8.660 LABORATORY AND X-RAY

8.660.1 DEFINITIONS

Independent Certified Laboratory means a certified laboratory that performs diagnostic tests and is independent both of the attending or consulting physician's office and of a hospital except where a hospital laboratory has obtained Medicare certification as an independent laboratory and is billing for recipients who are not admitted as patients in the hospital. Clinical Laboratory Services mean microbiological, serological, chemical, hematological, radiobioassay, cytological, immunohematological, pathological or other examinations of fluids derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or the assessment of a medical condition.

Anatomical Laboratory Services mean examinations of tissues derived from the human body for the purpose of providing information for the diagnosis, prevention or treatment of any disease or the assessment of a medical condition.

Certified Clinical Laboratory means a provider who possesses a certificate of waiver or a certificate of registration from the Centers for Medicare and Medicaid Services or its designated agency as meeting Centers for Medicare and Medicaid Services guidelines and whose personnel and director are qualified to perform laboratory services.

X-Ray Services mean services performed by a provider whose x-ray equipment has been certified by the Colorado Department of Public Health and Environment as meeting Medicare guidelines and whose personnel and director are qualified to operate said equipment.

8.660.2 CONDITIONS OF PARTICIPATION

8.660.2. A Certified Clinical Laboratories and providers of X-Ray Services shall enroll as providers in the Medical Assistance Program.

8.660.2.B. All participating laboratories, including out-of-state independent clinical laboratories, shall be certified by the state agency to participate under Medicaid. All laboratories shall provide proof of certification status through the provision of the CLIA (Clinical Laboratory Improvement Amendments of 1988) number to the Department.

8.660.2.C. Providers of X-Ray Services shall be certified by the Colorado Department of Public Health and Environment and shall provide proof of Medicare certification on the Medicaid provider enrollment forms.

8.660.3 LIMITATIONS AND BENEFITS

8.660.3.A. Laboratory and X-Ray Services are a benefit under all of the following conditions:

1. 1. The services have been authorized by a licensed physician.
2. 2. The services are performed to diagnose conditions and illnesses with specific symptoms.
3. 3. The services are performed to prevent or treat conditions that are benefits under the Medical Assistance Program.
4. 4. The services are not routine diagnostic tests performed without apparent relationship to treatment or diagnosis for a specific illness, symptom, complaint or injury.
5. 5. The laboratory services are performed by a certified laboratory in accordance with the Clinical Laboratory Improvement Amendments of 1988 (CLIA).
6. 6. The X-Ray Services are performed by a provider certified by the Colorado Department of Public Health and Environment and enrolled as a Medicaid provider. 8.660.3.B. Collection, handling and/or conveyance of specimens for transfer from physicians' offices to a Certified Clinical Laboratory is reimbursable to the physician. 8.660.3.C. Transfer of a specimen from one Certified Clinical Laboratory to another is a benefit and is reimbursable to the first certified laboratory if the laboratory's equipment is not functioning or the laboratory is not certified to perform the tests ordered by the physician.

8.660.4 BILLING PROCEDURES

8.660.4.A. Certified providers of clinical laboratory and X-Ray Services shall bill the Department directly using the designated billing method, the correct Current Procedural Terminology and Healthcare Common Procedure Coding System procedure codes and modifiers as required. Providers shall bill the amount of their usual and customary charges to the general public. 8.660.4.B. Laboratory tests and x-rays performed under the personal supervision of the authorizing physician must be billed directly on the physician's services claim form. 8.660.4.C. Laboratory tests and x-rays not performed by the authorizing physician or under his/her direct personal supervision cannot be billed by the physician except for physicians in a Certified Clinical Laboratory group practice. A Certified Clinical Laboratory group practice may only bill for those laboratory and X-Ray Services actually performed or supervised by a physician member of the group or performed by a qualified employee of the group. Payment shall be made to the authorizing physician or the group practice.

8.660.4.D. Laboratory and X-Ray Services performed by a hospital-based or independent laboratory or x- ray provider and submitted to an unrelated physician for interpretation may only be billed by the laboratory or x-ray provider for the technical component. 8.660.4.E. Practitioner and clinic providers rendering professional interpretation and not direct laboratory or X-Ray Services may only bill the professional component.

8.660.5 REIMBURSEMENT

8.660.5.A. Reimbursement for certified laboratory and X-Ray Services shall be the lowest of the following:

1. 1. Submitted charges.
2. 2. Fee schedule as determined by the Department.

8.660.5.B. Services rendered by a hospital-based laboratory during an inpatient stay are included in the hospital Diagnosis Related Group or inpatient rate and shall not be billed or reimbursed separately.

8.660.5.C. Each certified laboratory provider shall be reimbursed for only those tests performed in the specialties or sub-specialties for which it is certified. 8.660.5.D. Reimbursement for out-of-state certified independent clinical laboratory or X-Ray Services shall be subject to Department reimbursement rates.

8.660.5.E. The reimbursement methodology at 8.660.5.A - 8.660.5.D does not apply to payments for those services/procedures that are reimbursed under a capitated or contracted agreement accomplished through competitive bid or other arrangement.