Coverage Indications, Limitations, and/or Medical Necessity

Introduction:

This policy does not address sacral conditions, injections or neurotomies. Sacral injections, identified on the claim by the ICD-10 code M43.27, M43.28, M53.2X7, M53.2X8, M53.3, M53.87 or M53.88 are not subject to the requirements of this local coverage determination (LCD).

Facet joints are paired diarthrodial articulations of the superior and inferior articular processes of adjacent vertebrae. The medial branches (MB) of the dorsal rami of the segmental nerves innervate facet joints and the MB nerves from the two adjacent dorsal rami innervate each joint. [Exceptions to this rule are the C2-3 facet joint, which is innervated by the third occipital nerve and the L5-S1 facet joint, which is innervated by the L4 MB and the L5 dorsal ramus.]

Facet joint injection techniques are used in the diagnosis and/or treatment of chronic neck and back pain. However, the evidence of clinical efficacy and utility has not been well-established in the medical literature, which is replete with non-comparable and inadequately designed studies. Further, there is a singular dearth of long-term outcomes reports. This is particularly problematic given the steroid dosages administered. These drugs alone may develop the relief experienced by patients but are associated with serious adverse health events and could as well be administered orally. Hence, ongoing coverage requires outcomes reporting as described in this LCD to allow future analysis of clinical efficacy.

Definitions

A zygapophyseal (aka facet) joint “level” refers to the zygapophyseal joint or the two medial branch (MB) nerves that innervate that zygapophyseal joint.
A “session” is defined as all injections/blocks/radiofrequency (RF) procedures performed on one day and includes medial branch blocks (MBB), intraarticular injections (IA), facet cyst ruptures and RF ablations.

A “region” is all injections performed in the cervical/thoracic area or all injections performed in lumbar (not sacral) spinal areas.
"Diagnosis” of facet-mediated pain requires the establishment of pain relief following dual medial branch blocks (MBBs) performed at different sessions. Neither physical exam nor imaging has adequate diagnostic power to confidently distinguish the facet joint as the pain source.

Indications

Patient must have a history of at least 3 months of moderate to severe pain with functional impairment and the pain is inadequately responsive to conservative care such as non-steroidal anti-inflammatory drugs (NSAIDs), acetaminophen and/or physical therapy (as tolerated).

The pain is predominantly axial and, with the possible exception of facet joint cysts, not associated with radiculopathy or neurogenic claudication.

There is no non-facet pathology that could explain the source of the patient’s pain, such as fracture, tumor, infection or significant deformity.

Clinical assessment implicates the facet joint as the putative source of pain.

General Procedure Requirements:

Pre-procedural documentation must include a complete initial evaluation including history and an appropriately focused musculoskeletal and neurological physical examination. There should be a summary of pertinent diagnostic tests or procedures justifying the possible presence of facet joint pain.

A procedure note must be legible and include sufficient detail to allow reconstruction of the procedure. Required elements of the note include a description of the techniques employed, nerves injected and sites(s) of injections, drugs and doses with volumes and concentrations, as well as pre and post-procedural pain assessments. With RF neurotomy, electrode position, cannula size, lesion parameters and electrical stimulation parameters and findings must be specified and documented.

Facet joint interventions (diagnostic and/or therapeutic) must be performed under fluoroscopic or computed tomographic (CT) guidance. Facet joint interventions performed under ultrasound guidance will not be reimbursed.

A hard (plain radiograph with conventional film or specialized paper) digital copy image or images which adequately document the needle position and contrast medium flow (excluding RF ablations and those cases in which using contrast is contra-indicated, such as patients with documented contrast allergies) must be retained and submitted if requested.

In order to maintain target specificity, total intra-articular (IA) injection volume must not exceed 1.0 ml per cervical joint or 2 ml per lumbar joint, including contrast. Larger volumes may be used only when performing a purposeful facet cyst rupture in the lumbar spine.

Total MBB anesthetic volume shall be limited to a maximum of 0.5 ml per MB nerve for diagnostic purposes and 2 ml for therapeutic. For a third occipital nerve block, up to 1.0 mL is allowed for diagnostic and 2 ml for therapeutic purposes.

