HHS grants patients direct access to laboratory reports

HHS grants patients direct access to laboratory reports

The Department of Health and Human Services (HHS) announced the final rule allowing laboratories to deliver laboratory test reports directly to patients and their “personal representatives.”  The rule is scheduled to be published in the Federal Register on February 6th.

Under HIPAA, according to the new rule, laboratories that are “Covered Entities” are now required to provide individuals access to their laboratory test reports within 30 days of the request.  The 30 day timeframe provides laboratories sufficient time to ensure the treating or ordering physicians receive the report in advance of the patient and can counsel, interpret, and explain the laboratory results. The final rule does not require that laboratories interpret test results for patients.

The rule preempts laws in 13 states and lifts a federal exemption effective in 26 more states.

The effective date of the regulation will be 60 days from the publication date, April 7th, 2014.   Covered Entities must comply within 180 days from the effective date, October 6th, 2014.

Published Rule: https://www.federalregister.gov/articles/2014/02/06/2014-02280/clia-program-and-hipaa-privacy-rule-patients-access-to-test-reports

The HHS Press Release describes the change as “strengthening patients’ rights to access lab test reports:” http://www.hhs.gov/news/press/2014pres/02/20140203a.html

The final rule was issued jointly by three agencies within HHS: the Centers for Medicare & Medicaid Services (CMS), which is generally responsible for laboratory regulation under CLIA, the Centers for Disease Control and Prevention (CDC), which provides scientific and technical advice to CMS related to CLIA, and the Office for Civil Rights (OCR), which is responsible for enforcing the HIPAA Privacy Rule.

Background

Prior to this ruling, CLIA-certified laboratories in most states could only release test results to the authorized treating or ordering physicians or if explicitly directed to do so by one of these physicians.  The rule was designed to ensure that a patient had their results explained by licensed health care professional.

For example, in the past in California, a patient’s request to a laboratory for a copy of a their cancer testing results or genetic testing results would be denied, and the patient instead guided to contact their physician.

The proposed rule, originally published back in September 2011, was written to amend the Clinical Laboratory Improvement Amendments to specify that laboratories, upon a patients request, could provide completed test reports patients.  The change was also designed to more easily facilitate authorized electronic exchange of patient results between providers and electronic medical records (EMR) and personal health record (PHR) systems.

What do laboratories need to do?

  1. Revise policies, procedures, and denial processes for release of patient reports
  2. Update Notice of Privacy Practices to reflect the new regulation.
  3. Redefine their “designated record set” to explicitly include the laboratory result report
  4. Review your patient verification and authorized representative procedures
  5. Enhance record-keeping and electronic release processes for patient reports.
  6. Update training materials and train your customer services teams on the new rules.

Approximately 33,000 laboratories in the United States need to revise their policies and Notice of Privacy Practices, about 2900 of these labs are in California.

Double-Helix can help your laboratory review your existing policies, procedures, and privacy statement in advance of the regulation deadline.  Please contact us to get started.

Tags: CLIA HHS HIPAA