[Federal Register: November 23, 2001 (Volume 66, Number 226)]
[Rules and Regulations]
[Page 58837-58886]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23no01-9]

[[pp. 58837-58886]] Medicare Program; Negotiated Rulemaking: Coverage and
Administrative Policies for Clinical Diagnostic Laboratory Services

[[Continued from page 58836]]

[[Page 58837]]

999.2....................................... Other vascular complications
999.8....................................... Other transfusion reactions
V08......................................... Asymptomatic HIV infection
V12.1....................................... History of nutritional deficiency
V12.3....................................... Personal history of diseases of blood and blood-forming organs
V12.50-V12.59............................... Diseases of circulatory system
V15.1....................................... Personal history of surgery to heart and great vessels
V15.2....................................... Personal history of surgery of other major organs
V42.0....................................... Kidney replaced by transplant
V42.1....................................... Heart replaced by transplant
V42.2....................................... Heart valve replaced by transplant
V42.6....................................... Lung replaced by transplant
V42.7....................................... Liver replaced by transplant
V42.8....................................... Other specified organ or tissue replaced by transplant
V43.2....................................... Heart replaced by other means
V43.3....................................... Heart valve replaced by other means
V43.4....................................... Blood vessel replaced by other means
V43.60...................................... Unspecified joint replaced by other means
V58.2....................................... Transfusion of blood products
V58.61...................................... Long-term (current) use of anticoagulants
V72.84...................................... Pre-operative examination, unspecified
----------------------------------------------------------------------------------------------------------------

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

[[Page 58838]]

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 chlamydia diseases
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-V.79.9................................ 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

CMD Clinical Laboratory Workgroup.
1999 CPT Physicians' Current Procedural Terminology, American
Medical Association.
Wintrobe's Clinical Hematology 9th Ed. Lea and Febinger.
Harrison's Principles of Internal Medicine, McGraw Hill, 14th Ed.,
1997.
Diagnostic Tests Handbook, Springhouse Corporation, 1987.
Hemostasis and Thrombosis: Basic Principles and Clinical Practice.
Colman, et al editors, J.B. Lippincott, 3rd Edition, 1994, pp 896-898
and 1045-1046.
Disorders of Hemostasis, Ratnoff, Oscar D. and Forbes, Charles D.,
W.B. Saunders Company, 1996.
Merck Manual of Diagnosis and Therapy, 16th Edition (should be
replaced with 17th Edition when available in 1999.)
``Performance of the Coumatrak System at a Large Anticoagulation
Clinic''. Coagulation and Transfusion Medicine. January 1995. p98-102.
``Monitoring Oral Anticoagulation Therapy with Point-of-Care
Devices. Correlation and Caveats''. Clinical Chemistry: No. 9, 1997,
p1785-1786.
``College of Americal Pathologists Conference XXXI on Laboratory
Monitoring of Anticoagulant Therapy''. Arch.Pathol.Lab.Med. Vol.122.
September 1998. p768-780.
``A Structured Teaching and Self-management Program for Patients
Receiving Oral Anti-coagulation''. JAMA; 1999; 281: 145-150.

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-CM code is submitted, the underlying
sign, symptom, or condition must be related to the indications for the
test.
6. If a specific condition is known and is the reason for a pre-
operative test, submit the text description or ICD-9-CM code describing
the condition with the order/referral. If a specific condition or
disease is not known, and the pre-operative test is for pre-operative
clearance only, assign code V72.84.
7. Assign codes 289.8--other specified disease of blood and blood-
forming organs only when a specific disease exists and is indexed to
289.8 (for example, myelofibrosis). Do not assign code 289.8 to report
a patient on long term use of anticoagulant therapy (e.g. to report a
PT value or re-check need for medication adjustment.) Assign code
V58.61 to referrals for PT checks or re-checks. (Reference AHA's Coding
Clinic, March-April, pg 12--1987, 2nd quarter pg 8--1989)

Medicare National Coverage Decision for Serum Iron Studies
Other Names/Abbreviations

Description

Serum iron studies are useful in the evaluation of disorders of
iron metabolism, particularly iron deficiency and iron excess. Iron
studies are best performed when the patient is fasting in the morning
and has abstained from medications that may influence iron balance.
Iron deficiency is the most common cause of anemia. In young
children on a milk diet, iron deficiency is often secondary to dietary
deficiency. In adults, iron deficiency is usually the result of blood
loss and is only occasionally secondary to dietary

[[Page 58839]]

deficiency or malabsorption. Following major surgery the patient may
have iron deficient erythropoiesis for months or years if adequate iron
replacement has not been given. High doses of supplemental iron may
cause the serum iron to be elevated. Serum iron may also be altered in
acute and chronic inflammatory and neoplastic conditions.
Total iron binding capacity (TIBC) is an indirect measure of
transferrin, a protein that binds and transports iron. TIBC quantifies
transferrin by the amount of iron that it can bind. TIBC and
transferrin are elevated in iron deficiency, and with oral
contraceptive use, and during pregnancy. TIBC and transferrin may be
decreased in malabsorption syndromes or in those affected with chronic
diseases. The percent saturation represents the ratio of iron to the
TIBC.
Assays for ferritin are also useful in assessing iron balance. Low
concentrations are associated with iron deficiency and are highly
specific. High concentrations are found in hemosiderosis (iron overload
without associated tissue injury) and hemochromatosis (iron overload
with associated tissue injury). In these conditions the iron is
elevated, the TIBC and transferrin are within the reference range or
low, and the percent saturation is elevated. Serum ferritin can be
useful for both initiating and monitoring treatment for iron overload.
ransferrin and ferritin belong to a group of serum proteins known as
acute phase reactants, and are increased in response to stressful or
inflammatory conditions and also can occur with infection and tissue
injury due to surgery, trauma or necrosis. Ferritin and iron/TIBC (or
transferrin) are affected by acute and chronic inflammatory conditions,
and in patients with these disorders, tests of iron status may be
difficult to interpret.

HCPCS Codes (alpha numeric, CPT AMA)

Indications

1. Ferritin (82728), iron (83540) and either iron binding capacity
(83550) or transferrin (84466) are useful in the differential diagnosis
of iron deficiency, anemia, and for iron overload conditions.
A. The following presentations are examples that may support the
use of these studies for evaluating iron deficiency:
Certain abnormal blood count values (i.e., decreased mean
corpuscular volume (MCV), decreased hemoglobin/hematocrit when the MCV
is low or normal, or increased red cell distribution width (RDW) and
low or normal MCV).
Abnormal appetite (pica)
Acute or chronic gastrointestinal blood loss
Hematuria
Menorrhagia
Malabsorption
Status post-gastrectomy
Status post-gastrojejunostomy
Malnutrition
Preoperative autologous blood collection(s)
Malignant, chronic inflammatory and infectious conditions
Associated with anemia which may present in a similar manner to iron
deficiency anemia
Following a significant surgical procedure where blood
loss had occurred and had not been repaired with adequate iron
replacement.
B. The following presentations are examples that may support the
use of these studies for evaluating iron overload:
Chronic Hepatitis
Diabetes
Hyperpigmentation of skin
Arthropathy
Cirrhosis
Hypogonadism
Hypopituitarism
Impaired porphyrin metabolism
Heart failure
Multiple transfusions
Sideroblastic anemia
Thalassemia major
Cardiomyopathy, cardiac dysrhythmias and conduction
distrubances
2. Follow-up testing may be appropriate to monitor response to
therapy, e.g., oral or parenteral iron, ascorbic acid, and
erythropoietin.
3. Iron studies may be appropriate in patients after treatment for
other nutritional deficiency anemias, such as folate and vitamin B12,
because iron deficiency may not be revealed until such a nutritional
deficiency is treated.
4. Serum ferritin may be appropriate for monitoring iron status in
patients with chronic renal disease with or without dialysis.
5. Serum iron may also be indicated for evaluation of toxic effects
of iron and other metals (e.g., nickel, cadmium, aluminum, lead)
whether due to accidental, intentional exposure or metabolic causes.

Limitations

1. Iron studies should be used to diagnose and manage iron
deficiency or iron overload states. These tests are not to be used
solely to assess acute phase reactants where disease management will be
unchanged. For example, infections and malignancies are associated with
elevations in acute phase reactants such as ferritin, and decreases in
serum iron concentration, but iron studies would only be medically
necessary if results of iron studies might alter the management of the
primary diagnosis or might warrant direct treatment of an iron disorder
or condition.
2. If a normal serum ferritin level is documented, repeat testing
would not ordinarily be medically necessary unless there is a change in
the patient's condition, and ferritin assessment is needed for the
ongoing management of the patient. For example, a patient presents with
new onset insulin-dependent diabetes mellitus and has a serum ferritin
level performed for the suspicion of hemochromatosis. If the ferritin
level is normal, the repeat ferritin for diabetes mellitus would not be
medically necessary.
3. When an End Stage Renal Disease (ESRD) patient is tested for
ferritin, testing more frequently than every three months (the
frequency authorized by 3167.3, Fiscal Intermediary manual) requires
documentation of medical necessity [e.g., other than ``Chronic Renal
Failure'' (ICD-9-CM 585) or ``Renal Failure, Unspecified'' (ICD-9-CM
586)].
4. It is ordinarily not necessary to measure both transferrin and
TIBC at the same time because TIBC is an indirect measure of
transferrin. When transferrin is ordered as part of the nutritional
assessment for evaluating malnutrition, it is not necessary to order

[[Page 58840]]

other iron studies unless iron deficiency or iron overload is suspected
as well.
5. It is not ordinarily necessary to measure both iron/TIBC (or
transferrin) and ferritin in initial patient testing. If clinically
indicated after evaluation of the initial iron studies, it may be
appropriate to perform additional iron studies either on the initial
specimen or on a subsequently obtained specimen. After a diagnosis of
iron deficiency or iron overload is established, either iron/TIBC (or
transferrin) or ferritin may be medically necessary for monitoring, but
not both.
6. It would not ordinarily be considered medically necessary to do
a ferritin as a preoperative test except in the presence of anemia or
recent autologous blood collections prior to the surgery.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
Code Description
----------------------------------------------------------------------------------------------------------------
002.0-002.9................................. Typhoid and paratyphoid fevers
003.0-003.9................................. Other salmonella infections
006.0-006.9................................. Amebiasis
007.0-007.9................................. Other protozoal intestinal diseases
008.00-008.8................................ Intestinal infections due to other organisms
009.0-009.3................................. Ill-defined intestinal infections
011.50-011.56............................... Tuberculous bronchiectasis
014.00-014.86............................... Tuberculosis of intestines, peritoneum, and mesenteric glands
015.00-015.96............................... Tuberculosis of bones and joints
016.00-016.06............................... Tuberculosis of kidney
016.10-016.16............................... Tuberculosis of bladder
016.20-016.26............................... Tuberculosis of ureter
016.30-016.36............................... Tuberculosis of other urinary organs
042......................................... Human Immunodeficiency virus (HIV) disease
070.0-070.9................................. Viral hepatitis
140.0-149.9................................. Malignant neoplasm of lip oral cavity and pharynx
150.0-159.9................................. Malignant neoplasm of digestive organs and peritoneum
160.0-165.9................................. Malignant neoplasm of respiratory and intrathoracic organs
170.0-176.9................................. Malignant neoplasm of bone, connective tissue, skin and breast
179-189.9................................... Malignant neoplasm of genitourinary organs
190.0-199.1................................. Malignant neoplasm of other and unspecified sites
200.0-208.91................................ Malignant neoplasm of lymphatic and hematopoietic tissue
210.0-229.9................................. Benign neoplasms
230.0-234.9................................. Carcinoma in situ
235.0-238.9................................. Neoplasms of uncertain behavior
239.0-239.9................................. Neoplasms of unspecified nature
250.00-250.93............................... Diabetes mellitus
253.2....................................... Panhypopituitarism
253.7....................................... Iatrogenic pituitary disorders
253.8....................................... Other disorders of the pituitary and other syndromes of
diencephalohypophyseal origin
256.3....................................... Other ovarian failure
257.2....................................... Other testicular hypofunction
260......................................... Kwashiorkor
261......................................... Nutritional marasmus
262......................................... Other severe protein-calorie malnutrition
263.0-263.9................................. Other and unspecified protein-calorie malnutrition
275.0....................................... Disorders of iron metabolism
277.1....................................... Disorders of porphyrin metabolism
280.0-280.9................................. Iron deficiency anemias
281.0-281.9................................. Other deficiency anemias
282.4....................................... Thalassemias
285.0....................................... Sideroblastic anemia (includes hemochromatosis with refractory
anemia)
285.1....................................... Acute post-hemorrhagic anemia
285.9....................................... Anemia, unspecified
286.0-286.9................................. Coagulation defects (congenital factor disorders)
287.0-287.9................................. Purpura and other hemorrhagic conditions
306.4....................................... Physiological malfunction arising from mental factors,
gastrointestinal
307.1....................................... Anexoria nervosa
307.50-307.59............................... Other and unspecified disorders of eating
425.4....................................... Other primary cardiomyopathies
425.5....................................... Alcoholic cardiomyopathy
425.7....................................... Nutritional and metabolic cardiomyopathy
425.8....................................... Cardiomyopathy in other diseases classified elsewhere
425.9....................................... Secondary cardiomyopathy, unspecified
426.0-426.9................................. Conduction disorders
427.0-427.9................................. Cardiac dysrhythmias
428.0-428.9................................. Heart Failure
530.7....................................... Gastroesophageal laceration-hemorrhage syndrome
530.82...................................... Esophageal hemorrhage
531.00-531.91............................... Gastric ulcer
532.00-532.91............................... Duodenal ulcer
533.00-533.91............................... Peptic ulcer, site unspecified

[[Page 58841]]

