CMS Pub. 100-04, ch. 16, § 60.1.1

Medicare allows separate charges made by laboratories for drawing or collecting

specimens whether or not the specimens are referred to hospitals or independent

laboratories. The laboratory does not bill for routine handling charges where a specimen

is referred by one laboratory to another.

Payment for the specimen collection fee is made based on the clinical laboratory fee

schedule.

Medicare allows payment for a specimen collection fee when it is medically necessary

for a trained technician to draw a specimen from either a nursing home patient, a non-hospital inpatient or homebound patient.

The trained technician must personally draw the specimen, i.e., venipuncture or urine

sample by catheterization. Medicare does not allow a specimen collection fee to the

visiting technician if a patient in a facility is (a) not confined to the facility, or (b) the

facility has personnel on duty qualified to perform the specimen collection. Medical

necessity for such services exists, for example, where a trained technician draws a blood

specimen from a homebound or an institutionalized patient. A patient need not be

bedridden to be homebound.

However, where the specimen is a type that would require only the services of a

messenger and would not require the skills of a trained technician, e.g., urine or sputum, a

specimen pickup service would not be considered medically necessary. (See Chapters 7

and 15 of Pub. 100-02, the Medicare Benefit Policy Manual for a discussion of

“homebound” and a more complete definition of a medically necessary laboratory service

to a homebound or an institutional patient.)

Claims Annotation

In addition to the usual information required on claim forms (including the name of the

prescribing physician), all independent laboratory claims for such specimen drawing

prescribed by a physician should be appropriately annotated, e.g., “patient confined to

home,” “patient homebound,” or “patient in nursing home, no qualified person on duty to

draw specimen.” A/B MACs (B) must assure the validity of the annotation through

scientific claims samples as well as through regular bill review techniques. (This could

be done by use of the information in A/B MAC (B) files, and where necessary, contact

with the prescribing physician.)

Medical Necessity Requirement

If a physician requests an independent laboratory to obtain specimens in situations which

do not meet, or without regard to whether they meet, the medical necessity criteria in

Chapter 15 of the Medicare Benefit Policy Manual, an educational contact with the

prescribing physician is warranted and, where necessary, corroborating documentation

should be obtained on claims until the A/B MAC (B) is assured that the physician

prescribes such services only when the criteria are met.

The specimen collection fee is paid based on the location of the independent laboratory

where the test is performed and is billed in conjunction with a covered laboratory test.