The Department of Health and Human Services announced a proposal last month that will override state laws and give patients test results straight from the lab -- by mail or electronically. The HHS claims it is meant to empower patients and facilitate their participation in making health care decision. But they also admit a further purpose in hoping to enable wider deployment of
personal health records systems, mainly electronic health records (EHR), which for many physicians is cost prohibitive ($50,000+) and confusing and inefficient for others.
U.S. health regulators continue to promote innovation in health information technology, and especially health information access and exchange, in a broader effort by President Barack Obama's administration to update the U.S. medical records system. In May, HHS proposed another rule allowing patients to see a list of everyone who has accessed their electronic medical records.
Currently, thirteen states forbid labs to send results directly to the
patient. Seven allow it only after they are sent to the doctor. Twenty-three states do not have any laws about this one way or the other, including Mississippi. And seven allow labs to send results directly to patients.
HHS Secretary Kathleen Sebelius says it will encourage patients in being more likely to ask the right questions, make better decisions, and receive better care. The Department says this regulation will affect 22,000 labs and impose $56 million dollars in lab compliance costs. These costs no doubt will be passed on to patients.
HHS is hoping as well that this regulation may possibly reduce overall healthcare costs when patients are able to directly access laboratory results without the need for a follow-up visit to the healthcare provider who ordered the test. But this bureaucratic notion fails to take into account liability issues.
Physicians surveyed express concern that it will worsen the problem of poor communication over test results, as well as defuse the responsibility over getting the results. Is it the physician’s or the patient’s responsibility? Other concerns are that it will create patient anxiety in receiving results out of context. Patient who may misinterpret results out of context may also fail to act properly in follow-up -- or perhaps misunderstand a result (“Oh my gosh, my cancer has returned!”). There are also concerns that it may degrade the patient-physician relationship.
Physicians employed by laboratories who perform the tests assert, along with others, that it will empower the patient to participate in the health decision-making process.
The underlying reason the proposal is being made is to address a system problem (the slow deployment of electronic medical records by physicians around the country) without regard to and perhaps at the expense of welfare of the patient-doctor relationship.
Labs will be able to charge the patient a reasonable fee reflecting the actual cost of supplies and postage, as well as the cost of providing a summary or explanation if the patient so requests. It is unclear how laboratories will ensure that the person requesting lab results is actually the patient or a designated representative but it will be the responsibility of the lab to confirm the identity of the person requesting the lab results.
The regulation will go into effect sometime next year. The 60 day comment period will end on November 14th, then labs have 240 days after publication in the Federal Register by which they must be compliant. Quest Labs has already established a digital portal in the seven states currently permitting direct to patient lab results.
As you may be aware, our office has always offered copies of lab and x-ray results which help to either facilitate understanding of the medical problem or ensure reception of important health information by the consultant in the case of a referral.
For most patients this regulation will probably not cause much of a problem. But simply be aware that when you begin receiving lab results directly from the labs know that a disposition or action should be taken within the context of your particular medical problem or situation, and not based on a more general or broader application you might hear or read about on the Internet.
At the end of the day, communication is key to avoiding misunderstanding.
I would be interested in learning if you’ve ever encountered problems obtaining lab results for either you or a family member.