Definitions

As used in 101 CMR 320.00, terms have the meanings ascribed in 101 CMR 320.02. Allowable Fee. The amount of reimbursement that is paid by all governmental units for a laboratory service, as set forth in 101 CMR 320.04 and 101 CMR 320.05. Bulk Purchase. A single purchase of a laboratory service (one or more tests) to be uniformly and concurrently performed on a minimum of 40 specimens of the same type. A single purchase of various, non-uniform laboratory services, such as by a physician, is not considered a bulk purchase, regardless of the number of specimens presented by such a purchaser to the laboratory. Charge. The price of a laboratory service as determined by the clinical laboratory performing the service. Clinical Laboratory. A laboratory where microbiological, chemical, hematological, biophysical, cytological, immuno-hematological, or pathological examinations are performed on materials derived from the human body to provide information for the diagnosis, prevention, or treatment of a disease or assessment of a medical condition. Center. The Center for Health Information and Analysis established under M.G.L. c. 12C. Eligible Provider of Laboratory Services. A person licensed by an appropriate Board of Registration to perform clinical laboratory services, such registration being in accordance with the provisions of M.G.L. c. 112; or an independent laboratory. Such persons and laboratories must meet all conditions of participation that have been or may be adopted by a governmental unit that purchases laboratory services. For purposes of 101 CMR 320.00, eligible providers of laboratory services do not include hospital laboratories. EOHHS. The Executive Office of Health and Human Services established under M.G.L. c. 6A. Fee Schedule. (Description of Service and HCPCS/CPT Procedure Code). The Healthcare Common Procedure Coding System (HCPCS), which is based upon the American Medical Association (AMA) Current Procedural Terminology (CPT), is the basis by which all procedures are performed. The CPT handbook is updated by the AMA annually. All non-physician codes and terminology is defined by the Centers for Medicare & Medicaid Services (CMS) and set forth in the HCPCS file. Governmental Unit. The Commonwealth, any department, division, agency, board, or commission of the Commonwealth and any political subdivision of the Commonwealth. Independent Clinical Laboratory. A clinical laboratory that is operated independently from a hospital or from an attending or consulting physician's office. If the laboratory is operated or directed by one or more licensed physicians, it must offer its services to other physicians to qualify as an independent clinical laboratory. In cases where two or more distinct, physically separated laboratory facilities operate under the same name and the same director, each facility that performs clinical laboratory services is treated as a separate independent clinical laboratory. Profile (or Panel) Tests. Any group of tests, whether performed manually, automated, or semi- automated, that is ordered for a specific patient on a specified day, and has at least one of the following characteristics. (a) The group of tests is designated as a profile or panel by the clinical laboratory performing the tests. (b) The group of tests is performed by the clinical laboratory and the customary charge is less than the sum of that clinical laboratory's usual and customary charges for the individual tests in that group. Publicly Aided Individual. A person who receives medical care and services for which a governmental unit is liable, in whole or in part, under a statutory program of public assistance. Rate. The lesser of the charge or the allowable fee, as defined in 101 CMR 320.02. Usual and Customary Charge. The lowest fee charged by an independent clinical laboratory for any laboratory service (including individual and profile tests) specified by 101 CMR 320.00 or by such independent clinical laboratory, which fee is in effect at the time such laboratory service is performed, other than a fee offered for a bulk purchase, as defined in 101 CMR 320.02.