“Labs must give patients access to Test Results”, says HHS
The U.S Department of Health and Human Services (HHS) has suggested amendments to the Clinical Laboratory Improvement Amendments (CLIA) of 1988 regulations by lifting the legal barriers in health data exchange. This move ensures that patients and patient representatives can directly access lab test results when requested, without the intervention of their physician. The new rule also eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) to an individual’s right to access his or her protected health information when it is held by a CLIA-certified or CLIA-exempt laboratory. This means strong protections to patient’s privacy while sharing the lab test results.
Under the HIPAA rule, the patient or the patient representative can see and directly request the lab for the lab test results, including an electronic copy of the result. The patient may have to pay additional charges for the electronic media (when required), but the lab must send the results to the patient within 30 days of placing the request.
The final rule is officially slated to be published in the Federal Register on February 6, 2014. The final rule was issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services, which is generally responsible for laboratory regulation under CLIA; the Centers for Disease Control and Prevention, which provides scientific and technical advice to CMS related to CLIA; and the Office for Civil Rights, which is responsible for enforcing the HIPAA Privacy Rule.
"HHS's final rule means millions of Americans who previously could not access their laboratory and other health care data from clinical laboratory companies like Quest can now do so without first requiring the approval of their healthcare provider”, says Dr. Jon Cohen, senior vice president and chief medical officer of Quest Diagnostics.
Click here to read the 101-page final regulation.
So, what it means for the laboratories????
By sending the results to the patients, the patients are satisfied with the healthcare system. However, for laboratories to implement this, they will have to override the State Laws. This new rule overrules the laws in 13 states that prohibit access of lab results to patients. In addition, there are 26 states and territories that do not have any law in place for direct access of lab results. Therefore, a total of 39 states and territories will be affected by this new rule. Only 9 states presently allow the results to be directly sent to the patient and 7 states allow result access after the approval of the physician. Therefore, the laboratories will find it difficult to adapt to this new rule and to set up the protocols and policies, patient validation when they get a request from the patient. Therefore, in short, it’s Merry Time for the patients, but Challenging Time ahead for Laboratories! This challenge can be addressed through innovation by Health IT companies.