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HIPAA and Personal Health Records (PHRs)

The American Bar Association’s Joint Committee on Employee Benefits has posted its report of its annual question and answer session with representatives from HHS’s Office for Civil Rights (OCR). 

The following are some excerpts from the Q&A session between the Department of Health and Human Services and the Joint Committee on Employee Benefits.   For those employers or Third Party Administrators (TPAs) offering participants health risk assessments (HRAs) or electronic personal health records (PHRs) you should be aware of the opinions of the OCR on whether certain scenarios would violate the HIPAA Privacy rules. 

Question 3:  If an individual executes a valid HIPAA authorization with a specified expiration date and subsequently dies before the expiration date, how does that affect the validity of the authorization?  If no expiration date is specified, does that change the result?  If the individual no longer has the ability to revoke the authorization (because they are deceased) is the scope of the authorization altered?  Has HHS made any efforts to coordinate state laws that may control this issue?

Proposed Answer 3: the Privacy Rule required that an Authorization contain either an expiration date or an expiration event that related to the individual or the purpose of the use or disclosure. 45 C.F.R. 164.508©(1)(v).  An Authorization remains valid until its expiration date or event, unless effectively revoked in writing by the individual before that date or event. In the case of a deceased participant, an executor or personal representative could revoke the authorization in writing. The death of a participant does not by itself limit the scope of an authorization. The fact that the expiration date on an Authorization may exceed a time period established by State law does not invalidate the Authorization under the Privacy Rule, but a more restrictive State law would control how long the Authorization is effective.

Answer 3:  OCR agreed with the answer, and stated that the authorization remains valid unless it expires or is revoked.  A state law could impact this outcome, but the state law would have to be evaluated along with the specific facts of the case.  Except for specific cases (investigations or enforcement actions) or in addressing requests for preemption exception determinations, OCR does not make determinations as to the application of a state law.

Question 4:  May a self-insured employer discipline an employee based on enrollment information that shows that an employee has improperly enrolled a dependent in the employer’s health plan (e.g., ineligible ex-spouses, ineligible children above a specific age who are not college students, etc.)?

Proposed Answer 4:  In 2005, this group discussed the extent to which a group health plan could audit claims data and if the plan discovered evidence that an individual had committed a claims fraud under the plan, that data could be used for purposes of terminating the individual’s coverage under the plan.  At that time, HHS/OCR  representatives opined that it would be very difficult for an employer to use any evidence of the fraud to discipline the employee without running afoul of the Privacy Rule, since the claims data is, by its nature, Protected Health Information (PHI).  (The discussion regarding audits is reports in Q&A-5, at www.abanet.org/jceb/2005/qa05hhs.pdf.)  However, that question only addressed claims data, not enrollment data.

The preamble to the 2002 modification to the Privacy Rule states that indivudally identifiable health information received or created by the group health plan for enrollment purposes is PHI under the Privacy Rule.  67 Fed.Reg. 53181, 53208 (Aug. 14, 2002).  Therefore, when enrollment information is transferred by an employer to the group health plan, it becomes PHI. 

An employer may discipline an employee who improperly enrolls a dependent in the employer’s group health plan without violating the Privacy Rule, provided that the employer takes such action without regard to any claims data or other PHI (other than PHI that is enrollment information) that it holds with respect to the employee or dependent. 

Answer 4:  the Privacy Rule regulates the conduct of covered entities, not of employers acting in their employment capacity.  An employer’s disciplining of an employee could, on the other hand, violate the amended plan documents and the plan sponsor’s certification pursuant to 45 C.F.R. 164.504(f)(2)(ii).  OCR distinguished between information obtained by an employer under the enrollment provision in 45 C.F.R. 164.504 (f)(1)(iii), and information obtained through a plan administration activity.  If the employer as a plan sponsor ahs taken responsibility for enrollment and eligibility, then information that the plan sponsor obtains from the Group Health Plan (GHP) regarding whether an individual is participating in the GHP is not subject to the plan document restriction on the sponsor’s use of that information.  In order for the plan sponsor to obtain claims information, it must amend its plan document and agree not to use or disclose it for employment-related activities (including disciplining an employee).

