Proposed Local Coverage Determination (LCD)

Pain Management

DL33622

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Proposed LCD
Proposed LCDs are works in progress that are available on the Medicare Coverage Database site for public review. Proposed LCDs are not necessarily a reflection of the current policies or practices of the contractor.

Document Note

Posted: 11/3/2022
Due to a technical disruption in the LCD comments mailbox address, the comment period for this proposed LCD has been extended through 12/5/2022.

This LCD is being taken to the open meeting to reflect the removal of information regarding sacroiliac (SI) joint injections as this will now be an individual draft LCD. Otherwise, the LCD is not open for official comment.

Note History

Contractor Information

Proposed LCD Information

Document Information

Source LCD ID
L33622
Proposed LCD ID
DL33622
Proposed LCD Title
Pain Management
AMA CPT / ADA CDT / AHA NUBC Copyright Statement

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Issue

Issue Description

Information regarding sacroiliac (SI) joint injections has been removed and will become a new LCD. 

CMS National Coverage Policy

Language quoted from Centers for Medicare and Medicaid Services (CMS), National Coverage Determinations (NCDs) and coverage provisions in interpretive manuals is italicized throughout the policy. NCDs and coverage provisions in interpretive manuals are not subject to the Local Coverage Determination (LCD) Review Process (42 CFR 405.860[b] and 42 CFR 426 [Subpart D]). In addition, an administrative law judge may not review an NCD. See Section 1869(f)(1)(A)(i) of the Social Security Act.

Unless otherwise specified, italicized text represents quotation from one or more of the following CMS sources:

Title XVIII of the Social Security Act (SSA):

Section 1862(a)(1)(A) excludes expenses incurred for items or services which are not reasonable and necessary for the diagnosis or treatment of illness or injury or to improve the functioning of a malformed body member.

Section 1833(e) prohibits Medicare payment for any claim which lacks the necessary information to process the claim.

Code of Federal Regulations:

42 CFR, Section 410.32, indicates that diagnostic tests may only be ordered by the treating physician (or other treating practitioner acting within the scope of his or her license and Medicare requirements) who furnishes a consultation or treats a beneficiary for a specific medical problem and who uses the results in the management of the beneficiary's specific medical problem. Tests not ordered by the physician (or other qualified non-physician provider) who is treating the beneficiary are not reasonable and necessary (see Sec. 411.15(k)(1) of this chapter).

CMS Publications:

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15:

    50 – 50.6 Drugs and Biologicals

CMS Publication 100-02, Medicare Benefit Policy Manual, Chapter 15:

    80 Requirements for Diagnostic X-Ray, Diagnostic Laboratory, and Other Diagnostic Tests

CMS Publication 100-03, Medicare National Coverage Determinations (NCD) Manual, Chapter 1:

      30.3 Acupuncture

 

      150.7 Prolotherapy, Joint Sclerotherapy, and Ligamentous Injections with Sclerosing Agents

 

      220.1 Computed Tomography

 

    280.14 Infusion Pumps

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 12:

      40 Surgeons and Global Surgery

 

      50 Payment for Anesthesiology Services

 

      70 Payment Conditions for Radiology Services

 

    140.3.2 Anesthesia Time and Calculation of Anesthesia Time Units

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 13:

      10 ICD-9-CM Coding for Diagnostic Tests

 

      20 Payment Conditions for Radiology Services

 

    30 Computerized Axial Tomography (CT) Procedures

CMS Publication 100-04, Medicare Claims Processing Manual, Chapter 23:

    20.9 Correct Coding Initiative (CCI)

CMS Publication 100-08, Program Integrity Manual, Chapter 13:

    13.5.1 – Reasonable and Necessary Provisions in LCDs

National Correct Coding Initiative Policy Manual for Medicare Services, Chapter II: Anesthesia Services. CPT Codes 00000-09999.

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract:

Acute pain is elicited by the injury of body tissues and activation of nociceptive transducers at the site of local tissue damage. This type of pain is often a reason to seek health care, and it occurs after trauma, surgical interventions, and some disease processes.

Chronic pain has been defined as "persistent or episodic pain of duration or intensity that adversely affects the function or well-being of the patient, attributable to any nonmalignant etiology" ("Practice Guidelines for Chronic Pain Management: A Report by the American Society of Anesthesiologists Task Force on Pain Management, Chronic Pain Section"). In addition, the pain has been refractory to repeated attempts at medical management and usually has been present for at least three to six months.

