HHS Unveils Final Rule To Give Patients Direct Access to Lab Results
On Monday, the Obama administration released a final rule allowing patients and their designees to directly access laboratory results, instead of having to request them from physicians, the Washington Post reports (Somashekhar, Washington Post, 2/3).
Details of Final Rule
The rule, which amends the Clinical Laboratory Improvement Act, allows both patients and designees -- such as developers of personal health record systems -- to access the results.
In addition, the rule eliminates CLIA-covered labs' Health Insurance Portability and Accountability Act exemptions. Under the rule, CLIA-covered labs must provide patients with copies of their lab test results within 30 days of receiving a request.
The rule will take effect 60 days after it is published in the Federal Register, which likely will occur on Thursday. Labs will have 180 days from the rule's effective date to comply.
Costs Associated With Rule
The rule estimates that compliance will cost labs about $59 million annually for the first five years. However, the rule recommends that labs offset the costs with "a reasonable, cost-based fee" charged to patients who request copies of their results (Conn, Modern Healthcare, 2/3).
HHS expects labs to receive between 175,646 and 3.5 million requests annually. According to HHS, nearly 22,861 labs do not have systems in place to accommodate such requests, and establishing those systems will cost them a total of between $2 million and $10 million (Beck, Wall Street Journal, 2/3).
Reaction
HHS Secretary Kathleen Sebelius in a statement said the rule will give individuals broader control over their health care, possibly "empower[ing]" them "to track their health progress, make decisions with their health care professionals and adhere to important treatment plans" (Kennedy, USA Today, 2/3).
Consumer groups also said the rule will empower patients, as well as reduce inaccuracies and physician burdens.
However, the American Medical Association and the American Association of Family Physicians warned that allowing patients to directly access their lab results could lead to confusion.
AAFP President Reid Blackwelder said that "harm" can come from patients receiving abnormal results and not "know[ing] what to do with that information."
However, neither group opposed the rule (Washington Post, 2/3).
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