Like it or not, the push for transparency and patients' control over their health information just got a lot more personal for most clinical laboratories. While patients historically have had the right under the privacy regulations promulgated pursuant to the Health Insurance Portability and Accountability Act of 1996 (the "HIPAA Privacy Rules")1 to access their own health records (except on certain rare occasions), there has been an exception for laboratory test results maintained by a laboratory certified pursuant to the Clinical Laboratory Improvement Amendments ("CLIA").2 When the HIPAA Privacy Rules initially were drafted, the drafters deferred to the CLIA regulations regarding to whom test results may be released. The CLIA regulations provide that test results may be released "only to authorized persons and, if applicable, the individual responsible for using the test results and the laboratory that initially requested the test."3 "Authorized persons," as defined under state laws, often include physicians and practitioners but not the patient. A new rule issued by the United States Department of Health and Human Services ("HHS") on February 6, 2014 will allow, and in most cases will effectively require, laboratories to provide patients direct access to their laboratory test results. Practically, the new rule allows patients to forego requesting the results from the ordering provider and to request the results directly from the laboratory.
The new rule has two components. First, effective on April 7, 2014, CLIA-certified labs may now directly provide the patient, the patient's personal representative, or a person designated by the patient with copies of his or her laboratory test results.4 Second, effective October 6, 2014, pursuant to a corresponding revision to the HIPAA Privacy Rule, laboratories that qualify as HIPAA "covered entities" (which are essentially any laboratories that electronically submit claims) will be required to provide laboratory test results to patients (or their authorized representatives) upon request.5 As a result, between April 7, 2014 and October 6, 2014, state law controls, meaning a CLIA-laboratory may provide access to patients (or their personal representative or someone else they have authorized) only if such access is permissible under state law.
Do not let the word "may" in the amended CLIA regulation deceive you. As of October 6, 2014 when the HIPAA regulatory changes take effect, state law will be pre-empted and all "covered entity" laboratories will be required to provide direct access to patients and their personal representatives, with very narrow exceptions.6 Generally speaking, the CLIA covered entity laboratory would be acting in violation of the HIPAA Privacy Rule if it did not provide a patient's test results to the patient or patient's personal representative upon their request.
Historically patients have been perceived as incapable of receiving and understanding test results absent the guidance of a knowledgeable medical professional to interpret the results. HHS acknowledged that the concerns related to unnecessary patient anxiety and self-diagnosis still exist; however, HHS has taken the position that the benefits derived from patient empowerment and involvement in their own care outweigh the risk of overreaction to abnormal laboratory results.7
The practical implications of the expanded right of access are starting to take hold as industry stakeholders scurry to iron out logistics. While HHS disagrees, the new rules are likely to create increased administrative costs and additional burdens on clinical laboratories. Laboratories that qualify as "covered entities" will need to implement policies to ensure compliance with the HIPAA Privacy Rule, specifically the provisions pertaining to verification and authentication.8 Laboratories likely will need to review the information gathered as part of their test ordering procedures to determine if they have sufficient information to allow them to confirm the identity of patients such that they can respond to patient requests for information and determine when applicable exceptions apply. For example, when questionable, laboratories may consider asking the ordering provider to identify whether, in his or her professional judgment, providing the test results to the patient may endanger the life or physical safety of the patient. In such an instance, if the patient does request access, the laboratory has taken some affirmative step to ensure that the HIPAA "endanger the life" exception does not apply to the request. Similarly, while in most cases the parent of a minor child is considered a personal representative of the child, there are certain situations in which the parent of a minor child is not allowed to access his or her child's health information. Laboratories will need to become familiar with the HIPAA Privacy Rule, and its nuances, and work to develop policies to protect the laboratory from inadvertently providing access to test results to unauthorized individuals.
Stakeholders should consult regulatory counsel if any questions related to the implementation of the aforementioned regulations should arise.
1 See 42 CFR § 164.500, et.seq.
2 See Id. at Part 493.
3 42 CFR § 493.1291(f).
4 The amended provision at 42 CFR § 493.1291(l) provides that, "Upon request by a patient (or the patient's personal representative), the laboratory may provide patients, their personal representatives, and those persons specified under 45 CFR 164.524(c)(3)(ii), as applicable, with access to completed test reports that, using the laboratory’s authentication process, can be identified as belonging to that patient."
5 Under the amended HIPAA Privacy Rule, CLIA laboratories that are covered entities under the HIPAA Privacy Rule have the same obligations as other types of healthcare providers to provide individuals (or their personal representatives) with access to their protected health information in accordance with 45 CFR § 164.524. See 79 Fed. Reg. 7292.
6 Id. at 7291.
7 Id. at 7292.
8 See 45 CFR § 164.524(h).