**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.]