Pain associated with cancer includes pain associated with disease progression as well as treatments. Pain associated with cancer can have multiple causes—namely, disease progression, treatment (e.g., neuropathic pain resulting from radiation therapy), and co-occurring diseases (e.g., arthritis). Regardless of whether the pain associated with cancer stems from disease progression, treatment, or a co-occurring disease, it may be either acute or chronic.

Spinal pain generates from multiple structures in the spine. Certain conditions may not be detectable using currently available technology or biochemical studies. However, for a structure to be implicated, it should have been shown to be a source of pain in patients, using diagnostic techniques of known reliability and validity. The structures responsible for pain in the spine, include but are not limited to, the vertebral bodies, intervertebral discs, spinal cord, nerve roots, facet joints, ligaments, muscles, atlanto-occipital joints and atlanto-axial joints. 

Postlaminectomy syndrome/failed back syndrome or pain following operative procedures of the spine, sometimes known as failed management syndrome, is becoming an increasingly common entity in modern medicine. Other spinal conditions causing pain include various degenerative disorders such as spinal stenosis, spondylolysis, spondylolisthesis, degenerative scoliosis, idiopathic vertebrogenic sclerosis, diffuse idiopathic spinal hyperostosis, and segmental instability. Degenerative conditions other than disc disruption and facet arthritis may contribute to approximately 5% to 10% of spinal pain.

Neural blockade is one technique used in chronic pain management. Neural blockade is the interruption of neural transmission by the injection of a local anesthetic agent or other drug. Nerve block therapy can be used to answer specific questions resulting from a careful evaluation of the patient's pain problem and to gain insight into the underlying problem causing the pain. Success of the nerve block is determined by the adequacy of interruption of nerve function, and the effect of that blockade on the patient's pain. The goal of chronic pain management is to achieve optimal pain control, recognizing that a pain-free state may not be achievable; minimize adverse outcomes; enhance functional abilities and physical and psychological well-being; and enhance the quality of life for patients with chronic pain.

The decision to treat chronic pain by invasive or destructive procedures must be based on a thorough evaluation of the patient and include a systematic assessment of the location, intensity, and pathophysiology of the pain. A detailed pain history that includes prior treatment and response to treatment is essential. A detailed physical examination and review of all pertinent diagnostic tests is also needed. This local coverage determination documents National Government Services indications and limitations for pain management treatment.

For complete coverage detail, please review each of the following sections: Indications and Limitations for Specific Types of Injections, Limitations for All Diagnostic and Therapeutic Pain Management Services. Documentation Requirements and Utilization Guidelines have been moved to Coding and Billing article A52863. 
 


Indications and Limitations for Specific Types of Injections

TRIGGER POINT INJECTIONS


Trigger point injection is one of the many modalities utilized in the management of chronic pain. Myofascial trigger points are self-sustaining hyperirritative foci that may occur in any skeletal muscle in response to strain produced by acute or chronic overload. These trigger points produce a referred pain pattern characteristic for that individual muscle. Production of a referred pain pattern differentiates myofascial pain syndrome from tender points and fibromyalgia. Each pattern becomes part of a single muscle myofascial pain syndrome (MPS); and each of these single muscle syndromes is responsive to appropriate treatment, which includes injection therapy. Injection is achieved with needle insertion and the administration of agents such as local anesthetics.

Indications:

The diagnosis of trigger points requires a detailed history and thorough physical examination. The following clinical features are present most consistently, and are helpful in making the diagnosis:

  • History of onset of the painful condition, and its presumed cause (injury, sprain, etc.);
  • Distribution pattern of pain consistent with the referral pattern of the trigger points;
  • Restriction of range of motion with increased sensitivity to stretch;
  • Muscular deconditioning in the affected area;
  • Focal tenderness of a trigger point;
  • Palpable taut band of muscle in which trigger point is located;
  • Local taut response to snapping palpation or needle insertion; and
  • Reproduction of referred pain pattern upon stimulation of the trigger point.

The goal is to treat the cause of the pain and not just the symptom of pain. Other treatment modalities include:

  • Pharmacologic treatment including analgesics and medications to induce sleep and relax muscles (i.e. antidepressants, neuroleptics, or non steroidal anti-inflammatory drugs); and
  • Nonpharmacologic treatment modalities (i.e., osteopathic manual medicine techniques, massage, ultrasonography, application of heat or ice, transcutaneous electrical nerve stimulation, Spray and Stretch technique); and
  • For trigger points in the acute state of formation (before additional pathologic changes develop), effective treatment may be delivered through physical therapy.

