# COMAR Title 10 — Maryland Department of Health

## Subtitle 09 — Medical Care Programs

### Chapter 09 — Medical Laboratories

**Authority:** Health-General Article, §§2-104(b), 15-103, and 15-105, Annotated Code of Maryland

**Administrative History:** Effective date: August 31, 1977 (4:18 Md. R. 1398)

**Administrative History:** Regulation .01 amended effective August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159)

**Administrative History:** Regulation .02 amended effective February 6, 1989 (16:2 Md. R. 159)

**Administrative History:** Regulation .02 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)

**Administrative History:** Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159)

**Administrative History:** Regulation .03A repealed effective September 21, 1979 (6:19 Md. R. 1518)

**Administrative History:** Regulation .03E amended effective December 15, 1978 (5:25 Md. R. 1854); August 22, 1988 (15:17 Md. R. 2049)

**Administrative History:** Regulation .03E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)

**Administrative History:** Regulation .03I adopted effective January 6, 1983 (9:26 Md. R. 2572)

**Administrative History:** Regulation .03J adopted effective January 30, 1984 (11:2 Md. R. 113)

**Administrative History:** Regulation .03 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)

**Administrative History:** Regulation .04A amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159)

**Administrative History:** Regulation .04A amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)

**Administrative History:** Regulation .04C adopted effective July 11, 1988 (15:14 Md. R. 1654)

**Administrative History:** Regulation .05 amended effective September 21, 1979 (6:19 Md. R. 1518); August 22, 1988 (15:17 Md. R. 2049); February 6, 1989 (16:2 Md. R. 159)

**Administrative History:** Regulation .05A and D amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)

**Administrative History:** Regulation .05B repealed effective August 12, 1985 (12:16 Md. R. 1606)

**Administrative History:** Regulation .07 amended as an emergency provision effective September 16, 1992 (19:20 Md. R. 1812); amended permanently effective January 1, 1993 (19:25 Md. R. 2205)

**Administrative History:** Regulation .07B amended effective February 6, 1989 (16:2 Md. R. 159)

**Administrative History:** Regulation .07D amended effective December 15, 1978 (5:25 Md. R. 1854); February 15, 1982 (9:3 Md. R. 221)

**Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1982 (9:13 Md. R. 1347); adopted permanently effective November 1, 1982 (9:21 Md. R. 2106)

**Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1984 (11:13 Md. R. 1169); adopted permanently effective October 29, 1984 (11:21 Md. R. 1812)

**Administrative History:** Regulation .07E amended effective December 6, 1982 (9:24 Md. R. 2390); November 21, 1983 (10:23 Md. R. 2063); May 27, 1984 (11:10 Md. R. 863); March 11, 1985 (12:5 Md. R. 482); July 15, 1985 (12:14 Md. R. 1432); August 12, 1985 (12:16 Md. R. 1606); March 10, 1986 (13:5 Md. R. 542); June 2, 1986 (13:11 Md. R. 1273); December 1, 1986 (13:22 Md. R. 2398)

**Administrative History:** Regulation .07E amended as an emergency provision effective July 1, 1986 (13:14 Md. R. 1626); adopted permanently effective October 6, 1986 (13:20 Md. R. 2210)

**Administrative History:** Regulation .07E amended as an emergency provision effective October 1, 1986 (13:22 Md. R. 2393); emergency status expired February 8, 1987

**Administrative History:** Regulation .07E repealed and new Regulation .07E adopted effective February 9, 1987 (14:3 Md. R. 273); amended October 5, 1987 (14:20 Md. R. 2142); February 22, 1988 (15:4 Md. R. 473); July 11, 1988 (15:14 Md. R. 1654); July 25, 1988 (15:14 Md. R. 1654); December 12, 1988 (15:25 Md. R. 2903)

**Administrative History:** Regulation .07E amended as an emergency provision effective March 15, 1990 (17:7 Md. R. 843); emergency status expired June 30, 1990; amended permanently effective July 9, 1990 (17:13 Md. R. 1611)

