Article Type
Response to Comments

Original Effective Date
07/23/2026

Retirement Date
N/A

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Article Guidance

Article Text

The following are the comment summaries and contractor responses for Novitas Solutions Proposed Local Coverage Determination (LCD) DL35010, Trigger Point Injections, which was posted for comment 02/19/2026 through 04/04/2026 and presented at the March 2026 Open Meeting. A multi-jurisdictional Contractor Advisory Committee (CAC) Meeting for Trigger Point Injections was conducted via webinar in April 2023. Novitas Solutions appreciates the comments received from stakeholders during the open comment period. All comments were reviewed in their entirety. Submitted comments that cite published, peer-reviewed literature provide a suitable source of data that may inform draft policy revision(s). However, while anecdotal or unpublished information not subject to peer review offer important perspectives, their influence on policy determinations is limited, reflecting the established evidence hierarchy which prioritizes more rigorously vetted sources.

Pursuant to the CMS Program Integrity Manual (CMS Pub. 100-08) Chapter 13, In conducting a review, MACs shall use the available evidence of general acceptance by the medical community, such as published original research in peer-reviewed medical journals, systematic reviews and meta-analyses, evidence-based consensus statements and clinical guidelines. Accordingly, the final policy and our response to comments are grounded in the best currently available published clinical evidence. This approach ensures that our decisions are informed by the best available research, ultimately supporting optimal health outcomes in Medicare beneficiaries.

NOTE: Novitas Solutions reviews all submitted comments; however, MACs may choose to consolidate similar thematic comments, redact, or withhold certain submissions (or portions thereof) such as those containing unrelated proprietary subject matter or inappropriate language. This may result in discrepancies between the number of comments in the article and the actual number of comments received

