By Rebecca McCurry
HHS issues new rule allowing patients access to their lab test reports
In an effort to give patients better access to their lab test results, HHS issued a rule as a joint effort by the CDC, Centers for Medicare and Medicaid, and Office for Civil Rights. "The right to access personal health information is a cornerstone of the Health Insurance Portability and Accountability Act (HIPPA) Privacy Rule, “said Kathleen Sebelius, secretary for the HHS. “Information like lab results can empower patients to track their health progress, make decisions with their health care professionals, and adhere to important treatment plans."
The rule is an amendment to the 1998 Clinical Laboratory Improvement Amendments and “at the same time … eliminates the exception under the Health Insurance Portability and Accountability Act of 1996 (HIPAA) Privacy Rule 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.”
Quest Diagnostics issued a press release commending the rule in which Jon Cohen, M.D., senior vice president and chief medical officer, Quest Diagnostics, said, “Patient engagement is essential to creating a healthcare system that delivers better health outcomes at lower costs. 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. That's a huge win for patients who want to take responsibility for their healthcare and engage in a richer dialogue with their providers in the interest of making informed clinical decisions."
Cohen continues, “Studies show that patients who have access to their health records tend to be more engaged in decision making than those who don't, and may even be more likely to follow treatment protocols and other behaviors that promote favorable outcomes. We're hopeful that the ruling will empower consumers to openly communicate with their physicians regarding tests, procedures and therapies, and actively participate in their healthcare."
The Quest release cites a 2009 study performed by the Annals of Internal Medicine which “found that patients were not informed of more than seven percent of abnormal blood test results," as well as a study “published in Lab Medicine in 2007, found that ‘patients want information on their lab results’ and suggests patients would be more satisfied with the healthcare system if given greater data access.”
FierceHealthIT reports the final rule, which was published in the Federal Register Feb. 6, will "eliminate an exception under HIPPA that kept patients from accessing their own protected health information when it was held by a CLIA-certified or CLIA-exempt lab. The rule stipulates, "We expect significant benefits to flow to patients as a result of increased access to their laboratory test results."
The Department of Health and Human Services believes that this new rule will cost labs more than $932,000 in 2014. By 2017, it is expected that this access will cost labs about $1 million a year, with the cost estimates based on the assumptions that came from discussions with two different laboratories who already provide test results to their patients.