**Administrative History:** Regulation .07F amended effective April 9, 1984 (11:7 Md. R. 625)

**Administrative History:** Regulation .07H amended as an emergency provision effective February 1, 1979 (6:2 Md. R. 71); emergency status extended at 6:12 Md. R. 1045; adopted permanently effective June 1, 1979 (6:11 Md. R. 979)

**Administrative History:** Regulation .07K amended as an emergency provision effective July 1, 1978 (5:14 Md. R. 1131); adopted permanently effective November 3, 1978 (5:22 Md. R. 1673)

**Administrative History:** Regulation .07K amended effective January 30, 1984 (11:2 Md. R. 113); September 10, 1984 (11:18 Md. R. 1584)

**Administrative History:** Regulation .07K amended as an emergency provision effective January 28, 1991 (18:3 Md. R. 301); emergency status expired April 8, 1991 (18:9 Md. R. 1004)

**Administrative History:** Regulation .07K amended as an emergency provision effective April 9, 1991 (18:9 Md. R. 1005); amended permanently effective October 7, 1991 (18:18 Md. R. 2004)

**Administrative History:** Regulation .07L adopted effective December 15, 1978 (5:25 Md. R. 1854)

**Administrative History:** Regulation .07M adopted effective February 6, 1989 (16:2 Md. R. 159)

**Administrative History:** Regulation .08A amended effective May 12, 1986 (13:9 Md. R. 1029)

**Administrative History:** Regulation .09A, D amended effective August 17, 1981 (8:16 Md. R. 1365)

**Administrative History:** Regulation .10 amended effective June 6, 1983 (10:11 Md. R. 974)

**Administrative History:** Regulation .11 adopted effective October 25, 1982 (9:21 Md. R. 2106)

**Administrative History:** Chapter revised as an emergency provision effective July 21, 1995 (22:16 Md. R. 1218); adopted permanently effective November 20, 1995 (22:23 Md. R. 1801)

**Administrative History:** Regulation .01B amended effective September 18, 2000 (27:18 Md. R. 1665); April 29, 2002 (29:8 Md. R. 700); July 24, 2023 (50:14 Md. R. 593)

**Administrative History:** Regulation .03A amended effective April 29, 2002 (29:8 Md. R. 700); July 16, 2018 (45:14 Md. R. 696)

**Administrative History:** Regulation .03B amended effective July 24, 2023 (50:14 Md. R. 593)

**Administrative History:** Regulation .04 amended effective September 18, 2000 (27:18 Md. R. 1665)

**Administrative History:** Regulation .04A amended effective April 29, 2002 (29:8 Md. R. 700); January 1, 2018 (44:26 Md. R. 1214); July 24, 2023 (50:14 Md. R. 593)

**Administrative History:** Regulation .05 amended effective September 18, 2000 (27:18 Md. R. 1665); October 10, 2016 (43:20 Md. R. 1109); January 1, 2018 (44:26 Md. R. 1214)

**Administrative History:** Regulation .05A amended effective April 29, 2002 (29:8 Md. R. 700)

**Administrative History:** Regulation .05B amended effective July 24, 2023 (50:14 Md. R. 593)

**Administrative History:** Regulation .06 adopted effective July 24, 2023 (50:14 Md. R. 593)

**Administrative History:** Regulation .07B amended effective January 1, 2018 (44:26 Md. R. 1214)

**Administrative History:** Regulation .07B, D amended effective April 29, 2002 (29:8 Md. R. 700)

**Administrative History:** Regulation .07C, D amended effective September 18, 2000 (27:18 Md. R. 1665)

**Administrative History:** Regulation .07C, H amended effective July 4, 2016 (43:13 Md. R. 712)

**Administrative History:** Regulation .07D amended effective December 12, 2011 (38:25 Md. R. 1581); February 27, 2017 (44:4 Md. R. 252)

