CMS Pub. 100-02, ch. 7, § 40.1.2.13

Effective February 5, 1998, venipuncture for the purposes of obtaining a blood sample

can no longer be the sole reason for Medicare home health eligibility. However, if a

beneficiary qualifies for home health eligibility based on a skilled need other than solely

venipuncture (e.g., eligibility based on the skilled nursing service of wound care and

meets all other Medicare home health eligibility criteria), medically reasonable and

necessary venipuncture coverage may continue under a home health plan of care.

Sections 1814(a)(2)(C) and 1835(a)(2)(A) of the Act specifically exclude venipuncture,

as a basis for qualifying for Medicare home health services if this is the sole skilled

service the beneficiary requires. However, the Medicare home health benefit will

continue to pay for a blood draw if the beneficiary has a need for another qualified skilled

service and meets all home health eligibility criteria. This specific requirement applies to

home health services furnished on or after February 5, 1998.

For venipuncture to be reasonable and necessary:

1. The physician or allowed practitioner order for the venipuncture for a laboratory

test should be associated with a specific symptom or diagnosis, or the

documentation should clarify the need for the test when it is not diagnosis/illness

specific. In addition, the treatment must be recognized (in the Physician's Desk

Reference, or other authoritative source) as being reasonable and necessary to the

treatment of the illness or injury for venipuncture and monitoring the treatment

must also be reasonable and necessary.

2. The frequency of testing should be consistent with accepted standards of medical

practice for continued monitoring of a diagnosis, medical problem, or treatment

regimen. Even where the laboratory results are consistently stable, periodic

venipuncture may be reasonable and necessary because of the nature of the

treatment.

3. The home health record must document the rationale for the blood draw as well as

the results.

Examples of reasonable and necessary venipuncture for stabilized patients

include, but are not limited to those described below.

a. Captopril may cause side effects such as leukopenia and agranulocytosis

and it is standard medical practice to monitor the white blood cell count

and differential count on a routine basis (every 3 months) when the results

are stable and the patient is asymptomatic.

b. In monitoring phenytoin (e.g., Dilantin) administration, the difference

between a therapeutic and a toxic level of phenytoin in the blood is very

slight and it is therefore appropriate to monitor the level on a routine basis

(every 3 months) when the results are stable and the patient is

asymptomatic.

c. Venipuncture for fasting blood sugar (FBS)

• An unstable insulin dependent or noninsulin dependent diabetic would

require FBS more frequently than once per month if ordered by the

physician or allowed practitioner.

• Where there is a new diagnosis or where there has been a recent

exacerbation, but the patient is not unstable, monitoring once per month

would be reasonable and necessary.

• A stable insulin or noninsulin dependent diabetic would require

monitoring every 2-3 months.

d. Venipuncture for prothrombin

• Where the documentation shows that the dosage is being adjusted,

monitoring would be reasonable and necessary as ordered by the

physician or allowed practitioner.

• Where the results are stable within the therapeutic ranges, monthly

monitoring would be reasonable and necessary.

• Where the results remain within nontherapeutic ranges, there must be

specific documentation of the factors that indicate why continued

monitoring is reasonable and necessary.

EXAMPLE: A patient with coronary artery disease was hospitalized with atrial

fibrillation and subsequently discharged to the HHA with orders for anticoagulation

therapy as well as other skilled nursing care. If indicated, monthly venipuncture to report

prothrombin (protime) levels to the physician or allowed practitioner would be

reasonable and necessary even though the patient's prothrombin time tests indicate

essential stability. The home health record must document the rationale for the blood

draw as well as the results.