L29210-LCD

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Local Coverage Determination (LCD) for Lacrimal Punctal Plugs (L29210)

Contractor Information

Contractor Name

First Coast Service Options, Inc. opens in new window

Contractor Number 09102

Contractor Type MAC - Part B

LCD Information

Document Information

LCD ID Number L29210

LCD Title

Lacrimal Punctal Plugs

Contractor's Determination Number 68761

Primary Geographic Jurisdiction opens in new window Florida

Oversight Region Region IV

AMA CPT/ADA CDT Copyright Statement

Applicable FARS/DFARS Apply to Government Use. Fee schedules, relative value units, conversion factors and/or related components are not assigned by the AMA, are not part of CPT, and the AMA is not recommending their use. The AMA does not directly or indirectly practice medicine or dispense medical services. The AMA assumes no liability for data contained or not contained herein. The Code on Dental Procedures and Nomenclature (Code) is published in Current Dental Terminology (CDT). Copyright © American Dental Association. All rights reserved. CDT and CDT-2010 are trademarks of the American Dental Association.

Original Determination Effective Date

For services performed on or after 02/02/2009 Original Determination Ending Date

Revision Effective Date

For services performed on or after 06/14/2011 Revision Ending Date

CMS National Coverage Policy N/A

Indications and Limitations of Coverage and/or Medical Necessity

Dry eye is a disorder of the tear film due to tear deficiency or excessive tear evaporation and involves damage to the ocular surface, which may result in an epithelial disorder called keratoconjunctivitis sicca (KCS), dry eye syndrome (DES) or dysfunctional tear syndrome (DTS) and is associated with symptoms which include: dryness, redness, burning, reflex tearing, itching, foreign body sensation, grittiness, stinging, soreness, photophobia and pain. In moderate cases, the ocular discomfort becomes marked and visual acuity may be reduced. Diabetic patients and patients with other corneal neuropathies may exhibit signs of DES with or without discomfort.

To determine the appropriate treatment, an eye examination should be performed to exclude other causes of irritation of the ocular surface. These may include eyelid malposition, inturned eyelashes, incomplete lid closure, allergies, meibomian gland disease, ocular inflammatory processes or systemic diseases (i.e., rheumatoid arthritis, diabetes). Corneal sensation should also be assessed when trigeminal nerve dysfunction is suspected.

When medical therapy is not effective, punctual occlusion may be accomplished by inserting lacrimal punctal plugs into the punctal orifice to decrease tear clearance and increase retention of the tear film by blocking the outflow of tears to the nasolacrimal system.

The occlusion of lacrimal puncta by collagen plugs (temporary/dissolvable) is generally used for the diagnosis of dry eye syndrome. The collagen plugs dissolve within one to two weeks. If a trial of temporary punctual occlusion proves successful, semi-permanent/non-dissolvable occlusion is usually considered.

Silicone or thermal labile polymer plugs (semi-permanent/non-dissolvable) are therapeutic and are generally

used after the diagnosis has been made. After the silicone plugs are inserted, the patient intermittently returns to the physician to insure the integrity of the plugs.

While the choice of initially using collagen (temporary/dissolvable) or silicone (semi-permanent/non-dissolvable) is left to the clinician’s discretion, the semi-permanent plugs afford a more extensive trial of punctal closure, and may better serve to delineate candidates for permanent closure.

FCSO Medicare will consider lacrimal punctal plugs medically reasonable and necessary for patients with the following:

• Symptomatic, moderate, or severe dry eye syndrome when more conservative treatments (i.e., artificial tears) have proven to be ineffective; and

• A diagnosis of aqueous tear deficiency has been confirmed by:

Ø One or more of the following diagnostic tests: tear break-up time (TBUT), Schirmer test, ocular surface dye staining pattern (rose bengal, sodium fluorescein, or lissamine green); and

Ø Slit-lamp biomicroscopy exam.

The CMS On-line Manual System, Pub. 100-8, Program Integrity Manual, Chapter 13, Section 13.5.1

(http://www.cms.hhs.gov/manuals/downloads/pim83c13.pdf) outlines 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. A qualified physician for this service/procedure is defined as follows: A) Physician is properly enrolled in Medicare. B) Training and expertise must have been acquired within the framework of an accredited residency and/or fellowship program in the applicable specialty/subspecialty in the United States or must reflect equivalent education, training, and expertise endorsed by an academic institution in the United States and/or by the applicable specialty/subspecialty society in the United States.

Coding Information

Bill Type Codes:

Contractors may specify Bill Types to help providers identify those Bill Types typically used to report this service. Absence of a Bill Type does not guarantee that the policy does not apply to that Bill Type. Complete absence of all Bill Types indicates that coverage is not influenced by Bill Type and the policy should be assumed to apply equally to all claims.

