[Federal Register: November 23, 2001 (Volume 66, Number 226)]
[Rules and Regulations]
[Page 58887-58890]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no01-10]

[[pp. 58887-58890]] Medicare Program; Negotiated Rulemaking: Coverage and
Administrative Policies for Clinical Diagnostic Laboratory Services

[[Continued from page 58886]]

[[Page 58887]]

certainty for that encounter/visit, such as signs, symptoms, abnormal
test results, exposure to communicable disease or other reasons for the
visit. (From Coding Clinic for ICD-9-CM, Fourth Quarter 1995, page 45.)
5. When a non-specific ICD-9 code is submitted, the underlying
sign, symptom, or condition must be related to the indications for the
test above.

Medicare National Coverage Decision for Fecal Occult Blood

Description:

The fecal occult blood test detects the presence of trace amounts
of blood in stool. The procedure is performed by testing one or several
small samples of one, two or three different stool specimens.
This test may be performed with or without evidence of iron
deficiency anemia, which may be related to gastrointestinal blood loss.
The range of causes for blood loss include inflammatory causes,
including acid-peptic disease, non-steroidal anti-inflammatory drug
use, hiatal hernia, Crohn's disease, ulcerative colitis,
gastroenteritis, and colon ulcers. It is also seen with infectious
causes, including hookworm, stronglyoidal ascariasis, tuberculosis, and
enteroamebiasis. Vascular causes include angiodysplasia, hemangiomas,
varices, blue rubber bleb nevus syndrome, and watermelon stomach.
Tumors and neoplastic causes include lymphoma, leiomyosarcoma, lipomas,
adenocarcinoma and primary and secondary metastases to the GI tract.
Drugs such as nonsteroidal anti-inflammatory drugs also cause bleeding.
There are extra gastrointestinal causes such as hemoptysis, epistaxis,
and oropharyngeal bleeding. Artifactual causes include hematuria, and
menstrual bleeding. In addition, there may be other causes such as
coagulopathies, gastrostomy tubes or other appliances, factitial
causes, and long distance running.
Three basic types of fecal hemoglobin assays exist, each directed
at a different component of the hemoglobin molecule.
(1) Immunoassays recognize antigenic sites on the globin portion
and are least affected by diet or proximal gut bleeding, but the
antigen may be destroyed by fecal flora.
(2) The heme-porphyrin assay measures heme-derived porphyrin and is
least influenced by enterocolic metabolism or fecal storage. This assay
does not discriminate dietary from endogenous heme. The capacity to
detect proximal gut bleeding reduces its specificity for colorectal
cancer screening but makes it more useful for evaluating overall GI
bleeding in case finding for iron deficiency anemia.
(3) The guaiac-based test is the most widely used. It requires the
peroxidase activity of an intact heme moiety to be reactive. Positivity
rates fall with storage. Fecal hydration such as adding a drop of water
increases the test reactivity but also increases false positivity.
Of these three tests, the guaiac-based test is the most sensitive
for detecting lower bowel bleeding. Because of this sensitivity, it is
advisable, when it is used for screening, to defer the guaiac-based
test if other studies of the colon are performed prior to the test.
Similarly, this test's sensitivity may result in a false positive if
the patient has recently ingested meat. Both of these cautions are
appropriate when the test is used for screening, but when appropriate
indications are present, the test should be done despite its
limitations.

HCPCS Codes (alpha numeric, CPT AMA)

----------------------------------------------------------------------------------------------------------------
Code Descriptor
----------------------------------------------------------------------------------------------------------------
82270....................................... Blood, occult; feces, 1-3 simultaneous determinations
----------------------------------------------------------------------------------------------------------------

Indications

1. To evaluate known or suspected alimentary tract conditions that
might cause bleeding into the intestinal tract.
2. To evaluate unexpected anemia.
3. To evaluate abnormal signs, symptoms, or complaints that might
be associated with loss of blood.
4. To evaluate patient complaints of black or red-tinged stools.

Limitations

1. Code 82270 is reported once for the testing of up to three
separate specimens (comprising either one or two tests per specimen).
2. In patients who are taking non-steroidal anti-inflammatory drugs
and have a history of gastrointestinal bleeding but no other signs,
symptoms, or complaints associated with gastrointestinal blood loss,
testing for occult blood may generally be appropriate no more than once
every three months.
3. When testing is done for the purpose of screening for colorectal
cancer in the absence of signs, symptoms, conditions, or complaints
associated with gastrointestinal blood loss, HCPCS code G0107
(Colorectal cancer screening; fecal-occult blood test, 1-3 simultaneous
determinations) should be used. Coverage of colorectal cancer screening
is described in HCFA Program Memorandum Transmittal No. AB-97-24
(November, 1997).