534.00-534.91............................... Gastrojejunal ulcer
535.00-535.61............................... Gastritis and duodenitis
536.0-536.9................................. Disorders of function of stomach
537.83...................................... Angiodysplasia of stomach and duodenum with hemorrhage
555.0-555.9................................. Regional enteritis
556.0-556.9................................. Ulcerative colitis
557.0....................................... Acute vascular insufficiency of intestine
557.1....................................... Chronic vascular insufficiency of intestine
562.02...................................... Diverticulosis of small intestine without hemorrhage
562.03...................................... Diverticulitis of small intestine without hemorrhage
562.12...................................... Diverticulosis of colon with hemorrhage
562.13...................................... Diverticulitis of colon with hemorrhage
569.3....................................... Hemorrhage of rectum and anus
569.85...................................... Angiodysplasia of intestine with hemorrhage
570......................................... Acute and subacute necrosis of liver
571.0-571.9................................. Chronic liver disease and cirrhosis
572.0-572.8................................. Liver abscess and sequelae of chronic liver disease
573.0-573.9................................. Other disorders of liver
578.0-578.9................................. Gastrointestinal hemorrhage
579.0-579.3................................. Intestinal malabsorption
579.8-579.9................................. Other specified and unspecified intestinal malabsorption
581.0-581.9................................. Nephrotic syndrome
585......................................... Chronic renal failure
586......................................... Renal failure, unspecified
608.3....................................... Atrophy of testis
626.0-626.9................................. Disorders of menstruation and other abnormal bleeding from female
genital tract
627.0....................................... Premenopausal menorrhagia
627.1....................................... Postmenopausal bleeding
648.20-648.24............................... Other current conditions in the mother classifiable elsewhere, but
complicating pregnancy, childbirth, or the puerperium: Anemia
698.0-698.9................................. Pruritis and related conditions
704.00-704.09............................... Alopecia
709.00-709.09............................... Dyschromia
713.0....................................... Arthropathy associated with other endocrine and matabolic
disorders
716.40-716.99............................... Other and unspecified arthropathies
719.40-719.49............................... Pain in joint
773.2....................................... Hemolytic disease due to other and unspecified isoimmunization
773.3....................................... Hydrops fetalis due to isoimmunization
773.4....................................... Kernicterus due to isoimmunization
773.5....................................... Late anemia due to isoimmunization
783.9....................................... Other symptoms concerning nutrition, metabolism and development
790.0....................................... Abnormality of red blood cells
790.4....................................... Nonspecific elevation of levels of transaminase or lactic acid
dehydrogenase [LDH]
790.5....................................... Other nonspecific abnormal serum enzyme levels
790.6....................................... Other abnormal blood chemistry
799.4....................................... Cachexia
964.0....................................... Poisoning by agents primarily affecting blood constituents, iron
compounds
984.0-984.9................................. Toxic effect of lead and its compounds (including fumes)
996.85...................................... Complications of transplanted organ, bone marrow
999.8....................................... Other transfusion reaction
V08......................................... Asymptomatic HIV infection
V12.1....................................... Personal history of nutritional deficiency
V12.3....................................... Personal history of diseases of blood and blood forming organs
V15.1....................................... Personal history of surgery to heart and great vessels
V15.2....................................... Personal history of surgery to other major organs
V43.2....................................... Heart replaced by other means
V43.3....................................... Heart valve replaced by other means
V43.4....................................... Blood vessel replaced by other means
V43.60...................................... Unspecified joint replaced by other means
V56.0....................................... Extracorporeal dialysis
V56.8....................................... Other dialysis
V72.84...................................... Pre-operative examination, unspecified
----------------------------------------------------------------------------------------------------------------

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.

[[Page 58842]]

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 chlamydia diseases
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-V.79.9................................ 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

CDC. Recommendations to prevent and control iron deficiency in the
United States. MMWR 1998; 47(RR-3):1-29.
Powell LW, George DK, McDonnell SM, Kowdley KV. Diagnosis of
hemochromatosis. Ann.Intern.Med. 1998;129:925-931.
Spiekerman AM. Proteins used in nutritional assessment.
Clin.Lab.Med. 1993;13:353-369.
Wallach JB. Handbook of Interpretation of Diagnostic Tests.
Lippincott-Raven Publishers (Philadelphia) 1998, pp. 170-180.
Van Walraven C, Goel V, Chan B. Effect of Population-Based
Interventions on Laboratory Utilization. JAMA. 1998; 280:2028-2033.
Guyatt GH, Patterson C, Ali M, Singer J, Levine M, Turpie I, Meyer
R. Diagnosis of Iron-Deficiency Anemia in the Elderly. AmJMed. 1990;
88:205-209.
Burns ER, Goldberg SN, Lawrence C, Wenz B. AJCP. 1990; 3: 240-245.
Burns ER, et al. Brief Clinical Observations. AmJMed. 1991; 90:653-
654.
Yang Q, et al. Hemochromatosis-associated Mortality in the United
States from 1979 to 1992: An Analysis of Multiple-Cause Mortality Data.
AnIntMed. 1998; 129:946-953.

Coding Guidelines

1. Any claim for a test listed in AHCPCS CODES@ above must be
submitted with an ICD-9-CM diagnosis

[[Page 58843]]

code or comparable narrative. ICD-9-CM code V82.9 (special screening of
other conditions, unspecified condition), or comparable narratives
should be used to indicate screening tests performed in the absence of
a specific sign, symptom, or complaint. Use of V82.9 or comparable
narrative will result in the denial of claims as non covered screening
services. (Note: this language may be inappropriate for screening tests
that are specifically covered by statute, such as pap smears.) All ICD-
9-CM diagnosis codes must be coded to the highest level of specificity.
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 or fifth-digit classifications are
provided, they must be assigned. 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 nonspecific ICD-9-CM code is submitted, the underlying
sign, symptom, or condition must be related to the indications for the
test above.

Medicare National Coverage Decision for Collagen Crosslinks, Any Method

Other Names/Abbreviations

Description

Collagen crosslinks, part of the matrix of bone upon which bone
mineral is deposited, are biochemical markers the excretion of which
provide a quantitative measurement of bone resorption. Elevated levels
of urinary collagen crosslinks indicate elevated bone resorption.
Elevated bone resorption contributes to age-related and postmenopausal
loss of bone leading to osteoporosis and increased risk of fracture.
The collagen crosslinks assay can be performed by immunoassay or by
high performance liquid chromatography (HPLC). Collagen crosslink
immunoassays measure the pyridinoline crosslinks and associated
telopeptides in urine.
Bone is constantly undergoing a metabolic process called turnover
or remodeling. This includes a degradation process, bone resorption,
mediated by the action of osteoclasts, and a building process, bone
formation, mediated by the action of osteoblasts. Remodeling is
required for the maintenance and overall health of bone and is tightly
coupled; that is, resorption and formation must be in balance. In
abnormal states of bone remodeling, when resorption exceeds formation,
it results in a net loss of bone. The measurement of specific, bone-
derived resorption products provides analytical data about the rate of
bone resorption.
Osteoporosis is a condition characterized by low bone mass and
structural deterioration of bone tissue, leading to bone fragility and
an increased susceptibility to fractures of the hip, spine, and wrist.
The term primary osteoporosis is applied where the causal factor in the
disease is menopause or aging. The term secondary osteoporosis is
applied where the causal factor is something other than menopause or
aging, such as long-term administration of glucocorticosteroids,
endocrine-related disorders (other than loss of estrogen due to
menopause), and certain bone diseases such as cancer of the bone.
With respect to quantifying bone resorption, collagen crosslink
tests can provide adjunct diagnostic information in concert with bone
mass measurements. Bone mass measurements and biochemical markers may
have complementary roles to play in assessing effectiveness of
osteoporosis treatment. Proper management of osteoporosis patients, who
are on long-term therapeutic regimens, may include laboratory testing
of biochemical markers of bone turnover, such as collagen crosslinks,
that provide a profile of bone turnover responses within weeks of
therapy. Changes in collagen crosslinks are determined following
commencement of antiresorptive therapy. These can be measured over a
shorter time interval, such as three months, when compared to bone mass
density. If bone resorption is not elevated, repeat testing is not
medically necessary.

HCPCS Codes (Alpha numeric, CPT AMA)

Indications

Generally speaking, collagen crosslink testing is useful mostly in
``fast losers'' of bone. The age when these bone markers can help
direct therapy is often pre-Medicare. By the time a fast loser of bone
reaches age 65, she will most likely have been stabilized by
appropriate therapy or have lost so much bone mass that further testing
is useless. Coverage for bone marker assays may be established,
however, for younger Medicare beneficiaries and for those men and women
who might become fast losers because of some other therapy such as
glucocorticoids. Safeguards should be incorporated to prevent excessive
use of tests in patients for whom they have no clinical relevance.
Collagen crosslinks testing is used to:
Identify individuals with elevated bone resorption, who
have osteoporosis in whom response to treatment is being monitored;
Predict response (as assessed by bone mass measurements)
to FDA approved antiresorptive therapy in postmenopausal women;

[[Page 58844]]

Assess response to treatment of patients with
osteoporosis, Paget's disease of the bone, or risk for osteoporosis
where treatment may include FDA approved antiresorptive agents, anti-
estrogens or selective estrogen receptor moderators.

Limitations

Because of significant specimen to specimen collagen crosslink
physiologic variability (15-20%), current recommendations for
appropriate utilization include: one or two base-line assays from
specified urine collections on separate days; followed by a repeat
assay about three months after starting anti-resorptive therapy;
followed by a repeat assay in 12 months after the three-month assay;
and thereafter not more than annually, unless there is a change in
therapy in which circumstance an additional test may be indicated three
months after the initiation of new therapy.
Some collagen crosslink assays may not be appropriate for use in
some disorders, according to FDA labeling restrictions.

ICD-9-CM Codes Covered by Medicare Program

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.

ICD-9-CM Codes Denied

[[Page 58845]]

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 chlamydia diseases
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-V.79.9................................ 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.

Sources of Information

Arnaud CD. Osteoporosis: Using `bone markers' for diagnosis and
monitoring. Geriatrics 1996; 51:24-30.
Chesnut CH, III, Bell NH, Clark G, et al. Hormone replacement
therapy in postmenopausal women: urinary N-telopeptide of type I
collagen monitors therapeutic effect and predicts response of bone
mineral density. Am. J. Med. 1997;102:29-37.
Garnero P, Delmas PD. Clinical usefulness of markers of bone
remodelling in osteoporosis. In: Meunier PJ (ed).
Osteoporosis:diagnosis and management. London:Martin Dunitz Ltd.
1998:79-101.
Garnero P, Shih WJ, Gineyts E, et al. Comparison of new biochemical
markers of bone turnover in late postmenopausal osteoporotic women in
response to alendronate treatment. J. Clin. Endocrinol.
Metab.1994;79:1693-700.
Harper KD, Weber TJ. Secondary osteoporosis--Diagnostic
considerations.
Endocrinol. Metab.Clin. North Am. 1998;27:325-48.
Hesley RP, Shepard KA, Jenkins DK, Riggs BL. Monitoring estrogen
replacement therapy and identifying rapid bone losers with an
immunoassay for deoxypyridinoline. Osteoporos.Int. 1998;8:159-64.
Melton LJ, III, Khosla S, Atkinson EJ, et al. Relationship of bone
turnover to bone density and fractures. J.Bone Miner.Res.1997;12:1083-
91.
Millard PS. Prevention of osteoporosis: making sense of the
published evidence. In: Rosen CJ (ed). Osteoporosis: diagnostic and
therapeutic principles. Totowa: Humana Press Inc. 1996:275-85.
Rosen CJ. Biochemical markers of bone turnover. In: Rosen CJ(ed).
Osteoporosis: diagnostic and therapeutic principles. Totowa: Humana
Press Inc. 1996:129-41.
Schneider DL, Barrett-Connor EL. Urinary N-Telopeptide levels
discriminate normal, osteopenic, and osteoporotic bone mineral density.
Arch. Intern. Med. 1997;157:1241-5.

Coding Guidelines

[[Page 58846]]

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.
6. When the indication for the test is long-term administration of
glucocorticosteroids, use ICD-9-CM code V58.69.

Medicare National Coverage Decision for Blood Glucose Testing

Description

This policy is intended to apply to blood samples used to determine
glucose levels.
Blood glucose determination may be done using whole blood, serum or
plasma. It may be sampled by capillary puncture, as in the fingerstick
method, or by vein puncture or arterial sampling. The method for assay
may be by color comparison of an indicator stick, by meter assay of
whole blood or a filtrate of whole blood, using a device approved for
home monitoring, or by using a laboratory assay system using serum or
plasma. The convenience of the meter or stick color method allows a
patient to have access to blood glucose values in less than a minute or
so and has become a standard of care for control of blood glucose, even
in the inpatient setting.

HCPCS Codes (Alpha numeric, CPT-AMA)

Indications

Blood glucose values are often necessary for the management of
patients with diabetes mellitus, where hyperglycemia and hypoglycemia
are often present. They are also critical in the determination of
control of blood glucose levels in the patient with impaired fasting
glucose (FPG 110-125 mg/dL), the patient with insulin resistance
syndrome and/or carbohydrate intolerance (excessive rise in glucose
following ingestion of glucose or glucose sources of food), in the
patient with a hypoglycemia disorder such as nesidioblastosis or
insulinoma, and in patients with a catabolic or malnutrition state. In
addition to those conditions already listed, glucose testing may be
medically necessary in patients with tuberculosis, unexplained chronic
or recurrent infections, alcoholism, coronary artery disease
(especially in women), or unexplained skin conditions (including
pruritis, local skin infections, ulceration and gangrene without an
established cause). Many medical conditions may be a consequence of a
sustained elevated or depressed glucose level. These include comas,
seizures or epilepsy, confusion, abnormal hunger, abnormal weight loss
or gain, and loss of sensation. Evaluation of glucose may also be
indicated in patients on medications known to affect carbohydrate
metabolism.

Limitations

Frequent home blood glucose testing by diabetic patients should be
encouraged. In stable, non-hospitalized patients who are unable or
unwilling to do home monitoring, it may be reasonable and necessary to
measure quantitative blood glucose up to four times annually.
Depending upon the age of the patient, type of diabetes, degree of
control, complications of diabetes, and other co-morbid conditions,
more frequent testing than four times annually may be reasonable and
necessary.
In some patients presenting with nonspecific signs, symptoms, or
diseases not normally associated with disturbances in glucose
metabolism, a single blood glucose test may be medically necessary.
Repeat testing may not be indicated unless abnormal results are found
or unless there is a change in clinical condition. If repeat testing is
performed, a specific diagnosis code (e.g., diabetes) should be
reported to support medical necessity. However, repeat testing may be
indicated where results are normal in patients with conditions where
there is a confirmed continuing risk of glucose metabolism abnormality
(e.g., monitoring glucocorticoid therapy).

