Lab Results for All! Of Data Liberation, Participatory Medicine, and Government 2.0

On September 14, HHS released for comment draft lab results regulations that will, if finalized, effectively bathe the Achilles’ heel of health data in the River Styx of ¡data liberación!  Lab results will be made available to patients, just like all other health data.  (See the HHS presser and YouTube video from the consumer health summit … “Putting the ‘I’ in Health IT.”)

Forgive me for mixing my metaphors (or whatever it is I just did), but even though there are just a couple dozen words of regulations at issue here, this is a big deal.

When HIPAA established a federal right for each individual to obtain a copy of his or her health records, in paper or electronic format, there were a couple of types of records called out as specifically exempt from this general rule of data liberation, in the HIPAA Privacy Rule, 45 CFR § 164.524(a)(1): psychotherapy notes, information compiled for use in an administrative or court proceeding, and lab results from what is known as a CLIA lab or a CLIA-exempt lab (including  “reference labs,” as in your specimens get referred there by the lab that collects them, or freestanding labs that a patient may be referred to for a test; these are not the labs that are in-house at many doctors’ offices, hospitals and other health care facilities — the in-house labs are part of the “parent” provider organization and their results are part of the parents’ health records already subject to HIPAA).

(“CLIA” stands for the Clinical Laboratory Improvement Amendments of 1988, which established quality standards for certain laboratory testing.)

This carveout of lab results from patient-accessible records has long been a thorn in the side of the e-patient.  This month, the federales announced that they would step forward as Androcles to the e-patient lion (to jumble a reference or two), and pull out the thorn, by proposing to amend both the CLIA regs and the HIPAA regs.  The HIPAA regs include the exception described above: all records must be made accessible upon request except labs and a couple others.  The lab results exception will be deleted from the HIPAA regs if the change is finalized.  The CLIA regs prohibit lab delivery of results directly to patients.  The proposed amendment says that the labs “may” release the results directly to patients.  The net effect is that patients will have the right to request the results, and since labs will be permitted to release them, they will have to do so.

As some readers will recall, HIPAA regs were subjected to a state-by-state “pre-emption analysis” when they came out.  (Generally speaking, Federal law “pre-empts” state law unless state law is more protective of an individual’s rights or health.)  The feds note:

A number of States [most, actually] have laws that prohibit a laboratory from releasing a test report directly to the patient or that prohibit the release without the ordering provider’s consent. If adopted, the proposed changes to § 164.524 [of the HIPAA regs] would preempt any contrary State laws that prohibit the HIPAA-covered laboratory from directly providing access to the individual.

Thus, labs in most states have some work to do in figuring out how they will actually release results directly to patients once the regs are finalized and effective (which could be about a year, folks, so sit tight).

Here’s where it gets fun, folks:

While individuals can obtain test results through the ordering provider, we believe that the advent of certain health reform concepts (for example, individualized medicine and an individual’s active involvement in his or her own health care) would be best served by revisiting the CLIA limitations on the disclosure of laboratory test results.

CMS goes on to say that the HIT Policy Committee  at ONC, established by the HITECH Act, says that “CLIA regulations are perceived by some stakeholders as imposing barriers to the exchange of health information.  These stakeholders . . .  believe that the individual’s access to his or her own records is impeded, preventing patients from a more active role in their personal health care decisions ” … so we’re going to change them.  [Paraphrase and emphasis mine.]

Let me restate this, folks: the regs are being changed to give greater patient access to health data not because of a recent change in the law, but becuase patients and patient advocates spoke up, and the HIT Policy Committee got the message.

I had the opportunity to hear Dr. Farzad Mostashari (National Coordinator for Health IT), Lygeia Ricciardi (Senior Policy Advisor for Consumer eHealth), and Jodi Daniel (Director, Office of Policy & Planning) speak at an ONC town meeting at this week’s Health 2.0 conference and they are nothing if not passionate about promoting patient access to health data. (Please take a look at my mini video interviews with Dr. Mostashari and Ms. Ricciardi, if you need any confirmation.)

This change may improve patient access to lab results, but only if the right to obtain the results is ushered in together with an education campaign that alerts patients to this new right, and if the results are presented in a manner that includes some minimal level of interpretation (and I recognize that too much interpretation will cross the line into the communication that needs to take place between the patient and his or her clinician).  On the question of how lab results should be presented to patients, at Health 2.0, Thomas Goetz, of Wired magazine, presented a  patient-friendly lab report tool, to be rolled out soon by his company, 1 + 1 Labs.  Other approaches, of course, are possible, since numerous institutions already provide this data directly to patients.

A certain percentage of lab results never make their way to the patient — and the patient education piece of the rollout could result in that percentage being reduced, or even eliminated.

