Book:The Comprehensive Guide to Physician Office Laboratory Setup and Operation/The clinical environment/Regulatory compliance: HIPAA and PPACA

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1.4 Regulatory compliance: HIPAA and PPACA

Clinical laboratories must comply with the Health Insurance Portability and Accountability Act of 1996 (HIPAA). Among HIPAAs many goals is the desire to improve privacy and security protections for an individual's personal and identifying health information. As such, laboratories are required to implement measures that prevent unauthorized disclosure of and access to a patient's protected health information (PHI) in the laboratory. In the original implementation of HIPAA, this meant that laboratory staff were discouraged from giving laboratory test results to a patient without physician permission.[1] However, in February 2014, the Department of Health and Human Services wanted to encourage patients to take a more proactive approach to their own health care by giving them a mechanism to learn more about their own health. The HHS put into place an amendment to CLIA that became effective in April 2014, allowing patients to request laboratory results directly from a laboratory. Under the change, laboratories (including POLs) were required to give patients their laboratory results within 30 days of a written request by the patient or authorized agent, while still maintaining safeguards related to patient data and other sections of HIPAA.[2] This of course applies to the POL and their associated physician offices, which remain the second-most common violator of HIPAA privacy regulations.[3]

Another federal statute that impacts laboratory testing is the Patient Protection and Affordable Care Act (PPACA), signed in 2010 by President Barack Obama. When enacted, this law cut fees paid for laboratory testing and established accountable care organizations (ACOs). Both the cuts to the Medicare Clinical Laboratory Fee Schedule and the creation of ACOs initially posed challenges to the laboratory—especially in the physician office—as economic concerns were expected to cause a laboratory to no longer have incentive to offer some forms of testing.[4] However, the PPACA brought with it a beneficial transition from an incentivized volumetric approach to clinical testing (fee for service) to a preventative approach focused on quality patient outcomes (value-based service).[5] This healthcare outcome approach matched will with the growing demand for point-of-care testing (POCT), which "promotes these goals with rapid test results that providers can use to immediately inform patients of their condition or progress, and modify their treatment on-site."[6] And while POCT—particularly CLIA-waived testing—can happen in many clinical labs, from the hospital to the urgent care clinic, it has become a significant source of testing for the POL.[7]


  1. Garrels, Marti; Oatis, Carol S. (2014). Laboratory and Diagnostic Testing in Ambulatory Care: A Guide for Healthcare Professionals (3rd ed.). Elsevier Health Sciences. pp. 368. ISBN 9780323292368. Retrieved 18 April 2022. 
  2. "CLIA Program and HIPAA Privacy Rule; Patients' Access to Test Reports" (PDF). Federal Register 79 (25): 7290–7316. 6 February 2014. Retrieved 18 April 2022. 
  3. Robeznieks, A. (3 March 2021). "Common HIPAA violations physicians should guard against". American Medical Associations. Retrieved 18 April 2022. 
  4. Hughes, D.; Cammarata, B. (16 January 2014). "Clinical labs under ACA: Challenge and opportunity". Law360. Retrieved 18 April 2022. 
  5. Laughlin, S. (22 October 2015). "The LIS, the healthcare market, and the POL". Medical Laboratory Observer. Retrieved 18 April 2022. 
  6. Rothenberg, I.Z. (9 July 2018). "Point of Care Testing (POCT): What’s New?". Physicians Office Resource. Retrieved 18 April 2022. 
  7. Rothenberg, I.Z. (1 July 2021). "The Increase in Waived Testing in the Physician Office". Physicians Office Resource. Retrieved 18 April 2022.