ICD-9-CM Codes Covered by Medicare Program

[[Page 58847]]

263.0-263.9................................. Malnutrition
271.0-271.9................................. Disorders of carbohydrate transport and metabolism
272.0-272-4................................. Disorders of lipoid metabolism
275.0....................................... Hemochromotosis
276.0-276.9................................. Disorders of fluid, electrolyte and acid-base balance
278.3....................................... Hypercarotinemia
293.0....................................... Acute delirium
294.9....................................... Unspecified organic brain syndrome
298.9....................................... Unspecified psychosis
300.9....................................... Unspecified neurotic disorder
310.1....................................... Organic personality syndrome
337.9....................................... Autonomic nervous system neuropathy
345.10-345.11............................... Generalized convulsive epilepsy
348.3....................................... Encephalopathy, unspecified
355.9....................................... Neuropathy, not otherwise specified
356.9....................................... Unspecified hereditary and idiopathic peripheral neuropathy
357.9....................................... Unspecified inflammatory and toxic neuropathy
362.10...................................... Background retinopathy
362.18...................................... Retinal vasculitis
362.29...................................... Nondiabetic proliferative retinopathy
362.50-362.57............................... Degeneration of macular posterior pole
362.60-362.66............................... Peripherial retinal degeneration
362.81-362.89............................... Other retinal disorders
362.0....................................... Unspecified retinal disorders
365.04...................................... Borderline glaucoma, ocular hypertension
365.32...................................... Corticosteriod-induced glaucoma residual
366.00-366.09............................... Presenile cataract
366.10-366.19............................... Senile cataract
367.1....................................... Acute myopia
368.8....................................... Other specified visual disturbance
373.00...................................... Blepharitis
377.24...................................... Pseudopapilledema
377.9....................................... Autonomic nervous system neuropathy
378.50-378.55............................... Paralytic strabiamus
379.45...................................... Argyll-Robertson pupils
410.00-410.92............................... Acute myocardial infarctions
414.00-414.19............................... Coronary atherosclerosis and aneurysm of heart
425.9....................................... Secondary cardiomyopathy, unspecified
440.23...................................... Arteriosclerosis of extremities with ulceration
440.24...................................... Arteriosclerosis of extremities with gangrene
440.9....................................... Arteriosclerosis, not otherwise specified
458.0....................................... Postural hypotension
462......................................... Acute pharyngitis
466.0....................................... Acute bronchitis
480.0-486................................... Pneumonia
490......................................... Recurrent bronchitis, not specified as acute or chronic
491.0-491.9................................. Chronic bronchitis
527.7....................................... Disturbance of salivory secretion (drymouth)
528.0....................................... Stomatitis
535.50-535.51............................... Gastritis
536.8....................................... Dyspepsia
571.8....................................... Other chronic nonalcoholic liver disease
572.0-572.8................................. Liver abscess and sequelae of chronic liver disease
574.50-574.51............................... Choledocholitiasis
575.0-575.12................................ Cholecystitis
576.1....................................... Cholangitis
577.0....................................... Acute pancreatitis
577.1....................................... Chronic pancreatitis
577.8....................................... Pancreatic multiple calculi
590.00-590.9................................ Infections of the kidney
595.9....................................... Recurrent cystitis
596.4....................................... Bladder atony
596.53...................................... Bladder paresis
599.0....................................... Urinary tract infection, recurrent
607.84...................................... Impotence of organic origin
608.89...................................... Other disorders male genital organs
616.10...................................... Vulvovaginitis
626.0....................................... Amenorrhea
626.4....................................... Irregular menses
628.9....................................... Infertility--female
648.00...................................... Diabetes mellitus complicating pregnancy, Childbirth or the
puerperium, unspecified as to episode of care or not applicable
648.03...................................... Diabetes mellitus complicating pregnancy, Childbirth or the
puerperium, antipartum condition or complication

[[Page 58848]]

648.04...................................... Diabetes mellitus complicating pregnancy, Childbirth or the
puerperium, postpartum condition or complication
648.80...................................... Abnormal glucose tolerance complicating pregnancy, childbirth or
the puerperium, unspecified as to episode of care or not
applicable
648.83...................................... Abnormal glucose tolerance complicating pregnancy, childbirth or
the puerperium, antipartum condition or complication
648.84...................................... Abnormal glucose tolerance complicating pregnancy, childbirth or
the puerperium, postpartum condition or complication
656.60-656.63............................... Fetal problems affecting management of mother--large for-date of
fetus
657.00-657.03............................... Polyhydramnios
680.0-680.9................................. Carbuncle and furuncle
686.00-686.9................................ Infections of skin and subcutaneous tissue
698.0....................................... Pruritis ani
698.1....................................... Pruritis of genital organs
704.1....................................... Hirsutism
705.0....................................... Anhidrosis
707.0-707.9................................. Chronic ulcer of skin
709.3....................................... Degenerative skin disorders
729.1....................................... Myalgia
730.07-730.27............................... Osteomyelitis of tarsal bones
780.01...................................... Coma
780.02...................................... Transient alteration of awareness
780.09...................................... Alteration of consciousness, other
780.2....................................... Syncope and collapse
780.31...................................... Febrile convulsions
780.39...................................... Seizures, not otherwise specified
780.4....................................... Dizziness and giddiness
780.71-780.79............................... Malaise and fatigue
780.8....................................... Hyperhidrosis
781.0....................................... Abnormal involuntary movements
782.0....................................... Loss of vibratory sensation
783.1....................................... Abnormal weight gain
783.2....................................... Abnormal loss of weight
783.5....................................... Polydipsia
783.6....................................... Polyphagia
785.0....................................... Tachycardia
785.4....................................... Gangrene
786.01...................................... Hyperventilation
786.09...................................... Dyspnea,
786.50...................................... Chest pain, unspecified
787.6....................................... Fecal incontinence
787.91...................................... Diarrhea
788.41-788.43............................... Frequency of urination and polyuria
789.1....................................... Hepatomegaly
790.2....................................... Abnormal glucose tolerance test
790.6....................................... Other abnormal blood chemistry (hyperglycemia)
791.0....................................... Proteinuria
791.5....................................... Glycosuria
796.1....................................... Abnormal reflex
799.4....................................... Cachexia
V23.0-.9.................................... Supervision of high risk pregnancy
V67.2....................................... Follow-up examination, following chemotherapy
V67.51...................................... Follow up examination with high-risk medication not elsewhere
classified
V58.69...................................... Long term current use of other medication
----------------------------------------------------------------------------------------------------------------

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.

[[Page 58849]]

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 chlamydia diseases
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-V.79.9................................ 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

AACE Guidelines for the Management of Diabetes Mellitus, Endocrine
Practice (1995)1:149-157.
Bower, Bruce F. and Robert E. Moore, Endocrine Function and
Carbohydrates.
Clinical Laboratory Medicine, Kenneth D. McClatchy, editor.
Baltimore/Williams & Wilkins, 1994. pp 321-323.
Report of the Expert Committee on the Diagnosis and Classification
of Diabetes Mellitus, Diabetes Care, Volume 20, Number 7, July 1997,
pages 1183 et seq.
Roberts, H.J., Difficult Diagnoses. W. B. Saunders Co., pp 69-70.

Coding Guidelines

[[Page 58850]]

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.
6. A diagnostic statement of impaired glucose tolerance must be
evaluated in the context of the documentation in the medical record in
order to assign the most accurate ICD-9-CM code. An abnormally elevated
fasting blood glucose level in the absence of the diagnosis of diabetes
is classified to Code 790.6--other abnormal blood chemistry. If the
provider bases the diagnostic statement of impaired glucose tolerance''
on an abnormal glucose tolerance test, the condition is classified to
790.2--normal glucose tolerance test. Both conditions are considered
indications for ordering glycated hemoglobin or glycated protein
testing in the absence of the diagnosis of diabetes mellitus.
7. When a patient is under treatment for a condition for which the
tests in this policy are applicable, the ICD-9-CM code that best
describes the condition is most frequently listed as the reason for the
test.
8. When laboratory testing is done solely to monitor response to
medication, the most accurate ICD-9-CM code to describe the reason for
the test would be V58.69--long term use of medication.
9. Periodic follow-up for encounters for laboratory testing for a
patient with a prior history of a disease, who is no longer under
treatment for the condition, would be coded with an appropriate code
from the V67 category--follow-up examination.
10. According to ICD-9-CM coding conventions, codes that appear in
italics in the Alphabetic and/or Tabular columns of ICD-9-CM are
considered manifestation codes that require the underlying condition to
be coded and sequenced ahead of the manifestation. For example, the
diagnostic statement, ``thyrotoxic exophthalmos (376.21),'' which
appears in italics in the tabular listing, requires that the thyroid
disorder (242.0-242.9) is coded and sequenced ahead of thyrotoxic
exophthalmos. Therefore, a diagnostic statement that is listed as a
manifestation in ICD-9-CM must be expanded to include the underlying
disease in order to accurately code the condition.

Documentation Requirements

The ordering physician must include evidence in the patient's
clinical record that an evaluation of history and physical preceded the
ordering of glucose testing and that manifestations of abnormal glucose
levels were present to warrant the testing.

Medicare National Coverage Decision for Glycated Hemoglobin/glycated
Protein

Description

The management of diabetes mellitus requires regular determinations
of blood glucose levels. Glycated hemoglobin/protein levels are used to
assess long-term glucose control in diabetes. Alternative names for
these tests include glycated or glycosylated hemoglobin or Hgb,
hemoglobin glycated or glycosylated protein, and fructosamine.
Glycated hemoglobin (equivalent to hemoglobin A1) refers to total
glycosylated hemoglobin present in erythrocytes, usually determined by
affinity or ion-exchange chromatographic methodology. Hemoglobin A1c
refers to the major component of hemoglobin A1, usually determined by
ion-exchange affinity chromatography, immunoassay or agar gel
electrophoresis.
Fructosamine or glycated protein refers to glycosylated protein
present in a serum or plasma sample. Glycated protein refers to
measurement of the component of the specific protein that is glycated
usually by colorimetric method or affinity chromatography.
Glycated hemoglobin in whole blood assesses glycemic control over a
period of 4-8 weeks and appears to be the more appropriate test for
monitoring a patient who is capable of maintaining long-term, stable
control. Measurement may be medically necessary every 3 months to
determine whether a patient's metabolic control has been on average
within the target range. More frequent assessments, every 1-2 months,
may be appropriate in the patient whose diabetes regimen has been
altered to improve control or in whom evidence is present that
intercurrent events may have altered a previously satisfactory level of
control (for example, post-major surgery or as a result of
glucocorticoid therapy). Glycated protein in serum/plasma assesses
glycemic control over a period of 1-2 weeks. It may be reasonable and
necessary to monitor glycated protein monthly in pregnant diabetic
women. Glycated hemoglobin/protein test results may be low, indicating
significant, persistent hypoglycemia, in nesidioblastosis or
insulinoma, conditions which are accompanied by inappropriate
hyperinsulinemia. A below normal test value is helpful in establishing
the patient's hypoglycemic state in those conditions.

HCPCS Codes (alpha numeric, CPT AMA)

Indications

Glycated hemoglobin/protein testing is widely accepted as medically
necessary for the management and control of diabetes. It is also
valuable to assess hyperglycemia, a history of hyperglycemia or
dangerous hypoglycemia. Glycated protein testing may be used in place
of glycated hemoglobin in the management of diabetic patients, and is
particularly useful in patients who have abnormalities of erythrocytes
such as hemolytic anemia or hemoglobinopathies.

Limitations

It is not considered reasonable and necessary to perform glycated
hemoglobin tests more often than every

[[Page 58851]]

three months on a controlled diabetic patient to determine whether the
patient's metabolic control has been on average within the target
range. It is not considered reasonable and necessary for these tests to
be performed more frequently than once a month for diabetic pregnant
women. Testing for uncontrolled type one or two diabetes mellitus may
require testing more than four times a year. The above Description
Section provides the clinical basis for those situations in which
testing more frequently than four times per annum is indicated, and
medical necessity documentation must support such testing in excess of
the above guidelines.
Many methods for the analysis of glycated hemoglobin show
significant interference from elevated levels of fetal hemoglobin or by
variant hemoglobin molecules. When the glycated hemoglobin assay is
initially performed in these patients, the laboratory may inform the
ordering physician of a possible analytical interference. Alternative
testing, including glycated protein, for example, fructosamine, may be
indicated for the monitoring of the degree of glycemic control in this
situation. It is therefore conceivable that a patient will have both a
glycated hemoglobin and glycated protein ordered on the same day. This
should be limited to the initial assay of glycated hemoglobin, with
subsequent exclusive use of glycated protein.
These tests are not considered to be medically necessary for the
diagnosis of diabetes.

ICD-9-CM Codes Covered by the Medicare Program

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.

[[Page 58852]]

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 chlamydia diseases
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-V.79.9................................ 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

Bower, Bruce F. and Robert E. Moore, Endocrine Function and
Carbohydrates. Clinical Laboratory Medicine, Kenneth D. McClatchy,
editor. Baltimore/Williams & Wilkins, 1994. pp. 321-323.
Tests of Glycemia in Diabetes. Diabetes Care. 1/98, 21:Supp. 1:S69-
S71.
American Association of Clinical Endocrinologists Guidelines for
the Management of Diabetes Mellitus
Dons, Robert F., Endocrine and Metabolic Testing Manual, Third
Edition. Expert Committee on Glycated Hb. Diabetes Care,. 11/84,
7:6:602-606. Evaluation of Glycated Hb in Diabetes, Diabetes. 7/91,
30:613-617.
Foster, Daniel W., Diabetes Mellitus, Harrison's Principles of
Internal Medicine. 13th ed., Kurt J. Isselbacher et al. Editors, New
York/McGraw-Hill, 1994, pg. 1990.
Management of Diabetes in Older Patients. Practical Therapeutics.
1991, Drugs 41:4:548-565.
Koch, David D., Fructosamine: How Useful Is It?, Laboratory
Medicine, Volume 21, No. 8, August 1990, pp. 497-503.
Report of the Expert Committee on the Diagnosis and Classification
of Diabetes Mellitus, Diabetes Care, Volume 20, Number 7, July 1997,
pp. 1183 et seq.
Sacks, David B., Carbohydrates. In Tietz Textbook of Clinical
Chemistry, 2nd Ed., Carl A. Burtis and Edward R. Ashwood, editors.
Philadelphia, W.B. Saunders Co., 1994. pp. 980-988.
Tests of Glycemia in Diabetes, American Diabetes Association,
Diabetes Care, Volume 20, Supplement I, January 1997, pp. 518-520.

