AAMC Comments on Proposal to Allow Patients Direct Access to Test Results
November 18, 2011—In a Nov. 14 comment letter, the AAMC asked that the Centers for Medicare and Medicaid Services (CMS) and other Department of Health and Human Services (HHS) agencies significantly revise a proposed rule amending the Clinical Laboratory Improvement Amendments of 1988 (CLIA). The rule, published in the Sept. 14 Federal Register, proposes allowing patients to have direct access to completed test results.
While acknowledging that certain test results reasonably could be made available directly, the letter expresses concern that certain test results—such as those that show an initial diagnosis for a potentially life-threatening condition—are best delivered by a physician who can help the patient understand the prognosis, treatment options, and support services that are available.
Ivy Baer, J.D.
Sr. Director and Regulatory Counsel
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