Code of Maine Rules
10 - DEPARTMENT OF HEALTH AND HUMAN SERVICES
144 - DEPARTMENT OF HEALTH AND HUMAN SERVICES - GENERAL
Chapter 101 - MAINECARE BENEFITS MANUAL (FORMERLY MAINE MEDICAL ASSISTANCE MANUAL)
Chapter II - Specific Policies By Service
Section 144-101-II-55 - Laboratory Services
Subsection 144-101-II-55.01 - DEFINITIONS

55.01-1 Laboratory Services

Laboratory Services ordered by or under the direction of a physician or a licensed practitioner of the healing arts within the scope of his or her practice as defined by state law; and provided by a laboratory that is in compliance with the pertinent sections of 22 M.R.S.A. symbol 167 if "Kino MT" is 112011 et seq. (Maine Medical Laboratory Act) and the rules and regulations promulgated thereunder, meets the requirements for participation in Medicare and is in compliance with the rules implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88).

55.01-2 Medical/Clinical Laboratory

Any institution, building or place which provides through its ownership or operation an organization which employs methods and instruments for the examination of blood, tissues, secretions, and excretions of the human body or any function of the human body in order to diagnose disease, follow the course of disease, aid in the treatment of such disease, or detect drugs or toxic substances or which produces information used as a basis for health advice or which purports to offer such examinations unless otherwise provided by law.

55.01-3 Physician's Office Laboratory

A laboratory operated by a physician or group practice exclusively to provide Laboratory Services for its own patients that is in compliance with the pertinent Sections of 22 M.R.S.A. symbol 167 if "Kino MT" is 112011 et seq. and the rules and regulations promulgated thereunder and meets the requirements for participation in Medicare and is in compliance with the rules implementing the Clinical Laboratory Improvement Amendments of 1988 (CLIA 88).

55.01-4 Practitioner of the Healing Arts

Physicians and all others registered or licensed in the healing arts, including, but not limited to, nurse practitioners, podiatrists, optometrists, chiropractors, physical therapists, occupational therapists, speech therapists, dentists, psychologists and physicians' assistants.

55.01-5 Group Practice Laboratory

A laboratory established for the mutual use of physician or group practice owners, is considered an Independent Clinical Laboratory (See 55.01-3 and 55.01-5).

55.01-6 Independent Clinical Laboratories

An Independent Clinical Laboratory is one which is not under direct jurisdiction of a hospital or the patient's attending physician. For reimbursement under Title XIX, the independent laboratory must be certified as an Independent Clinical Laboratory in accordance with the Medicare conditions of participation and must be licensed under the provisions of 22 M.R.S.A. symbol 167 if "Kino MT" is 112011 et seq. and the rules and regulations promulgated thereunder and be in compliance with the rules implementing the Clinical Laboratory Improvement Amendments of 1988(CLIA 88).

55.01-7 Prior Authorization

Prior Authorization is the process of obtaining prior approval from the Department as to the medical necessity and eligibility for certain MaineCare services before they are delivered, as set forth herein and in Chapter I, Section 1 of the MaineCare Benefits Manual (MBM).