**Administrative History:** Regulation .07D, E amended effective June 14, 2021 (48:12 Md. R. 472)

**Administrative History:** Regulation .07D, M amended effective July 24, 2023 (50:14 Md. R. 593)

**Administrative History:** Regulation .07G amended effective April 4, 2011 (38:7 Md. R. 430)

**Administrative History:** Regulation .07L-P adopted effective September 18, 2000 (27:18 Md. R. 1665)

**Administrative History:** Regulation .07L amended effective July 31, 2017 (44:15 Md. R. 759)

#### Regulation .01 Definitions.

*COMAR 10.09.09.01*

A. In addition to the definitions contained in §B of this regulation, definitions set forth in COMAR 10.09.36.01 are applicable to this chapter.

B. Terms Defined.

  (1) “Authorized practitioner” means a physician, osteopath, dentist, podiatrist, nurse midwife, nurse anesthetist, nurse practitioner, or physician assistant employed by a physician or clinic.

  (2) Freestanding Clinic.

    (a) “Freestanding clinic” means a health care facility that is not licensed as a hospital, part of a hospital, or nursing home and is not administratively part of a physician's, dentist's, or osteopath's office, but which has a separate staff functioning under the direction of a clinic administrator or health officer and is organized and operated to provide ambulatory health services.

    (b) “Freestanding clinic” does not include a clinic or clinic site located in a participant’s home.

  (3) “Hospital” means any institution which falls within the jurisdiction of Health-General Article, Title 19, Subtitle 3, Annotated Code of Maryland, and which is licensed pursuant to COMAR 10.07.01 or other applicable standards established by the state in which the service is provided.

  (4) “Medical laboratory” means a licensed or certified facility, place, establishment, or institution, operated for the examination of material derived from the human body, by means of one or more of the scientific disciplines, for the purpose of obtaining scientific data that may be used to determine the presence, source, progress, or identity of disease agents, and to aid in the prevention, diagnosis, treatment, and management of human disease.

  (5) “Order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed.

  (6) “Participant” means an individual who is certified as eligible for, and is receiving, Medical Assistance benefits.

  (7) “Preauthorization” means the approval required from the Department or its designee before services can be rendered.

  (8) “Reference laboratory” means a medical laboratory, which is enrolled with the Program as either a provider or a renderer, to which a medical laboratory provider refers specimens from Medical Assistance participants for analysis.

  (9) “Referring laboratory” means a medical laboratory provider that refers specimens from Medical Assistance participants for analysis.

  (10) “Special handling” means a circumstance in which specimen collection and pickup are accomplished as independent procedures to be responsive to the medical needs of the participant or to preserve viability or condition of the specimen.

  (11) “Standing order” means a request, or a copy of a request, initiated by and traceable to an authorized practitioner, authorizing the performance of specific medical laboratory services to be supplied over a specific time period, that identifies the participant, the authorized ordering practitioner, the medical laboratory services requested, and the date executed.

#### Regulation .02 License Requirements.

*COMAR 10.09.09.02*

A. The provider shall meet all license requirements as set forth in COMAR 10.09.36.02.

B. Medical laboratories are required to ensure that Clinical Laboratory Improvement Amendments (CLIA) certification exists for all clinical laboratory services performed.

C. Medical laboratories located in Maryland shall be in compliance with COMAR 10.10.01.

D. Out-of-State Laboratories.

  (1) Laboratories with representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed, and that requirements of applicable sections of COMAR 10.10.01 are met.

  (2) Laboratories without representation or specimen pick-up in Maryland shall be in compliance with the applicable standards of the state and locality in which the laboratory is located and ensure that CLIA certification exists for all clinical laboratory services performed.

#### Regulation .03 Conditions for Participation.

*COMAR 10.09.09.03*

A. General requirements for participation in the Program are that a provider shall meet all conditions for participation as set forth in COMAR 10.09.36.03, except that a signature on the services order specified in COMAR 10.09.36.03A(19) is not required.