Response To Comments

Number	Comment	Response
1	Several comments were received from beneficiaries, physicians, and medical professionals regarding the frequency limitations for trigger point injections (TPIs). Most commenters requested that TPIs not be limited to five (5) within a 12-month period, or that the policy be restructured so coverage is determined based on documented medical necessity for each anatomic site treated. Additionally, one comment requested the removal of any restrictions on repeated treatment of the same muscle. Some commenters recommended allowing clinician discretion to provide up to six (6) sessions within a rolling 12-month period for selected patients. One commenter stated that no evidence shows that treating additional distinct muscle groups is unreasonable or unnecessary, nor that limiting treatment to five sessions within 12 months is medically appropriate when new trigger points are identified. They believed that medical literature consistently shows that TPI effectively relieves symptoms when active trigger points are present. This commenter stated that the rules are scientifically unsupported, clinically indefensible, and restrictive of physicians’ ability to deliver appropriate, evidence-based care to patients. However, no literature was provided to support the proposed increase in treatment frequency.	Thank you for your comments. In the absence of definitive professional society guidelines, and based on available evidence, prevailing clinical practice, and expert consensus, a minimum interval of three months between TPI sessions is recommended to reduce the potential risk of adverse effects associated with repeated injections. No more than four (4) TPI sessions within a 12-month period are considered reasonable and necessary. In alignment with ACOEM guidelines, routine administration of four (4) or more TPI sessions per year would not be expected without clear documentation of medical necessity and inclusion of TPIs as part of a comprehensive, multimodal treatment plan. Subject matter experts (SMEs) participating in the multijurisdictional Contractor Advisory Committee (CAC) reported that TPIs are not customarily administered more frequently than every three months in routine clinical practice. This position is further supported by jurisdiction specific SME survey data, in which the majority of experts identified an approximate three month interval between injections as the appropriate standard of care. The publication inclusion criteria, along with the search terms and methodological protocols used in the development of this LCD, are detailed in the Evidence Landscape section of the policy. Furthermore, the proposed policy increases frequency from three sessions in its original form to four sessions in 12 months.
2	A comment was received asserting that the available evidence does not definitively support the use of anesthetic only injections over corticosteroid or combination injectates. The commenter indicated that preserving clinician discretion in the selection of injectates is consistent with CMS evidence standards and guidance from relevant specialty societies. Another comment was received stating that the exclusion of corticosteroids and other biologic agents as covered injectates is inconsistent with established clinical practice. However, no clinical evidence was provided to support the addition of further medications to the list of accepted injectates.	Thank you for your comments. Overall, a wide range of injectates for TPIs have been evaluated in clinical studies. To date, no single injectate has demonstrated clear clinical superiority, and the overall certainty of the available evidence remains low. Evidence supporting the use of corticosteroids as an injectate for TPIs is limited, and current specialty society guidelines do not recommend their routine use. Specifically, these guidelines indicate that the addition of corticosteroids to a local anesthetic does not provide sufficient additional clinical benefit to outweigh the potential risks (moderate level of certainty) and recommend that TPIs with local anesthetic alone be considered.
3	Comments were submitted indicating disagreement with the proposal to deny coverage for TPIs performed under ultrasound guidance (CPT 76942) indicating that the ultrasound is necessary in anatomically high-risk regions and in scenarios when guidance is necessary to accurately reach the therapeutic target.	Thank you for your comments. There are currently no clinical guidelines that support the routine use of ultrasound or other imaging guidance for TPIs. The diagnosis of a trigger point is based on physical examination, specifically through direct palpation and identification of the affected area. Direct palpation is the standard method used for both diagnosis and localization prior to injection. While ultrasound guidance has been studied to assess whether it may enhance the safety and accuracy of needle placement, existing society guidelines indicate that the evidence remains limited and of overall low quality. These guidelines support the performance of TPIs using palpation alone. Additional high-quality research is needed to evaluate the long-term efficacy, safety, and clinical benefit of image-guided techniques compared to traditional palpation- and landmark-based approaches.
4	Some comments were received regarding the limitation of covered diagnoses, noting that this approach may not encompass all patients who present with myofascial pain associated with other conditions. A reference list of literature was submitted for the inclusion of additional coverage diagnoses.	Thank you for your comments and related citation references. All submitted literature is carefully evaluated for relevancy, evidence-based material, and certainty of evidence. This LCD is specifically limited in scope to the use of trigger point injections (TPIs) for the treatment of myofascial pain associated with identifiable trigger points. The coverage criteria and associated diagnoses are therefore intentionally focused on conditions that meet the clinical definition and diagnostic criteria of trigger points. While we recognize that myofascial pain may occur in association with a variety of other conditions, expansion of covered diagnoses beyond those directly related to trigger points falls outside the scope of this policy. Accordingly, the LCD does not address or include broader conditions in which myofascial pain may be a secondary component without clearly defined trigger points. All submitted references were considered; however, literature supporting broader diagnostic inclusion typically addressed conditions or treatment contexts beyond the defined scope of TPIs for myofascial pain syndrome (MPS). As such, these materials did not support changes to the current coverage framework. Therefore, no revisions to covered diagnoses have been made.