ICD-9-CM Codes Covered by Medicare Program

[[Page 58888]]

095.3....................................... Syphilis of liver
098.0....................................... Gonococcal infections, acute, lower enitourinary tract
098.7....................................... Gonococcal infection anus and rectum
098.84...................................... Gonococcal endocaritis
123.0-123.9................................. Other cestode infection
124......................................... Trichinosis
127.0-127.9................................. Other intestinal helminthiases
139.8....................................... Late effects of other and unspecified infectious and parasitic
diseases
150.0-157.9................................. Malignant neoplasm of digestive organisms
159.0--0.159.9.............................. Malignant neoplasm of other and ill-defined sites within the
digestive organs and peritoneum
176.3....................................... Kaposi's sarcoma, gastrointestinal sites
197.4-197.5................................. Secondary malignant neoplasm of intestines
197.8....................................... Secondary malignant neoplasm of other digestive organs and spleen
199.0....................................... Disseminated malignant neoplasm
204.00-204.91............................... Lymphoid leukemia
205.00-208.91............................... Leukemia
211.0-211.9................................. Benign neoplasm of other parts of digestive system
228.04...................................... Hemangioma of intra-abdominal structures
230.2-230.9................................. Carcinoma in situ of digestive organs
235.2....................................... Neoplasm of uncertain behavior of stomach, intestines, and rectum
235.5....................................... Neoplasm of uncertain behavior of other and unspecified digestive
organs
239.0....................................... Neoplasm of unspecified nature, digestive system
280.0-280.9................................. Iron deficiency anemias
285.0-285.9................................. Other and unspecified anemias
286.0-286.9................................. Coagulation defects
287.0-287.9................................. Purpura and other hemorrhagic conditions
448.0....................................... Hereditary hemorrhagic telangiectasia
455.0-455.8................................. Hemorrhoids
456.0-456.21................................ Esophageal varices with or without mention of bleeding
530.10-535.61............................... Diseases of the esophagus, stomach, and duodenum
536.2....................................... Persistent vomiting
536.8-536.9................................. Dyspepsia and other specified and unspecified functional disorders
of the stomach
537.0-537.4................................. Other disorders of stomach and duodenum
537.82-537.83............................... Angiodysplasia of stomach and duodenum
537.89...................................... Other specified disorders of stomach and duodenum
555.0-558.9................................. Non-infectious enteritis and colitis
560.0-560.39................................ Intestinal obstruction/impaction without mention of hernia
562.10-562.13............................... Diverticulosis/diverticulitis of colon
564.0-564.9................................. Functional digestive disorders, not elsewhere classified
565.0-565.1................................. Anal fissure and fistula
569.0....................................... Anal and rectal polyp
569.1....................................... Rectal prolapse
569.3....................................... Hemorrhage of rectum and anus
569.41-569.49............................... Other specified disorders of rectum and anus
569.82-569.83............................... Ulceration and perforation of intestine
569.84-569.85............................... Angiodysplasia of intestine with or without mention of hemorrhage
571.0-571.9................................. Chronic liver disease and cirrhosis
577.0....................................... Acute pancreatitis
577.0-577.9................................. Diseases of the pancreas
578.0-578.9................................. Gastrointestinal hemorrhage
579.0....................................... Celiac disease
579.8....................................... Other specified intestinal malabsorption
596.1....................................... Intestinovesical fistula
617.5....................................... Endometriosis of intestine
780.71...................................... Chronic fatigue syndrome
780.79...................................... Other malaise and fatigue
783.0....................................... Anorexia
783.2....................................... Abnormal loss of weight
787.01-787.03............................... Nausea and vomiting
787.1....................................... Heartburn
787.2....................................... Dysphagia
787.7....................................... Abnormal feces
787.91...................................... Diarrhea
787.99...................................... Other symptoms involving digestive system
789.00-789.09............................... Abdominal pain
789.30-789.39............................... Abdominal or pelvic swelling, mass, or lump
789.40-789.49............................... Abdominal rigidity
789.5....................................... Ascites
789.60-789.69............................... Abdominal tenderness
790.92...................................... Abnormal coagulation profile
792.1....................................... Nonspecific abnormal findings in stool contents
793.6....................................... Nonspecific abnormal findings on radiological and other
examination, abdominal area, including retroperitoneum
794.8....................................... Nonspecific abnormal results of function studies, liver

