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By Ralph Lindeman
The Department of Health and Human Services Sept. 12 proposed a rule that would allow patients or their representatives direct access to their laboratory test results.
The proposed rule, which will be published in the Federal Register on Sept. 14, would modify regulations under two statutes that impose restrictions on patient access to lab results. The statutes are the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and the Health Insurance Portability and Accountability Act (HIPAA) of 1996.
There will be a 60-day public comment period on the proposal.
In proposing the rule, HHS said it wanted to recognize current health reform concepts, such as individuals' involvement in their own health care, by allowing patients easier access to health information.
“When it comes to health care, information is power,” HHS Secretary Kathleen Sebelius said in a statement. “When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care.”
The proposed rule was issued jointly by HHS, the Centers for Medicare & Medicaid Services, the Centers for Disease Control and Prevention, and the HHS Office for Civil Rights.
HHS said the move to relax current restrictions on patient access to laboratory results came about as a result of a review by the Health Information Technology Policy Committee. The federal advisory panel seeks to identify barriers to the adoption and use of health information technology.
The committee concluded that current CLIA and HIPAA regulations prevent patients from taking a more active role in their personal health decisions, HHS said in an introduction to the proposed rule.
Specifically, under a current CLIA regulation (42 C.F.R. § 493.1291(f)), patients in states that do not provide individual access to test results must request and receive the results through their health care provider, according to HHS.
Currently, 39 states—encompassing some 22,671 laboratories—prohibit a laboratory from releasing a test report directly to the patient or prohibit the release without the consent of the health care provider, HHS noted. HHS said it intends that the proposed rule would preempt the law in these states.
The proposed rule would also modify exceptions under HIPAA that impose restrictions on the release of certain laboratory results. A privacy rule (45 C.F.R. § 164.524) issued under HIPAA—which provides individuals with a general rights of access to health records—contains exceptions for laboratory results from CLIA-certified laboratories, HHS said.
“Because CMS is proposing to amend the CLIA regulations to allow CLIA-certified laboratories to provide patients with direct access to their test reports, there is no longer a need for the exceptions at §164.524 for CLIA and CLIA-exempt laboratories,” HHS said. “Unless these exceptions are removed from the Privacy Rule, they would serve as a barrier to individuals' right of access to test reports.”
After the notice and comment period, laboratories would be required to comply with the new rule within 180 days after the effective date of the final rule, which would be 60 days after the final rule is published in the Federal Register, HHS said.
HHS said the proposed rule, if it becomes final, would not constitute an “economically significant rule,” which Office of Management and Budget guidelines define as one imposing overall annual costs of more than $100 million. HHS estimated that the rule, if implemented in 2011, would impose compliance costs of $3 million to $56 million.
The first-year costs would include initial costs of developing an internal process to handle patient requests for laboratory results, which HHS estimated would range from $2.2 million to $10.2 million. Because the start-up costs would not be necessary in subsequent years, HHS said it expected that compliance costs would diminish over time.
In measuring benefits of the proposed rule, HHS noted it would have a positive but not quantifiable impact on patients, a majority of whom express a preference for being able to obtain test results directly from a laboratory.
Other benefits include reduced workload for health care provider offices, which would be relieved from having to request test results, and fewer patients who fail to seek appropriate medical care, HHS said.
The proposed rule is at http://op.bna.com/hl.nsf/r?Open=bbrk-8lmne8 .
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