Coding Guidelines

[[Page 58853]]

exposure to communicable diseases, should be assigned, not a screening
code. 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.
6. A diagnostic statement of impaired glucose tolerance must be
evaluated in the context of the documentation in the medical record in
order to assign the most accurate ICD-9-CM code. An abnormally elevated
fasting blood glucose level in the absence of the diagnosis of diabetes
is classified to Code 790.6--other abnormal blood chemistry. If the
provider bases the diagnostic statement of impaired glucose tolerance''
on an abnormal glucose tolerance test, the condition is classified to
790.2--normal glucose tolerance test. Both conditions are considered
indications for ordering glycated hemoglobin or glycated protein
testing in the absence of the diagnosis of diabetes mellitus.

Medicare National Coverage Decision For Thyroid Testing

Other Names/Abbreviations

Description

Thyroid function studies are used to delineate the presence or
absence of hormonal abnormalities of the thyroid and pituitary glands.
These abnormalities may be either primary or secondary and often but
not always accompany clinically defined signs and symptoms indicative
of thyroid dysfunction.
Laboratory evaluation of thyroid function has become more
scientifically defined. Tests can be done with increased specificity,
thereby reducing the number of tests needed to diagnose and follow
treatment of most thyroid disease.
Measurements of serum sensitive thyroid-stimulating hormone (TSH)
levels, complemented by determination of thyroid hormone levels [free
thyroxine (fT-4) or total thyroxine (T4) with Triiodothyronine (T3)
uptake] are used for diagnosis and follow-up of patients with thyroid
disorders. Additional tests may be necessary to evaluate certain
complex diagnostic problems or on hospitalized patients, where many
circumstances can skew tests results. When a test for total thyroxine
(total T4 or T4 radioimmunoassay) or T3 uptake is performed,
calculation of the free thyroxine index (FTI) is useful to correct for
abnormal results for either total T4 or T3 uptake due to protein
binding effects.

HCPCS Codes (alpha numeric, CPT AMA)

Indications

Thyroid function tests are used to define hyper function,
euthyroidism, or hypofunction of thyroid disease. Thyroid testing may
be reasonable and necessary to:
Distinguish between primary and secondary hypothyroidism;
Confirm or rule out primary hypothyroidism;
Monitor thyroid hormone levels (for example, patients with
goiter, thyroid nodules, or thyroid cancer);
Monitor drug therapy in patients with primary
hypothyroidism;
Confirm or rule out primary hyperthyroidism; and
Monitor therapy in patients with hyperthyroidism.
Thyroid function testing may be medically necessary in patients
with disease or neoplasm of the thyroid and other endocrine glands.
Thyroid function testing may also be medically necessary in patients
with metabolic disorders; malnutrition; hyperlipidemia; certain types
of anemia; psychosis and non-psychotic personality disorders;
unexplained depression; ophthalmologic disorders; various cardiac
arrhythmias; disorders of menstruation; skin conditions; myalgias; and
a wide array of signs and symptoms, including alterations in
consciousness; malaise; hypothermia; symptoms of the nervous and
musculoskeletal system; skin and integumentary system; nutrition and
metabolism; cardiovascular; and gastrointestinal system. It may be
medically necessary to do follow-up thyroid testing in patients with a
personal history of malignant neoplasm of the endocrine system and in
patients on long-term thyroid drug therapy.

Limitations

Testing may be covered up to two times a year in clinically stable
patients; more frequent testing may be reasonable and necessary for
patients whose thyroid therapy has been altered or in whom symptoms or
signs of hyperthyroidism or hypothyroidism are noted.

ICD-9-CM Codes Covered by Medicare Program

[[Page 58854]]

194.8....................................... Malignant neoplasm of other endocrine glands and related
structures, other
198.89...................................... Secondary malignant neoplasm of the thyroid
220......................................... Benign neoplasm of ovary
226......................................... Benign neoplasm of thyroid gland
227.3....................................... Benign neoplasm of pituitary gland and craniopharyngeal duct
234.8....................................... Carcinoma in situ of other and unspecified sites
237.4....................................... Neoplasm of uncertain behavior of other and unspecified endocrine
glands
239.7....................................... Neoplasm of unspecified nature, thyroid gland
240.0-240.9................................. Goiter specified and unspecified
241.0-241.9................................. Nontoxic nodular goiter
242.00-242.91............................... Thyrotoxicosis with or without goiter
243......................................... Congenital hypothyroidism
244.0-244.9................................. Acquired hypothyroidism
245.0-245.9................................. Thyroiditis
246.0-246.9................................. Other disorders of thyroid
250.00-250.93............................... Diabetes mellitus
252.1....................................... Hypoparathyroidism
253.1....................................... Other and unspecified anterior pituitary hyper function
253.2....................................... Panhypopituitarism
253.3-253.4................................. Pituitary dwarfism
253.4....................................... Other anterior pituitary disorders
253.7....................................... Iatrogenic pituitary disorders
255.2....................................... Adrenogenital disorders
255.4....................................... Corticoadrenal insufficiency
256.3....................................... Ovarian failure
257.2....................................... Testicular hypofunction
258.0-258.9................................. Polyglandular dysfunction
262......................................... Malnutrition, severe
263.0-263.9................................. Malnutrition, other and unspecified
266.0....................................... Ariboflavinosis
272.0....................................... Pure hypercholesterolemia
272.2....................................... Mixed hyperlipidemia
272.4....................................... Other and unspecified hyperlipidemia
275.40-275.49............................... Calcium disorders
276.0....................................... Hyposmolality and/or hypernatremia
276.1....................................... Hyposmolality and/or hyponatremia
278.3....................................... Hypercarotinemia
279.4....................................... Autoimmune disorder, not classified elsewhere
281.0....................................... Pernicious anemia
281.9....................................... Unspecified deficiency anemia
283.0....................................... Autoimmune hemolytic anemia
285.9....................................... Anemia, unspecified
290.0....................................... Senile dementia, uncomplicated
290.10-290.13............................... Presenile dementia
290.20-290.21............................... Senile dementia with delusional or depressive features
290.3....................................... Senile dementia with delirium
293.0-293.1................................. Delirium
293.81-293.89............................... Transient organic mental disorders
294.8....................................... Other specified organic brain syndromes
296.00-296.99............................... Affective psychoses
297.0....................................... Paranoid state, simple
297.1....................................... Paranoia
297.9....................................... Unspecified paranoid state
298.3....................................... Acute paranoid reaction
300.00-300.09............................... Anxiety states
307.9....................................... Agitation--other and unspecified special symptoms or syndromes,
not elsewhere classified
310.1....................................... Organic personality syndrome
311......................................... Depressive disorder, not elsewhere classified
331.0-331.2................................. Alzheimer's, pick's disease, Senile degeneration of brain
333.1....................................... Essential and other specified forms of tremor
333.99...................................... Other extrapyramidao diseases and abnormal movement disorders
354.0....................................... Carpal Tunnel syndrome
356.9....................................... Idiopathic peripheral neuropathy, unspecified polyneuropathy
358.1....................................... Myasthenic syndromes in diseases classified elsewhere
359.5....................................... Myopathy in endocrine diseases classified elsewhere
359.9....................................... Myopathy, unspecified
368.2....................................... Diplopia
372.71...................................... Conjunctival hyperemia
372.73...................................... Conjunctival edema
374.41...................................... Lid retraction or lag
374.82...................................... Eyelid edema
376.21...................................... Thyrotoxic exophthalmos
376.22...................................... Exophthalmic ophthlmoplegia
376.30-376.31............................... Exophthalmic conditions, unspecified and constant

[[Page 58855]]

376.33-376.34............................... Orbital edema or congestion, intermittent exophthalmos
378.50-378.55............................... Paralytic strabismus
401.0-401.9................................. Essential hypertension
403.00-403.91............................... Hypertensive renal disease
404.00-404.93............................... Hypertensive heart and renal disease
423.9....................................... Unspecified disease of pericardium
425.7....................................... Nutritional and metabolic cardiomyopathy
427.0....................................... Paroxysmal supraventricular tachycardia
427.2....................................... Paroxysmal tachycardia, unspecified
427.31...................................... Atrial fibrillation
427.89...................................... Other specified cardiac dysrhythmia
427.9....................................... Cardiac dysrhythmia, unspecified
428.0....................................... Congestive heart failure
428.1....................................... Left heart failure
429.3....................................... Cardiomegaly
511.9....................................... Unspecified pleural effusion
518.81...................................... Acute respiratory failure
529.8....................................... Other specified conditions of the tongue
560.1....................................... Paralytic ileus
564.0....................................... Constipation
564.7....................................... Megacolon, other than Hirschsprung's
568.82...................................... Peritoneal effusion (chronic)
625.3....................................... Dysmenorrhea
626.0-626.2................................. Disorders of menstruation
626.4....................................... Irregular menstrual cycle
648.10-648.14............................... Other current conditions in the mother, classifiable elsewhere,
but complicating pregnancy, childbirth, or the puerperium,
thyroid dysfunction
676.20-676.24............................... Engorgement of breast associated with childbirth and disorders of
lactation
698.9....................................... Unspecified pruritic disorder
701.1....................................... Keratoderma, acquired (dry skin)
703.8....................................... Other specified diseases of nail (Brittle nails)
704.00-704.09............................... Alopecia
709.01...................................... Vitiligo
710.0-710.9................................. Diffuse disease of connective tissue
728.2....................................... Muscle wasting
728.9....................................... Unspecified disorder of muscle, ligament, and fascia
729.1....................................... Myalgia and myositis, unspecified
729.82...................................... Musculoskeletal cramp
730.30-730.39............................... Periostitis without osteomyelitis
733.09...................................... Osteoporosis, drug induced
750.15...................................... Macroglossia, congenital
759.2....................................... Anomaly of other endocrine glands
780.01...................................... Coma
780.02...................................... Transient alteration of awareness
780.09...................................... Alteration of consciousness, other
780.50-780.52............................... Insomnia
780.6....................................... Fever
780.71-780.79............................... Malaise and fatigue
780.8....................................... Hyperhidrosis
780.9....................................... Other general symptoms (hyperthermia)
781.0....................................... Abnormal involuntary movements
781.3....................................... Lack of coordination, ataxia
782.0....................................... Disturbance of skin sensation
782.3....................................... Localized edema
782.8....................................... Changes in skin texture
782.9....................................... Other symptoms involving skin and integumentary tissues
783.1....................................... Abnormal weight gain
783.2....................................... Abnormal loss of weight
783.6....................................... Polyphagia
784.1....................................... Throat pain
784.49...................................... Voice disturbance
784.5....................................... Other speech disturbance
785.0....................................... Tachycardia, unspecified
785.1....................................... Palpitations
785.9....................................... Other symptoms involving cardiovascular system
786.09...................................... Other symptoms involving respiratory system
786.1....................................... Stridor
787.2....................................... Dysphagia
787.91-787.99............................... Other symptoms involving digestive system
789.5....................................... Ascites
793.9....................................... Nonspecific abnormal findings on radiological and other
examination, other (neck)
794.5....................................... Thyroid, abnormal scan or uptake
796.1....................................... Other nonspecific abnormal findings, abnormal reflex
799.2....................................... Nervousness

[[Page 58856]]

990......................................... Effects of radiation, unspecified
V10.87...................................... Personal history of malignant neoplasm of the thyroid
V10.88...................................... Personal history of malignant neoplasm of other endocrine gland
V12.2....................................... Personal history of endocrine, metabolic and immunity disorders
V58.69...................................... Long term (current) use of other medications
V67.0-V67.9................................. Follow-up examination
----------------------------------------------------------------------------------------------------------------

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 routine 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 chlamydia diseases
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

[[Page 58857]]

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

AACE Clinical Practice Guidelines for the Diagnosis and Management
of Thyroid Nodules, Endocrine Practice (1996) 2:1, pp. 78-84.
AACE Clinical Practice Guidelines for the Evaluation and Treatment
of Hyperthyroidism and Hypothyroidism, Endocrine Practice (1995) 1:1,
pp. 54-62.
AACE Clinical Practice Guidelines for the Management of Thyroid
Carcinoma, Endocrine Practice (1997) 3:1, pp. 60-71.
Cooper DS. Treatment of thyrotoxicosis. In Braverman LE, Utiger RD,
eds. Werner and Ingbar's The Thyroid: A Fundamental and Clinical Text.
6th ed. Philadelphia, Pa: JB Lippincott Co; 1991: 887-916.
Endocrinology. DeGroot LJ, et. al. Eds. 3rd ed. Philadelphia, Pa:
W.B. Saunders Co.; 1995.
Endocrinology and Metabolism. Felig, P, Baxter, JD, Frohman, LA,
eds.3rd ed. McGraw-Hill, Inc.: 1995.
Franklyn JA. The Management of Hyperthyroidism. N Engl J Med. 1994;
330(24):1731-1738.
Glenn GC and the Laboratory Testing Strategy Task Force of the
College of American Pathologists. Practice parameter on laboratory
panel testing for screening and case finding in asymptomatic adults.
Arch Pathol LabMed. 1996:120:929-43.
Larsen PR, Ingbar SH. The Thyroid Gland. In: Wilson JD, Foster DW,
eds. Williams Textbook of Endocrinology. 9th ed. Philadelphia, Pa: WB
Saunders Co; 1992:357-487.
The Merck Manual, 16th Edition, pp. 1072-1081.

