Code of Massachusetts Regulations › 130 CMR - DIVISION OF MEDICAL ASSISTANCE › Title 130 CMR 401.000 - Independent Clinical Laboratory Services › Section 401.402 - Definitions

Current through Register 1525, July 5, 2024
The following terms used in
				130 CMR 401.000 have the
				meanings given in 130 CMR 401.402 unless the context clearly requires a
				different meaning. The reimbursability of services defined in 130 CMR 401.402
				is not determined by these definitions, but by application of regulations
				elsewhere in
				130 CMR 401.000 and
				450.000.
Authorized Prescriber
- any individual
				who is authorized under state law to prescribe drugs pursuant to M.G.L. c. 94C
				and also authorized to order the test under M.G.L. c. 111D and for the sole
				purpose of ordering medically necessary drug screen services, Massachusetts
				Department of Public Health licensed substance abuse treatment programs only
				when such requests are initiated in writing by a physician who is employed or
				contracted by the substance abuse treatment program to make such requests and
				whose written request fully complies with all requirements set forth in
				130 CMR 401.416(A)
				through (C).
Bulk Purchase
- a single purchase of
				the same laboratory services (one or more tests) to be uniformly and
				concurrently performed on a minimum of 40 specimens.
Clinical Laboratory
- a laboratory
				that conducts microbiological, serological, chemical, hematological,
				biophysical, radiobioassay, cytological, immunohematological, immunological,
				pathological, or other examinations of materials derived from the human body,
				to provide information for the assessment of a medical condition or for the
				diagnosis, prevention, or treatment of any disease.
Hospital Laboratory
- a clinical
				laboratory that is owned and operated by a hospital, licensed by the
				Massachusetts Department of Public Health, and an approved Medicare
				provider.
Independent Clinical Laboratory
- a
				freestanding clinical laboratory that is not affiliated with a hospital.
Panel Test
- any group of tests,
				whether performed manually, automatedly, or semiautomatedly, that is ordered
				for a specified member on a specified day and has at least one of the following
				characteristics:
(1) the group of tests is designated as a panel by the clinical
				laboratory performing the tests; or
(2) the group of tests is performed by the clinical laboratory
				at a usual and customary fee that is lower than the sum of that laboratory's
				usual and customary fees for the individual tests in that group.
Referring Laboratory
- a clinical
				laboratory that forwards specimens to another clinical laboratory for specific
				tests that cannot be performed by the referring laboratory.
Standing Order
- a request by an
				authorized prescriber for an independent clinical laboratory to repeat one or
				more tests over a specified period of time.
Subsidiary-related Entity
- a wholly
				owned subsidiary of a testing or referring laboratory, or both.
Testing Laboratory
- a clinical
				laboratory that performs one or more tests on a specimen forwarded by a
				referring laboratory.
Usual and Customary Fee
- the lowest
				fee in effect at the time of service, other than a fee offered for a bulk
				purchase, that is charged by an independent clinical laboratory for any
				laboratory service, including profile tests, specified in the fee schedule or
				by the laboratory.