Definitions

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.