The 2019 Maryland Legislative Session closed on April 8th with an exciting development related to laboratory testing. As we previously reported (see here), Maryland law currently prohibits directly or indirectly advertising or soliciting for medical laboratories. Two bills were introduced earlier this year to address this state-specific constraint. On the last day of the Legislative Session, the Maryland General Assembly unanimously passed SB495, which creates certain exceptions to the advertising prohibition.
SB495 allows advertising or soliciting business for two categories of laboratory tests:
- Tests used for screening, diagnosing, managing, or treating a physical or mental condition or disease; and
- Ancestry testing and DNA testing used for detecting and reporting genetic evidence of parental lineage and genetic ethnicity.
The exception only applies to laboratory tests that are ordered by a physician and performed by a CLIA-certified laboratory. In addition, the company advertising the tests must be a HIPAA covered entity or a business associate of a HIPAA covered entity. The advertisements may not make claims about the reliability and validity of the test that are inconsistent with CLIA and must disclose that the tests may or may not be covered by health insurance.
SB495 does not allow all laboratory tests to be advertised in Maryland. In addition to the restrictions outlined above, SB495 specifically states that germline genetic or genomic tests used for the analysis, diagnosis, or prediction of human diseases may not directly or indirectly advertise or solicit business.
SB495 will allow the State to take legal action to restrict the marketing of a laboratory test if the test poses a threat to public health or is not in compliance with the exception requirements.
It is expected that Governor Hogan will sign SB495 next month and that the changes will go into effect on October 1, 2019.