A Statement from the American Clinical Laboratory Association (ACLA) on the HHS-CMS Final Rule Allowing Patients Direct Access to Personal Laboratory Results

On behalf of ACLA — a not-for-profit association representing the nation’s leading national and regional clinical laboratories on key issues of common concern, including federal and state government reimbursement and regulatory policies – ACLA President Alan Mertz issued the following statement:

The ACLA today expressed its support for a new regulation issued by the Department of Health and Human Services (HHS), to be released in the Federal Register on Thursday, February 6 that will permit patients to request copies of their personal laboratory results. As patients have become more active participants in decisions about their own health care, obtaining their own medical information, including the results of clinical laboratory tests, will assist them in making more informed decisions.  HHS’ action will permit residents of many states to access this information for the first time. 

ACLA applauds HHS and the Centers for Medicare & Medicaid Services (CMS) for making a clear, unequivocal statement that the rule will now preempt more restrictive state laws that previously limited patient access and will alleviate any ambiguity and confusion for health care consumers.

ACLA cautions patients, however, that it is vitally important to seek advice and guidance from their physicians and health care professionals on the interpretation and meaning of particulartest results.  While laboratories will make this information available, as required, ACLA encourages patients to work closely with their physicians and health care providers to understand the meaning of what is often very complex medical information. This will be especially important for more sophisticated tests with results that could cause anxiety to patients who may have difficulty understanding the meaning of the results or its implications.

Because laboratories typically do not have direct contact with the patient, as they often obtain specimens from the physician’s office, labs will be diligent in ensuring that the individual making the request has a right to that information.  Laboratories will continue to be vigilant in protecting the confidentiality of sensitive and private health care information.

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