Maine's Limited License for Waived Testing

Maine has its own Medical Laboratory Act (22 M.R.S. chapter 411), and it reaches waived testing. The Department of Health and Human Services rules (10-144 C.M.R. chapter 256) say it in one line: "Medical laboratories that perform only tests categorized as waived by CLIA are issued a limited license to perform only those waived tests for which the supervisor is qualified" (§ 4.3.3). For a site that is not exempt, that limited license sits on top of the federal Certificate of Waiver.

Who is exempt?

The Act lists the exemptions in 22 M.R.S. § 2013-A(1), and the rules restate them in section 3.6. The ones that matter for waived testing:

• Practitioners testing their own patients. The statute names "Physicians, physician associates, family nurse practitioners, Medicare-certified rural health clinics, professional associations or group practices" performing tests "exclusively for the examination of their own patients." The rules add that such labs are exempt "if they perform only tests that are within the scope of their CLIA certificate."
• School, college and workplace labs "under the direct supervision of" a licensed physician, physician assistant or nurse practitioner (in the rule's wording), serving only students or employees.
• Hospital labs, government labs, research and teaching labs that serve no patients, and radiology.
• Health screening laboratories holding a department permit.

Two limits stand out. First, "laboratories incorporated for the mutual use of physician or group practice owners are subject to all provisions of this Act" (§ 2013-A(1)(C)). A shared lab company owned by several practices is not exempt. Second, the list does not include pharmacies, and it does not reach med spas, IV clinics or urgent care centers owned by outside investors, or employer clinics outside the workplace exemption. Under section 3.7 of the rules, "Except as provided in Section 3.6 of these rules, medical laboratories must secure a department-issued state medical laboratory license."

What does the application require?

Section 4 of the rules sets out the license application:

1. A department-approved form and fee for each location. "A separate application and application fee must be submitted for each laboratory location."
2. A fire inspection. "An applicant for an initial license must secure a report of a satisfactory inspection by the Office of the State Fire Marshal, Maine Department of Public Safety. The cost of an inspection shall be borne by the applicant."
3. A copy of the CLIA certificate. "A copy of the laboratory's CLIA certification must accompany the application for a state license." In practice, the federal certificate comes first.
4. Any CLIA or accreditation inspection report, if the lab has had one.
5. The basics: lab name and location, the owners, the director, and a description of services.

When the owner is not the director, "the department issues the license jointly to the owner and the director" (§ 4.3.2). The license lists the director, the lab's official name and address, the testing specialties and categories certified by CLIA, and its effective and expiration dates.

The CMS-116 goes separately to Maine's CLIA program in the Division of Licensing and Regulatory Services. CMS's State Agency list (updated May 2026) gives CliaLab.DHHS@maine.gov and (207) 287-9339.

How much does a Maine license cost?

As of October 2026, the rules set the application fee at "$500 for the first category of testing" and "$60 for each additional category," and renewal at "$200 for the first category of testing" and "$60 for each additional category." The statute sets the same renewal amounts (22 M.R.S. § 2017). The federal fee is separate and goes to CMS: $248 every two years for a Certificate of Waiver, as of October 2026.

A health screening laboratory permit, used for screening events rather than diagnosis, costs $100, expires 24 months after issue, and is not renewable.

How long does a license last?

Three years. "A license shall expire 3 years after the date of issuance unless renewed" (22 M.R.S. § 2017). Renewal forms, fee and documents must reach the department "at least thirty (30) calendar days prior to the expiration date of the license" (rules § 4.10). Because the federal certificate runs two years and the Maine license three, the two renewals drift apart. A group with several Maine sites ends up with a different pair of dates at each one, which is where tracking pays for itself.

What happens when a site moves, or changes director or owner?

Maine wants a new license first. Rules § 4.6: "A new license, for the unexpired length of time of the original license, may be secured when there is a new location, director or owner. The new license must be obtained prior to the actual change." Plan director handoffs and acquisitions around that, not around the federal 30-day notice.

The Act also has teeth for operating without a license. The rules note that running an unlicensed nonexempt lab "constitutes a crime punishable, upon conviction, by a fine not less than $50 and not more than $500, or by imprisonment for not more than one year, or both."

Does a Maine license cover out-of-state testing?

The Act applies to labs "operating in the State." A licensed Maine lab may refer specimens out of state, and the report must say the findings came from the other lab (22 M.R.S. § 2015). No separate Maine license for labs located elsewhere was found in the Act. See testing specimens from other states for the states that do require one.

Where do we fit in a Maine opening?

We check whether your site fits an exemption, prepare the CMS-116 and the state license application with the test list from each kit's instructions, and list what the fire marshal inspection and the CLIA certificate copy need to accompany. Your owner and director review and sign; your organization pays the state, CMS and the fire inspection directly. Our State Lab License or Permit service is $699 per state on top of the $399 Certificate of Waiver Application. The Maine requirements page has the contacts.