EEOC Proposes to Regulate Employer Wellness Plans Under GINA and ADA to Be More Consistent with HIPAA and ACA.

Last month, the EEOC proposed to amend its regulations under Title II the Genetic Information Non-discrimination Act (GINA) governing employer wellness programs that are part of group health plans (and are already subject to similar limitations under HIPAA and the ACA).  It also signaled that it might issue regulations governing the electronic security of employer records containing genetic information and wellness programs that seek the same information but are not part of a group health plan (which is already subject to HIPAA).   Unlike the current GINA regulation at 29 C.F.R. §1635.8(b)(2)(ii), the proposed regulations would permit an employer to provide financial and non-financial “inducements” (including penalties) in exchange for information gathered during a Health Risk Assessment (HRA) about the “current and past health status” of the employee’s spouse, if the spouse voluntarily consents, provides written authorization, and is covered by the health plan and if the program would have a reasonable likelihood of improving health or preventing disease.  This information would include, for instance, blood pressure, cholesterol, glucose levels, etc.  The proposed regulation does not similarly cover information about the employee’s children or the results of any genetic tests or other genetic information about the spouse. These regulations are similar to last April’s proposed regulations to govern employee wellness plans under the ADA, which also permit up financial incentives up to 30% of the cost of the health coverage.  In addition, the proposed regulations prohibit employers from conditioning the incentive on waiving the confidentiality of the genetic information (or agreeing to its sale).  

The EEOC’s current GINA regulations only permit an employer to seek genetic information (i.e., medical histories and information about an employee’s spouse, parents or children) in connection with a wellness program if, among other things, a financial incentive is not conditioned on the provision of the information.  The employer’s program may include a HRA or questionnaire seeking such information, but only if it is made clear that the financial incentive “will be made available whether or not the participant answers questions regarding genetic information.”  This existing regulation will still govern questions about the employee’s children, but a limited exemption is being created by the proposal to permit inducements for an employee’s spouse to participate in the wellness program and provide information about his or her current or past health status. 

As mentioned and like the proposed ADA regulations and existing HIPAA/ACA regulations, the program seeking this information must have a reasonable chance of improving health or preventing disease.  An employer can run afoul of this requirement when it seeks genetic information but then fails to provide follow-up information or advice, makes it overly burdensome (in time, intrusiveness or expense) for the participants to earn the reward (or avoid the penalty), or merely shifts costs from the employer to the employees based on their health. 

A HRA may include a questionnaire or medical examination, or both.  It must still comply with existing GINA regulations regarding consent, authorization, and confidentiality, etc.  

As mentioned, the financial incentive is limited to a similar 30% amount earlier discussed in the proposed ADA regulations (and apply under HIPAA and ACA for only health contingent programs).  However, while the ADA limitation was for employee-only health costs, the GINA provision can apply to the cost of family or employee +1 health plans, less the amount of incentive for the employee: 

The maximum amount of the inducement for an employee's spouse to provide information about current or past health status may not exceed 30 percent of the total cost of coverage for the plan in which the employee is enrolled less 30 percent of the total cost of self-only coverage.  For example, if an employer offers health insurance coverage at a total cost of $14,000 for employees and their dependents and $6,000 for self-only coverage, the maximum inducement the employer can offer for the employee and the employee's spouse to provide information about their current or past health status is 30 percent of $14,000, or $4,200. The maximum amount of the $4,200 inducement that could be offered for the employee's spouse to provide current or past health status information is $4,200 minus $1,800 (30 percent of the cost of self-only coverage), or $2,400.

 . . .The maximum amount of the inducement the employer may offer to the employee for participation is 30 percent of the cost of self-only coverage. For example, if an employer offers health insurance coverage at a total cost of $14,000 for employees and their dependents and $6,000 for self-only coverage, the maximum inducement that may be offered for the employee to respond to disability-related inquiries or take medical examinations is $1,800.

The EEOC explains that “the term “inducements” includes both financial and in-kind inducements, such as time-off awards, prizes, or other items of value, in the form of either rewards or penalties.”  Employers remain free to structure their incentives in a variety of ways, only some of which are subject to GINA:

However, an employer would be free to offer all or part of the $2,400 inducement in other ways as well, such as for the employee, the spouse, and/or another of the employee's dependents to undertake activities that would qualify as participatory or health-contingent programs but do not include requests for genetic information, disability-related inquiries, or medical examinations. Thus, in the example above, an employer could offer $1,800 for the employee to answer disability-related questions and/or to take medical examinations as part of a health risk assessment, could offer the same amount for the employee's spouse to answer the same questions and to take the same medical examinations, and could offer the remaining $600 for the employee, the spouse, or both to undertake an activity-based health-contingent program, such as a program that requires participants to walk a certain amount each week. Additionally, a wellness program may offer inducements in accordance with HIPAA and the Affordable Care Act without regard to the limits on apportionment set forth in this proposed rule if neither the employee nor the employee's spouse are required to provide current or past health status information, so long as the wellness program otherwise complies with the requirements of the ADA and GINA.