5	Comments were received from the Mayo Clinic Pain Medicine Enterprise team opposing the LCD, arguing that it is medically unsound, legally deficient, and more restrictive than commercial payer policies. Legally, they stated that, under SSA §1862(a)(1)(A), this MAC has imposed benefit exclusions, administrative requirements, and utilization controls that do not meet medical necessity, apply uniformly to beneficiaries, and provide sufficient moderate-to-high quality scientific evidence to support coverage criteria elements in the cited SSA. They state that the proposed coverage criteria in the LCD lacks adequate evidentiary support, improperly overrides treating clinicians’ medical judgment, and creates an elevated risk of patient harm, increased appeals, and higher overall costs. They suggest that the LCD relies on an incomplete and biased evidence review which excludes real-world practice studies, broader relevant conditions, and an over-reliance on small or indirect studies and expert opinion. Their specific objections are as follows: exclusion of ultrasound-guided TPIs stating modern guidelines support ultrasound use in high-risk or anatomically complex situations; rigid physical exam requirements such as palpable nodules and taut bands is non-validated and inconsistent with real-world diagnosis of myofascial pain; mandatory participation in multimodal therapy programs is deemed legally unauthorized, medically unsupported, and harmful to patient access; injectate restrictions (disallowance of local anesthetic alone) contradict evidence and guidelines showing local anesthetic alone is effective and safer; exclusion of TPIs for those with low back pain (LBP), fibromyalgia, and related conditions are inconsistent with evidence and that TPI can be beneficial for selected patients; frequency limits and annual caps are unsupported by evidence; provider attestation requirements are unlawful, administratively burdensome, and contrary to CMS policy; and that the LCD structurally lacks clear organization, rationale, and transparent linking of each coverage criterion to supporting evidence which undermines due process and appeals. They recommend withdrawing and revising the proposed LCD, removing unsupported exclusions and rigid criteria, reassessing evidentiary methodology, aligning coverage rules with accepted clinical practice and multidisciplinary expert input, and ensuring each criterion is clearly justified with appropriate medical evidence and legal authority. A reference list of citations was provided with their comments.	Thank you for your comments. Although no full-text articles were submitted, we did review the 71 references listed in the comment document. Forty-four unique references were identified, and 35 were already included in the LCD bibliography. Nine references were not included. Of the nine references not included six required purchases and were not publicly accessible. These references addressed topics such as muscle blocks for thoracic outlet syndrome and general diagnostic discussions of MPS published more than 12 years ago. The subject matters were outside the scope of this LCD and did not address covered indications or outcome based evidence relevant to this policy. Of the remaining three references, two were publicly accessible. One was a narrative review of ultrasound-guided interventions for thoracic spine and chest wall pain, which is outside the scope of this LCD as it does not evaluate TPIs or MPS. Another reference (Finnoff et al) was a general position statement on interventional musculoskeletal ultrasound that evaluates ultrasound-guided injections broadly across joints and soft tissues; however, it does not evaluate TPIs or MPS specifically, and does not provide outcome based evidence supporting image-guided TPIs. The final reference could not be identified through database searches. Therefore, none of the additional references changed the evidence review or coverage determinations for this LCD. The approach to diagnosis of myofascial pain for the treatment of TPIs is supported by the citations referenced in the bibliography. Inadvertently, a citation for the multimodal program was removed during the LCD revision. The citation was added to the final version of the LCD. The reference speaks to practice guidelines in which TPIs should be considered for treatment of patients with myofascial pain as part of a multimodal approach to pain management. The need for provider attestation reduces automatic denials, does not require excess documentation to be submitted with the claim, and improves patient access to treatment as long as the requirements of attestation are met. For concerns regarding frequency and annual TPI limitations, please see comment response #1. For concerns regarding injectate use, please see comment response #2. For concerns regarding ultrasound guidance with TPIs, please see comment response #3. For concerns regarding covered diagnoses, please see comment response #4.
6	A comment was received that “multimodal program” and “active participation” should be better defined. The commenter stated that TPIs often facilitate patient participation in pain intervention programs. No literature was submitted with this comment.	Thank you for your comment. Currently, the multimodal program and what is determined as active participation are left to the discretion of the provider. While literature often states physical therapy as the most common adjunctive treatment in trigger point pain management, we have deliberately chosen not to define treatment modalities which allows the provider to determine individualized interventions (i.e., provider-monitored stretching program, heat, ice, etc.) However, as stated in the policy, the documentation must clearly demonstrate the patient’s involvement in the multimodal program to support the medical necessity of TPIs.

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Associated Documents

Related Local Coverage Documents
Articles
A57751 - Billing and Coding: Trigger Point Injections (Future)
LCDs
L35010 - Trigger Point Injections (Future)
DL35010 - Trigger Point Injections

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Updated On	Effective Dates	Status
07/17/2026	07/23/2026 - N/A	Currently in Effect	You are here

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Contents

Response to Comments: Trigger Point Injections

Document Note

Note History

Contractor Information

Article Information

General Information

CMS National Coverage Policy

Article Guidance

Response To Comments

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