[[Page 58889]]

863.0-863.90................................ Injury to gastrointestinal tract
864.00-864.09............................... Injury to liver without mention of open wound into cavity
864.11-864.19............................... Injury to liver with open wound into cavity
866.00-866.03............................... Injury to kidney without mention of open wound into cavity
866.10-866.13............................... Injury to kidney with open wound into cavity
902.0-902.9................................. Injury to blood vessels of abdomen and pelvis
926.11-926.19............................... Crushing injury of trunk, other specified sites
926.8....................................... Crushing injury of trunk, multiple sites
926.9....................................... Crushing injury of trunk, unspecified site
964.2....................................... Poisoning by agents primarily affecting blood constituents,
anticoagulants
995.2....................................... Unspecified adverse effect of drug, medicinal, and biological
substance
V10.00-.09.................................. Personal history of malignant neoplasm, gastrointestinal tract
V12.00...................................... Personal history of unspecified infectious and parasitic disease
V12.72...................................... Personal history of colonic polyps
V58.61...................................... Long term (current) use of anticoagulants
V58.69...................................... Long term (current) use of other medications
V67.51...................................... Following treatment with high risk medication, not elsewhere
specified
----------------------------------------------------------------------------------------------------------------

Reasons for Denial

Note: This section was not negotiated by the Negotiated
Rulemaking Committee. This section includes HCFA's interpretation of
its longstanding policies and is included for informational
purposes.

Tests for screening purposes that are performed in the
absence of signs, symptoms, complaints, or personal history of disease
or injury are not covered except as explicitly authorized by statute.
These include exams required by insurance companies, business
establishments, government agencies, or other third parties.
Tests that are not reasonable and necessary for the
diagnosis or treatment of an illness or injury are not covered
according to the statute.
Failure to provide documentation of the medical necessity
of tests may result in denial of claims. Such documentation may include
notes documenting relevant signs, symptoms or abnormal findings that
substantiate the medical necessity for ordering the tests. In addition,
failure to provide independent verification that the test was ordered
by the treating physician (or qualified nonphysician practitioner)
through documentation in the physician's office may result in denial.
A claim for a test for which there is a national coverage
or local medical review policy will be denied as not reasonable and
necessary if it is submitted without an ICD-9-CM code or narrative
diagnosis listed as covered in the policy unless other medical
documentation justifying the necessity is submitted with the claim.
If a national or local policy identifies a frequency
expectation, a claim for a test that exceeds that expectation may be
denied as not reasonable and necessary, unless it is submitted with
documentation justifying increased frequency.
Tests that are not ordered by a treating physician or
other qualified treating nonphysician practitioner acting within the
scope of their license and in compliance with Medicare requirements
will be denied as not reasonable and necessary.
Failure of the laboratory performing the test to have the
appropriate Clinical Laboratory Improvement Amendment of 1988 (CLIA)
certificate for the testing performed will result in denial of claims.

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
Code Description
----------------------------------------------------------------------------------------------------------------
798.0-798.9................................. Sudden death, cause unknown
V15.85...................................... Exposure to potentially hazardous body fluids
V16.1....................................... Family history of malignant neoplasm, trachea, bronchus, and lung
V16.2....................................... Family history of malignant neoplasm, other respiratory and
intrathoracic organs
V16.4....................................... Family history of malignant neoplasm, genital organs
V16.5....................................... Family history of malignant neoplasm, urinary organs
V16.6....................................... Family history of malignant neoplasm, leukemia
V16.7....................................... Family history of malignant neoplasm, other lymphatic and
hematopoietic neoplasms
V16.8....................................... Family history of malignant neoplasm, other specified malignant
neoplasm
V16.9....................................... Family history of malignant neoplasm, unspecified malignant
neoplasm
V17.0-V17.8................................. Family history of certain chronic disabling diseases
V18.0-V18.8................................. Family history of certain other specific conditions
V19.0-V19.8................................. Family history of other conditions
V20.0-V20.2................................. Health supervision of infant or child
V28.0-V28.9................................. Antenatal screenings
V50.0-V50.9................................. Elective surgery for purposes other than remedying health states
V53.2....................................... Fitting and adjustment of hearing aid
V60.0-V60.9................................. Housing, household, and economic circumstances
V62.0....................................... Unemployment
V62.1....................................... Adverse effects of work environment
V65.0....................................... Healthy persons accompanying sick persons
V65.1....................................... Persons consulting on behalf of another person
V68.0-V68.9................................. Encounters for administrative purposes
V70.0-V70.9................................. General medical examinations
V73.0-V73.99................................ Special screening examinations for viral and chlamydial diseases