Title I of the ADA prohibits medical examinations and inquiries except in certain limited circumstances, such as “voluntary medical examinations, including voluntary medical histories, which are part of an employee health program available to employees at that worksite.”   42 U.S.C. § 12112(e)(4)(B).  Moreover, this information must remain subject to the same confidentiality obligations that cover other disability-related inquiries and examinations, although the EEOC proposes to extend the protections for wellness program information.   Under the EEOC’s recently proposed ADA regulations, “an employer may offer limited incentives up to a maximum of 30 percent of the total cost of employee-only coverage, whether in the form of a reward or penalty, to promote an employee’s participation in a  wellness program that includes disability-related inquiries or medical examinations as long as participation is voluntary.”  Wellness programs which do not involve medical inquiries or testing would not be subject to the proposed ADA limitations on financial incentives.  The EEOC also indicated that employees with disabilities should receive reasonable accommodations in order to receive the financial incentives or avoid the penalties. Employers may not take adverse action against employees who refuse to participate or fail to achieve certain health outcomes.   Finally, the EEOC invited comments on, among other things, whether it should raise the incentive percentage to 50% (as permitted by HIPAA) for tobacco cessation programs which include nicotine testing and other biometric measures.   

The proposed GINA regulations incorporate some of these issues:

(vii) Nothing contained in paragraphs (b)(2)(ii) through (vi) of this section limits the rights or protections of an individual under the Americans with Disabilities Act (ADA), as amended, or other applicable civil rights laws, or under the Health Insurance Portability and Accountability Act (HIPAA), as amended by GINA. For example, if an employer offers an inducement for participation in disease management programs or other programs that promote healthy lifestyles and/or require individuals to meet particular health goals, the employer must make reasonable accommodations to the extent required by the ADA; that is, the employer must make “modifications or adjustments that enable a covered entity's employee with a disability to enjoy equal benefits and privileges of employment as are enjoyed by its other similarly situated employees without disabilities” unless “such covered entity can demonstrate that the accommodation would impose an undue hardship on the operation of its business.”  . . . In addition, if the employer's wellness program provides (directly, through reimbursement, or otherwise) medical care (including genetic counseling), the program may constitute a group health plan and must comply with the special requirements for wellness programs that condition rewards on an individual satisfying a standard related to a health factor, including the requirement to provide an individual with a “reasonable alternative (or waiver of the otherwise applicable standard)” under HIPAA, when “it is unreasonably difficult due to a medical condition to satisfy” or “medically inadvisable to attempt to satisfy” the otherwise applicable standard.

The EEOC is considering even more modifications of the GINA regulations and seeks comments on the following issues: 

·        Whether employees should still receive inducements if the spouse refuses to disclose the requested information, but provides medical certification that the employee is under active medical treatment;

·        Whether the authorization requirement be limited only to wellness programs that offer more than de minimis rewards or penalties and how that would be defined;

·        Whether employers should be required to implement more specific electronic protections of medical and genetic information that is stored electronically to avoid hackers breaching the confidentiality of those records;

·        Whether employers offer (or are likely to offer in the future) wellness programs outside of a group health plan or group health insurance coverage that use inducements to encourage employees' spouses to provide information about current or past health status as part of a HRA, and the extent to which the GINA regulations should allow inducements provided as part of such programs. 

The proposed ADA regulations would require changes in gathering, using and maintaining information gathered under a wellness plan.  It would require the employer to notify employees “what medical information will be obtained, how the medical information will be used, who will receive the medical information, the restrictions on its disclosure, and the methods the covered entity uses to prevent improper disclosure of medical information.” It also would mandate that “medical information collected through an employee health program only may be  provided to a covered entity under the ADA in aggregate terms that do not disclose, or are not reasonably likely to disclose, the identity of specific individuals, except as needed to administer the health plan and except as permitted under 1630.14(d)(4).”  While HIPAA would govern when the employer is the plan administrator, the EEOC proposes its own requirements to essentially extend HIPAA’s Privacy Rule to employer non-administrators receiving information from a wellness program: “the aggregate information that the employer may receive from the wellness program under section 1630.14(d)(6) must be deidentified in accordance with the HIPAA Privacy Rule. Further, other disclosures of protected health information from the wellness program may only be made in accordance with the Privacy Rule.”