In total, no more than 100 mg of triamcinolone or methylprednisolone or 15 mg of betamethasone or dexamethasone or equivalents shall be injected during any single session.

Both diagnostic and therapeutic IA facet joint injections and medial branch blocks (see criteria below) may be acceptably performed without steroids.

Provider Qualifications
Provider Qualification requirements must be met. Patient safety and quality of care mandate that healthcare professionals who perform facet joint injections, medial branch blocks and facet joint radiofrequency neurotomy are appropriately experienced and/or trained to provide and manage the services. The CMS Internet-Only Manual, Pub. 100-08, Medicare Program Integrity Manual, Chapter 13, Section 13.5.1 underscores this point and states that "reasonable and necessary" services must be "ordered and/or furnished by qualified personnel." Services will be considered medically reasonable and necessary only if performed by appropriately experienced and/or formally trained providers.

The following training requirement applies only to those providers who have not provided these specific interventional pain management services on a regular basis (at least two times per month) during the ten years prior to the effective date of this LCD as may be established by claims billings. A basic requirement of payment is training and/or credentialing by a formal residency/fellowship program and/or other training program that is accredited by a nationally-recognized body and whose core curriculum includes the performance and management of the procedures addressed in this policy. Recognized accrediting bodies include only those whose program accreditation gains the trainee eligibility to sit for a healthcare-related licensing exam or licensing itself, which in turn allows the licensee to perform these procedures. At a minimum, training must cover and develop an understanding of anatomy and drug pharmacodynamics and kinetics, the technical performance of the procedure(s) and utilization of the required associated imaging modalities and the diagnosis and management of potential complications from the intervention.

The following credentialing requirement applies to all providers of the services addressed in this policy. If the practitioner works in a hospital facility at any time and/or is credentialed by a hospital for any procedure, the practitioner must be credentialed to perform the same procedure in the outpatient setting.

Diagnostic Facet Joint Injections

Dual MBBs (a series of two MBBs) are necessary to diagnose facet pain due to the unacceptably high false positive rate of single MBB injections.
A second confirmatory MBB is allowed if documentation indicates the first MBB produced significant relief of primary (index) pain ≥ 50% as evidenced by documented functional improvement, increased range of motion, a decreased requirement for pain medications and duration of relief is consistent with the agent employed.

Intra-articular facet block will not be reimbursed as a diagnostic test unless medial branch blocks cannot be performed due to specific documented anatomic restrictions.

Therapeutic Injections

Either intra-articular or medial branch blocks may provide temporary or long-lasting or permanent relief of facet-mediated pain. Injections may be repeated if the first injection results in significant pain relief (≥ 50%) for at least 3 months. (See the Limitations of Coverage section for the total number of injections that may be performed in one year).
Recurrent pain at the site of a previously treated facet joint may be treated without additional diagnostic blocks if documentation supports ≥ 50% pain relief from the previous block(s) as evidenced by functional improvement, increased range of motion and decreased requirement for pain medications, that has lasted at least 3 months.

Thermal Medial Branch Radiofrequency Neurotomy (includes RF and microwave technologies):

Facet joint denervation with RF medial branch neurotomy may be considered only when dual MBBs provide significant relief of the primary or index pain and duration of relief is consistent with the agent employed (see notation above regarding therapeutic blocks).
Repeat denervation procedures involving the same joint will only be considered medically necessary if the patient experienced ≥ 50% improvement of pain and improvement in patient specific activities of daily living (ADLs) that are documented for at least 6 months.

Limitations of Coverage:

A maximum of five (5) facet joint injection sessions inclusive of medial branch blocks, intraarticular injections, facet cyst rupture and RF ablations may be performed per rolling 12 month year in the cervical/thoracic spine and five (5) in the lumbar spine.

For each covered spinal region (cervical/thoracic or lumbar), no more than two (2) thermal RF sessions will be reimbursed in any rolling 12 month year, involving no more than four (4) joints per session, e.g., two (2) bilateral levels or four (4) unilateral levels.