[[Page 58890]]

V74.0-V74.9................................. Special screening examinations for bacterial and spirochetal
diseases
V75.0-V75.9................................. Special screening examination for other infectious diseases
V76.0....................................... Special screening for malignant neoplasms, respiratory organs
V76.3....................................... Special screening for malignant neoplasms, bladder
V76.42-V76.9................................ Special screening for malignant neoplasms, (sites other than
breast, cervix, and rectum)
V77.0-V77.9................................. Special screening for endocrine, nutrition, metabolic, and
immunity disorders
V78.0-V78.9................................. Special screening for disorders of blood and blood-forming organs
V79.0-V79.9................................. Special screening for mental disorders
V80.0-V80.3................................. Special screening for neurological, eye, and ear diseases
V81.0-V81.6................................. Special screening for cardiovascular, respiratory, and
genitourinary diseases
V82.0-V82.9................................. Special screening for other conditions
----------------------------------------------------------------------------------------------------------------

ICD-9-CM Codes That Do Not Support Medical Necessity

Any ICD-9-CM code not listed in either of the ICD-9-CM sections
above.

Sources of Information

Ahlquist, D.A., ``Approach to the patient with occult
gastrointestinal bleeding,'' in Tadatake, Y. (ed.), Textbook of
Gastroenterology (2nd ed.), 1995, J.B. Lippincott, pp. 699-717. Tietz,
N.W. (ed.), Clinical guide to Laboratory Tests (3rd ed.), 1995, pp.452-
454.
Schleisenger, M.H., Wall, S.D., et al., ``Part X. Gastrointestinal
Diseases'' in Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook
of Medicine (18th ed.), 1988, W.B. Saunders, pp. 656-807.
Harrison's Principles of Internal Medicine (14th ed.), 1998, McGraw
Hill.
Wallach, J., Interpretation of Diagnostic Tests, 1996, Little Brown
and Co.
Illustrated Guide to Diagnostic Tests (2nd ed.), 1997, Springhouse
Corporation.
Sleisenger and Fordtrans's Gastrointestinal and Liver Disease (6th
ed.), 1997, W.B. Saunders.

Coding Guidelines

1. Any claim for a test listed in ``HCPCS CODES'' above must be
submitted with an ICD-9-CM diagnosis code or comparable narrative.
Codes that describe symptoms and signs, as opposed to diagnoses, should
be provided for reporting purposes when a diagnosis has not been
established by the physician. (Based on Coding Clinic for ICD-9-CM,
Fourth Quarter 1995, page 43.)
2. Screening is the testing for disease or disease precursors so
that early detection and treatment can be provided for those who test
positive for the disease. Screening tests are performed when no
specific sign, symptom, or diagnosis is present and the patient has not
been exposed to a disease. The testing of a person to rule out or to
confirm a suspected diagnosis because the patient has a sign and/or
symptom is a diagnostic test, not a screening. In these cases, the sign
or symptom should be used to explain the reason for the test. When the
reason for performing a test is because the patient has had contact
with, or exposure to, a communicable disease, the appropriate code from
category V01, Contact with or exposure to communicable diseases, should
be assigned, not a screening code, but the test may still be considered
screening and not covered by Medicare. For screening tests, the
appropriate ICD-9-CM screening code from categories V28 or V73-V82 (or
comparable narrative) should be used. (From Coding Clinic for ICD-9-CM,
Fourth Quarter 1996, pages 50 and 52)
3. A three-digit code is to be used only if it is not further
subdivided. Where fourth-digit and/or fifth-digit subclassifications
are provided, they must be assigned. A code is invalid if it has not
been coded to the full number of digits required for that code. (From
Coding Clinic for ICD-9-CM. Fourth Quarter, 1995, page 44.)
4. Diagnoses documented as ``probable,'' ``suspected,''
``questionable,'' ``rule-out,'' or ``working diagnosis'' should not be
coded as though they exist. Rather, code the condition(s) to the
highest degree of certainty for that encounter/visit, such as signs,
symptoms, abnormal test results, exposure to communicable disease or
other reasons for the visit. (From Coding Clinic for ICD-9-CM, Fourth
Quarter 1995, page 45.)
5. When a non-specific ICD-9 code is submitted, the underlying
sign, symptom, or condition must be related to the indications for the
test above.
[FR Doc. 01-29027 Filed 11-21-01; 8:45 am]
BILLING CODE 4120-01-P