CMS Publishes Final Rule Amending CLIA and HIPAA

Healthcare Training Resource
February 6, 2014 — 1,115 views  
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The Centres for Medicare & Medicaid Services (CMS), published its final rule to ammend the Clinical Laboratory Improvement Amendments (CLIA) of 1988 and the Health Insurance Portability and Acoountability Act (HIPAA) of 1996. The rule permits laboratories certified by the CLIA, to hand out test result reports to their respective patients, on request. The rule preempts many state laws which prohibit labs from giving out test reports to patients directly.

Laboratories Argue Their Concerns

Many commenters addressed their concerns over the final rule, stating that recipients would not be able to understand the test reports. Another poimt was that it can create confusion and stress among patients, if the reports are given out directly without the presence of an intermediate physician.The ACLA (American Clinical Laboratory Association) persistently argued that test results associated to genetic testing, were complex as well as sensitive, and that they should not be released to the pateint before the physician. The CMS turned down the idea of differentiating the rule for each testing case, and said the rule would encourage patients to actively involve themselves in regards to their healthcare and interact with providers. The CMS also pointed out that laboratories don't need to interpret the test reports for the patients who ask for a report and only need to provide test report copies. It expects that the physician provide an in-depth information on the test, and also that patients ask for results only after speaking to the physician.

The rule also aims at ensuring that patients can access their PHI (Protected Health information), as per HIPAA. Under HIPAA, regulated entities are required to give patients or their personal representatives PHI access, on request. The state laws exempted laboratories certified by the CLIA from this. But the CMS clearly pointed out that the final rule means, laboratories should address the patient's request to access all PHI, which may include billing information, test results and such.

How This Could Pan Out

The regulations mean that about 23,000 laboratories across 39 territories and states, will require to come up with new procedures to give patients test report access. Along with this, more than 33,000 laboratories will have to re-work on their notices to include the individual rights to access test results. This could cost millions to laboratories, with patient request reponse costs exceeding $52 million every year. The rule goes into effect sixty days from the time it is published. The covered entities should comply with requirements related to the HIPAA, in the final rule, within the 240 day margin, after the publication.

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