CMS Pub. 100-03, ch. 1, § 190.11

(PT/INR) Monitoring for Anticoagulation Management – Effective

March 19, 2008

(Rev. 90, Issued: 07-25-08, Effective: 03-19-08, Implementation: 08-25-08)

A. General

Use of the International Normalized Ratio (INR) or prothrombin time (PT) - standard

measurement for reporting the blood’s clotting time) - allows physicians to determine the

level of anticoagulation in a patient independent of the laboratory reagents used. The

INR is the ratio of the patient’s PT (extrinsic or tissue-factor dependent coagulation

pathway) compared to the mean PT for a group of normal individuals. Maintaining

patients within his/her prescribed therapeutic range minimizes adverse events associated

with inadequate or excessive anticoagulation such as serious bleeding or thromboembolic

events. Patient self-testing and self-management through the use of a home INR monitor

may be used to improve the time in therapeutic rate (TTR) for select groups of patients.

Increased TTR leads to improved clinical outcomes and reductions in thromboembolic

and hemorrhagic events.

Warfarin (also prescribed under other trade names, e.g., Coumadin®) is a self-administered, oral anticoagulant (blood thinner) medication that affects the vitamin K-

dependent clotting factors II, VII, IX and X. It is widely used for various medical

conditions, and has a narrow therapeutic index, meaning it is a drug with less than a 2-fold difference between median lethal dose and median effective dose. For this reason,

since October 4, 2006, it falls under the category of a Food and Drug Administration

(FDA) “black-box” drug whose dosage must be closely monitored to avoid serious

complications. A PT/INR monitoring system is a portable testing device that includes a

finger-stick and an FDA-cleared meter that measures the time it takes for a person’s

blood plasma to clot.

B. Nationally Covered Indications

For services furnished on or after March 19, 2008, Medicare will cover the use of home

PT/INR monitoring for chronic, oral anticoagulation management for patients with

mechanical heart valves, chronic atrial fibrillation, or venous thromboembolism

(inclusive of deep venous thrombosis and pulmonary embolism) on warfarin. The

monitor and the home testing must be prescribed by a treating physician as provided at 42

CFR 410.32(a), and all of the following requirements must be met:

1. The patient must have been anticoagulated for at least 3 months prior to use of the

home INR device; and,

2. The patient must undergo a face- to-face educational program on anticoagulation

management and must have demonstrated the correct use of the device prior to its use in

the home; and,

3. The patient continues to correctly use the device in the context of t he management

of the anticoagulation therapy following the initiation of home monitoring; and,

4. Self-testing with the device should not occur more frequently than once a week.

C. Nationally Non-Covered Indications

N/A

D. Other

1. All other indications for home PT/INR monitoring not indicated as nationally covered

above remain at local A/B MAC’s discretion.

2. This national coverage determination (NCD) is distinct from, and makes no changes

to, the PT clinical laboratory NCD at section 190.17 of Publication 100-03 of the NCD

Manual.

(This NCD last reviewed March 2008.)

190.12 - Urine Culture, Bacterial

(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable)

PM AB-02-110

A bacterial urine culture is a laboratory procedure performed on a urine specimen to

establish the probable etiology of a presumed urinary tract infection. It is common

practice to do a urinalysis prior to a urine culture. A urine culture may also be used as

part of the evaluation and management of another related condition. The procedure

includes aerobic agar-based isolation of bacteria or other cultivable organisms present,

and quantitation of types present based on morphologic criteria. Isolates deemed

significant may be subjected to additional identification and susceptibility procedures as

requested by the ordering physician. The physician’s request may be through clearly

documented and communicated laboratory protocols.

Indications

1. A patient’s urinalysis is abnormal suggesting urinary tract infection, for example

abnormal microscopic (hematuria, pyuria, bacteriuria); abnormal biochemical urinalysis

(positive leukocyte esterase, nitrite, protein, blood); a Gram’s stain positive for

microorganisms; positive bacteriuria screen by a non-culture technique; or other

significant abnormality of a urinalysis. While it is not essential to evaluate a urine

specimen by one of these methods before a urine culture is performed, certain clinical

presentations with highly suggestive signs and symptoms may lend themselves to an

antecedent urinalysis procedure where follow-up culture depends upon an initial positive

or abnormal test result.

2. A patient has clinical signs and symptoms indicative of a possible urinary tract

infection (UTI). Acute lower UTI may present with urgency, frequency, nocturia,

dysuria, discharge or incontinence. These findings may also be noted in upper UTI with

additional systemic symptoms (for example, fever, chills, lethargy); or pain in the

costovertebral, abdominal, or pelvic areas. Signs and symptoms may overlap

considerably with other inflammatory conditions of the genitourinary tract (for example,

prostatitis, urethritis, vaginitis, or cervicitis). Elderly or immunocompromised patients,

or patients with neurologic disorders may present atypically (for example, general

debility, acute mental status changes, declining functional status).