After myofascial pain syndrome is established as described above, trigger point injection may be indicated when noninvasive medical management is not successful or as first line treatment. Additionally, trigger point injection is indicated when the movement of a joint is mechanically blocked as is the case of the coccygeus muscle.

Limitations:

Only one trigger point injection procedure should be reported on any particular day, no matter how many sites or regions are injected.

The local anesthetic administered in conjunction with trigger point injections is included in the practice expense for these procedures.

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.

Only injections of local anesthetics and corticosteroids are covered. Injections consisting of only saline and/or botanical substances are not supported in the peer-reviewed literature and are not considered medically necessary. Prior to January 21, 2020, dry needling is not a covered service. Effective January 21, 2020, Medicare will cover all types of acupuncture including dry needling for chronic low back pain within specific guidelines in accordance with NCD 30.3.3.



INJECTION OF TENDON SHEATHS, LIGAMENTS, GANGLION CYSTS, CARPAL AND TARSAL TUNNELS

Injection into tendon sheaths, ligaments, ganglion cysts, tarsal or carpal tunnel is sometimes indicated to provide relief of pain and to reduce the inflammation in these structures when response to conservative measures has failed or is not indicated.

For the purposes of clarity the following descriptions are offered for each term:

Ligament - A band of tissue that connects bones.

Tendon - A fibrous cord of connective tissue attaching a muscle to a bone or other structure. A tendon sheath is the lining enclosing a tendon. It facilitates movement around the tendon.

Ganglion cyst - These knot like masses are non-cancerous and fluid filled cysts that arise from the ligaments, joint linings, or tendon sheaths.

Carpal tunnel - This is a passageway that runs from the forearm through the wrist. The median nerve and nine tendons pass through the tunnel.

Tarsal tunnel - A passageway on the medial side of the tarsus. The posterior tibial nerve passes through the tunnel.

Indications for Tendon Sheath, Ligament, Ganglion Cysts, Carpal and Tarsal Tunnel Injections:

Injection into tendon sheaths, their origins or insertions, ligaments, or ganglion cysts is indicated to relieve substantial pain and/or significant functional disability that results from inflammation or other pathological changes in those structures. Proper use of this modality should be part of an overall management plan including diagnostic evaluation in order to clearly identify and properly treat the primary cause.

Other conservative therapy has not provided acceptable relief, is contraindicated, or not appropriate.

There is a reasonable likelihood that injection will significantly improve the patient's pain and/or functional disability.

Injection of a carpal tunnel may be indicated for the patient with mild to moderate symptoms when pharmaceutical and other conservative measures have failed or are not otherwise indicated.

Injection of the tarsal tunnel may be indicated for conservative management of tarsal tunnel syndrome.

Limitations for Tendon Sheath, Ligament, Ganglion Cysts, Carpal and Tarsal Tunnel Injections:

When a given specific tendon, ligament, tunnel, or cyst is injected, it will be considered one injection service regardless of the number of injections administered at that specific anatomical location on a single date of service.

LIMITATIONS FOR ALL PAIN MANAGEMENT SERVICES

General anesthesia or monitored anesthesia care (MAC) is rarely, if ever required for injections addressed in this policy. In fact, general anesthesia is contraindicated for diagnostic blocks (Manchikanti et al, 2005). Further, monitored anesthesia care or heavy sedation may provide false-positive results.

Provider Qualifications
The CMS Manual System, Pub. 100-8, Program Integrity Manual, Chapter 13, Section 5.1 (http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf) states that "reasonable and necessary" services are "ordered and/or furnished by qualified personnel." 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 spinal pain management procedures 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. (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). A practitioner who works in a hospital or ASC facility at any time should be credentialed by the facility for any procedure also performed in an office setting.

Summary of Evidence

N/A

Analysis of Evidence (Rationale for Determination)

N/A

Proposed Process Information

Synopsis of Changes
Changes Fields Changed
Information regarding sacroiliac (SI) joint injections has been removed from the Indications and Limitations section of the LCD. Coverage Indications, Limitations and/or Medical Necessity
Associated Information
N/A
Sources of Information

This bibliography presents those sources that were obtained during the development of this policy. National Government Services is not responsible for the continuing viability of Web site addresses listed below.

  1. Alvarez DJ, Rockwell PG. Trigger points: diagnosis and management. Am Fam Phys. 2002;64(4):653-660.

  2. American Medical Association (2004). CPT Assistant. Chicago IL.

  3. Aydin SM, Gharibo CG, Mehnert M, Stitik TP. The role of radiofrequency ablation for sacroiliac joint pain: a meta-analysis. PM R. 2010 Sep;2(9):842-851.