999x Not Applicable

Revenue Codes:

Contractors may specify Revenue Codes to help providers identify those Revenue Codes typically used to report this service. In most instances Revenue Codes are purely advisory; unless specified in the policy services reported under other Revenue Codes are equally subject to this coverage determination. Complete absence of all Revenue Codes indicates that coverage is not influenced by Revenue Code and the policy should be assumed to apply equally to all Revenue Codes.

99999 Not Applicable

CPT/HCPCS Codes

68761 CLOSURE OF THE LACRIMAL PUNCTUM; BY PLUG, EACH

ICD-9 Codes that Support Medical Necessity

370.33 KERATOCONJUNCTIVITIS SICCA NOT SPECIFIED AS SJOGREN'S

375.15 TEAR FILM INSUFFICIENCY UNSPECIFIED

Diagnoses that Support Medical Necessity N/A

ICD-9 Codes that DO NOT Support Medical Necessity XX000 Not Applicable

ICD-9 Codes that DO NOT Support Medical Necessity Asterisk Explanation

Diagnoses that DO NOT Support Medical Necessity N/A

General Information

Documentations Requirements

Medical record documentation must include the following:

• Patient’s complaints normally associated with dry eye syndrome (e.g., dryness, redness, burning, reflex tearing, itching, foreign body sensation, grittiness, stinging, soreness, photophobia and pain).

• Results of physical examination, including external examination and slit-lamp biomicroscopy exam.

• Results of one or more of the following diagnostic tests: tear break-up time test (TBUT), Schirmer test, ocular surface dye staining pattern (rose bengal, fluorescein, or lissamine green).

• Evidence of trial period of artificial tears that proved unsuccessful in relieving the patient’s symptoms, preceding the decision to place the lacrimal punctal plugs.

• Operative report to include the type of plug used and which puncta were involved.

Documentation on follow-up visits after placement of the collagen or silicone plugs must indicate the status of the patient’s symptoms.

All coverage criteria must be clearly documented in the patient’s medical record and made available to Medicare upon request.

Appendices

Utilization Guidelines It is expected that these services would be performed as indicated by current medical literature and/or standards of practice. When services are performed in excess of established parameters, they may be subject to review for medical necessity.

Generally, repetitive use of temporary lacrimal punctal plugs for treatment of dry eye syndrome would not be expected.

Sources of Information and Basis for Decision

Altan-Yaycioglu, R., Gencoglu, E., Akova, Y., Dursun, D., Cengiz, F., & Akman, A. (2005). Silicone verus collagen plugs for treating dry eye: results of a prospective randomized trial including lacrimal scintigraphy. American Journal of Ophthalmology. Retrieved March 30, 2007 from mdconsult database (68579271).

American Academy of Ophthalmology. (2003). Preferred Practice Patterns for Dry Eye Syndrome. Retrieved March 30, 2007 from www.aao.org website.

Clinician SynerMed Communications. (2006). State-of-the-art management of chronic dry eye: a growing public health concern, 24(16), 1-18.

Corcoran, K. (2005). Find the proper documentation requirements and reimbursement potential for diagnosing and treating dry eye syndrome. Optometric Management. Retrieved on April 5, 2007 from www.optometric.com (71542).

CPT Assistant, June 1996, p.11.

Optometric Clinical Practice Guideline. (2002). Care of the Patient with Ocular Surface Disorders. Retrieved March 30, 2007 from www.aoa.org website.

Yanoff. (2007). Ophthalmology (2nd ed.). Retrieved March 30, 2007 from mdconsult database (68579271).

Advisory Committee Meeting Notes This Local Coverage Determination (LCD) does not reflect the sole opinion of the contractor or Contractor Medical Director. Although the final decision rests with the contractor, this LCD was

developed in cooperation with advisory groups, which includes representatives from numerous societies.

Start Date of Comment Period

End Date of Comment Period

Start Date of Notice Period 12/04/2008

Revision History Number 1

Revision History Explanation Revision Number1 Start Date of Comment Period:N/A

Start Date of Notice Period:07/01/2011 Revised Effective Date 06/14/2011

LCR B2011-075

June 2011 Connection

Explanation of Revision: Based on an outside request to clarify our current training statement outlined in this LCD, language under the “Indications and Limitations” section of the LCD has been deleted and replaced with a revised statement regarding the qualification and training. Revisions will be effective based on process date.

Revision Number:Original

Start Date of Comment Period:N/A Start Date of Notice Period:12/04/2008 Revised Effective Date:02/02/2009

LCR B2009-

December 2008 Bulletin

This LCD consolidates and replaces all previous policies and publications on this subject by the carrier predecessors of First Coast Service Options, Inc. (Triple S and FCSO).

For Florida (00590) this LCD (L29210) replaces LCD L25285 as the policy in notice. This document (L29210) is effective on 02/02/2009.

Reason for Change