3. The patient is being evaluated for suspected urosepsis, fever of unknown origin, or

other systemic manifestations of infection but without a known source. Signs and

symptoms used to define sepsis have been well established.

4. A test-of-cure is generally not indicated in an uncomplicated infection. However, it

may be indicated if the patient is being evaluated for response to therapy and there is a

complicating co-existing urinary abnormality including structural or functional

abnormalities, calculi, foreign bodies, or ureteral/renal stents or there is clinical or

laboratory evidence of failure to respond as described in Indications 1 and 2.

5. In surgical procedures involving major manipulations of the genitourinary tract,

preoperative examination to detect occult infection may be indicated in selected cases

(for example, prior to renal transplantation, manipulation or removal of kidney stones, or

transurethral surgery of the bladder of prostate).

6. Urine culture may be indicated to detect occult infection in renal transplantation

recipients on immunosuppressive therapy.

Limitations

1. CPT 87086 may be used one time per encounter.

2. Colony count restrictions on coverage of CPT 87088 do not apply as they may be

highly variable according to syndrome or other clinical circumstances (for example,

antecedent therapy, collection time, degree of hydration).

3. CPT 87088, 87184, and 87186 may be used multiple times in association with or

independent of 87086, as urinary tract infections may be polymicrobial.

4. Testing for asymptomatic bacteriuria as part of a prenatal evaluation may be

medically appropriate but is considered screening and therefore not covered by Medicare.

The U.S. Preventive Services Task Force has concluded that screening for asymptomatic

bacteriuria outside of the narrow indication for pregnant women is generally not

indicated. There are insufficient data to recommend screening in ambulatory elderly

patients including those with diabetes. Testing may be clinically indicated on other

grounds including likelihood of recurrence or potential adverse effects of antibiotics, but

is considered screening in the absence of clinical or laboratory evidence of infection.

190.13 - Human Immunodeficiency Virus (HIV) Testing (Prognosis

Including Monitoring)

(Rev. 17, Issued: 07-02-04) (Effective/Implementation: Not Applicable)

PM AB-02-110

HIV quantification is achieved through the use of a number of different assays, which

measure the amount of circulating viral RNA. Assays vary both in methods used to

detect viral RNA as well as in ability to detect viral levels at lower limits. However, all

employ some type of nucleic acid amplification technique to enhance sensitivity, and

results are expressed as the HIV copy number.

Quantification assays of HIV plasma RNA are used prognostically to assess relative risk

for disease progression and predict time to death, as well as to assess efficacy of

antiretroviral therapies over time.

The HIV quantification is often performed together with CD4+ T cell counts, which

provide information on extent of HIV induced immune system damage already incurred.

Indications

1. A plasma HIV RNA baseline level may be medically necessary in any patient with

confirmed HIV infection.

2. Regular periodic measurement of plasma HIV RNA levels may be medically

necessary to determine risk for disease progression in an HIV-infected individual and to

determine when to initiate antiretroviral treatment regimens.

3. In clinical situations where the risk of HIV infection is significant and initiation of

therapy is anticipated, a baseline HIV quantification may be performed. These situation

include:

a. Persistence of borderline or equivocal serologic reactivity in an at-risk

individual.

b. Signs and symptoms of acute retroviral syndrome characterized by fever,

malaise, lymphadenopathy and rash in an at-risk individual

Limitations

1. Viral quantification may be appropriate for prognostic use including baseline

determination, periodic monitoring and monitoring of response to therapy. Use as a

diagnostic test method is not indicated.

2. Measurement of plasma HIV RNA levels should be performed at the time of

establishment of an HIV infection diagnosis. For an accurate baseline, 2 specimens in a

2-week period are appropriate.

3. For prognosis including anti-retroviral therapy monitoring, regular, periodic

measurements are appropriate. The frequency of viral load testing should be consistent

with the most current Centers for Disease Control and Prevention guidelines for use of

antiretroviral agents in adults and adolescents or pediatrics.

4. Because differences in absolute HIV copy number are known to occur using different

assays, plasma HIV RNA levels should be measured by the same analytical method. A

change in assay method may necessitate re-establishment of a baseline.

5. Nucleic acid quantification techniques are representative of rapidly emerging and

evolving new technologies. As such, users are advised to remain current of FDA-approved status.