Question 6: There has been much discussion in the trade press regarding electronic personal health records (PHR).  Many of these discussions concern health care providers establishing and maintaining the PHR.  PHR arrangements also are provided by employer-sponsored plans through full-insured arrangements with a health insurance carrier.  Assume a plan contracts with a health insurance carrier to provide fully-insured group health benefits.  The coverage also includes a free service provided by the carrier to provide employees with electronic personal health records (PHR).  Although the carrier and a data storage company provide the service, it is part of the group health benefit provided by the group health plan.  For employees that wish to participate, claims and other health information such as lab results will be stored and sent to a data management service so that participants may start to keep a personal electronic health record.  The plan has no access to any of the information in order to administer the service.  Must the plan execute a business associate agreement with the insurance carrier in order for the carrier to access PHI for this purpose?  Is the plan required to disclose the arrangement in its Notice of Privacy Practices?

Proposed Answer 6: The group health plan is not required to have a business associate agreement with the carrier where the service is offered through a fully-insured arrangement.  See generally, 45 C.F.R. 164.506©(5).  The carrier itself is a covered entity under HIPAA, is responsible for complying with HIPAA, and is required to have a business associate agreement with the data storage company.

A general description of the arrangement should be included in the Notice of Privacy Practices.  However, the health insurance carrier, not the plan, is responsible for providing the Notice.  45 C.F.R. 164.520.

Answer 6: OCR agreed that no business associate agreement is required between the plan and the carrier.  The carrier would be responsible for providing the Notice of  Privacy Practices.  They noted that the disclosure in question generally falls into the definition of “health care operations.”  The requirements for the Notice of Privacy Practices do not require an example for every type of disclosure, so a general description of this specific arrangement is not necessarily required, although it may be a prudent thing to do.

Questions7: Recently, health plans, specifically employer-sponsored self insured group health plans, have started to provide PHRs for their employees and dependents who participate in the health plan.  These PHRs are typically accessible from a secure website using a specific user name and password.  In addition, one vendor’s particular type of PHR automatically integrates with a health plan’s third party claims administrators, so that when a participant goes to a physician and that physician files a claim with the third party claim administrator, the claims administrator will transmit a copy of the claim to the PHR vendor, and the PHR vendor will then automatically upload the claim into the participant’s PHR.  The PHR and the automatic update process are provided for all participants without their request. However, in order to access the PHR, the participant must sign on to the secure website to view the PHR.  If a participant did not want an PHR for some reason, the participant would not be required to view the PHR on the secure website, but it would still be resident in the PHR vendor’s computer system in case the participant changed his or her mind in the future.  The PHR is not removed from the computer system, because if it was, then the participant’s PHR would not automatically update.  If the participant changed his or her mind in the future and wanted the PHR, the PHR would then not contain any updates and would need to be started from scratch.  Because PHR’s are provided without the consent of the participant or spouse, does this violate the HIPAA privacy rules?

Proposed Answer 7: No.  Assuming all of the appropriate business associate contracts are in place, a PHR provided by a health plan is part of the health plan’s health care operations activities, and can be created and updated without the consent of the individual who is the subject of the PHR.

Answer 7: OCR agreed with the proposed response and state that the provision of a PHR  is part of the health care operations, and individual consent or authorization is not needed.  Going forward when discussing the development of PHRs in the context of the framework enunciated by the American Health Information Community (AHIC), there is envisioned a heightened degree of consumer control in regard to an individual’s PHR.  In addition, OCR cautioned that, as the industry moves towards connectivity and interoperability of individual’s health information, it is envisioned that such a system would incorporate some form of consumer choice as to whether and how much to participate.

Question 8:  A group health plan contacts with a health insurance carrier to provide fully-insured group health benefits for its employees and dependents.  The carrier provides, at no additional charge to the plan, a service designed to assist employers in assessing the health risks of their employee population.  Under this service, the carrier administers a health risk assessment program (HRA) where employees can voluntarily fill out an online questionnaire that asks questions concerning height, weight, physical activity, and medical claims history.  Individuals who complete the HRA receive a personalized health report from the carrier that assesses their health status and provides information on how the individual can improve or maintain their health status.  The carrier contracts with a third party to assist in administering the program.  The carrier also prepares a report for the plan sponsor that summarized the results of the HRAs completed and provides aggregate information including the medical history of those who completed the HRA.    It does not include names, social security numbers, health plan account numbers, birth dates or specific dates of treatment, but does include the ages of the individuals who completed the survey and includes information about past diagnosis or recent treatment received. Other than this aggregate summary report, the plan sponsor does not have access to any other information from the HRAs or access to the completed HRAs. 