There is opposition to the proposed rule by some providers, who express a concern that a patient who receives lab results directly may well (a) misintepret a value that is “normal” for the population at large but that might not be “normal” for her and/or (b) fail to communicate with the clinician who ordered the test.  In our fee-for-service world, some cynics may say that some clinicians are being inappropriately incentivized to seek another billable patient encounter for discussion of results.  In the future of bundled, episodic, prospective payment systems, this would not be a concern.  In fact, since we will be asking the entire health care system to be doing more with less as a result of the nation’s fiscal and political environments, frictionless sharing of information should be welcomed by providers.  Providers will continue to receive lab results, and will continue to be expected to discuss them with their patients.

Comments on the draft rule are invited, and the Society for Participatory Medicine will be supporting this change.

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12 Responses to “Lab Results for All! Of Data Liberation, Participatory Medicine, and Government 2.0”

  1. jonmcrawford says:

    I think it was a murdering of metaphors, but worth it! This is exciting!

  2. David Harlow says:

    Readers of this post might be interested in listening to all or part of the ONC town hall meeting at the Health 2.0 conference in San Francisco (September 2011) (about 45 min. – amateur recording by yours truly; warning: autoplay) http://j.mp/mPWp7P. Farzad Mostashari and two key senior staffers, Lygeia Ricciardi and Jodi Daniel, discuss the ONC broadening of focus from providers to include patients (very beginning of recording is clipped, but you didn’t miss much). Another way in which this broader focus is demonstrated is by the redesign and expansion of the http://HealthIT.gov website, which now includes more robust patient-focused content. (“Putting the “I” in Health IT” … You can take the pledge to empower individuals to be partners in their health through health IT.

  3. David, thanks a million for this post, which I was unable to fully absorb last week while wrapped up in travel. You did a great job of spelling out the details and the consumer-level impact. This is why I’m so glad you’re SPM’s policy chair!

    I want to spotlight these takeaways:

    We (that’s you!) can comment. On the page David cited, here are the addresses where you can comment. Do it! Participate! I will too, in addition to SPM’s formal statement.

    As reason for the change, the feds say “an individual’s active involvement in his or her own health care… would be best served by” these changes. Did I just hear our government explicitly recognize participatory medicine, patient engagement?? Woohoo! (I know those people believe in it, but it’s awesome to hear it explicitly cited.)

    Under the proposed regulations “patients will have the right to request the results, and [labs] will have to do so.” Yes, that’s a huge enabler for empowered, engaged patients.

    “A certain percentage of lab results never make their way to the patient”: I can never find the cite (we really should have it on this blog) but I think it was a 2010 article in NEJM or one of the internal medicine journals: 1 in 14 lab results is NEVER communicated to the patient, and that includes both good and bad news.

    Including a cancer diagnosis. I have personally met two people, one US, one Dutch, whose cancer diagnosis was lost in a folder or a year or more.

    To grasp the impact of that, readers, imagine an industry where 1 in 14 invoices is accidentally never sent out, or 1 in 14 checks. It’s unimaginable except in some underdeveloped incompetent bureaucracy – and that’s exactly what the data shows is apparently true for much of healthcare.

    (A side note: modern EMR systems can be programmed to automatically deliver lab results, immediately or after a few days. This is one example of why EMR adoption is so important, and why nobody can be patient-centered and object to the EMR movement.

    More, from a separate angle, in the next comment.

  4. Finally, I’ll add a compassionate and pragmatic aspect: as consumers are forced (or enabled, your choice) to fend for themselves and make responsible choices, they MUST have the information.

    As I cited in my Thursday post, tens of millions of families are on their own to make healthcare spending decisions in an era of unaffordability. How can they do that if they don’t have the information?

    Past policies have withheld this information from consumers. The whole point of the data is to monitor health and prevent problems; whoever is making those decisions – physicians or families – obviously needs the information.

    Give us our data! Let patients help!

  5. David Harlow says:

    Here’s a link to the abstract of the journal article Dave was remembering:

    Arch Intern Med — Abstract: Frequency of Failure to Inform Patients of Clinically Significant Outpatient Test Results, June 22, 2009, Casalino et al. 169 (12): 1123 – http://bit.ly/pY2wDv [updated 9/11/13: http://www.ncbi.nlm.nih.gov/pubmed/19546413%5D

    “Physician practices fail to inform patients of abnormal results about 7% of the time, according to a June 22, 2009, Archives of Internal Medicine study of more than 5,000 patient records at 23 primary care clinics.” This quote is from the AMA’s American Medical News, where the study is cited as supporting the position of opponents of the proposed rule. (Both views, pro and con, are laid out in that piece.)

    See: amednews: HHS wants to give patients test results straight from lab :: Oct 3, 2011 … American Medical News – http://bit.ly/r8JbvS

  6. […] should be provided to the patient upon request.  See the post on e-patients.net explaining the proposed rule on access to lab results and its background.  Following discussion in the comments to the blog post and on the listserv […]

  7. […] should be provided to the patient upon request. See the post on e-patients.net explaining the proposed rule on access to lab results and its background. Following discussion in the comments to the blog post and on the listserv, […]

  8. […] test results is because 7% of all results never get delivered, when they’re on paper (see here); and another biggie is the speed and convenience of […]

  9. […] As I wrote then in a post on lab test results and proposed changes to the HIPAA rules: […]

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