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RETIRED Local Coverage Determination (LCD)

Infrared Coagulation (IRC) of Hemorrhoids

L34422

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Retired

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Note History

Contractor Information

LCD Information

Document Information

Source LCD ID
N/A
LCD ID
L34422
Original ICD-9 LCD ID
Not Applicable
LCD Title
Infrared Coagulation (IRC) of Hemorrhoids
Proposed LCD in Comment Period
N/A
Source Proposed LCD
N/A
Original Effective Date
For services performed on or after 10/01/2015
Revision Effective Date
For services performed on or after 07/06/2023
Revision Ending Date
03/01/2024
Retirement Date
03/01/2024
Notice Period Start Date
N/A
Notice Period End Date
N/A

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Issue

Issue Description

This LCD outlines limited coverage for this service with specific details under Coverage Indications, Limitations and/or Medical Necessity.
Issue - Explanation of Change Between Proposed LCD and Final LCD

CMS National Coverage Policy

Title XVIII of the Social Security Act, §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.

Title XVIII of the Social Security Act §1861(s)(2) services and supplies (including drugs and biologicals which are not usually self-administered by the patient) furnished as an incident to a physician’s professional service, of kinds which are commonly furnished in physicians’ offices and are commonly either rendered without charge or included in the physicians’ bills 

Title XVIII of the Social Security Act §1862(a)(14) which are other than physicians’ services certified nurse-midwife services, qualified psychologist services, and services of a certified registered nurse anesthetist, and which are furnished to an individual who is a patient of a hospital or critical access hospital by an entity other than the hospital or critical access hospital, unless the services are furnished under arrangements with the entity made by the hospital or critical access hospital 

Title 42 CFR §410.74 Physician assistants' services

Title 42 CFR §410.75 Nurse practitioners' services

Title 42 CFR §410.76 Clinical nurse specialists' services.

CMS Internet-Only Manual, Pub 100-02, Medicare Benefit Policy Manual, Chapter 15, §260 Ambulatory Surgical Center Services, §260.1 Definition of Ambulatory Surgical Center (ASC), §260.2 Ambulatory Surgical Center Services, §260.3 Services Furnished in ASCs Which are Not ASC Facility Services, §260.4 Coverage of Services in ASCs, Which are Not ASC Services, §260.5 List of Covered Ambulatory Surgical Center Procedures, §260.5.1 Nature and Applicability of ASC List, §260.5.2 Nomenclature and Organization of the List

Coverage Guidance

Coverage Indications, Limitations, and/or Medical Necessity

Abstract

Hemorrhoids are engorgement or enlargement of normal fibrovascular cushions and are thought to be caused by increased pressure in the anal canal. Common sources of pressure that may contribute to hemorrhoids include constipation, straining with defecation, diarrhea, sitting or standing for long periods, obesity, heavy lifting, pregnancy, and childbirth.

A precise definition of hemorrhoids does not exist because the exact nature of the condition is not completely understood. Recent concepts of the pathophysiology of hemorrhoids have revealed that hemorrhoids are not varicosities; instead they are vascular cushions composed of arterioles, venules, and arteriolar-venular communications that slide down or prolapse, become congested and enlarged, and bleed. Three cushions lie in the following constant sites: left lateral; right anterolateral; and right posterolateral. Smaller discrete secondary cushions may be present between the main cushions. These cushions are present at birth and represent a normal anatomic feature of the anal canal. Therefore, the term “hemorrhoids” should refer to symptomatic abnormalities of the normal vascular hemorrhoidal tissue of the anal canal. In the absence of symptoms, the presence of even very large cushions is not an indication for treatment.

Hemorrhoids can be divided into those originating above the dentate line (internal) and those originating below the dentate line (external). This anatomic “border” is of special interest because external pain fibers end at the dentate line and most people have no sensation above this line. External hemorrhoids are rarely symptomatic unless thrombosed. Internal hemorrhoids are classified by history, symptomatology, and physical examination. They are graded as follows:

  • Grade I – bleeding without prolapse

  • Grade II – prolapse with spontaneous reduction

  • Grade III – prolapse with manual reduction required

  • Grade IV – incarcerated, irreducible prolapse.

Initial treatment for chronic symptoms of hemorrhoidal disease should be conservative, and typically includes lifestyle changes such as a high fiber diet, additional fiber supplements, and increased water intake. If symptoms persist in spite of conservative therapy in patients with Grade I, II, or III disease, local treatment is appropriate in the form of infrared coagulation (IRC), local sclerosing injection, or rubber band ligation (RBL). Operative treatment is reserved for symptomatic patients with Grade III or IV hemorrhoids.