  4. Bogduk N, Clinical Anatomy of the Lumbar Spine and Sacrum. Churchill Livingstone 1997:127-247.

  5. Cardone DA, Tallia A.F. Joint and soft tissue injection. Am Fam Phys. 2002;66(2):283-287.

  6. Cheng J, Pope JE, Dalton JE, Cheng O Bensitel A. Comparative Outcomes of Cooled Versus Traditional Radiofrequency Ablation of the Lateral Branches for Sacroiliac Joint Pain. Clin J Pain. 2013 Feb:29(2):132-137.

  7. Cohen SP, Abdi S. Lateral branch blocks as a treatment for sacroiliac joint pain: A pilot study. Regional Anesthesia and Pain Medicine. 2003 March-April;28(2):113–119.

  8. Cohen SP, Hurley RW, Buckenmaier CC 3rd, Kurihara C, Morlando b, Dragovich A. Randomized placebo-controlled study evaluating lateral branch radiofrequency denervation for sacroiliac joint pain. Anesthesiology. 2008 Aug;109(2):279-288.

  9. Cohen SP, Strassels SA, Kurihara C, et al. Outcome predictors for sacroiliac joint (lateral branch) radiofrequency denervation. Reg Anesth Pain Med. 2009 May-Jun;34(3):206-214.

  10. Cummings TM, White AR. Needling therapies in the management of myofascial trigger point pain: a systemic review. Arch Phys Med Rehabil. 2001;82:986-992.

  11. Dreyfuss P, Henning T, Malladi N, Goldstein B, Bogduk N. The ability of multi-site, multi-depth sacral lateral branch blocks to anesthetize the sacroiliac joint complex. Pain Medicine. 2009;10(4):680-688.

  12. Dussault RG, Kaplan PA, & Anderson, MW. Fluoroscopy-guided sacroiliac joint injections. Radiology. 2000;214:273-277.

  13. Hansen HC. Is fluoroscopy necessary for sacroiliac joint injections? Pain Physician. 2003;6:155-158. http://www.painphysicianjournal.com. Accessed 07/14/2008.

  14. Hansen HC, Helm S. Sacroiliac joint pain and dysfunction. Pain Physician. 2003;6:179-189. http://www.painphysicianjournal.com. Accessed 07/14/2008.

  15. Hansen HC, McKenzie-Brown AM, Cohen SP, Swicegood JR, Colson JD, Manchikanti L. Sacroiliac joint interventions: A systematic review. Pain Physician. 2007;10:165-184.

  16. Hansen H, Manchikanti L, Simopoulos TT, et al. A systematic evaluation of the therapeutic effectiveness of sacroiliac joint interventions. Pain Physician. 2012;15:E247-E278.

  17. Ho KY, Hadi MA, Pasutharnchat K, Tan KH. Cooled radiofrequency denervation for treatment of sacroiliac joint pain: two-year results from 20 cases. J Pain Res. 2013 Jul 4;6:505-511.

  18. Jaworski CA. Current understanding of tendinopathies and treatment options. American Family Physician. 2007;76(6):773-774.

  19. Johnson GW, Cadwallander K, Scheffel SB, Epperly TD. Treatment of lateral epicondylitis. American Family Physician. 2007;76:843-853.

  20. Kapural L, Nageeb F, Kapural M, Cata JP, Narouze S, Mekhail N. Cooled radiofrequency xystem for the treatment of chronic pain from sacroiliitis: the first case-series. Pain Pract. 2008 Sep-Oct;8(5):348-354.

  21. Karaman H, Kavak GÖ, Tüfek A, et al. Cooled radiofrequency application for treatment of sacroiliac joint pain. Acta Neurochir (Wien). 2011 Jul;153(7):1461-1468.

  22. Kietrys DM, Palombaro KM, Azzaretto E, Hubler R, Schaller B, Schlussel JM, Tucker M. Effectiveness of dry needling for upper-quarter myofascial pain: A systematic review and meta-analysis. Journal of Orthopaedic & Sports Physical Therapy. 2013 Sep;43(9):620-634.

  23. Kim PS. Role of injection therapy: review of indications for trigger point injections, regional blocks, facet joint injections, and intra-articular injections. Current Opinion in Rheumatology. 2002;14:52-57.

  24. Lavelle ED, Lavelle W, Smith HS. Myofascial trigger points. Med Clin N Am. 2007;91:220-239.

  25. Leblanc KE. Sacroiliac sprain: an overlooked cause of back pain. Am Fam Phys. 1992;46(5):1459-1463.

  26. Manchikanti L, Abdi S, Atluri S, et al. An update of comprehensive evidence-based guidelines for interventional techniques in chronic spinal pain. Part II: guidance and recommendations. Pain Physician. 2013;16:S49-S283.