 

NOTICE: This summary is designed merely to inform and alert you of recent legal developments. It does not constitute legal advice and does not apply to any particular situation because different facts could lead to different results. Information here can be changed or amended without notice. Readers should not act upon this information without legal advice. If you have any questions about anything you have read, you should consult with or retain an employment attorney.

DOL Updates FMLA Medical Certification Forms to Include GINA Safe Harbor Warning to Physicians

Last month, the DOL published new FMLA Medical Certification forms to include safe harbor language from the Genetic Information Non-Discrimination Act (GINA) advising healthcare providers in cryptic language to not include genetic information, genetic tests or family medical histories when responding to the FMLA requests for information about the employee.  The new forms are good until May 31, 2018. This is probably a good time to remind employers who request medical information about employees (concerning FMLA and ADA requests) to include similar language in their requests for medical information in order to avoid violating GINA.

GINA prohibits employers from requesting or using genetic information from or about employees.  Genetic information has been defined to include family medical histories.  If an employer lawfully requests medical information about an employee (pursuant to, for instance, an FMLA leave request, FMLA return to work notice, and/or ADA reasonable accommodation) and then receives genetic information in response to the lawful request, the employer can still be liable for violating GINA unless it specifically directed the healthcare provider to NOT provide genetic information.  In particular, the GINA regulations create a safe harbor for employers if they provide the following disclaimer (or something similar) with a request for medical information:

The Genetic Information Nondiscrimination Act of 2008 (GINA) prohibits employers and other entities covered by GINA Title II from requesting or requiring genetic information of an individual or family member of the individual, except as specifically allowed by this law. To comply with this law, we are asking that you not provide any genetic information when responding to this request for medical information. `Genetic information' as defined by GINA, includes an individual's family medical history, the results of an individual's or family member's genetic tests, the fact that an individual or an individual's family member sought or received genetic services, and genetic information of a fetus carried by an individual or an individual's family member or an embryo lawfully held by an individual or family member receiving assistive reproductive services.”

The new FMLA medical certification form for individual employees contains the following language directed to the healthcare provider as though they are intimately familiar with the terms of the GINA regulatory definitions:

 Do not provide information about genetic tests, as defined in 29 C.F.R. § 1635.3(f), genetic services, as defined in 29 C.F.R. § 1635.3(e), or the manifestation of disease or disorder in the employee’s family members, 29 C.F.R. § 1635.3(b).

Employers are also not liable for inadvertent receipt of genetic information or for receiving information lawfully acquired under the FMLA when medical/family leave is sought to care for an ill family member, whose medical history is directly relevant to the FMLA leave request.  The GINA regulations specifically provide that it does not violate the Act to request information about family medical history:

Where the covered entity requests family medical history to comply with the certification provisions of the Family and Medical Leave Act of 1993 (29 U.S.C. 2601 et seq.) or State or local family and medical leave laws, or pursuant to a policy (even in the absence of requirements of Federal, State, or local leave laws) that permits the use of leave to care for a sick family member and that requires all employees to provide information about the health condition of the family member to substantiate the need for leave.

In light of this, the FMLA medical certification form concerning a family member’s serious health condition contains a slightly different warning to physicians about GINA:

 Do not provide information about genetic tests, as defined in 29 C.F.R. § 1635.3(f), or genetic services, as defined in 29 C.F.R. § 1635.3(e).

NOTICE: This summary is designed merely to inform and alert you of recent legal developments. It does not constitute legal advice and does not apply to any particular situation because different facts could lead to different results. Information here can be changed or amended without notice. Readers should not act upon this information without legal advice. If you have any questions about anything you have read, you should consult with or retain an employment attorney.

EEOC Revises Its “Equal Employment Opportunity Is the Law” Poster To Reflect November 21 Effective Date of Genetic Information Nondiscrimination Act

The EEOC has posted on its website the new EEO Is the Law poster which reflects the November 21 effective date of GINA. Every employer with more than 15 employees and most federal contractors are required to post a notice about the rights of applicants and employees under Title VII, the ADA, the ADEA, the GINA, the Equal Pay Act, Executive Order 11246, the Rehabilitation Act and the Vietnam Era Veterans Readjustment Assistance Act, etc. Employers may post a supplemental poster next to their existing poster of employees news rights under GINA and the ADAA or may post an all new poster which incorporates the new rights under GINA. Employers may print out these posters in English and Spanish directly from the EEOC website or may order larger (and more readable) version to be mailed.

GINA was enacted in 2008 and has broader application to employers and healthcare providers than its name implies. Title I applies to group health plans sponsored by private employers, unions, and state and local government employers, issuers in the group and individuals health insurance markets, etc.