The underlying goal of nonsurgical therapy is fixation of the hemorrhoidal cushion. The most common methods currently being employed are injection sclerotherapy, RBL, and IRC. A number of studies have demonstrated that IRC and RBL demonstrate comparable efficacy. However, treatment options are individualized as RBL is more likely to be associated with pain and potential complications, whereas IRC may require additional treatment sessions for recurrence of symptoms. The choice of treatment should be individualized based on patient preference and operator experience.

IRC is indicated for the outpatient treatment of Grade I and II internal hemorrhoids. IRC may occasionally be utilized for Grade III internal hemorrhoids. Photocoagulation relies on tissue coagulation by infrared radiation, with tissue destruction limited to the depth of 3 mm. Many studies have demonstrated that IRC relieves symptoms with success rates comparable to alternatives. Further, the ease and rapidity of administration without side effects are considered by some authors to outweigh the possible need for repeat IRC treatments. This Local Coverage Determination (LCD) discusses medically necessary indications and limitations for IRC of hemorrhoids.

Indications and Limitations:

Initial treatment for chronic symptoms of hemorrhoidal disease should include conservative treatment and typically begins with lifestyle changes such as a high fiber diet, fiber supplements, and increased water intake. At least 6 weeks may be required for significant improvement. Conservative treatment should continue even if a procedure is required.

IRC is considered reasonable and necessary for patients with symptomatic Grade I or Grade II internal hemorrhoids that have not responded to conservative treatment. The most common symptoms are bleeding and prolapse. IRC may occasionally be utilized for symptomatic Grade III internal hemorrhoids.

Although IRC has thus far shown to have less morbidity than RBL, most studies also show that additional treatment is more likely to be required in some patients, particularly those with Grade II or III hemorrhoids.

The medical literature has scant information regarding the long-term outcome for IRC. However, 80 – 90% of patients having RBL have reported themselves cured or greatly improved 5 years after RBL. Therefore, Medicare would not expect to see requests for repeat IRC payment until years after the initial treatment period and for only a minority of patients.

Other Comments:

For outpatient settings other than a Comprehensive Outpatient Rehabilitation Facility (CORF), references to "physicians" throughout this policy include nonphysicians, such as nurse practitioners, clinical nurse specialists and physician assistants. Such nonphysician practitioners, with certain exceptions, may certify, order and establish the plan of care as authorized by state law. [See Sections 1861(s)(2) and 1862(a)(14) of Title XVIII of the Social Security Act; 42 CFR, Sections 410.74, 410.75, 410.76 and 419.22; 58 FR 18543, April 7, 2000.]
Summary of Evidence

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Analysis of Evidence (Rationale for Determination)

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Proposed Process Information

Synopsis of Changes
Changes Fields Changed
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Associated Information
Sources of Information
Bibliography
Open Meetings
Meeting Date Meeting States Meeting Information
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Contractor Advisory Committee (CAC) Meetings
Meeting Date Meeting States Meeting Information
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MAC Meeting Information URLs
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Proposed LCD Posting Date
Comment Period Start Date
Comment Period End Date
Reason for Proposed LCD
Requestor Information
This request was MAC initiated.
Requestor Name Requestor Letter
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Contact for Comments on Proposed LCD

Coding Information

Bill Type Codes

Code Description

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Revenue Codes

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CPT/HCPCS Codes

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ICD-10-CM Codes that Support Medical Necessity

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Group 1

Group 1 Paragraph:

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 Group 1 Codes:

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ICD-10-CM Codes that DO NOT Support Medical Necessity

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Group 1

Group 1 Paragraph:

N/A

 Group 1 Codes:

N/A

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Additional ICD-10 Information

General Information

Associated Information

Documentation Requirements

The patient's medical record must contain documentation that fully supports the medical necessity for services included within this LCD (see "Coverage Indications, Limitations and/or Medical Necessity"). This documentation includes, but is not limited to, relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Additional documentation specific to the treatment of internal hemorrhoids with IRC as it is covered by Medicare includes a history and physical findings supporting a diagnosis of symptomatic Grade I, Grade II or Grade III hemorrhoids; any prior treatments for hemorrhoids and patient response; the type of conservative treatments utilized, symptoms response, and time allowed for the resolution of symptoms; and the grade of hemorrhoid (Grade I, II or III) being treated.

The medical record must also contain documentation that supports the medical necessity for repeat IRC (please see “Coverage Indications, Limitations, and/or Medical Necessity”). Documentation should reflect that a reasonable amount of time has elapsed to prove failure from the first treatment. This documentation includes, but is not limited to relevant medical history, physical examination, and results of pertinent diagnostic tests or procedures.

Documentation must be legible and maintained in the patient’s medical record and made available to the A/B MAC upon request.
Sources of Information
N/A
Bibliography

Alonso-Coello P, Castillejo MM. Office evaluation and treatment of hemorrhoids. Journal of Family Practice. 2003;52(5):366-374.

