[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

----------------------------------------------------------------------------------------------------------------
                    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

[[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)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82728.......................................  Ferritin
83540.......................................  Iron
83550.......................................  Iron Binding capacity
84466.......................................  Transferrin
----------------------------------------------------------------------------------------------------------------

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.


     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

[[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)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82523.......................................  Collagen cross links, any method
----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
242.00-242.91...............................  Thyrotoxicosis
245.2.......................................  Chronic lymphocytic thyroiditis (only if thyrotoxic)
246.9.......................................  Unspecified disorder of thyroid
252.0.......................................  Hyperparathyroidism
256.2.......................................  Postablative ovarian failure
256.3.......................................  Other ovarian failure
256.8.......................................  Other ovarian dysfunction
256.9.......................................  Unspecified ovarian dysfunction
268.9.......................................  Unspecified vitamin D deficiency
269.3.......................................  Mineral deficiency, not elsewhere classified
627.0.......................................  Premenopausal menorrhagia
627.1.......................................  Postmenopausal bleeding
627.2.......................................  Menopausal or female climacteric state
627.4.......................................  States associated with artificial menopause
627.8.......................................  Other specified menopausal and postmenopausal disorders
627.9.......................................  Unspecified menopausal & postmenopausal disorder
731.0.......................................  Osteitis deformans without mention of bone tumor (Paget's disease
                                               of bone)
733.00-733.09...............................  Osteoporosis
733.10-733.19...............................  Pathological fracture
733.90......................................  Disorder of bone and cartilage, unspecified
805.8.......................................  Fracture of vertebral column without mention of spiral cord
                                               injury, unspecified, closed
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.


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

ICD-9-CM Codes Denied

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
798.0-798.9.................................  Sudden death, cause unknown
V15.85......................................  Exposure to potentially hazardous body fluids
V16.1.......................................  Family history of malignant neoplasm, trachea, bronchus, and lung
V16.2.......................................  Family history of malignant neoplasm, other respiratory and
                                               intrathoracic organs
V16.4.......................................  Family history of malignant neoplasm, genital organs

[[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

    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

[[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)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82947.......................................  Glucose; quantitative, blood (except reagent strip)
82948.......................................  Glucose; blood, reagent strip
82962.......................................  Glucose, blood by glucose monitoring device(s) cleared by the FDA
                                               specifically for home use.
----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
011.00-011.96...............................  Tuberculosis
038.0-038.9.................................  Septicemia
112.1.......................................  Recurrent vaginal candidiasis
112.3.......................................  Interdigital candidiasis
118.........................................  Opportunistic mycoses
157.4.......................................  Malignant neoplasm of Islets of Langerhans
158.0.......................................  Malignant neoplasm of retroperitoneum
211.7.......................................  Benign neoplasm of Islets of Langerhans
242.00-242.91...............................  Thyrotoxicosis
250.00-250.93...............................  Diabetes mellitus
251.0-251.9.................................  Disorders of pancreatic internal secretion
253.0-253.9.................................  Disorders of the pituitary gland
255.0.......................................  Cushing syndrome

[[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.


     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

[[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

    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.

[[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)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
82985.......................................  Glycated protein
83036.......................................  Hemoglobin; glycated
----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
----------------------------------------------------------------------------------------------------------------
211.7.......................................  Benign neoplasm of islets of Langerhans
250.00-250.93...............................  Diabetes mellitus & various related codes
251.0.......................................  Hypoglycemic coma
251.1.......................................  Other specified hypoglycemia
251.2.......................................  Hypoglycemia unspecified
251.3.......................................  Post-surgical hypoinsulinemia
251.4.......................................  Abnormality of secretion of glucagon
251.8.......................................  Other specified disorders of pancreatic internal secretion
251.9.......................................  Unspecified disorder of pancreatic internal secretion
258.0-258.9.................................  Polyglandular dysfunction
271.4.......................................  Renal glycosuria
275.0.......................................  Hemochromatosis
577.1.......................................  Chronic pancreatitis
579.3.......................................  Other and unspecified postsurgical nonabsorption
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, antepartum condition or complication
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, antepartum condition or complication
648.84......................................  Abnormal glucose tolerance complicating pregnancy, childbirth or
                                               the puerperium, postpartum condition or complication
790.2.......................................  Abnormal glucose tolerance test
790.6.......................................  Other abnormal blood chemistry (hyperglycemia)
962.3.......................................  Poisoning by insulin and antidiabetic agents
V12.2.......................................  Personal history of endocrine, metabolic, and immunity disorders
V58.69......................................  Long-term 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.


     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

[[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

    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 in 
seemingly well individuals so that early detection and treatment can be 
provided for those who test positive for the disease. Screening tests 
are performed when no related 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

[[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)

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Descriptor
----------------------------------------------------------------------------------------------------------------
84436.......................................  Thyroxine; total
84439.......................................  Thyroxine; free
84443.......................................  Thyroid stimulating hormone (TSH)
84479.......................................  Thyroid hormone (T3 or T4) uptake or thyroid hormone binding ratio
                                               (THBR)
----------------------------------------------------------------------------------------------------------------

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

----------------------------------------------------------------------------------------------------------------
                    Code                                                  Description
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017.50-017.56...............................  Tuberculosis of the thyroid gland
183.0.......................................  Malignant neoplasm of ovary
193.........................................  Malignant neoplasm of thyroid gland

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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

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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

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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
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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.