Summary

The Centers for Medicare & Medicaid Services (CMS) published a final rule on February 6, 2014  that will allow patients to have direct access to their laboratory test results.  Both the Clinical Laboratory Improvement Amendments (CLIA) and the Health Insurance Portability and Accountability Act (HIPAA) govern a patient’s direct access to laboratory test results.  The final rule amends CLIA regulations and the HIPAA Privacy Rule in order to provide patients with greater access to their health information and thereby empower individuals to take an active role in their healthcare.  

Changes to CLIA Regulations

CLIA establishes uniform quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results.  Under CLIA, a “laboratory” is any facility that does testing on human specimens to provide information for the diagnosis, prevention, or treatment of disease or impairment, or the assessment of health.  See42 CFR 493.2.  Formerly, laboratories subject to CLIA were allowed to disclose test results only to: (1) a person responsible for using the test results in the treatment context; (2) a referring laboratory that initially requested the test; or (3) an “authorized person,” defined as an individual authorized under state law to receive test results. State laws vary in their definitions of “authorized persons” permitted to receive laboratory test results, with some states specifically authorizing disclosure to the patient, some specifically prohibiting direct disclosure to the patient, some authorizing direct disclosure to the patient only with the requesting provider’s approval, and others remaining silent on the issue.  Where a state remains silent on the issue or defines an “authorized person” only as a health care provider, CLIA has restricted direct disclosure to the patient.  As a result, except for patients in states that expressly authorize direct disclosure of test results to the patient, most patients have only been able to access laboratory test results through their health care provider.  

Under the final rule, CLIA laboratories are now permitted to provide test results directly to the patient, the patient’s personal representative, or a person designated by the patient, so long as the laboratory can authenticate that the person requesting the results is the person who provided the specimen.  Unless the laboratory is also subject to the HIPAA Privacy Rule (discussed below), the laboratory subject to CLIA will not be required to provide patients with access to test reports.  In addition, the laboratory will remain subject to state laws affirmatively restricting direct patient access as the permissive final rule is not contrary to these state restrictions and therefore the state laws are not preempted.

CMS did not specify how to verify an individual’s identity but did cite the verification standard in the HIPAA Privacy Rule.  The Privacy Rule allows covered entities to use discretion in determining means of verification, so long as reliance on those means is reasonable.  Verification may vary depending on how the patient requests access (e.g., requiring photo identification where the patient requests test results in person or requesting authentication credentials when the patient requests test results by form or over the phone).  Likewise, the final rule does not specify a format for a patient to request or receive access to their test results, presuming that the requirements already specified in the Privacy Rule will govern.  

Changes to the Privacy Rule

The final rule also amends the HIPAA Privacy Rule.  The Privacy Rule requires covered entities to provide individuals the right to access protected health information (PHI) that is maintained in a designated record set.  A laboratory is a “covered entity” only if it conducts electronic covered transactions, such as transmitting health care claims to a health plan, requesting prior authorization from a health plan, or inquiring about an individual’s coverage to a health plan.  A “designated record set” includes laboratory test reports when the laboratory falls under the definition of a covered entity.  To achieve consistency with CLIA regulations, an individual’s right of access under the Privacy Rule did not previously apply to PHI maintained by laboratories in states with CMS-approved laboratory programs exempt from CLIA certification -- currently Washington and New York -- (CLIA-exempt laboratories) or laboratories subject to CLIA if the provision of access to the patient would be prohibited by law (i.e., all states except those that expressly permitted direct disclosure to the patient).

However, with the final rule’s changes to the CLIA regulations to remove the restriction on direct disclosure of test results to patients, it is no longer necessary for the Privacy Rule to defer to CLIA requirements.  Therefore, the final rule amends the Privacy Rule to remove the exceptions relating to CLIA and CLIA-exempt laboratories.  Now, CLIA or CLIA-exempt laboratories that are covered entities have the same obligations as other covered health care providers to provide individuals with access to their PHI, including laboratory test results.  This requirement will preempt contrary state laws that prohibit laboratories from releasing test results directly to the patient or that require the ordering provider’s consent.  As with CLIA regulations, laboratories must first satisfy the patient identity verification requirement of the Privacy Rule before providing access to test results.  Accordingly, where a laboratory receives an anonymous test order, the laboratory is under no obligation to provide access to the requesting individual. 

Conclusions

Under the final rule, laboratories are permitted release test results to individual patients or their representatives and are required to provide patients with these test results upon the patient’s request if the laboratory is a covered entity under HIPAA.  The final rule does not require laboratories to interpret test results for patients or include any statement advising the patient to seek the counsel of a physician.  However, laboratories are free to include such advisory statements or any other explanatory or educational materials.  

Implications for Clinical Research Testing.  The changes in the final rule may extend beyond routine diagnostic testing and have a limited effect on clinical research testing.  CLIA regulations specifically exempt “[r]esearch laboratories that test human specimens but do not report patient specific results for the diagnosis, prevention, or treatment of any disease or impairment of, or the assessment of the health of individual patients.”  See 42 CFR 493.3(b)(2).  Thus, the changes to CLIA regulations that preempt state law and permit individual patient access to a laboratory’s test results apply only where the laboratory reports patient-specific results to another entity and the results are available to be used for health care for individual patients.

Moreover, it is important to remember that the Privacy Rule remains applicable only to laboratories that are covered entities under HIPAA.  A laboratory is a covered entity only if it conducts electronic covered transactions, such as transmitting health care claims to a health plan, requesting prior authorization from a health plan, or inquiring about an individual’s coverage to a health plan.  Most research laboratories do not meet the definition of a “covered entity” and therefore are not subject to the Privacy Rule.  Consequently, where CLIA regulations apply to research laboratory testing but the Privacy Rule does not, the research laboratory will only be permitted, not required, to release a patient’s test results directly to the patient, subject to applicable state laws that restrict such access. 

Implications for Notice of Privacy Practices.  The Privacy Rule requires a covered entity to revise its Notice of Privacy Practices (NPP) to reflect any material changes.  Consequently, affected laboratories will need to revise NPPs to inform individuals of their new rights and how to exercise them.  Previously, the Department of Health and Human Services Office of Civil Rights (OCR) announced an enforcement delay for other NPP revisions stemming from the Omnibus Rule implementing the Health Information Technology for Economic and Clinical Health Act.  This delay was intended to allow covered entities to consolidate Omnibus Rule NPP revisions with the requirements of these impending CLIA revisions.  OCR has not announced whether the publication of the CLIA final rule will trigger the end of the NPP enforcement delay.  However, OCR has indicated that it will provide at least 30 days advance notice of the end of the enforcement delay. 

Implementation.  The final rule is published in the Federal Register as of February 6 and takes effect 60 days after publication.  Laboratories subject to HIPAA will have an additional 180 days after publication of the final rule to come into compliance and thereafter will be required to supply test reports to patients within 30 days of any request.   However, where 30 days may not be sufficient to complete the test performed or prepare the report, the Privacy Rule allows covered entities to gain an additional 30-day extension upon notifying the patient with a description of the cause for delay.

Krissa Webb also contributed to this article.