Proposed LCD - Trigger Point Injections (TPI) (DL39656)

CMS National Coverage PolicyItalicizedfont represents CMS national language/wording copied directly from CMS Manuals or CMS Transmittals. Contractors are prohibited from changing national language/wording.Title XVIII of the Social Security Act, 1862(a)(1)(A) allows coverage and payment for only those services that are considered to be reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.Title XVIII of the Social Security Act, 1862(a)(1)(D) Investigational or ExperimentalIOM Citations:CMS IOM Publication 100-08,Medicare Program Integrity Manual,~ Chapter 13, 13.5.4 Reasonable and Necessary Provision in an LCDSocial Security Act (Title XVIII) Standard References:Title XVIII of the Social Security Act, Section 1862(a)(1)(A) states that no Medicare payment shall be made for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury.Title XVIII of the Social Security Act, Section 1862(a)(7). This section excludes routine physical examinations.Code of Federal Regulations (CFR) References:CFR, Title 42, Ch. IV,  410.74 Physician assistants services, 410.75 Nurse practitioners services and  410.76 Clinical nurse specialists services.NCDsNCD 30.3.3 Acupuncture for Chronic Low Back PainCoverage Indications, Limitations, and/or Medical NecessityInitial Trigger Point InjectionTrigger point injections (TPI) will be considered medically reasonable and necessary to treat myofascial pain caused by trigger points when all the following requirements are met:There is a focal area of pain in the skeletal muscle.There is clinical evidence of a trigger point defined as pain in a skeletal muscle that is associated with at least 2 of the following findings: the presence of a hyperirritable spot and/or taut band identified by palpation and possible referred painANDThe physical examination identifies a focal hypersensitive bundle or nodule of muscle fiber harder than normal consistency with or without a local twitch response and referred painANDNon-invasive conservative therapy is not successful as first line treatmentORmovement of a joint or limb is limited or blockedORthe TPI is necessary for diagnostic confirmation.Subsequent TPIRepeat Trigger point injections in previously injected trigger points will be considered medically reasonable and necessary to treat myofascial pain syndrome when all the following requirements are met:There is a positive pain response from the most recent TPI defined as providing consistent minimum of 50% relief of primary (index) pain after the TPI measured by the SAME pain scale* at baseline and post-injectionANDConsistent pain relief from the most recent previous TPI lasting at least 6 weeks1ANDThe myofascial pain has reoccurred and is causing objective functional limitations measured by a functional scale obtained at baseline and after TPI which demonstrated at least 50% improvement from the previous TPI.*Note: The scales used to measure pain and/or disability must be documented in the medical record. Acceptable scales include but are not limited to: verbal rating scales, Numerical Rating Scale (NRS) and Visual Analog Scale (VAS) for pain assessment, and Pain Disability Assessment Scale (PDAS), Oswestry Disability Index (ODI), Oswestry Low Back Pain Disability Questionnaire (OSW), Quebec Back Pain Disability Scale (QUE), Roland Morris Pain Scale, Back Pain Functional Scale (BPFS), and the PROMIS profile domains to assess function.Limitations: No more than three (3) TPI sessions will be reimbursed per rolling 12 months.Requirements:Patients should be part of an ongoing conservative treatment program and documentation to support the patient is actively participating in a rehabilitation program, home exercise program or functional restoration program is in the medical record.There should be at least 6 weeks duration before TPI is repeated in the same location.Trigger point primary index pain must be measured prior to the injection at the beginning of the session.The post procedure pain level must be measured after the TPI at the conclusion of the session using the same scale* utilized at baseline.When documenting the percentage of pain relief from the primary (index) pain compared to the post-injection pain levels, it is insufficient to report only a percentage of pain relief and/or a nonspecific statement of the duration of pain relief. The documentation should include a specific assessment of the duration of relief being consistent or inconsistent with the agent used for the injection and the specific dates the measurements were obtained using the SAME pain scale* used at baseline.When documenting the ability to perform previously painful movements and activities of daily living (ADLs) it is insufficient to provide a vague or nonspecific statement regarding the improvement of previously painful movements and activities of daily living (ADLs). The documentation should include a functional assessment to show clinically meaningful improvement with painful movements and ADLs, if this metric is used to justify the efficacy of the TPI Providers should use established and measurable goals and objective scales to assess functionality and ADLs measures.Limitations:A TPI involves the use of a local anesthetic and does not include injections of biologics (e.g., platelet rich plasma, stem cells, amniotic fluid, etc.) and/or any other injectates.It is not considered medically reasonable and necessary to perform TPI into multiple muscle groups in different anatomical regions during the same session.It is not considered medically reasonable and necessary to perform multiple blocks (ESI, sympathetic blocks, facet blocks etc.) during the same session as TPI.Trigger points injections for treatment of headache, neck pain or low back pain in absence of actual trigger points, diffuse muscle pain, a chronic pain syndrome, lumbosacral canal stenosis, fibromyalgia, non-malignant multifocal musculoskeletal pain, complex regional pain syndrome, sexual dysfunction/ pelvic pain, whiplash, neuropathic pain, and hemiplegic shoulder painare considered investigational and therefore are not considered medically reasonable and necessary.Use of fluoroscopy or MRI guidance for performance of TPI is not considered reasonable and necessary.The use of ultrasound guidance for the performance of TPI is considered investigational.Trigger point injections used on a routine basis, e.g., on a regular periodic and continuous basis, for patients with chronic non-malignant pain syndromes are not considered medically necessary.Provider Qualifications:The Medicare Program Integrity Manual states services will be considered medically reasonable and necessary only if performed by appropriately trained providers.Patient safety and quality of care mandate that healthcare professionals who perform TPI injections/procedures for chronic pain (not surgical anesthesia) are appropriately trained and/or credentialed by a formal residency/fellowship program and/or are certified by either an accredited and nationally recognized organization or by a post-graduate training course accredited by an established national accrediting body or accredited professional training program whose core curriculum includes the performance and management of the procedures addressed in this policy. Credentialing or privileges are required for procedures performed in inpatient and outpatient settings.2All aspects of care must be within the provider's medical licensure and scope of practice. Reimbursement for procedures utilizing imaging techniques may be made to providers who meet training requirements for the procedures in this policy only if their respective state allows such in their practice act and formally licenses or certifies the practitioner to use and interpret these imaging modalities (ionizing radiation and associated contrast material, magnetic resonance imaging, ultrasound). At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics as well as proficiency in diagnosis and management of disease, the technical performance of the procedure, and utilization of the required associated imaging modalities.General InformationAssociated InformationN/ASources of InformationN/ABibliography