Gordon PH, Nivatvongs S. Principles and Practice of Surgery for the Colon, Rectum, and Anus. Second Edition, 1999.

Gupta PJ. Infrared coagulation vs. rubber band ligation in early stage hemorrhoids. Braz J Med Biol Res. 2003;36(10):1433-1439.

Helton WS. 2001 consensus statement on benign anorectal disease. Journal of Gastrointestinal Surgery. 2002;6(3):302-303.

Hulme-Moir M, Bartolo DC. Hemorrhoids. Gastroenterology Clinics of North America. 2001;30(1):183-197.

Johanson JF. Nonsurgical treatment of hemorrhoids. Journal of Gastrointestinal Surgery. 2002;6(3):290-294.

Johanson JF, Rimm A. Optimal nonsurgical treatment of hemorrhoids: a comparative analysis of infrared coagulation, rubber band ligation, and injection sclerotherapy. Am J Gastroenterol. 1992;87(11):1600-1606.

MacRae HM, McLeod RS. Comparison of hemorrhoidal treatment modalities. A meta-analysis. Dis Colon Rectum. 1995;38(7):687-694.

Nisar PJ, Scholefield JH. Managing haemorrhoids. British Medical Journal. 2003;327(7419):847-851.

Pfenninger JL. Modern treatments for internal haemorrhoids: scalpel surgery is now rarely needed. British Medical Journal. 1997;314(7089):1211-1212.

Pfenninger JL, Surrell J. Nonsurgical treatment options for internal hemorrhoids. Am Fam Physician. 1995;52(3):821-34, 839-41. Review. Erratum in: Am Fam Physician. 1996;53(3):866.

Poen AC, Felt-Bersma RJ, Cuesta MA, Deville W, Meuwissen SGM. A randomized controlled trial of rubber band ligation vs. infra-red coagulation in the treatment of internal haemorrhoids. Eur J Gastroenterol Hepatol. 2000;12(5):535-539.

Rivadeneiria DE, Steele SR, Ternent C, et al. Practice parameters in the management of hemorrhoids. Dis Colon & Rectum. 2011;54(9):1059-1064.

Santiago EL, Parra MG, Mendoza Olivares FJ, Pellicer Bautista FJ, Herrerías Gutiérrez JM. Effectiveness of hemorrhoidal treatment by rubber band ligation and infrared photocoagulation. Rev Esp Enferm Dig. 2001;93(4):243-247.

Schussman LC, Lutz LJ. Outpatient management of hemorrhoids. Primary Care. 1986;13(3):527-541.

Walker AJ, Leicester RJ, Nicholls RJ, Mann CV. A prospective study of infrared coagulation, injection and rubber band ligation in the treatment of hemorrhoids. Int J Colorectal Dis. 1990;5(2):113-116.

Revision History Information

Revision History Date Revision History Number Revision History Explanation Reasons for Change
03/01/2024 R13

This LCD is being retired because it is not up to date with 21st Century Cures requirements and no claims have been received for these services.
  • LCD Being Retired
07/06/2023 R12

Under CMS National Coverage Policy updated section headings for regulations and deleted the following regulation: CMS Internet-Only Manual, Pub. 100-02, Medicare Benefit Policy Manual, Chapter 15 §260.5.3 Rebundling of CPT Codes. Formatting and typographical errors were corrected throughout the LCD.

  • Provider Education/Guidance
09/16/2021 R11

Removed contract number (A and B and HHH MAC. J-M-11004) Palmetto GBA as it was inadvertently Added to Revision number 10.
  • Provider Education/Guidance
08/05/2021 R10

Under CMS National Coverage Policy revised verbiage and added additional verbiage for §260.2, §260.3, §260.4 and §260.5, §260.5.1-§260.5.3. Under Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, punctuation and typographical errors were corrected throughout the LCD.

  • Provider Education/Guidance
10/24/2019 R9

This LCD is being revised in order to adhere to CMS requirements per Chapter 13, Section 13.5.1 of the Program Integrity Manual, to remove all coding from LCDs. There has been no change in coverage with this LCD revision. Regulations regarding billing and coding were removed from the CMS National Coverage Policy section of this LCD and placed in the related Billing and Coding: Infrared Coagulation (IRC) of Hemorrhoids A54038 article. Under CMS National Coverage Policy added regulations Title XVIII of the Social Security Act §1861 (s)(2), Title XVIII of the Social Security Act §1862 (a)(14), Title 42 CFR §410.74 Physician assistants' services, Title 42 CFR §410.75 Nurse practitioners' services, and Title 42 CFR §410.76 Clinical nurse specialists' services.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

