Some patients who receive genetic testing may be concerned about the privacy of their results and whether insurance companies could use a genetic diagnosis to deny coverage or determine premiums.
The Federal Genetic Information Nondiscrimination Act (GINA) prevents insurers from discriminating against patients. There are state laws that add further protections to prevent genetic discrimination by insurers. According to the National Institutes of Health, some states have enacted privacy rules, some have pending legislation, and some have been vetoed while others have not. However, current federal laws do not prohibit the use of family history or genetic test results by life, long-term care, or disability insurers. See State Standards below.
- 23 states have employment nondiscrimination statutes regarding genetic test results that are enacted; 19 statutes are pending
- 14 states have statutes pertaining to health insurance coverage regarding genetic test results; 10 statutes are pending
- 40 states have health insurance nondiscrimination statutes regarding genetic testing; 5 statutes are pending
- Five states have other lines of insurance nondiscrimination statutes regarding genetic testing; 1 statute is pending
- 39 statutes exist, some states have more than one privacy rule, such as Illinois (which has three) regarding genetic test results that are enacted; there are 40 pending statutes; some states have more than one pending, such as Tennessee
- 15 states have statutes regarding genetic research; there is one pending statute,
- Eleven statutes pertain to the use of residual newborn screening specimens that are enacted; California has three; Minnesota has two; Oklahoma has two.
Accuracy, Avoiding Patient Identification Errors in Genetic Test Results
It is common for health care providers and hospitals to college a specimen and send it out to a reference lab. The reference lab performs the test and sends the results back to the provider who is treating the patient. If the reference lab test results are not integrated and interoperable with the provider’s Electronic Health Record (E.H.R.) results are still sent by fax. This creates the risk of patient identification errors. A test result that is sent by fax to a hospital, for example must be integrated with the hospital E.H.R. A matching exercise to ensure that the right patient (same name, data of birth at a minimum) is entered. If the support staff are distracted, untrained, or over worked they can enter the information into the wrong chart. There are common circumstances where this has been known to happen.[i]
Hospitals are Subject to HIPAA and CLIA Accuracy Standards, Including Correct Patient Identification as Provided for Under Both HIPAA and CLIA
Hospitals that submit electronic bills for payment are HIPAA Covered Entities. Hospitals that bill for any lab test requiring a CLIA certificate of registration, CLIA certificate of compliance or a CLIA certificate of accreditation are covered by CLIA. [ii] Both HIPAA and CLIA require that Standards are met to ensure the accuracy of patient identities and that measures are implemented to detect and correct errors.
[i] See ECRI.org web site, About ECRI and ECRI timeline since founding in 1968 https://www.ecri.org/about/ecri-history-trusted-voice-healthcare
[ii] The Clinical Laboratory Improvement Amendments of 1988 (CLIA) regulations include federal standards applicable to all U.S. facilities or sites that test human specimens for health assessment or to diagnose, prevent, or treat disease. CDC, in partnership with CMS and the FDA supports the CLIA program and clinical laboratory quality. Learn more about CLIA.