Must the plan obtain a HIPAA business associate agreement with the carrier under the HIPAA privacy rule?  Can the plan sponsor receive the aggregate summary report from the carrier without individual authorization?  Does the analysis change if the plan is self-insured and the carrier is simply administering the self-insured benefit providing the HRA program?  What are the plans obligations to disclose the arrangement in its Notice of Privacy Practices?

Proposed Answer 8: There is no requirement for the fully-insured plan to have a business associate agreement with the carrier.  See generally, 164.506©(5).  The carrier is itself a covered entity under HIPAA, and has its own obligations to comply with HIPAA and execute a business associate agreement with its own third party contractors.  HIPAA allows the disclosure of information for health care operations without individual authorization.  Health care operations include population-based activities related to improving health or reducing healthcare costs.  As a result, the aggregate summary report may be disclosed to the plan sponsor without individual authorization, as long as plan document amendments are made pursuant to 45 C.F.R. 164.504(f).

Where the plan sponsor is self-insuring the benefit, a HIPAA business associate agreement must be executed with the carrier.  The plan sponsor may receive the aggregate summary report, if the plan documents have been amended pursuant to 45 C.F.R. 164.504(f).

The Notice of Privacy Practices should provide a general description of the arrangement.  For a fully-insured plan, the health insurance carrier is responsible for providing the Notice.  The insured group health plan is not required to provide or maintain the Notice under 45 C.F.R. 164.520(a)(2)(ii) since information it receive in the aggregate summary report is “summary health information” as defined in 45 C.F.R. 164.504(a).  The self-insured plan must provide the Notice.

Answer 8:  OCR agreed that in the insured scenario, the plan is not required to obtain a HIPAA business associate agreement with the carrier.  In the self-insured example, a business associate agreement is required.

Concerning the disclosure of the aggregate summary report, OCR stated that the HIPAA regulation allows disclosure of health information to a plan sponsor (1) if the plan documents incorporate certain requirements including restricting the plan sponsor’s uses and disclosures to those permitted by the Privacy Rule and the plan sponsor needs this information to perform plan administration functions of the group health plan; (2) if the information is limited to “summary health information” (as the term is defined in 164.504(a)) and is provided pursuant to 164.504(f)(1)(ii) for purposes of the plan sponsor shopping or modifying the plan; or (3) if the information is de-identified in accordance with 164.514(a)-(c).  Note that even if the identifiers listed at 164.514(b)(2)(i) are stripped, the information is not de-identified if the covered entity has actual knowledge that the information could be used alone or in combination with other information to identify an individual. 

OCR agreed with the proposed answer concerning the responsibility for providing the Notice of Privacy Practices.  With respect to the description in the Notice itself, OCR state that the requirements for the Notice of Privacy Practices do not require an example of every type of disclosure, so a general description of this specific arrangement is not necessarily required, although it may be a prudent thing to do. 

Question 9: Some group health plans want to require that their employees complete a health risk assessment (HRA) in order to be eligible for coverage.  The plan would use the PHI obtained in the HRA in order to assess what types of wellness programs would work best to improve health outcomes in the plan.  Would this practice violate HIPAA privacy?

Proposed Answer 9: No. HIPAA privacy regulations allows the use of the PHI by a covered entity for health care operations, which includes population-based activities related to improving health or reducing healthcare costs.  It does not prohibit the disclosure of PHI by a plan participant as a condition of eligibility for health coverage.

Answer 9: OCR agreed with the answer, adding that HIPAA’s Privacy rules do not address the determination of eligibility for a group health plan.  They have forwarded inquires on this topic to the Department of Labor’s, Employee Benefits Security Administration, who is working with EEOC to address these types of questions.

Note: The EEOC is currently against the practice of requiring an employee to take a health risk assessment in order to be eligible for coverage in the employer’s group health plan.

For the full text of the Q&A session, click on the link below:

http://www.abanet.org/jceb/2007/HHS07Final.pdf

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