  • Provider Education/Guidance
05/30/2019 R8

All coding located in the Coding Information section and all verbiage regarding billing and coding under the Coverage Indications, Limitations and/or Medical Necessity and Associated Information sections has been moved into the related Billing and Coding: Infrared Coagulation (IRC) of Hemorrhoids article A54038 and removed from the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
05/09/2019 R7

Under subheading Indications and Limitations verbiage was changed to read The medical literature has scant information regarding the long-term outcomes for IRC. However, given published outcomes similar to RBL even after five years, Medicare would not expect to see requests for repeat IRC payment until years after the initial treatment period and for only a minority of patients. Under subheading Bibliography changes were made to citations to reflect AMA citation guidelines. Formatting, typographical errors and punctuation were corrected throughout the LCD. Acronyms were inserted and defined where appropriate throughout the LCD.

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.
  • Provider Education/Guidance
02/08/2018 R6

Under Associated Information-Documentation Requirements in the last paragraph deleted “be”. Under Bibliography moved the Sources of Information and corrected a spelling error in the following journal title: Walker AJ, Leicester RJ, Nicholls RJ, Mann CV. A prospective study of infrared coagulation, injection and rubber band ligation in the treatment of haemorrhoids. Int J Colorectal Dis. 1990;5(2):113-116. This revision becomes effective. 

At this time 21st Century Cures Act will apply to new and revised LCDs that restrict coverage which requires comment and notice. This revision is not a restriction to the coverage determination; and, therefore not all the fields included on the LCD are applicable as noted in this policy.

 
  • Provider Education/Guidance
  • Typographical Error
01/29/2018 R5 The Jurisdiction "J" Part A Contracts for Alabama (10111), Georgia (10211) and Tennessee (10311) are now being serviced by Palmetto GBA. The notice period for this LCD begins on 12/14/17 and ends on 01/28/18. Effective 01/29/18, these three contract numbers are being added to this LCD. No coverage, coding or other substantive changes (beyond the addition of the 3 Part A contract numbers) have been completed in this revision.
  • Change in Affiliated Contract Numbers
03/16/2017 R4 Under CMS National Coverage Policy revised the title of Pub 100-04 Chapter 9 Section 100 to now read: Frequency of Billing and Same Day Billing.
  • Provider Education/Guidance
  • Other
02/04/2016 R3 Under Coverage Indications, Limitations and/or Medical Necessity added "required" under Grade III description, corrected punctuation under Documentation Requirements and added "task" to Rivadeneira DE, Steele SR, Ternent C, et al. The Standards Practice Task Force of the American Society of Colon and Rectal Surgeons. Practice parameters in the management of hemorrhoids (revised). Dis Colon Rectum. 2011;54(9):1059-64 under Sources of Information and Basis for Decision.
  • Other
10/01/2015 R2 Per CMS Internet-Only Manual, Pub 100-08, Medicare Program Integrity Manual, Chapter 13, §13.1.3 LCDs consist of only “reasonable and necessary” information. All bill type and revenue codes have been removed.
  • Other (Bill type and/or revenue code removal)
10/01/2015 R1 Under CMS National Coverage Policy the section and the title cited for 42 CFR were corrected to now read §419 Prospective Payment System for Hospital Outpatient Department Services and deleted the verbiage “…published in the FR Vol.65, No.68, April 7, 2000”. The manual section title cited for CMS Internet-Only Manual, Pub 100-04, Medicare Claims Processing Manual, Chapter 9, §100 was corrected. Under Coverage Indications, Limitations and/or Medical Necessity-Indications and Limitations removed billing language found in the LCD and included this language in a supplemental instruction article attached to the LCD. Under Revenue Codes deleted the paragraph regarding the FISS HCPCS file. Under Sources of Information and Basis for Decision deleted the following cited resource: Blue Cross and Blue Shield Association Technology Evaluation Center. Technology evaluation: infrared coagulation of hemorrhoids. 1987: Washington. D.C. Author names were corrected for the following to now read: Linares SE, Gómez PM, Mendoza Olivares FJ, Pellicer Bautista FJ, Herrerías Gutiérrez JM. Effectiveness of hemorrhoidal treatment by rubber band ligation and infrared photocoagulation. Rev Esp Enferm Dig. 2001;93(4):238-247. The volume number and supplement number were corrected for the following to now read: Pfenninger JL. Modern treatments for internal haemorrhoids: Scalpel surgery is now rarely needed. British Medical Journal. 1997;314(7089):1211-1212.
  • Provider Education/Guidance
  • Typographical Error
  • Other
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Public Versions
Updated On Effective Dates Status
03/01/2024 07/06/2023 - 03/01/2024 Retired You are here
06/30/2023 07/06/2023 - N/A Superseded View
Some older versions have been archived. Please visit the MCD Archive Site to retrieve them.

Keywords

  • Hemorrhoids
  • IRC

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