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.
6. When a patient is under treatment for a condition for which the
tests in this policy are applicable, the ICD-9-CM code that best
describes the condition is most frequently listed as the reason for the
test.
7. When laboratory testing is done solely to monitor response to
medication, the most accurate ICD-9-CM code to describe the reason for
the test would be V58.69--long term use of medication.
8. Periodic follow-up for encounters for laboratory testing for a
patient with a prior history of a disease, who is no longer under
treatment for the condition, would be coded with an appropriate code
from the V67 category--follow-up examination.
9. According to ICD-9-CM coding conventions, codes that appear in
italics in the Alphabetic and/or Tabular columns of ICD-9-CM are
considered manifestation codes that require the underlying condition to
be coded and sequenced ahead of the manifestation. For example, the
diagnostic statement ``thyrotoxic exophthalmos (376.21),'' which
appears in italics in the tabular listing, requires that the thyroid
disorder (242.0-242.9) is coded and sequenced ahead of thyrotoxic
exophthalmos. Therefore, a diagnostic statement that is listed as a
manifestation in ICD-9-CM must be expanded to include the underlying
disease in order to accurately code the condition.
10. Use code 728.9 to report muscle weakness as the indication for
the test. Other diagnoses included in 728.9 do not support medical
necessity.
11. Use code 194.8 (Malignant neoplasm of other endocrine glands
and related structures, Other) to report multiple endocrine neoplasia
syndromes (MEN-1 and MEN-2). Other diagnoses included in 194.8 do not
support medical necessity.

Documentation Requirements

When these tests are billed at a greater frequency than the norm
(two per year), the ordering physician's documentation must support the
medical necessity of this frequency.

Medicare National Coverage Decision for Lipids
Other Names/Abbreviations

Description

Lipoproteins are a class of heterogeneous particles of varying
sizes and densities containing lipid and protein. These lipoproteins
include cholesterol esters and free cholesterol, triglycerides,
phospholipids and A, C, and E apoproteins. Total cholesterol comprises
all the cholesterol found in various lipoproteins.
Factors that affect blood cholesterol levels include age, sex, body
weight, diet, alcohol and tobacco use, exercise,

[[Page 58858]]

genetic factors, family history, medications, menopausal status, the
use of hormone replacement therapy, and chronic disorders such as
hypothyroidism, obstructive liver disease, pancreatic disease
(including diabetes), and kidney disease.
In many individuals, an elevated blood cholesterol level
constitutes an increased risk of developing coronary artery disease.
Blood levels of total cholesterol and various fractions of cholesterol,
especially low density lipoprotein cholesterol (LDL-C) and high density
lipoprotein cholesterol (HDL-C), are useful in assessing and monitoring
treatment for that risk in patients with cardiovascular and related
diseases.
Blood levels of the above cholesterol components including
triglyceride have been separated into desirable, borderline and high
risk categories by the National Heart, Lung and Blood Institute in
their report in 1993. These categories form a useful basis for
evaluation and treatment of patients with hyperlipidemia (See
Reference). Therapy to reduce these risk parameters includes diet,
exercise and medication, and fat weight loss, which is particularly
powerful when combined with diet and exercise.

HCPCS Codes (alpha numeric, CPT AMA)

----------------------------------------------------------------------------------------------------------------
Code Descriptor
----------------------------------------------------------------------------------------------------------------
80061....................................... Lipid panel
82465....................................... Cholesterol, serum, total
83715....................................... Lipoprotein, blood; electrophoretic separation and quantitation
83716....................................... Lipoprotein, blood: high resolution fractionation and quantitation
of lipoprotein cholesterols (for example, electrophoretic,
nuclear magnetic resonance, ultracentrifugation)
83718....................................... Lipoprotein, direct measurement; high density cholesterol (HDL
cholesterol)
83721....................................... Lipoprotein, direct measurement, LDL cholesterol
84478....................................... Triglycerides
----------------------------------------------------------------------------------------------------------------

Indications

The medical community recognizes lipid testing as appropriate for
evaluating atherosclerotic cardiovascular disease. Conditions in which
lipid testing may be indicated include:
Assessment of patients with atherosclerotic cardiovascular
disease;
Evaluation of primary dyslipidemias;
Any form of atherosclerotic disease;
Diagnostic evaluation of diseases associated with altered
lipid metabolism, such as: nephrotic syndrome, pancreatitis, hepatic
disease, and hypo and hyperthyroidism;
Secondary dyslipidemias, including diabetes mellitus,
disorders of gastrointestinal absorption, chronic renal failure; and
Signs or symptoms of dyslipidemias, such as skin lesions.
As follow-up to the initial screen for coronary heart
disease (total cholesterol + HDL cholesterol) when total cholesterol is
determined to be high (>240 mg/dL), or borderline-high (200-240 mg/dL)
plus two or more coronary heart disease risk factors, or an HDL
cholesterol 35 mg/dl.
To monitor the progress of patients on anti-lipid dietary
management and pharmacologic therapy for the treatment of elevated
blood lipid disorders, total cholesterol, HDL cholesterol and LDL
cholesterol may be used. Triglycerides may be obtained if this lipid
fraction is also elevated or if the patient is put on drugs (for
example, thiazide diuretics, beta blockers, estrogens, glucocorticoids,
and tamoxifen) which may raise the triglyceride level.
When monitoring long term anti-lipid dietary or pharmacologic
therapy and when following patients with borderline high total or LDL
cholesterol levels, it may be reasonable to perform the lipid panel
annually. A lipid panel (CPT code 80061) at a yearly interval will
usually be adequate while measurement of the serum total cholesterol
(CPT code 82465) or a measured LDL (CPT code 83721) should suffice for
interim visits if the patient does not have hypertriglyceridemia (for
example, ICD-9-CM code 272.1, Pure hyperglyceridemia).
Any one component of the panel or a measured LDL may be reasonable
and necessary up to six times the first year for monitoring dietary or
pharmacologic therapy. More frequent total cholesterol HDL cholesterol,
LDL cholesterol and triglyceride testing may be indicated for marked
elevations or for changes to anti-lipid therapy due to inadequate
initial patient response to dietary or pharmacologic therapy. The LDL
cholesterol or total cholesterol may be measured three times yearly
after treatment goals have been achieved.
Electrophoretic or other quantitation of lipoproteins (CPT codes
83715 and 83716) may be indicated if the patient has a primary disorder
of lipoid metabolism (ICD-9-CM codes 272.0 to 272.9).

Limitations

Lipid panel and hepatic panel testing may be used for patients with
severe psoriasis which has not responded to conventional therapy and
for which the retinoid estretinate has been prescribed and who have
developed hyperlipidemia or hepatic toxicity. Specific examples include
erythrodermia and generalized pustular type and psoriasis associated
with arthritis.
Routine screening and prophylactic testing for lipid disorder are
not covered by Medicare. While lipid screening may be medically
appropriate, Medicare by statute does not pay for it. Lipid testing in
asymptomatic individuals is considered to be screening regardless of
the presence of other risk factors such as family history, tobacco use,
etc.
Once a diagnosis is established, one or several specific tests are
usually adequate for monitoring the course of the disease.
Less specific diagnoses (for example, other chest pain) alone do
not support medical necessity of these tests.
When monitoring long term anti-lipid dietary or pharmacologic
therapy and when following patients with borderline high total or LDL
cholesterol levels, it is reasonable to perform the lipid panel
annually. A lipid panel (CPT code 80061) at a yearly interval will
usually be adequate while measurement of the serum total cholesterol
(CPT code 82465) or a measured LDL (CPT code 83721) should suffice for
interim visits if the patient does not have hypertriglyceridemia (for
example, ICD-9-CM code 272.1, Pure hyperglyceridemia).
Any one component of the panel or a measured LDL may be medically
necessary up to six times the first year for monitoring dietary or
pharmacologic therapy. More frequent total cholesterol HDL cholesterol,
LDL cholesterol and triglyceride testing may be indicated for

[[Page 58859]]

marked elevations or for changes to anti-lipid therapy due to
inadequate initial patient response to dietary or pharmacologic
therapy. The LDL cholesterol or total cholesterol may be measured three
times yearly after treatment goals have been achieved.
If no dietary or pharmacological therapy is advised, monitoring is
not necessary.
When evaluating non-specific chronic abnormalities of the liver
(for example, elevations of transaminase, alkaline phosphatase,
abnormal imaging studies, etc.), a lipid panel would generally not be
indicated more than twice per year.

ICD-9-CM Codes Covered by Medicare Program

----------------------------------------------------------------------------------------------------------------
Code Description
----------------------------------------------------------------------------------------------------------------
242.00-245.9................................ Disorders of the thyroid gland with hormonal dysfunction
250.00-250.93............................... Diabetes mellitus
255.0....................................... Cushing's syndrome
260......................................... Kwashiorkor
261......................................... Nutritional marasmus
262......................................... Other severe, protein-calorie malnutrition
263.0....................................... Malnutrition of moderate degree
263.1....................................... Malnutrition of mild degree
263.8....................................... Other protein-calorie malnutrition
263.9....................................... Unspecified protein-calorie malnutrition
270.0....................................... Disturbances of amino-acid transport
271.1....................................... Galactosemia
272.0....................................... Pure hypercholesterolemia
272.1....................................... Hyperglyceridemia
272.2....................................... Mixed hyperlipidemia (tuberous xanthoma)
272.3....................................... Hyperchylomicronemia
272.4....................................... Other and unspecified hyperlipidemia (unspecified xanthoma)
272.5....................................... Lipoprotein deficiencies
272.6....................................... Lipodystrophy
272.7....................................... Lipidoses
272.8....................................... Other disorders of lipoid metabolism
272.9....................................... Unspecified disorders of lipoid metabolism
277.3....................................... Amyloidosis
278.00...................................... Obesity
278.01...................................... Morbid obesity
303.90-303.92............................... Alcoholism
362.10-362.16............................... Other background retinopathy and retinal vascular change
362.30-362.34............................... Retinal vascular occlusion
362.82...................................... Retinal exudates and deposits
371.41...................................... Corneal arcus, juvenile
374.51...................................... Xanthelasma
379.22...................................... Crystalline deposits in vitreous
388.00...................................... Degenerative & vascular disorder of ear, unspecified
388.02...................................... Transient ischemic deafness
401.0, 401.9................................ Essential hypertension
402.00-402.91............................... Hypertensive heart disease
403.00-403.91............................... Hypertensive renal disease
404.00-404.93............................... Hypertensive heart and renal disease
405.01-405.99............................... Secondary hypertension
410.00-410.92............................... Acute myocardial infarction
411.0-411.1................................. Other acute & subacute forms of ischemic heart disease
411.81...................................... Coronary occlusion without myocardial infarction
411.89...................................... Other acute and subacute ischemic heart disease
412......................................... Old myocardial infarction
413.0-413.1................................. Angina pectoris
413.9....................................... Other and unspecified angina pectoris
414.00-414.03............................... Coronary atherosclerosis
414.04...................................... Coronary athrscl-artery bypass graft
414.05...................................... Coronary athrscl-unspec graft
414.10...................................... Aneurysm, heart (wall)
414.11...................................... Coronary vessel aneurysm
414.19...................................... Other aneurysm of heart
414.8....................................... Other specified forms of chronic ischemic heart disease
414.9....................................... Chronic ischemic heart disease, unspecified
428.0-428.9................................. Heart failure
429.2....................................... Arteriosclerotic cardiovascular disease
429.9....................................... Heart disease NOS
431......................................... Intracerebral hemorrhage
433.00-433.91............................... Occlusion & stenosis of precerebral arteries
434.00-434.91............................... Occlusion of cerebral arteries
435.0-435.9................................. Transient cerebral ischemia
437.0....................................... Other & ill-defined cerebrovascular disease
437.1....................................... Other generalized ischemic cerebrovascular disease
437.5....................................... Moyamoya disease

[[Page 58860]]

438.0-438.9................................. Late effects of cerebrovascular disease
440.0-440.9................................. Arteriosclerosis
441.00-441.9................................ Aortic aneurysms
442.0....................................... Upper extremity aneurysm
442.1....................................... Renal artery aneurysm
442.2....................................... Iliac artery aneurysm
444.0-444.9................................. Arterial embolism & thrombosis
557.1....................................... Chronic vascular insufficiency of intestine
571.8....................................... Other chronic non-alcoholic liver disease
571.9....................................... Unspecified chronic liver disease without mention of alcohol
573.8....................................... Other specified disorders of liver
573.9....................................... Unspecified disorders of liver
577.0-577.9................................. Pancreatic disease
579.3....................................... Other & unspecified postsurgical nonabsorption
579.8....................................... Other specified intestinal malabsorption
581.0-581.9................................. Nephrotic syndrome
584.5....................................... Acute renal failure with lesion of tubular necrosis
585......................................... Chronic renal failure
588.0....................................... Renal osteodystrophy
588.1....................................... Nephrogenic diabetes insipidus
588.8....................................... Other specified disorders resulting from impaired renal function
588.9....................................... Unspecified disorder resulting from impaired renal function
607.84...................................... Impotence of organic origin, penis disorder
646.70-646.71............................... Liver disorders in pregnancy
646.73...................................... Liver disorder antepartum
648.10-648.14............................... Thyroid disfunction in pregnancy and the puerperium
696.0....................................... Psoriatic arthropathy
696.1....................................... Other psoriasis
751.61...................................... Biliary atresia
764.10-764.19............................... ``Light for dates'' with signs of fetal malnutrition
786.50...................................... Chest pain unspecified
786.51...................................... Precordial pain
786.59...................................... Chest pain, other
789.1....................................... Hepatomegaly
790.4....................................... Abnormal transaminase
790.5....................................... Abnormal alkaline phosphatase
790.6....................................... Other abnormal blood chemistry
793.4....................................... Abnormal imaging study
987.9....................................... Toxic effect of unspecified gas or vapor
996.81...................................... Complication of transplanted organ, kidney
V42.0....................................... Transplanted organ, kidney
V42.7....................................... Organ replacement by transplant, liver
V58.69...................................... Long term (current) use of other medications
----------------------------------------------------------------------------------------------------------------

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.