B. Specific requirements for participation in the Program as a medical laboratory include all of the following:

  (1) Be in compliance with all applicable license, certification, environmental, legal, and professional requirements to perform the clinical laboratory services offered;

  (2) Maintain records adequate to substantiate the ordering, performance, and reporting of clinical laboratory services performed or referred;

  (3) Agree to seek reimbursement from the Program only for services set forth in Regulation .04 of this chapter when provided to eligible participants;

  (4) Agree to refrain from billing participants for noncovered services set forth in Regulation .05 of this chapter; and

  (5) Agree to abide by all provisions set forth in Regulation .07 of this chapter when seeking reimbursement from the Program.

#### Regulation .04 Covered Services.

*COMAR 10.09.09.04*

The Program covers the following services:

A. Medically necessary laboratory services, when the services are:

  (1) Rendered to participants in a physician's office, hospital, freestanding clinic, or medical laboratory;

  (2) Provided according to the laws and regulations of the state and locality in which they are rendered;

  (3) Rendered pursuant to a properly completed order or standing order;

  (4) Adequately documented in the provider’s files;

  (5) Clinical and diagnostic services for which certification by the Centers for Medicare and Medicaid Services (CMS) under CLIA exists, if required; and

  (6) Ordered by an individual who is enrolled as a provider in the Program with an active status on the date of service;

B. Transportation of specimens by medical laboratories when special handling is required by medical necessity when documentation is supplied to the provider by the authorized ordering practitioner; and

C. Collection of specimens by venipuncture, capillary puncture, or arterial puncture.

#### 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.

#### Regulation .06 Preauthorization Requirements.

*COMAR 10.09.09.06*

A. Preauthorization is required for any service identified as needing preauthorization in the current laboratory fee schedule, in accordance with Regulation .07D of this chapter.

B. The provider shall submit the request for preauthorization according to the procedures established by, and in the form designated by, the Department.

C. Preauthorization is issued when:

  (1) Program procedures are met; and

  (2) The provider submits to the Department adequate documentation demonstrating that the service to be preauthorized is medically necessary.

D. Preauthorization is valid for services rendered or initiated within 90 days of the date issued.

E. Preauthorization for Services Billed to Medicare.

  (1) If Medicare covers and approves a service for which preauthorization by the Program is normally required, the Program shall waive preauthorization requirements for that service.

  (2) If Medicare rejects the entire claim or any part of a claim for a service that normally requires preauthorization, and the claim is referred to the Program for payment, the Program shall pay only for the Medicare-rejected covered services if authorization for those services was obtained prior to the date of service.

#### Regulation .07 Payment Procedures.

*COMAR 10.09.09.07*

A. General policies for payment procedures that are applicable to all providers are set forth in COMAR 10.09.36.04.

B. Medical laboratory providers shall identify the individual who ordered the laboratory services by recording the individual practitioners National Provider Identifier (NPI) number on the claim.

C. Unless the service is free to individuals not covered by Medicaid, the provider shall charge the Program the lesser of:

  (1) The providers customary charge to the general public; or

  (2) The providers customary charge to other third-party payers.

D. Providers are reimbursed according to the 2022 Medical Laboratory Fee Schedule (Effective March 2022). All the provisions of this document are incorporated by reference.

E. The Department will pay for covered services the amount that is the lower of the following:

  (1) Provider's charge according to §C of this regulation; or

  (2) Departments maximum rates according to §D of this regulation.

F. Payments on Medicare claims are authorized if:

  (1) The provider accepts Medicare assignments;

  (2) Initial billing is made directly to Medicare according to Medicare guidelines; and

  (3) Medicare has determined that services were medically justified.

G. Supplemental payment on Medicare claims is made subject to the following provisions:

  (1) Deductible insurance will be paid in full;

  (2) Beginning with August 1, 2010 dates of service, coinsurance shall be paid:

    (a) In full for the following:

      (i) Mental health services;

      (ii) CPT codes that are priced by report;

      (iii) Claims for anesthesia services;

      (iv) Claims from a federally qualified health center; and

      (v) HCPCS codes beginning with A through W; and

    (b) For all other claims, at the lesser of:

      (i) 100 percent of the coinsurance amount; or

      (ii) The balance remaining after the Medicare payment is subtracted from the Medicaid rate; and

  (3) Services not covered by Medicare, but covered by the Program, will be paid according to §E of this regulation.

