# COMAR Title 10 — Maryland Department of Health

## Subtitle 09 — Medical Care Programs

### Chapter 09 — Medical Laboratories

#### Regulation .05 Limitations.

*COMAR 10.09.09.05*

The following are not covered:

A. Services for which the medical laboratory provider cannot supply a properly completed order or standing order identifying the individual practitioner who ordered the laboratory services;

B. Services not adequately documented in the participant’s medical records;

C. Services denied by Medicare as not medically necessary;

D. Clinical laboratory services, for which certification by HCFA under CLIA is required, when these services are performed by laboratories that are not certified to perform those services;

E. Procedures that the provider knows or should know are investigational or experimental in nature;

F. Services included by the Program as part of the charge made by an inpatient facility, hospital outpatient department, freestanding clinic, or other Program-recognized entity;

G. Medical laboratory services related to autopsies;

H. Medical laboratory services for which there was insufficient quantity of specimen, improper specimen handling, or other circumstances that would render the results unreliable; and

I. Laboratory services ordered by an:

  (1) Individual who is not enrolled as a provider in the Program with an active status on the date of service; and

  (2) Entity, facility, or another provider that is not an individual.