Neither conscious sedation nor Monitored Anesthesia Care (MAC) is routinely necessary for intra-articular facet joint injections or medial branch blocks and are not routinely reimbursable. Individual consideration may be given for payment in rare unique circumstances if the medical necessity of sedation is unequivocal and clearly documented.

Non-thermal RF modalities for facet joint denervation including chemical denervation (alcohol, phenol, etc.), laser therapy, cryotherapy, as well as pulsed RF are not covered.

Intraarticular and/or extraarticular facet joint prolotherapy is not covered.


CPT/HCPCS Codes

Group 1 Paragraph: N/A

Group 1 Codes:
CODE DESCRIPTION

64490 INJECTION(S), DIAGNOSTIC OR THERAPEUTIC AGENT, PARAVERTEBRAL FACET (ZYGAPOPHYSEAL) JOINT (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), CERVICAL OR THORACIC; SINGLE LEVEL

64491 INJECTION(S), DIAGNOSTIC OR THERAPEUTIC AGENT, PARAVERTEBRAL FACET (ZYGAPOPHYSEAL) JOINT (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), CERVICAL OR THORACIC; SECOND LEVEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

64492 INJECTION(S), DIAGNOSTIC OR THERAPEUTIC AGENT, PARAVERTEBRAL FACET (ZYGAPOPHYSEAL) JOINT (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), CERVICAL OR THORACIC; THIRD AND ANY ADDITIONAL LEVEL(S) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

64493 INJECTION(S), DIAGNOSTIC OR THERAPEUTIC AGENT, PARAVERTEBRAL FACET (ZYGAPOPHYSEAL) JOINT (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), LUMBAR OR SACRAL; SINGLE LEVEL

64494 INJECTION(S), DIAGNOSTIC OR THERAPEUTIC AGENT, PARAVERTEBRAL FACET (ZYGAPOPHYSEAL) JOINT (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), LUMBAR OR SACRAL; SECOND LEVEL (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

64495 INJECTION(S), DIAGNOSTIC OR THERAPEUTIC AGENT, PARAVERTEBRAL FACET (ZYGAPOPHYSEAL) JOINT (OR NERVES INNERVATING THAT JOINT) WITH IMAGE GUIDANCE (FLUOROSCOPY OR CT), LUMBAR OR SACRAL; THIRD AND ANY ADDITIONAL LEVEL(S) (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

64633 DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); CERVICAL OR THORACIC, SINGLE FACET JOINT

64634 DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); CERVICAL OR THORACIC, EACH ADDITIONAL FACET JOINT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)

64635 DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); LUMBAR OR SACRAL, SINGLE FACET JOINT

64636 DESTRUCTION BY NEUROLYTIC AGENT, PARAVERTEBRAL FACET JOINT NERVE(S), WITH IMAGING GUIDANCE (FLUOROSCOPY OR CT); LUMBAR OR SACRAL, EACH ADDITIONAL FACET JOINT (LIST SEPARATELY IN ADDITION TO CODE FOR PRIMARY PROCEDURE)


ICD-10 Codes that Support Medical Necessity
Group 1 Codes:
ICD-10 CODE DESCRIPTION
M47.811 Spondylosis without myelopathy or radiculopathy, occipito-atlanto-axial region
M47.812 Spondylosis without myelopathy or radiculopathy, cervical region
M47.813 Spondylosis without myelopathy or radiculopathy, cervicothoracic region
M47.814 Spondylosis without myelopathy or radiculopathy, thoracic region
M47.815 Spondylosis without myelopathy or radiculopathy, thoracolumbar region
M47.816 Spondylosis without myelopathy or radiculopathy, lumbar region
M47.817 Spondylosis without myelopathy or radiculopathy, lumbosacral region
M47.818 Spondylosis without myelopathy or radiculopathy, sacral and sacrococcygeal region
M62.830* Muscle spasm of back
M71.30 Other bursal cyst, unspecified site


References:
https://www.cms.gov/medicare-coverage-database/details/lcd-details.aspx?LCDId=36471&ContrId=391&ver=18&ContrVer=1&CntrctrSelected=391*1&Cntrctr=391&s=All&DocType=2%7c4&bc=AAgAAAQAAAAA&