[Code of Federal Regulations]
[Title 42, Volume 2]
[Revised as of October 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 42CFR410.37]

[Page 274-276]
 
                         TITLE 42--PUBLIC HEALTH
 
                    CHAPTER IV--CENTERS FOR MEDICARE
                          & MEDICAID SERVICES,
                        DEPARTMENT OF HEALTH AND
                             HUMAN SERVICES
 
PART 410_SUPPLEMENTARY MEDICAL INSURANCE (SMI) BENEFITS--Table of Contents
 
               Subpart B_Medical and Other Health Services
 
Sec. 410.37  Colorectal cancer screening tests: Conditions for and 
limitations on coverage.

    (a) Definitions. As used in this section, the following definitions 
apply:
    (1) Colorectal cancer screening tests means any of the following 
procedures furnished to an individual for the purpose of early detection 
of colorectal cancer:
    (i) Screening fecal-occult blood tests.
    (ii) Screening flexible sigmoidoscopies.
    (iii) In the case of an individual at high risk for colorectal 
cancer, screening colonoscopies.
    (iv) Screening barium enemas.
    (v) Other tests or procedures established by a national coverage 
determination, and modifications to tests under this paragraph, with 
such frequency and payment limits as CMS determines appropriate, in 
consultation with appropriate organizations
    (2) Screening fecal-occult blood test means--
    (i) A guaiac-based test for peroxidase activity, testing two samples 
from each of three consecutive stools, or,
    (ii) Other tests as determined by the Secretary through a national 
coverage determination.
    (3) An individual at high risk for colorectal cancer means an 
individual with--
    (i) A close relative (sibling, parent, or child) who has had 
colorectal cancer or an adenomatous polyp;
    (ii) A family history of familial adenomatous polyposis;
    (iii) A family history of hereditary nonpolyposis colorectal cancer;
    (iv) A personal history of adenomatous polyps; or
    (v) A personal history of colorectal cancer; or
    (vi) Inflammatory bowel disease, including Crohn's Disease, and 
ulcerative colitis.
    (4) Screening barium enema means--
    (i) A screening double contrast barium enema of the entire 
colorectum (including a physician's interpretation of the results of the 
procedure); or
    (ii) In the case of an individual whose attending physician decides 
that he or she cannot tolerate a screening double contrast barium enema, 
a screening single contrast barium enema of the entire colorectum 
(including a physician's interpretation of the results of the 
procedure).
    (5) An attending physician for purposes of this provision is a 
doctor of medicine or osteopathy (as defined in section 1861(r)(1) of 
the Act) who is fully knowledgeable about the beneficiary's medical 
condition, and who would be responsible using the results of any 
examination performed in the overall management of the beneficiary's 
specific medical problem.
    (b) Condition for coverage of screening fecal-occult blood tests. 
Medicare Part B pays for a screening fecal-occult blood test if it is 
ordered in writing by the beneficiary's attending physician.
    (c) Limitations on coverage of screening fecal-occult blood tests. 
(1) Payment may

[[Page 275]]

not be made for a screening fecal-occult blood test performed for an 
individual under age 50.
    (2) For an individual 50 years of age or over, payment may be made 
for a screening fecal-occult blood test performed after at least 11 
months have passed following the month in which the last screening 
fecal-occult blood test was performed.
    (d) Condition for coverage of flexible sigmoidoscopy screening. 
Medicare Part B pays for a flexible sigmoidoscopy screening service if 
it is performed by a doctor of medicine or osteopathy (as defined in 
section 1861(r)(1) of the Act), or by a physician assistant, nurse 
practitioner, or clinical nurse specialist (as defined in section 
1861(aa)(5) of the Act and Sec. Sec. 410.74, 410.75, and 410.76) who is 
authorized under State law to perform the examination.
    (e) Limitations on coverage of screening flexible sigmoidoscopies. 
(1) Payment may not be made for a screening flexible sigmoidoscopy 
performed for an individual under age 50.
    (2) For an individual 50 years of age or over, except as described 
in paragraph (e)(3) of this section, payment may be made for screening 
flexible sigmoidoscopy after at least 47 months have passed following 
the month in which the last screening flexible sigmoidoscopy or, as 
provided in paragraphs (h) and (i) of this section, the last screening 
barium enema was performed.
    (3) In the case of an individual who is not at high risk for 
colorectal cancer as described in paragraph (a)(3) of this section but 
who has had a screening colonoscopy performed, payment may be made for a 
screening flexible sigmoidosocopy only after at least 119 months have 
passed following the month in which the last screening colonoscopy was 
performed.
    (f) Condition for coverage of screening colonoscopies. Medicare Part 
B pays for a screening colonoscopy if it is performed by a doctor of 
medicine or osteopathy (as defined in section 1861(r)(1) of the Act).
    (g) Limitations on coverage of screening colonoscopies. (1) 
Effective for services furnished on or after January 1, 1998 through 
June 30, 2001, payment may not be made for a screening colonoscopy for 
an individual who is not at high risk for colorectal cancer as described 
in paragraph (a)(3) of this section.
    (2) Effective for services furnished on or after July 1, 2001, 
except as described in paragraph (g)(4) of this section, payment may be 
made for a screening colonoscopy performed for an individual who is not 
at high risk for colorectal cancer as described in paragraph (a)(3) of 
this section, after at least 119 months have passed following the month 
in which the last screening colonoscopy was performed.
    (3) Payment may be made for a screening colonoscopy performed for an 
individual who is at high risk for colorectal cancer as described in 
paragraph (a)(3) of this section, after at least 23 months have passed 
following the month in which the last screening colonoscopy was 
performed, or, as provided in paragraphs (h) and (i) of this section, 
the last screening barium enema was performed.
    (4) In the case of an individual who is not at high risk for 
colorectal cancer as described in paragraph (a)(3) of this section but 
who has had a screening flexible sigmoidoscopy performed, payment may be 
made for a screening colonoscopy only after at least 47 months have 
passed following the month in which the last screening flexible 
sigmoidoscopy was performed.
    (h) Conditions for coverage of screening barium enemas. Medicare 
Part B pays for a screening barium enema if it is ordered in writing by 
the beneficiary's attending physician.
    (i) Limitations on coverage of screening barium enemas. (1) In the 
case of an individual age 50 or over who is not at high risk of 
colorectal cancer, payment may be made for a screening barium enema 
examination performed after at least 47 months have passed following the 
month in which the last screening barium enema or screening flexible 
sigmoidoscopy was performed.
    (2) In the case of an individual who is at high risk for colorectal 
cancer, payment may be made for a screening barium enema examination 
performed after at least 23 months have passed following the month in 
which the last

[[Page 276]]

screening barium enema or the last screening colonoscopy was performed.

[62 FR 59100, Oct. 31, 1997, as amended at 66 FR 55329, Nov. 1, 2001; 67 
FR 80040, Dec. 31, 2002]