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Patient Access to Lab Test Results
AAFP Supports Proposed HHS Rule on Clinical Lab Services While Addressing Concerns
By News Staff
The proposed rule (13-page PDF; About PDFs) would amend the regulations tied to the Clinical Laboratory Improvement Amendments of 1988 to allow labs to give patients their test results on request. At the same time, the proposal would eliminate the Health Insurance Portability and Accountability Act privacy rule exception for an individual's access to lab reports. The amended privacy rule would preempt contrary state laws governing a patient's direct access to lab test results.
- HHS issued a proposed rule to amend regulations tied to the Clinical Laboratory Improvement Amendments of 1988.
- The proposed rule would give patients the right to receive their medical test reports directly from labs.
- In a letter to HHS, the Academy stated its general support for the proposal and offered suggestions to counter concerns that some patients would not understand their test results without a physician's interpretation.
To minimize these concerns, the Academy suggested to Berwick that physicians, patients and clinical laboratories collaborate to develop a standardized statement that would accompany lab results sent to patients. Such a statement should include contact information for the ordering physician and patient instructions explaining that clinical lab results are subject to physician interpretation.
Goertz offered the AAFP's expertise to help develop both the statement and a Medicare beneficiary guide that would list and summarize commonly ordered clinical lab services.
According to a table included in the proposed rule, 2010 data show that 39 states and U.S. territories have labs that would be impacted by the proposed amendments. Additional data show that the changes would affect 22,671 labs that processed more than 6 billion tests results in 2010.
Texas has the highest number of labs (3,211) that would be affected by the proposed rule, followed by North Carolina (1,424), Georgia (1,172), Ohio (1,112), Pennsylvania (1,095) and Illinois (1,077).