Massachusetts Clinical Laboratory Licensing: Waived-Only Labs Exempt Since 2022

For years, Massachusetts was a state where a site running even simple waived tests could need a state clinical laboratory license on top of its CLIA certificate. That ended in 2022. On October 24, 2022, the Department of Public Health (DPH) told clinical laboratories: "Effective immediately, clinical laboratories performing only Clinical Laboratory Improvement Amendments (CLIA) waived tests no longer require state clinical laboratory licensure."

What does the statute say now?

Massachusetts General Laws chapter 111D, section 4, requires a license to "maintain a clinical laboratory in the commonwealth apart from a hospital or clinic licensed under section 51 of chapter 111." Its list of exceptions now includes, at § 4(c), "a clinical laboratory performing only CLIA-waived tests; provided, that clinical laboratories performing non-CLIA waived tests in addition to CLIA-waived tests must obtain a clinical laboratory license."

Section 1 defines the term: a "CLIA-waived test" is "a test that the federal Centers for Medicare and Medicaid Services has determined qualifies for a Certificate of Waiver under the federal Clinical Laboratory Improvement Amendments of 1988." Massachusetts did not create its own list; it follows the federal categorization.

What does a waived-only Massachusetts lab still owe?

DPH's memo is explicit that the exemption is from state licensure, not from regulation. Labs "seeking to perform only CLIA-waived tests must apply for and receive a CLIA Certificate of Waiver prior to conducting CLIA-waived testing," and labs performing only waived tests must:

• "Comply with all applicable CLIA regulations."
• "Report to the Department of Public Health any specimen results that yields evidence significant from a public health standpoint of the presence or for the prevention, diagnosis or control of infectious diseases."
• "Adhere to all requirements set forth in MGL chapter 111D, section 8."

Section 8 is a list of prohibited practices. Among them: no commissions or rebates for specimen referrals, no false statements to the department, and no reports that fail to name the lab that actually performed the test and its director. Section 8 also limits examining a specimen to the written request of a licensed practitioner or other person the law authorizes, with exceptions for health promotion screening. A pharmacy or employer site planning its ordering workflow should read that clause with its counsel.

The federal side is unchanged. The CMS-116 goes to DPH's Clinical Laboratory Program, which CMS lists (May 2026) at CLIALab@mass.gov and (617) 660-5385, and the lab pays CMS from its emailed coupon: $248 every two years for a Certificate of Waiver, as of October 2026. See waived tests are not exempt from CLIA.

Who else is exempt?

Section 4 keeps the older exemptions, which DPH's memo summarizes in a footnote:

• labs maintained by not more than two licensed physicians, and labs maintained by three or more, "exclusively in connection with the diagnosis and treatment of the physician's own patients," but only if "the physician or the physician's assistant under the direct supervision of such physician performs all testing" and the lab "performs only laboratory tests which the commissioner, with the advice of the advisory committee on clinical laboratories, has determined to be exempt from licensure";
• labs maintained exclusively for research and teaching that do not report results for patient care or public health;
• insurance-related testing, and examinations of a company's own employees or officers; and
• labs "maintained exclusively for a health promotion screening program" that meet DPH standards.

Hospitals and clinics licensed under chapter 111 § 51 are outside the licensing requirement entirely.

When does a Massachusetts site need a license again?

The moment it adds anything that is not CLIA-waived and no other exemption applies. DPH: "Unless otherwise exempt, a clinical laboratory performing non-CLIA waived tests in addition to CLIA-waived tests is still required to obtain state clinical laboratory licensure and follow all statutory and regulatory requirements set forth in MGL chapter 111D and 105 CMR 180.000."

The common trigger is provider-performed microscopy. A practice that adds wet mounts or KOH preps holds a federal PPM certificate, and PPM procedures are not waived. Unless the physician-office exemption fits (the physician or a supervised assistant does all the testing, and the tests are on the commissioner's exempt list), that practice needs a state license. A license runs "not more than two years" (§ 5), and "No licensee shall transfer the license issued him... without first obtaining the department's written permission," which DPH must approve or deny within sixty days of filing.

Why do some sources still say waived labs need a license?

Because they predate the change. Guides and checklists written before October 2022 describe the earlier rule. When a source and the statute disagree, the statute controls, and § 4(c) is clear. The DPH memo was issued "to provide clinical laboratories with information and implementation guidance on recent statutory changes made to Massachusetts General Law (MGL) chapter 111D."

Where do we fit in?

For a waived-only Massachusetts site, our Certificate of Waiver Application is $399: the CMS-116 and test list for your owner or director to sign, and a note of the § 4(c) exemption for your records. Groups of five sites are $1,599. If your plans include microscopy or other nonwaived testing, our State Lab License or Permit service ($699 per state) prepares the state application for your director to sign. You pay CMS and the state directly. The Massachusetts requirements page keeps the details current.