  27. Manchikanti L, Singh V, Kloth D, Slipman CW, et al. Interventional techniquest in the management of chronic pain: Part 2.0. Pain Physician. 2001;4(1):24-98. http://www.asipp.org. Accessed 07/11/2008.

  28. Manchikanti L, Statts PS, Singh V, et al. Evidence-based practice guidelines for interventional techniques in the management of chronic spinal pain. Pain Physician. 2003;6:3-81. http://www.asipp.org. Accessed 07/11/2008.

  29. Muhlner SB. Review article: radiofrequency neurotomy for the treatment of sacroiliac joint syndrome. Curr Rev Musculoskelet Med. 2009;2:10–14.

  30. Patel N, Gross A, Brown L. Gekht G. A randomized, placebo-controlled study to assess the efficacy of lateral branch neurotomy for chronic sacroiliac joint pain. Pain Medicine. 2012;13:383-398.

  31. Physical Therapists & the Performance of Dry Needling An Educational Resource Paper. Produced by the APTA Department of Practice and APTA State Government Affairs January 2012.

  32. Practice Guidelines for Spinal Diagnostic and Treatment Procedures. International Spine Intervention Society. 2nd Edition.

  33. Schwarzer AC, Derby R, Aprill CN, Fortin J, Kine G, Bogduk N. Pain from the lumbar zygapophysial joints: a test of two models. J Spinal Disord. 1994;7(4):331-336.

  34. Simopoulos TT, Manchikanti L, Singh V, Gupta S, Hameed H, Diwan S, Cohen SP. A systematic evaluation of prevalence and diagnostic accuracy of sacroiliac joint interventions. Pain Physician. 2012;15:E305-E344.

  35. Slipman CW, Sterenfeld EB, Chou LH, Herzog R, Vresilovic E. The value of radionuclide imaging in the diagnosis of sacroiliac joint syndrome. Spine. 1996;21(19):2251-2254.

  36. Stelzer W, Aiglesberger M, Stelzer D, Stelzer V. Use of cooled radiofrequency lateral branch neurotomy for the treatment of sacroiliac joint-mediated low back pain: A large case series. Pain Medicine. 2013 Jan;14(1):29-35.

  37. van der Wurff P, Buijs EJ, Groen GJ. A multitest regimen of pain provocation tests as an aid to reduce unnecessary minimally invasive sacroiliac joint procedures. Arch Phys Med Rehabil. 2006 January;87:10-14.

  38. Waldman SD. Atlas of Pain Management Injection Techniques. Philadelphia: W.B. Saunders; 2000.

  39. Warfield CA. Principles and Practice of Pain Management. McGraw-Hill; 2004.

  40. Wellpoint Medical Policy - Percutaneous Neurolysis for Chronic Neck and Back Pain - Document #: SURG.00066.

  41. Yeung SS, Genaldy A, Deddens J, Alhemood A, Leung PC. Prevalence of musculoskeletal symptoms in single and multiple body regions and effects of perceived risk of injury among manual handling workers. Spine. 2002; 27:2166-2172.

  42. Zelle BA, Gruen GS, Brown S, George S. Sacroiliac joint dysfunction evaluation and management. Clin J Pain. 2005 September/October;21(5):446-455.
Bibliography

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Open Meetings
Meeting DateMeeting StatesMeeting Information
10/20/2022 Connecticut
Illinois
Maine
Massachusetts
Minnesota
New Hampshire
New York - Downstate
New York - Entire State
New York - Queens
New York - Upstate
Rhode Island
Vermont
Wisconsin

Virtual Meeting: 12:00-3:00 p.m. CT, 1:00-4:00 p.m. ET

Contractor Advisory Committee (CAC) Meetings
N/A
MAC Meeting Information URLs
N/A
Proposed LCD Posting Date
09/29/2022
Comment Period Start Date
09/29/2022
Comment Period End Date
12/05/2022
Reason for Proposed LCD
  • Provider Education/Guidance
Requestor Information
This request was MAC initiated.
Contact for Comments on Proposed LCD
National Government Services Medical Policy Unit
P.O. Box 7108
Indianapolis, IN 46207-7108
NGSDraftLCDComments@anthem.com

Associated Documents

Attachments
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Related Local Coverage Documents
Articles
DA52863 - Billing and Coding: Pain Management
Related National Coverage Documents
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Keywords

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