[[Page 58861]]

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 chlamydia diseases
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-V.79.9................................ 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

American Diabetes Association. Management of Dyslipidemia in Adults
with Diabetes. J. Florida M.A. 1998, 85:2 30-34.
Jialal, I. Evolving lipoprotein risk factors: lipoprotein (a) and
oxidizing low-density lipoprotein. Clin Chem 1998; 44:8(B) 1827-1832.
McMorrow, ME, Malarkey, L. Laboratory and Diagnostic Tests: A
Pocket Guide. W.B. Saunders Company. 206-207.
U.S. Department of Health and Human Services. National Cholesterol
Education Program. Recommendations for Improving Cholesterol
Measurement. NIH Publication 90-2964. February 1990.
National Institutes of Health. Second Report of the Expert Panel on
Detection, Evaluation, and Treatment of High Blood Cholesterol in
Adults. NIH Publication 93-3095. September 1993.
Bierman EL. Atherosclerosis and other forms of arteriosclerosis.
Harrison's Principles of Internal Medicine. Eds. Isselbacher KJ,
Braunwald E, Wilson JD, et al. McGraw-Hill. New York. 1994; 2058-2069.
Brown MS and Goldstein JL. The hyperlipoproteinemias and other
disorders of lipid metabolism. Harrison's Principles of Internal
Medicine. Eds. Isselbacher KJ, Braunwald E, Wilson JD, et al. McGraw-
Hill. New York. 1994; 1106-1116.

Coding Guidelines

[[Page 58862]]

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 nonspecific ICD-9-CM code is submitted, the underlying
sign, symptom, or condition must be related to the indications for the
test above.

Medicare National Coverage Decision for Digoxin Therapeutic Drug Assay

Other Names/Abbreviations

Description

A digoxin therapeutic drug assay is useful for diagnosis and
prevention of digoxin toxicity, and/or prevention for under dosage of
digoxin.

HCPCS Codes (alpha numeric, CPT AMA)

Indications

Digoxin levels may be performed to monitor drug levels of
individuals receiving digoxin therapy because the margin of safety
between side effects and toxicity is narrow or because the blood level
may not be high enough to achieve the desired clinical effect.
Clinical indications may include individuals on digoxin:
With symptoms, signs or electrocardiogram (ECG) suggestive
of digoxin toxicity;
Taking medications that influence absorption,
bioavailability, distribution, and/or elimination of digoxin;
With impaired renal, hepatic, gastrointestinal, or thyroid
function;
With pH and/or electrolyte abnormalities;
With unstable cardiovascular status, including
myocarditis;
Requiring monitoring of patient compliance.
Clinical indications may include individuals:
Suspected of accidental or intended overdose; or
Who have an acceptable cardiac diagnosis (as listed) and
for whom an accurate history of use of digoxin is unobtainable
The value of obtaining regular serum digoxin levels is uncertain,
but it may be reasonable to check levels once yearly after a steady
state is achieved. In addition, it may be reasonable to check the level
if:
Heart failure status worsens;
Renal function deteriorates;
Additional medications are added that could affect the
digoxin level; or
Signs or symptoms of toxicity develop.
Steady state will be reached in approximately 1 week in patients
with normal renal function, although 2-3 weeks may be needed in
patients with renal impairment. After changes in dosages or the
addition of a medication that could affect the digoxin level, it is
reasonable to check the digoxin level one week after the change or
addition. Based on the clinical situation, in cases of digoxin
toxicity, testing may need to be done more than once a week.
Digoxin is indicated for the treatment of patients with heart
failure due to systolic dysfunction and for reduction of the
ventricular response in patients with atrial fibrillation or flutter.
Digoxin may also be indicated for the treatment of other
supraventricular arrhythmias, particularly in the presence of heart
failure.

Limitations

This test is not appropriate for patients on digitoxin or treated
with digoxin FAB (fragment antigen binding) antibody.

ICD-9-CM Codes Covered by Medicare Program

[[Page 58863]]

398.91...................................... Rheumatic Heart Failure
402.01...................................... Hypertensive heart disease, malignant with CHF
402.11...................................... Hypertensive heart disease, benign with CHF
402.91...................................... Hypertensive heart disease, unspecified with CHF
403.00-403.91............................... Hypertensive renal disease
404.00-404.93............................... Hypertensive heart & renal disease
410.00-410.92............................... Acute myocardial infarction
411.0-411.89................................ Other acute & subacute forms of ischemic heart disease
413.0-413.9................................. Angina pectoris
422.0-422.99................................ Acute myocarditis
425.0-425.9................................. Cardiomyopathy
426.0-426.9................................. Conduction disorders
427.0-427.9................................. Cardiac dysrhythmias
428.0-428.9................................. Heart failure
429.2....................................... Cardiovascular disease, unspecified
429.4....................................... Heart Disturbances Postcardiac Surgery
429.5....................................... Rupture chordae tendinae
429.6....................................... Rupture papillary muscle
429.71...................................... Acquired cardiac septal defect
514......................................... Pulmonary congestion & hypostasis
579.9....................................... Unspecified Intestinal malabsorption
584.5-584.9................................. Acute renal failure
585......................................... Chronic renal failure
586......................................... Renal Failure, unspecified
587......................................... Renal sclerosis, unspecified
588.0....................................... Renal osteodystrophy
588.1....................................... Nephrogenic Diabetes Insipidus
588.8....................................... Impaired renal function (not elsewhere classified)
588.9....................................... Unspecified disorder resulting from impaired renal function
780.01...................................... Coma
780.02...................................... Transient alteration of awareness
780.09...................................... Other ill-defined general symptoms (drowsiness, semicoma,
somnolence, stupor, unconsciousness)
780.1....................................... Hallucinations
780.2....................................... Syncope & collapse
780.4....................................... Dizziness and giddiness
780.71-.79.................................. Malaise & fatigue
783.0....................................... Anorexia
784.0....................................... Headache
787.01-787.03............................... Nausea & vomiting
787.91...................................... Diarrhea
794.31...................................... Abnormal electrocardiogram
799.2....................................... Nervousness
972.0....................................... Poisoning by cardiac rhythm regulators
972.1....................................... Poisoning by cardiotonic glycosides & drugs of similar action
995.2....................................... Unspecified adverse effect of drug, medicinal and biological
substance
*E942.1..................................... Adverse effect of cardiotonic glycosides and drugs of similar
action
V58.69...................................... Encounter long term--Medication Use (not elsewhere classified)
----------------------------------------------------------------------------------------------------------------
* Code may not be reported as a stand-alone or first-listed code on the claim.

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.

[[Page 58864]]

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 chlamydia diseases
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

Doherty JE. Digitalis serum levels: clinical use. Ann Intern Med
1971 May; 74(5):787-789.
Duhme DW, Greenblatt DJ, Koch-Weser J. Reduction of digoxin
toxicity associated with measurement of serum levels. A report from the
Boston Collaborative Drug Surveillance Program. Ann Intern Med 1974
Apr; 80(4):516-519
Goldman RH. The use of serum digoxin levels in clinical practice.
JAMA 1974, Jul 15; 229(3):331-332.
Howanitz PJ, Steindel SJ. Digoxin therapeutic drug monitoring
practices. A College of American Pathologists Q-Probes study of 666
institutions and 18,679 toxic levels. Arch Pathol Lab Med 1993 Jul;
117(7):684-690.
Marcus FI. Pharmacokinetic interactions between digoxin and other
drugs. J Am Coll Cardiol 1985 May; 5(5 Suppl A):82A-90A.
Rodin SM, Johnson BF. Pharmacokinetic interactions with digoxin.
Clin Pharmaco-kinet 1988 Oct; 15(4):227-244.
Smith TW, Butler VP Jr, Haber E. Determination of therapeutic and
toxic serum digoxin concentrations by radioimmunoassay. N Engl J Med
1969 Nov 27; 281(22):1212-1216.
Smith TW, Haber E. Digoxin intoxication: the relationship of
clinical presentation to serum digoxin concentration. J Clin Invest
1970, Dec; 49 (12):2377-2386.
Valdes R Jr, Jortani SA, Gheorghiade M. Standards of laboratory
practice: cardiac drug monitoring. National Academy of Clinical
Biochemistry. Clin Chem 1998 May; 44(5): 1096-1109.
Konstam M, Dracup K, Baker D, et al. Heart Failure: Evaluation and
Care of Patients with Left-Ventricular Systolic Dysfunction. Clinical
Practice Guideline No. 11. AHCPR Publication No. 94-0612. Rockville,
MD: Agency for Health Care Policy and Research, Public Health Service,
U.S. Department of Health and Human Services. June 1994.

Coding Guidelines

[[Page 58865]]

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-CM code is submitted, the underlying
sign, symptom or condition must be related to the indications for the
test above.

Medicare National Coverage Decision for Alpha-fetoprotein
Other Names/Abbreviations: Afp

Description

Alpha-fetoprotein (AFP) is a polysaccharide found in some
carcinomas. It is effective as a biochemical marker for monitoring the
response of certain malignancies to therapy.

HCPCS Codes (alpha numeric CPT AMA)

Indications

AFP is useful for the diagnosis of hepatocellular carcinoma in
high-risk patients (such as alcoholic cirrhosis, cirrhosis of viral
etiology, hemochromatosis, and alpha1-antitrypsin
deficiency) and in separating patients with benign hepatocellular
neoplasms or metastases from those with hepatocellular carcinoma and,
as a non-specific tumor associated antigen, serves in marking germ cell
neoplasms of the testis, ovary, retro peritoneum, and mediastinum.

Limitations

ICD-9-CM Codes Covered by Medicare Program

[[Page 58866]]

V10.43...................................... Personal history of malignant neoplasm, ovary
V10.47...................................... Personal history of malignant neoplasm, testis
----------------------------------------------------------------------------------------------------------------

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.

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 chlamydia diseases
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
----------------------------------------------------------------------------------------------------------------

[[Page 58867]]

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

Tatsuta M. Yamamura H. Iishi H. Kasugai H. Okuda S.Value of serum
alpha-fetoprotein and ferritin in the diagnosis of hepatocellular
carcinoma. Oncology. 43(5):306-10, 1986.

Coding Guidelines

Medicare National Coverage Decision for Carcinoembryonic Antigen

Other Names/Abbreviations: CEA

Description

Carcinoembryonic antigen (CEA) is a protein polysaccharide found in
some carcinomas. It is effective as a biochemical marker for monitoring
the response of certain malignancies to therapy.

HCPCS Codes (Alpha numeric, CPT AMA)

Indications

CEA may be medically necessary for follow-up of patients with
colorectal carcinoma. It would however only be medically necessary at
treatment decision-making points. In some clinical situations (e.g.
adenocarcinoma of the lung, small cell carcinoma of the lung, and some
gastrointestinal carcinomas) when a more specific marker is not
expressed by the tumor, CEA may be a medically necessary alternative
marker for monitoring. Preoperative CEA may also be helpful in
determining the post-operative adequacy of surgical resection and
subsequent medical management. In general, a single tumor marker will
suffice in following patients with colorectal carcinoma or other
malignancies that express such tumor markers.
In following patients who have had treatment for colorectal
carcinoma, ASCO guideline suggests that if resection of liver
metastasis would be indicated, it is recommended that post-operative
CEA testing be performed every two to three months in patients with
initial stage II or stage III disease for at least two years after
diagnosis.
For patients with metastatic solid tumors which express CEA, CEA
may be measured at the start of the treatment and with subsequent
treatment cycles to assess the tumor's response to therapy.

Limitations

Serum CEA determinations are generally not indicated more
frequently than once per chemotherapy treatment cycle for patients with
metastatic solid tumors which express CEA or every two months post-
surgical treatment for patients who have had colorectal carcinoma.
However, it may be proper to order the test more frequently in certain
situations, for example, when there has been a significant change from
prior CEA level or a significant change in patient status which could
reflect disease progression or recurrence.
Testing with a diagnosis of an in situ carcinoma is not reasonably
done more frequently than once, unless the result is abnormal, in which
case the test may be repeated once.

ICD-9-CM Codes Covered by Medicare Program

[[Page 58868]]

162.0-162.9................................. Malignant neoplasm of trachea, bronchus, lung
174.0-174.9................................. Malignant neoplasm of female breast
175.0-175.9................................. Malignant neoplasm of male breast
183.0....................................... Malignant neoplasm of ovary
197.0....................................... Secondary malignant neoplasm of neoplasm of lung
197.4....................................... Secondary malignant neoplasm of small intestine
197.5....................................... Secondary malignant neoplasm of large intestine and rectum
230.3....................................... Carcinoma in situ of colon
230.4....................................... Carcinoma in situ of rectum
230.7....................................... Carcinoma in situ of other/unspecified parts of intestine
230.9....................................... Carcinoma in situ other and unspecified digestive organs
235.2....................................... Neoplasm of uncertain behavior of stomach, intestines, rectum
790.99...................................... Other nonspecific findings on examination of blood
V10.00...................................... Personal history of malignant neoplasm of gastro-intestinal tract,
unspecified
V10.3....................................... Personal history of malignant neoplasm, breast
V10.05...................................... Personal history of malignant neoplasm, large intestine
V10.06...................................... Personal history of malignant neoplasm, rectum, rectosigmoid
junction, anus
V10.11...................................... Personal history of malignant neoplasm, bronchus, and lung
V10.43...................................... Personal history of malignant neoplasm, ovary
V67.2....................................... Follow-up examination following chemotherapy
----------------------------------------------------------------------------------------------------------------

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.

ICD-9-CM Codes Denied

[[Page 58869]]

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 chlamydia diseases
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

Journal Clinical Oncol: 14 (10:2843-2877), 1996
Vauthey JN. Dudrick PS. Lind DS. Copeland EM 3rd. Management of
recurrent colorectal cancer: another look at carcinoembryonic
antigendetected recurrence [see comments]. [Review]
Digestive Diseases. 14(1):5-13, 1996 Jan-Feb.
Grem J. The prognostic importance of tumor markers in
adenocarcinomas of the gastrointestinal tract. [Review] [38 refs]
Current Opinion in Oncology. 9(4):380-7, 1997 Jul.
Bergamaschi R. Arnaud JP. Routine compared with nonscheduled
follow-up of patients with ``curative'' surgery for colorectal cancer.
Annals of Surgical Oncology. 3(5):464-9, 1996 Sep.
Kim YH. Ajani JA. Ota DM. Lynch P. Roth JA. Value of serial
carcinoembryonic antigen levels in patients with resectable
adenocarcinoma of the esophagus and stomach Cancer. 75(2):451-6, 1995
Jan 15.

