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10.09.09.00.htm 10.09.09.00. Title 10 DEPARTMENT OF HEALTH AND MENTAL HYGIENE 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
10.09.09.01.htm 10.09.09.01. 01 Definitions.. 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
10.09.09.02.htm 10.09.09.02. 02 License Requirements.. 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 b
10.09.09.03.htm 10.09.09.03. 03 Conditions for Participation.. 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(15) 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, environment
10.09.09.04.htm 10.09.09.04. 04 Covered Services.. The Program covers the following services:. A. Medically necessary laboratory services, when the services are:. 1) Rendered to recipients 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; and.
10.09.09.05.htm 10.09.09.05. 05 Limitations.. The following are not covered:. A. Services for which the medical laboratory provider cannot supply a properly completed order or standing order identifying the authorized ordering practitioner;B. Services not adequately documented in the recipient'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
10.09.09.06.htm 10.09.09.06. 06 Preauthorization Requirements. (Reserved).
10.09.09.07.htm 10.09.09.07. 07 Payment Procedures.. 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 authorized ordering practitioner who authorized the medical laboratory services by either:1) Recording the Maryland Medical Assistance Program individual practitioner identification number on the invoice; or2) Recording the name of the authorized ordering practitioner on the invoic
10.09.09.08.htm 10.09.09.08. 08 Recovery and Reimbursement.. General policies for recovery and reimbursement that are applicable to all providers are set forth in COMAR 10.09.36.07.
10.09.09.09.htm 10.09.09.09. 09 Cause for Suspension or Removal and Imposition of Sanctions.. 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.
10.09.09.10.htm 10.09.09.10. 10 Appeal Procedures.. General policies governing appeal procedures that are applicable to all providers are set forth in COMAR 10.09.36.09.
10.09.09.11.htm 10.09.09.11. 11 Interpretive Regulation.. General policies governing the interpretive regulations that are applicable to all providers are set forth in COMAR 10.09.36.10.
10.09.09.9999.htm 10.09.09.9999. Administrative History Effective date: August 31, 1977 (4:18 Md. R. 1398). Regulation .01 amended effective August 22, 1988 (15:17 Md. R. 2049) February 6, 1989 (16:2 Md. R. 159)Regulation .02 amended effective February 6, 1989 (16:2 Md. R. 159). 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)Regulation .03 amended effective February 6, 1989 (16:2 Md. R. 159).
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