Answering Your Questions About Patients' Direct Access to Lab Results
my blog last month regarding to the HHS mandate that laboratories must grant patients
access to their lab results on request, my mailbox has been inundated with comments and questions.
A few questions were asked by more than one writer and so I thought I would
seek direct guidance from HHS and answer the most commonly asked questions
new requirement reverse HIPAA?
both CLIA and HIPAA regulations have been adjusted to accommodate these requirements.
HIPAA privacy rules had always sought to protect how patient information was
secured and protected, and specify under what conditions such information could be
disclosed. In the final rule published
by HHS in February, some restrictions were removed from both HIPAA privacy rules and CLIA
is a very specific requirement and does not negate, reverse or cancel HIPAA. Maintaining the security
and confidentiality of patient results are still very much in effect.
will still need to verify the patient's identity before releasing results. In cases where results are
requested by a patient’s “personal representative,” the lab must verify both
the identity and authority of the patient’s legal designee.
Is there no concern
for how much this will cost labs?
am not sure about concern from the federal government, but CMS does estimate that about 23,000 labs will be
affected. It recognizes that processes, infrastructure and equipment might all have
to change. The agency estimates that labs will receive between 175,000 and 3.5
million patient requests annually and the cost of compliance might be as high as $59 million. Labs will be permitted to charge each patient a reasonable fee for each request.
Will this apply to
all labs including reference labs?
Good question. I
suspect the reasoning for this question is that patients do not generally have
a direct relationship with reference labs. For most reference labs the client
is a referring entity like a hospital, physician etc.
CMS says the rule
should be applied uniformly and applies to all laboratories. Their goal is to make
it easier to access results, wherever tests are performed, so reference labs
will not be exempt.
those states that prohibit release of results directly to patients?
I alluded to in my earlier post, this rule supersedes state law restricting the
release of results. About 13 states have some specific restriction on releasing
results to patients directly. This rule voids that prohibition and labs must now
release results to patients regardless of previous prohibition by state law.
Doesn’t this place a
legal burden on laboratories being asked to explain test results?
requirement is to provide the result to the patient within 30 days of receiving
a request from the patient. The mandate is not to interpret the result or to
explain the clinical significance to the patient. In many cases, the patient
will have already discussed the result with their physician by the time the lab
receives a request. Sometimes the patient just needs a valid copy for their records or to seek a second opinion.
groups like the American Medical Association have opposed this rule on the
basis that patients are not prepared to interpret their result and having free
access without a doctor’s help might actually be more harmful than helpful.
responded that this is based on the philosophy that the patient owns his or her
own results, and the benefits of direct access far outweigh any theoretical
risk. HHS also points out that the rule does not diminish the role of the
provider in interpreting and explaining lab results to patients. Diagnoses and
treatment will still be based on the full picture, not just a few lab results.
is interesting to note that several studies have shown that providers fail to
notify patients of abnormal results about 7 percent of the time. Some estimates
are even higher.
Direct access to one’s own results is designed
to empower the patient, not to burden labs and not to minimize the role of