Coding Guidelines

Medicare National Coverage Decision for Human Chorionic Gonadotropin

Other Names/Abbreviations: hCG

Description

Human chorionic gonadotropin.

HCPCS Codes (Alpha numeric, CPT AMA)

Indications

hCG is useful for monitoring and diagnosis of germ cell neoplasms
of the ovary, testis, mediastinum, retroperitoneum, and central nervous
system. In addition, hCG is useful for monitoring pregnant patients
with vaginal bleeding, hyperension and/or suspected fetal loss.

Limitations

Not more than once per month for diagnostic purposes. As needed for
monitoring of patient progress and treatment. Qualitative hCG assays
(CPT

[[Page 58870]]

84703) are not appropriate for medically managing patients with known
or suspected germ cell neoplasms.

ICD-9-CM Codes Covered by Medicare Program

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.

ICD-9-CM Codes Denied

[[Page 58871]]

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 chlamydia diseases
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

O'Callaghan A. Mead GM. Testicular carcinoma. [Review] [23 Refs]
Postgraduate Medical Journal. 73(862):4816, 1997 Aug.
Sawamura Y. Current diagnosis and treatment of central nervous
system germ cell tumours. [Review] [47 Refs] Current Opinion in
Neurology. 9(6):41923, 1996 Dec.
Wilkins M. Horwich A. Diagnosis and treatment of urological
malignancy: The testes. [Review] [23 Refs] British Journal of Hospital
Medicine. 55(4): 199203, 1996. Feb 21, Mar 5.

Coding Guidelines

Medicare National Coverage Decision for Tumor Antigen by Immunoassay--
CA125

Other Names/Abbreviations

Description

Immunoassay determinations of the serum levels of certain proteins
or carbohydrates serve as tumor markers. When elevated, serum
concentration of these markers may reflect tumor size and grade.

[[Page 58872]]

This policy specifically addresses tumor antigen CA125.

HCPCS Codes (alpha numeric, CPT AMA)

Indications

CA 125 is a high molecular weight serum tumor marker elevated in
80% of patients who present with epithelial ovarian carcinoma. It is
also elevated in carcinomas of the fallopian tube, endometrium, and
endocervix. An elevated level may also be associated with the presence
of a malignant mesothelioma.
A CA125 level may be obtained as part of the initial pre-operative
work-up for women presenting with a suspicious pelvic mass to be used
as a baseline for purposes of post-operative monitoring. Initial
declines in CA 125 after initial surgery and/or chemotherapy for
ovarian carcinoma are also measured by obtaining three serum levels
during the first month post treatment to determine the patient's CA 125
half-life, which has significant prognostic implications.
CA 125 levels are again obtained at the completion of chemotherapy
as an index of residual disease. Surveillance CA-125 measurements are
generally obtained every 3 months for 2 years, every 6 months for the
next 3 years, and yearly thereafter. CA 125 levels are also an
important indicator of a patient's response to therapy in the presence
of advanced or recurrent disease. In this setting, CA 125 levels may be
obtained prior to each treatment cycle.

Limitations

These services are not covered for the evaluation of patients with
signs or symptoms suggestive of malignancy. The service may be ordered
at times necessary to assess either the presence of recurrent disease
or the patient's response to treatment with subsequent treatment
cycles.
CA 125 is specifically not covered for aiding in the differential
diagnosis of patients with a pelvic mass as the sensitivity and
specificity of the test is not sufficient. In general, a single ``tumor
marker'' will suffice in following a patient with one of these
malignancies.

ICD-9-CM Codes Covered by Medicare Program

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.

[[Page 58873]]

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 chlamydia diseases
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

Coding Guidelines

Documentation Requirements

Indicated if service request for CA125 is requested more frequently
than stipulated.

[[Page 58874]]

Medicare National Coverage Decision for Tumor Antigen by Immunoassay CA
15-3/CA 27.29

Other Names/Abbreviations

Description

Immunoassay determinations of the serum levels of certain proteins
or carbohydrates serve as tumor markers. When elevated, serum
concentration of these markers may reflect tumor size and grade.
This policy specifically addresses the following tumor antigens: CA
15-3 and CA 27.29

HCPCS Codes (Alpha Numeric, CPT-AMA)

Indications

Multiple tumor markers are available for monitoring the response of
certain malignancies to therapy and assessing whether residual tumor
exists post-surgical therapy. CA 15-3 is often medically necessary to
aid in the management of patients with breast cancer. Serial testing
must be used in conjunction with other clinical methods for monitoring
breast cancer. For monitoring, if medically necessary, use consistently
either CA 15-3 or CA 27.29, not both. CA 27.29 is equivalent to CA 15-3
in its usage in management of patients with breast cancer.

Limitations

ICD-9-CM Codes Covered by Medicare Program

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.

ICD-9-CM Codes Denied

[[Page 58875]]

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 chlamydia diseases
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

Clinical Pancreatic Guideline for the Use of Tumor Markers in
Breast and Colorectal Cancer, American Society of Clinical Oncology. J
Clin Oncol 14:2843-2877, 1996.
Chan DW, Beveridge RA, Muss H, et al. Use of Triquant BR
Radioimmunoassay for Early Detection of Breast Cancer Recurrence in
Patients with Stage II and Stage III Disease. J Clin Oncol 1977,
15(6):2322-2328.
Bone GG, von Mensdorff-Pouilly S, Kenemans P, van Kamp GJ, et al.
Clinical and Technical Evaluation of ACS BR Serum Assay of MUC-1 Gene
Derived Glycoprotein in Breast Cancer, and Compared with CA15-3 Assays.
Clin Chem 1997, 43(4):585-593.

Coding Guidelines

Medicare National Coverage Decision for Tumor Antigen by Immunoassay CA
19-9

Other Names/Abbreviations:

Description

[[Page 58876]]

HCPCS Codes (Alpha Numeric, CPT AMA)

Indications

Multiple tumor markers are available for monitoring the response of
certain malignancies to therapy and assessing whether residual tumor
exists post-surgical therapy. Levels are useful in following the course
of patients with established diagnosis of pancreatic and biliary ductal
carcinoma. The test is not indicated for diagnosing these two diseases.

Limitations

ICD-9-CM Codes Covered by Medicare Program

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.

ICD-9-CM Codes Denied

[[Page 58877]]

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 chlamydia diseases
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

Clinical Pancreatic Guideline for the Use of Tumor Markers in
Breast and Colorectal Cancer, American Society of Clinical Oncology. J
Clin Oncol 14:2843-2877, 1996.
Richter JM, Christensen MR, Rustgi AK, and Silverstein MD. The
Clinical Utility of the CA19-9 Radioimmunoassay for the Diagnosis of
Pancreatic Cancer Presenting as Pain or Weight Loss: A Cost Effective
Analysis. Arch Intern Med 1989, 149:2292-2297.
Safi F, SchlosseW, Falkenreck S, et. al. Prognostic Value of CA 19-
9 Serum Course in Pancreatic Cancer. Hepaetogastroenterology 1998 Jan-
Feb; 45(19):253-9.

Coding Guidelines

Medicare National Coverage Decision for Prostate Specific Antigen

Other Names/Abbreviations: Total PSA

Description

PSA, a tumor marker for adenocarcinoma of the prostate, can predict
residual tumor in the post-operative phase of prostate cancer. Three to
six months after radical prostatectomy, PSA is reported to provide a
sensitive indicator of persistent disease. Six months following
introduction of antiandrogen therapy, PSA is reported as capable of
distinguishing patients with favorable response from those in whom
limited response is anticipated. PSA when used in conjunction with
other prostate cancer tests, such as digital rectal examination, may
assist in the decision making process for diagnosing prostate cancer.
PSA also, serves as a marker in following the progress of most prostate
tumors once a diagnosis has been established. This test is also an aid
in the management of prostate cancer patients and in detecting
metastatic or persistent disease in patients following treatment.

[[Page 58878]]

HCPCS Codes (alpha numeric, CPT AMA)

Indications

PSA is of proven value in differentiating benign from malignant
disease in men with lower urinary tract signs and symptoms (e.g.,
hematuria, slow urine stream, hesitancy, urgency, frequency, nocturia
and incontinence) as well as with patients with palpably abnormal
prostate glands on physician exam, and in patients with other
laboratory or imaging studies that suggest the possibility of a
malignant prostate disorder. PSA is also a marker used to follow the
progress of prostate cancer once a diagnosis has been established, such
as in detecting metastatic or persistent disease in patients who may
require additional treatment. PSA testing may also be useful in the
differential diagnosis of men presenting with as yet undiagnosed
disseminated metastatic disease.

Limitations

Generally, for patients with lower urinary tract signs or symptoms,
the test is performed only once per year unless there is a change in
the patient's medical condition. Testing with a diagnosis of in situ
carcinoma is not reasonably done more frequently than once, unless the
result is abnormal, in which case the test may be repeated once.

ICD-9-CM Codes Covered by Medicare Program

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.

[[Page 58879]]

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
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

Laboratory Test Handbook, 3rd edition, pp. 338-340.
Cooner WH, Mosley BR, Rutherford CL, et al. Prostate Cancer
Detection in a Clinical Urological Practice by Ultrasonography, Digital
Rectal Examination and Prostate Specific Antigen. J.Urol.1990;143:
1146-1154.

Coding Guidelines

[[Page 58880]]

symptom or condition must be related to the indications for the test
above.
6. To show elevated PSA, use ICD-9-CM code 790.93 (Elevated
prostate specific antigen). If a more specific diagnosis code has been
made, use the code for that diagnosis.

Medicare National Coverage Decision for Gamma Glutamyl Transferase

Other Names/Abbreviations: GGT

Description

Gamma glutamyltransferase (GGT) is an intracellular enzyme that
appears in blood following leakage from cells. Renal tubules, liver,
and pancreas contain high amounts, although the measurement of GGT in
serum is almost always used for assessment of hepatobiliary function.
Unlike other enzymes which are found in heart, skeletal muscle, and
intestinal mucosa as well as liver, the appearance of an elevated level
of GGT in serum is almost always the result of liver disease or injury.
It is specifically useful to differentiate elevated alkaline
phosphatase levels when the source of the alkaline phosphatase increase
(bone, liver, or placenta) is unclear. The combination of high alkaline
phosphatase and a normal GGT does not, however, rule out liver disease
completely.
As well as being a very specific marker of hepatobiliary function,
GGT is also a very sensitive marker for hepatocellular damage. Abnormal
concentrations typically appear before elevations of other liver
enzymes or bilirubin are evident. Obstruction of the biliary tract,
viral infection (e.g., hepatitis, mononucleosis), metastatic cancer,
exposure to hepatotoxins (e.g., organic solvents, drugs, alcohol), and
use of drugs that induce microsomal enzymes in the liver (e.g.,
cimetidine, barbiturates, phenytoin, and carbamazepine) all can cause a
moderate to marked increase in GGT serum concentration. In addition,
some drugs can cause or exacerbate liver dysfunction (e.g.,
atorvastatin, troglitazone, and others as noted in FDA
Contraindications and Warnings.)
GGT is useful for diagnosis of liver disease or injury, exclusion
of hepatobiliary involvement related to other diseases, and patient
management during the resolution of existing disease or following
injury.

HCPCS Codes (alpha numeric, CPT AMA)

Indications

1. To provide information about known or suspected hepatobiliary
disease, for example:
a. following chronic alcohol or drug ingestion;
b. following exposure to hepatotoxins;
c. when using medication known to have a potential for causing
liver toxicity (e.g., following the drug manufacturer's
recommendations); or
d. following infection (e.g., viral hepatitis and other specific
infections such as amebiasis, tuberculosis, psittacosis, and similar
infections)
2. To assess liver injury/function following diagnosis of primary
or secondary malignant neoplasms
3. To assess liver injury/function in a wide variety of disorders
and diseases known to cause liver involvement (e.g., diabetes mellitus,
malnutrition, disorders of iron and mineral metabolism, sarcoidosis,
amyloidosis, lupus, and hypertension)
4. To assess liver function related to gastrointestinal disease
5. To assess liver function related to pancreatic disease
6. To assess liver function in patients subsequent to liver
transplantation
7. To differentiate between the different sources of elevated
alkaline phosphatase activity

Limitations

When used to assess liver dysfunction secondary to existing non-
hepatobiliary disease with no change in signs, symptoms, or treatment,
it is generally not necessary to repeat a GGT determination after a
normal result has been obtained unless new indications are present.
If the GGT is the only ``liver'' enzyme abnormally high, it is
generally not necessary to pursue further evaluation for liver disease
for this specific indication.
When used to determine if other abnormal enzyme tests reflect liver
abnormality rather than other tissue, it generally is not necessary to
repeat a GGT more than one time per week. Because of the extreme
sensitivity of GGT as a marker for cytochrome oxidase induction or cell
membrane permeability, it is generally not useful in monitoring
patients with known liver disease.

