Draft language of new rule would change existing requirements on access to medical laboratory test results as defined in CLIA and HIPAA laws

Big changes lie ahead in how clinical laboratories and pathology groups must give patients access to their medical laboratory test results. Last week, federal agencies published a draft rule that specifies how patients or their authorized representatives are to be given direct access to their medical laboratory test results.

This draft rule was made public on September 12 by the Department of Health and Human Services (HHS), along with the Centers for Medicare and Medicaid Services (CMS), the Centers for Disease Control and Prevention (CDC), and the HHS Office for Civil Rights. Two days later, on September 14, the proposed rule was published in the Federal Register. There will be a 60-day period from the date of this publication for public comment on the proposed rule.

The proposed new rule represents major changes in federal laws governing how clinical laboratories and pathology groups must handle a patient’s laboratory test results. HSS and CMS want to use the proposed rule to supersede existing language in the Clinical Laboratory Improvement Amendments (CLIA) of 1988, as well as the Health Insurance Portability and Accountability Act (HIPAA) of 1996.

Health and Human Service Secretary Health and Human Service Secretary Kathleen Sebelius spoke at last week’s HHS Consumer Health IT Summit. It was at this conference that the Department of Health and Human Services released the draft language of a new rule that would require clinical laboratories to give patients direct access to their medical laboratory results.

Health and Human Service Secretary Health and Human Service Secretary Kathleen Sebelius spoke at last week’s HHS Consumer Health IT Summit. It was at this conference that the Department of Health and Human Services released the draft language of a new rule that would require clinical laboratories to give patients direct access to their medical laboratory results.

In the press release announcing the proposed new rule, CMS wrote “HHS Secretary Kathleen Sebelius today proposed new rules that would expand the rights of patients to access their health information through the use of health information technology (IT). Specifically, the new rules would empower patients and allow them to gain access to test results reports directly from labs. They would ensure that labs covered by the Health Insurance Portability and Accountability Act of 1996 (HIPAA) provide such information, upon request, directly to patients or their personal representatives.”

The proposed new rule is an effort by HHS to support current health reform concepts, such as personalized medicine and patient-directed health care. The goal is to make it easier for patients to access their health information, including laboratory test results.

“When it comes to healthcare, information is power,” said HHS Secretary Kathleen Sebelius, in the HSS press release. “When patients have their lab results, they are more likely to ask the right questions, make better decisions and receive better care.”

Proposed Rule Would Preempt State Laws Governing Lab Test Results

Under the 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 laboratory test results through their health care provider. At least 39 states (involving approximately 22,671 laboratories) prohibit a laboratory from releasing test results directly to the patient, or prohibit the release without the consent of the health care provider, according to a story posted by the Bureau of National Affairs (BNA). The proposed rule would preempt the law in these states.

The proposed rule would also preempt a provision of HIPAA (45 C.F.R.164.524) which restricts the release of certain laboratory results in the case of CLIA-certified laboratories, the article stated.

Proposed Changes Would Remove Impediments To HIT and HIE

In reviewing the targeted statutes, the Health Information Technology Policy Committee, a federal advisory panel, concluded that current CLIA and HIPAA regulations prevent patients from taking a more active role in their personal health decisions. The proposed rule consists of 45 pages. In the summary, HSS explained how CLIA limits a laboratory’s disclosure of laboratory test results to three categories of individuals:

  • the “authorized person,”
  • the person responsible for using the test results in the treatment context, and,
  • in the case of reference laboratories, the referring lab.

The summary further stated that “under the current CLIA rule, an authorized person is defined as ‘the individual authorized under state law to order or receive test results, or both.’” It then noted that, some states have laws that prevent patients from having direct access to the clinical laboratory test results and require them to “receive his or her results through the ordering provider.”

In its coverage of the new rule, Modern Healthcare wrote that “the rulemakers state that the federally chartered Health IT Policy Committee concluded that ‘CLIA regulations are perceived by some stakeholders as imposing barriers to the exchange of health information.’ The complaining stakeholders, they write, include ‘large and medium-sized laboratories, some public health laboratories, electronic health-record system vendors, health policy experts, health information exchange organizations (HIOs) and healthcare providers who believe that the individual’s access to his or her own records is impeded, preventing patients from a more active role in their personal healthcare decisions.’”

Research suggests that 70-80% of data in a patient’s permanent medical record consists of clinical laboratory records and results. Much clinical decision making is based upon—or assisted by—laboratory test results. Many health information exchange (HIE) initiatives recognize that effective sharing of clinical lab test results as a priority, but the legal and policy framework that permits the exchange of lab results is unclear, according to a 2010 report by the California Health Foundation.

The findings in the CHF report suggest that the current proposed rule is an effort to bring the most important federal health statutes into alignment with existing state and federal initiatives to leverage health information technologies and HIEs in ways that cut healthcare costs and improve coordination of patient care. Many of these statutes were enacted years before the development of effective EMR systems.

These laws sought to address concerns, such as confidentiality issues, patients’ failure to understand complex test results, and potential harm to patients, with possible liability issues for physicians and laboratories.

Pathologists and clinical laboratory managers interested in this proposed new federal rule can submit their views to federal officials during the 60-day comment period. At such time that HSS implements the final rule, it will mark another milestone in the trend to empower consumers to take more control over their healthcare.

 

—Pamela Scherer McLeod

Related Information:

HHS Proposes Rule to Allow Patients Direct Access to Laboratory Test Results

Proposal gives patients access to own lab results

Electronic Release of Clinical Laboratory Results: A Review of State and Federal Policy, Report by California Health Foundation.

Secretary Sebelius spotlights new efforts to empower patients to increase secure access to their health information

CMS proposes expanded lab-report access

THE DARK REPORT Coverage: More Reimbursement Threats for Lab Testing