DHHS Promulgates Rule Giving Patients Right to Receive Results Directly From Lab

Earlier in the week, the Department of Health & Human Services announced a new rule under the Health Insurance Portability and Accountability Act (HIPAA) and the Clinical Laboratory Improvements Amendment of 1988 (CLIA) giving patients the right to access test results directly from a diagnostic laboratory, instead of making them go through the physician who ordered the results.  The final rule is available here.

The quick summary of the new rule is that if a covered laboratory (which is a laboratory that conducts one or more transactions electronically – so pretty much any laboratory) keeps test results electronically, it must share those with the tested individual or his or her personal representative; if it does not have results stored electronically, it must make an electronic copy in a mutually agreeable format.  Non-CLIA labs are exempt, as well as a handful of other entities and tests.

One major objection to the new rule is that many patients are ill-equipped to understand the test results without consulting with their physicians, and as such, they may be apt to overreact to seemingly abnormal results or false positives.  I understand where this is coming from.  Years ago, I contracted a nasty case of pneumonia training for the Boston Marathon in the dead of winter in Chicago.  This was the first (and only) time I had ever had pneumonia, and I became worried that I wasn’t recovering as fast as I’d like.  I went to a specialist, who ordered a comprehensive breathing test to make sure it wasn’t asthma.  At the lab, I blew into a bunch of tubes.  After one test, the lab tech shook her head and asked if I was a heavy smoker.  I said no, and she got a deeply concerning look on her face.  I, of course, freaked out.  The day the results were supposed to be available, I called the pulmonologist to get the bad news.  Guess what?  The results were totally normal, for someone who was recovering from pneumonia.  (I eventually started to feel normal, but it took months.)

And that’s the problem.  There are any number of conditions that can make otherwise abnormal lab results perfectly acceptable.  I’m not saying that it’s enough to make the new rule a bad one; DHHS certainly didn’t think so.  It emphasized that physicians will still be expected to consult with their patients about the results, and noted that most labs report that patients ask for the direct results only after they have already spoken with their physicians about them.  I’m not entirely sure that’s responsive – the fact that physicians still will advise their patients doesn’t really address the concern that some patients will get the results before having that conversation, and even if most patients tend to wait until they talk to the physician before directly requesting the results, some evidently do not.  But I’ll set those qualms aside.  The rule is here to stay.

It is important to make one point, though.  Given that patients are able to call the lab and get their results directly, physicians ordering tests need to do a good job up front communicating to the tested individual as to the expected results and the results that are cause for concern.  For example, in my case, the pulmonologist should have told me that given my recent pneumonia, she expected my results might show diminished lung function (assuming I had the right to directly access them), and that would be completely normal.

If you have that conversation up front, it can save a lot of stress and concern on the part of the patient, and perhaps even unnecessary testing for those eager beaver patients who don’t want to wait to consult their doctor about potentially concerning results.