Summary Of Evidence

N/A

Analysis of Evidence

N/A

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.]