AAFP Supports Proposed HHS Rule on Clinical Lab Services While Addressing Concerns

The AAFP supports -- with reservations -- an HHS proposed rule that would, among other things, give patients the right to receive their medical test reports directly from labs.

In a Nov. 9 letter (2-page PDF; About PDFs) to CMS Administrator Donald Berwick, M.D., AAFP Board Chair Roland Goertz, M.D., M.B.A., of Waco, Texas, said the Academy's support for the proposed rule is based on the premise that patients' access to their personal health information increases the level of patient engagement and responsibility and is in keeping with the basic tenets of the patient-centered medical home.

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.

However, noted Goertz, some patients will not be able to comprehend their test reports, which is a concern for the AAFP. "Laboratory results are an integral part of the physician's diagnosis process, and interpreting the results is the responsibility of the ordering physicians," said Goertz. "The majority of patients are not trained to interpret their results."

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).