H. The provider may not bill the Department for:

  (1) Completion of forms and reports;

  (2) Broken or missed appointments; or

  (3) Services listed in Regulation .05 of this chapter.

I. Billing time limitations for claims submitted pursuant to this chapter are set forth in COMAR 10.09.36.

J. When seeking reimbursement for medical laboratory services which are subjected to panel billing regulations or are part of a panel, the medical laboratory provider shall bill the Department the panel rate or the sum of the charges of the individual tests, whichever is less.

K. A referring laboratory provider may bill the Program for laboratory services performed by a reference laboratory when the:

  (1) Reference laboratory is:

    (a) Enrolled with the Program as either a medical laboratory provider or a renderer; and

    (b) CLIA certified for the procedures performed;

  (2) Procedures which were referred, and the identity of the reference laboratory, are identified on the invoice; and

  (3) Referring laboratory charges not more than the amount it actually paid the reference laboratory.

L. Standing orders shall:

  (1) Conform to the specifications for orders found in Regulations .01 and .04 of this chapter;

  (2) Include:

    (a) A date which shall become the starting date of the order unless another starting date is specified on the order; and

    (b) Specific instructions outlining the schedule of services to be provided pursuant to the order; and

  (3) Be effective for a maximum of 90 days or, for dialysis patients, be effective for a maximum of 1 year.

M. All indices, calculated values, or other results that are not directly determined, are considered part of the parent procedures and are not separately billable to either the Program or the participant.

N. Only those panels or profiles that have a composition specified by CPT or the Program are reimbursable as panels or profiles by the Program. Reimbursement for these recognized panels or profiles is not authorized unless each and every component of the panel or profile is performed.

O. Two or more of the following chemistry tests shall be reimbursed at a rate that is the lesser of the provider's lowest charge to the general public or third-party payers, or the Program's maximum reimbursement for these chemistry tests when performed as panels:

  (1) Albumin, serum;

  (2) Bilirubin, direct;

  (3) Bilirubin, total;

  (4) Calcium, total;

  (5) Carbon dioxide (bicarbonate);

  (6) Chloride, blood;

  (7) Cholesterol, serum, total;

  (8) Creatine kinase (CK), (CPK), total;

  (9) Creatinine, blood;

  (10) Glucose, quantitative;

  (11) Glutamyltransferase, gamma (GGT);

  (12) Lactate dehydrogenase (LD), (LDH);

  (13) Phosphatase, alkaline;

  (14) Phosphorus, inorganic;

  (15) Potassium, serum;

  (16) Protein, total, except refractometry;

  (17) Protein, total, refractometric;

  (18) Sodium, serum;

  (19) Transferase, aspartate amino (AST) (SGOT);

  (20) Transferase, alanine amino (ALT) (SGPT);

  (21) Triglycerides;

  (22) Urea nitrogen, quantitative (BUN); and

  (23) Uric acid, blood.

P. All of the tests listed in §O of this regulation that are ordered on or performed on the same specimen shall be billed as if performed simultaneously.

#### Regulation .08 Recovery and Reimbursement.

*COMAR 10.09.09.08*

General policies for recovery and reimbursement that are applicable to all providers are set forth in COMAR 10.09.36.07.

#### Regulation .09 Cause for Suspension or Removal and Imposition of Sanctions.

*COMAR 10.09.09.09*

General policies governing cause for suspension or removal and imposing sanctions that are applicable to all providers are set forth in COMAR 10.09.36.08.

#### Regulation .10 Appeal Procedures.

*COMAR 10.09.09.10*

General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09.

#### Regulation .11 Interpretive Regulation.

*COMAR 10.09.09.11*

General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10.