ICD-9-CM Codes Covered by Medicare Program

[[Page 58881]]

042......................................... Human immunodeficiency virus (HIV) disease
054.0....................................... Eczema herpeticum
054.5....................................... Herpetic septicemia
060.0-060.1................................. Yellow fever
070.0-070.9................................. Viral hepatitis
072.71...................................... Mumps hepatitis
073.0....................................... Ornithosis, with pneumonia
074.8....................................... Other specified diseases due to Coxsackie virus
075......................................... Infectious mononucleosis
078.5....................................... Cytomegaloviral disease
079.99...................................... Unspecified viral infection
082.0-082.9................................. Tick-borne rickettsioses, stet
084.9....................................... Other pernicious complications of malaria
086.1....................................... Chagas disease with organ involvement other than heart
088.81...................................... Lyme disease
091.62...................................... Secondary syphilitic hepatitis
095.3....................................... Syphilis of liver
100.0....................................... Leptospirosis icterohemorrhagica
112.5....................................... Candidiasis, disseminated
115.00...................................... Infection by Histoplasma capsulatum without mention of
manifestation
120.9....................................... Schistosomiasis, unspecified
121.1....................................... Clonorchiasis
121.3....................................... Fascioliasis
122.0....................................... Echinococcus granulosus infection of liver
122.5....................................... Echinococcus multilocularis infection of liver
122.8....................................... Echinococcosis, unspecified, of liver
122.9....................................... Echinococcus, other and unspecified
130.5....................................... Hepatitis due to toxoplasmosis
135......................................... Sarcoidosis
150.0-159.9................................. Malignant neoplasm of digestive organs and peritoneum
160.0-165.9................................. Malignant neoplasm of respiratory and intrathoracic organs
170.0-176.9................................. Malignant neoplasm of bone, connective tissue, skin, and breast
179-189.9................................... Malignant neoplasm of genitourinary organs
200.00-208.91............................... Malignant neoplasm of lymphatic and hematopoietic tissue
211.5....................................... Benign neoplasm of liver and biliary passages
211.6....................................... Benign neoplasm of pancreas, except islets of Langerhans
211.7....................................... Benign neoplasm of islets of Langerhans
228.04...................................... Hemangioma of intra-abdominal structures
230.7....................................... Carcinoma in situ of other and unspecified parts of intestine
230.8....................................... Carcinoma in situ of liver and biliary system
230.9....................................... Carcinoma in situ other and unspecified digestive organs
235.0-238.9................................. Neoplasms of uncertain behavior
239.0....................................... Neoplasm of unspecified nature of digestive system
250.00-250.93............................... Diabetes mellitus
252.0....................................... Hyperparathyroidism
263.1....................................... Malnutrition of mild degree
263.9....................................... Unspecified protein-calorie malnutrition
268.0....................................... Rickets, active
268.2....................................... Osteomalacia, unspecified
269.0....................................... Deficiency of vitamin K
270.2....................................... Other disturbances of aromatic amino acid metabolism
270.9....................................... Unspecified disorder of amino acid metabolism
271.0....................................... Glycogenosis
272.0....................................... Pure hypercholesterolemia
272.1....................................... Pure hyperglyceridemia
272.2....................................... Mixed hyperlipidemia
272.4....................................... Other and unspecified hyperlipidemia
272.7....................................... Lipidoses
272.9....................................... Unspecified disorder of lipoid metabolism
275.0....................................... Disorders of iron metabolism
275.1....................................... Disorders of copper metabolism
275.3....................................... Disorders of phosphorus metabolism
275.40-275.49............................... Disorders of calcium metabolism
277.1....................................... Disorders of porphyrin metabolism
277.3....................................... Amyloidosis
277.4....................................... Disorders of bilirubin excretion
277.6....................................... Other deficiencies of circulating enzymes
282.60-282.69............................... Sickle cell anemia
286.6....................................... Defibrination syndrome
286.7....................................... Acquired coagulation factor deficiency
289.4....................................... Hypersplenism
291.0-291.9................................. Alcoholic psychoses
303.00-303.03............................... Acute alcoholic intoxication
303.90-303.93............................... Other and unspecified alcohol dependence

[[Page 58882]]

304.0-304.9................................. Drug dependence
305.00-305.93............................... Non-dependent abuse of drugs
357.5....................................... Alcoholic polyneuropathy
359.2....................................... Myotonic disorders
452......................................... Portal vein thrombosis
453.0-453.9................................. Other vein embolism and thrombosis
456.0-456.21................................ Esophageal varices
555.0-555.9................................. Regional enteritis
556.0-556.9................................. Ulcerative colitis
557.0....................................... Acute vascular insufficiency of intestine
558.1-558.9................................. Other noninfectious gastroenteritis and colitis
560.0-560.9................................. Intestinal obstruction without mention of hernia
562.01...................................... Diverticulitis of small intestine (without mention of hemorrhage)
562.03...................................... Diverticulitis of small intestine with hemorrhage
562.11...................................... Diverticulitis of colon (without mention of hemorrhage)
562.13...................................... Diverticulitis of colon with hemorrhage
567.0-567.9................................. Peritonitis
569.83...................................... Perforation of intestine
570......................................... Acute and subacute necrosis of liver
571.0-571.9................................. Chronic liver disease and cirrhosis
572.0-572.8................................. Liver abscess and sequelae of chronic liver disease
573.0-573.9................................. Other disorders of liver
574.00-574.91............................... Cholelithiasis
575.0-575.9................................. Other disorders of gallbladder
576.0-576.9................................. Other disorders of biliary tract
581.0-581.9................................. Nephrotic syndrome
582.0-582.9................................. Chronic glomerulonephritis
583.0-583.9................................. Nephritis and nephropathy not specified as acute or chronic
584.5-584.9................................. Acute renal failure
585......................................... Chronic renal failure
586......................................... Renal failure, unspecified
587......................................... Renal sclerosis, unspecified
588.0-588.9................................. Disorders resulting from impaired renal function
590.00-590.9................................ Infections of kidney
642.5....................................... Severe pre-eclampsia
646.7....................................... Liver disorders in pregnancy
782.4....................................... Jaundice, unspecified, not of newborn
789.1....................................... Hepatomegaly
790.4....................................... Nonspecific elevation of levels of transaminase or lactic acid
dehydrgenase
790.5....................................... Other nonspecific abnormal serum enzyme levels
960.0-979.9................................. Poisoning by drugs, medicinal, and biological substances
980.0-989.89................................ Toxic effects of substances chiefly nonmedical as to source
V42.7....................................... Organ replaced by transplant, liver
V58.61-V58.69............................... Long term (current) drug use
V67.1....................................... Follow-up examination, radiotherapy
V67.2....................................... Follow-up examination, chemotherapy
V67.51...................................... Follow-up examination after completed treatment with high-risk
medications, not elsewhere classified
----------------------------------------------------------------------------------------------------------------

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.

[[Page 58883]]

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
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

Ockner, R.K., ``Clinical approach to liver disease,'' in
Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine
(18th ed.), 1988, W.B. Saunders, pp. 808-809.
Ockner, R.K., ``Laboratory tests in liver disease,'' in Wyngaarden,
J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.),
1988, W.B. Saunders, pp. 814-817.
Gornall, A.G., and Goldberg, D.M., ``Hepatobiliary Disorders,'' in
Gornall, A.G. (ed.)., Applied Biochemistry of Clinical Disorders (2nd
ed.), 1986, J.B. Lippincott, pp. 211-246.
Scharschmidt, B.F., ``Parasitic, bacterial, fungal, and
granulomatous liver disease,'' in Wyngaarden, J.B., and Smith, L.H.
(eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B. Saunders, pp.
834-838.
Pincus, M.R., and Schaffner, J.A., ``Assessment of liver
function,'' in Henry, J.B. (ed.), Clinical Diagnosis and Management by
Laboratory Methods (19th ed.), 1996, W.B. Saunders, pp. 253-267.
Bordley, D.R., Nattinger, A.B., et al., ``Gastrointestinal,
Hepatobiliary, and Pancreatic Problems,'' in Panzer, R.J., Black, E.R.,
and Griner, P.F. (eds.), Diagnostic Strategies for Common Medical
Problems, 1991, American College of Physicians, pp. 94-185.
Tietz, N.W. (ed.), Clinical guide to Laboratory Tests (3rd ed.),
1995, pp. 286-287.
Zakim, D., and Boyer, T.D., Hepatology (2nd ed.), 1990, W.B.
Saunders.
Dufour, D.R., Clinical Use of Laboratory Data: A Practical Guide,
1998, Williams and Wilkins, pp. 142-155.
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

[[Page 58884]]

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.
Medicare National Coverage Decision for Hepatitis Panel

Description

This panel consists of the following tests:

Hepatitis B surface antigen (HBsAg) (CPT 87340)
Hepatitis C antibody (CPT 86803)
Hepatitis B core antibody (HBcAb), IgM Antibody (CPT 86705)
Hepatitis A antibody (HAAb), IgM Antibody (CPT 86709)

Hepatitis is an inflammation of the liver resulting from viruses,
drugs, toxins, and other etiologies. Viral hepatitis can be due to one
of at least five different viruses, designated Hepatitis A, B, C, D,
and E. Most cases are caused by Hepatitis A virus (HAV), Hepatitis B
virus (HBV), or Hepatitis C virus (HCV).
HAV is the most common cause of hepatitis in children and
adolescents in the United States. Prior exposure is indicated by a
positive IgG anti-HAV. Acute HAV is diagnosed by IgM anti-HAV, which
typically appears within four weeks of exposure, and which disappears
within three months of its appearance. IgG anti-HAV is similar in the
timing of its appearance, but it persists indefinitely. Its detection
indicates prior effective immunization or recovery from infection.
Although HAV is spread most commonly by fecal-oral exposure, parenteral
infection is possible during the acute viremia stage of the disease.
After exposure, standard immune globulin may be effective as a
prophylaxis.
HBV produces three separate antigens (surface, core, and e
(envelope) antigens) when it infects the liver, although only hepatitis
B surface antigen (HBsAg) is included as part of this panel. Following
exposure, the body normally responds by producing antibodies to each of
these antigens; one of which is included in this panel: hepatitis B
surface antibody (HBsAb)-IgM antibody , HBsAg is the earlier marker,
appearing in serum four to eight weeks after exposure, and typically
disappearing within six months after its appearance. If HBsAg remains
detectable for greater than six months, this indicates chronic HBV
infection. HBcAb, in the form of both IgG and IgM antibodies, are next
to appear in serum, typically becoming detectable two to three months
following exposure. The IgM antibody gradually declines or disappears
entirely one to two years following exposure, but the IgG usually
remains detectable for life. Because HBsAg is present for a relatively
short period and usually displays a low titer, a negative result does
not exclude an HBV diagnosis. HBcAb, on the other hand, rises to a much
higher titer and remains elevated for a longer period of time, but a
positive result is not diagnostic of acute disease, since it may be the
result of a prior infection. The last marker to appear in the course of
a typical infection is HBsAb, which appears in serum four to six months
following exposure, remains positive indefinitely, and confers
immunity. HBV is spread exclusively by exposure to infected blood or
body fluids; in the U.S., sexual transmission accounts for 30% to 60%
of new cases of HBV infection.
The diagnosis of acute HBV infection is best established by
documentation of a positive IgM antibody against the core antigen
(HBcAb-IgM) and by identification of a positive hepatitis B surface
antigen (HBsAg). The diagnosis of chronic HBV infection is established
primarily by identifying a positive hepatitis B surface antigen (HBsAg)
and demonstrating positive IgG antibody directed against the core
antigen (HBcAb-IgG). Additional tests such as Hepatitis B e antigen
(HBeAg) and Hepatitis B e antibody (HBeAb), the envelope antigen and
antibody, are not included in the Hepatitis Panel, but may be of
importance in assessing the infectivity of patients with HBV. Following
completion of a HBV vaccination series, HBsAb alone may be used monthly
for up to six months, or until a positive result is obtained, to verify
an adequate antibody response. HCV is the most common cause of post-
transfusion hepatitis; overall HCV is 0responsible for 15% to 20% of
all cases of acute hepatitis, and is the most common cause of chronic
liver disease. The test most commonly used to identify HCV measures HCV
antibodies, which appear in blood two to four months after infection.
False positive HCV results can occur. For example, a patient with a
recent yeast infection may produce a false positive anti-HCV result.
For this reason, at present positive results usually are confirmed by a
more specific technique. Like HBV, HCV is spread exclusively through
exposure to infected blood or body fluids.
This panel of tests is used for differential diagnosis in a patient
with symptoms of liver disease of injury. When the time of exposure or
the stage of the disease is not known, a patient with continued
symptoms of liver disease despite a completely negative Hepatitis Panel
may need a repeat panel approximately two weeks to two months later to
exclude the possibility of hepatitis. Once a diagnosis is established,
specific tests can be used to monitor the course of the disease.

[[Page 58885]]

HCPCS Codes (Alpha Numeric, CPT AMA)

Indications

1. To detect viral hepatitis infection when there are abnormal
liver function test results, with or without signs or symptoms of
hepatitis.
2. Prior to and subsequent to liver transplantation.

Limitations

After a hepatitis diagnosis has been established, only individual
tests, rather than the entire panel, are needed.

ICD-9-CM Codes Covered by Medicare Program

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.

ICD-9-CM Codes Denied

[[Page 58886]]

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
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

Ockner, R.K., ``Approaches to the diagnosis of jaundice,'' in
Wyngaarden, J.B., and Smith, L.H. (eds.), Cecil Textbook of Medicine
(18th ed.), 1988, W.B. Saunders, pp. 817-818.
Ockner, R.K., ``Acute viral hepatitis,'' in Wyngaarden, J.B., and
Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B.
Saunders, pp. 818-826.
Ockner, R.K., ``Chronic hepatitis,'' in Wyngaarden, J.B., and
Smith, L.H. (eds.), Cecil Textbook of Medicine (18th ed.), 1988, W.B.
Saunders, pp. 830-834.
Arvan, D.A., ``Acute viral hepatitis,'' in Panzer, R.J., Black,
E.R., and Griner, P.F. (eds.), Diagnostic Strategies for Common Medical
Problems, 1991, American College of Physicians, pp. 141-151.
Goldberg, D.M., ``Diagnostic Enzymology,'' in Gornall, A.G. (ed.),
Applied Biochemistry of Clinical Disorders (2nd ed.), 1986, J.B.
Lippincott, pp. 33-51.
Pincus, M.R., and Schaffner, J.A., ``Assessment of liver
function,'' in Henry, J.B. (ed.), Clinical Diagnosis and Management by
Laboratory Methods (19th ed.), 1996, W.B. Saunders, pp. 253-267.
Tietz, N.W. (ed.), Clinical Guide to Laboratory Tests (3rd ed.),
1995, pp. 320-327.
Zakim, D., and Boyer, T.D., Hepatology (2nd ed.), 1990, W.B.
Saunders.
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

[[Continued on page 58887]]