new rule for lab tests

  • 12th February 201412/02/14

“What do you mean that I have to schedule an office visit with the doctor to get my lab test information?” the increasingly frustrated patient asked the medical office manager over the phone.

“Well, that is just our office policy and the doctor says you would not understand the test results,” the office manager asserted.

“But, this is my information, and I should not have to pay another office visit copayment just to get my results,” the patient pleaded.

“Sorry, but we are a business and we cannot just let patients look at test information they do not understand,” the office manager stated firmly.

While this may sound like campy dialogue to most medical groups that promptly provide lab test results to patients, the federal government apparently was concerned that lab test information was not reaching some patients from their providers.

As a result, the Department of Health and Human Services (HHS) recently changed regulatory restrictions under both the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA).

Under the old framework, patients generally could not get test results directly from a lab. Some states like Oregon did permit such access, and others like Washington actually prohibited direct access. So a patchwork of varying access rights developed around the country.

What the new framework does is amend CLIA rules to allow patients to make a direct request to a lab for their test information. Also, HIPAA rules are amended to remove an earlier restriction on access to test results directly from a lab. This new framework will preempt any state law that is contrary to the new access rights granted to patients.

Some providers did raise concerns with HHS about allowing patients to get test results directly from labs without having a provider available to explain complex or abnormal results. HHS responded that the new rule would “not alter the role” of providers in explaining test results to patients, and that patients are expected to continue obtaining “advice about what those test results mean” from their providers. Notably, the rule does not prevent providers from sharing lab results with their patients as most providers did anyway before the rule change was drafted.

HHS published the new rule in the Federal Register on February 6, 2014.

As with all significant changes in health law, there will be some confusion and glitches as providers, labs, and patients learn more about what the new access right to lab tests means in practice when it goes into effect later in April 2014.