United States: EEOC Final Wellness Regulations Under The ADA And GINA Increase Compliance Burden For Wellness Programs

On May 17, 2016, the Equal Opportunity Commission (EEOC) published final rules under the Americans with Disabilities Act (ADA) and the Genetic Information Nondiscrimination Act (GINA). This guidance layers on top of, and in many instances is inconsistent with, previously issued guidance under HIPAA and the Affordable Care Act (ACA). The resulting interplay between the ADA, GINA and HIPAA/ACA can be particularly complex. Accordingly, employers need to examine their wellness programs to determine which, if any, of these rules apply and what steps may need to be taken to comply with them. In particular, the new ADA and GINA regulations may require employers to make one or more of the following adjustments to their wellness programs, depending upon the current design of the program:

• reduce the size of the reward for participating in the wellness program;

• provide employee notices regarding the details of the wellness program;

• eliminate provisions that deny employees the ability to enroll in the employer's health plan (or particular benefit options under the plan) if they refuse to participate in the wellness program;

• ensure that follow-up information or advice is provided to employees who must complete screenings or other tests that collect health information (or that the collected information is used to design a program to address identified conditions); and

• obtain authorizations from spouses who complete questionnaires or medical examinations in order to receive a wellness reward.

This Alert summarizes the new ADA and GINA rules, including the types of wellness programs that may be subject to those rules, and how they differ from existing ACA rules.

ADA Wellness Rules

The ADA prohibits employers from making disability-related inquiries or requiring medical examinations unless an exception applies. The subject of the final regulations is the voluntary employee health program exception which includes many wellness programs. In particular, the regulations clarify and expand upon prior EEOC guidance identifying the required parameters for a wellness program to fit within the voluntary employee health program exception. Those required parameters are as follows.

Reasonable design. The wellness program must have a reasonable chance of improving health or preventing disease, not be overly burdensome, not act as a subterfuge for violating the ADA, GINA or any other anti-discrimination employment law, and not be highly suspect in the method chosen to promote health or prevent disease. In that regard, the regulations provide that wellness programs:

• must, to the extent that they consist of a measurement, test, screening, or collection of health-related information, either:
  
  
  • provide results, follow-up information, or advice designed to improve the health of participating employees (such as providing feedback about specific risk factors); or
  • use the collected information to design a program that addresses at least a subset of the conditions identified (such as diabetes coaching if the wellness program reveals that a significant number of employees in the employer's workforce have diabetes); and
• cannot exist mainly to shift costs from the employer to targeted employees based on their health or to give an employer information to estimate future health care costs.

Voluntary. Employers cannot mandate participation in a wellness program or take any adverse employment action, retaliate against, interfere with, coerce, intimidate, or threaten employees in connection with the program. For example, employers cannot coerce an employee to participate in a wellness program or threaten to discipline an employee who does not participate. Additionally, employers cannot deny access to coverage under the employer's health plan (or to any particular benefit package within a plan) because of an employee's failure to participate in a wellness program.* For example, wellness programs cannot be used as a "gateway" to an enhanced benefit package within an employer's health plan.

* Such practices could be permissible under the ADA "insurance" exception - which allows employers to observe "underwriting" and "risk classification" terms of a bona fide benefit plan. In fact, two district courts have relied upon the "insurance" exception to permit employers to either deny access to health coverage or impose significant penalties with respect to that coverage for employees who refused to participate in the employer's wellness programs. However, the final regulations reiterate the EEOC's position that the insurance exception does not apply to wellness programs - since employers do not, in the EEOC's view, use wellness programs to collect or use information to set insurance premiums or determine whether employees with certain health conditions are insurable. Rather, employers use wellness programs to make employees healthier and to reduce health care costs, activities which do not constitute protected underwriting or risk classification. Which of these (EEOC or judicial) interpretations of the ADA insurance exception will prevail remains to be seen. In the meantime, employers relying upon the ADA insurance exception to maintain wellness programs that do not comport with one or more aspects of the final regulations (i.e., that do not fit within the voluntary employee health program exception) will be at risk of participant and EEOC challenges.

Maximum reward/penalty. According to the EEOC, the incentives for participation in a wellness program cannot be so substantial as to be coercive. Accordingly, a wellness program must limit the reward offered to employees in exchange for participation (or the penalty imposed for non-participation) to 30% of the total cost of employee-only coverage (including both the employee's and employer's contribution). The plan used to measure the limit will depend upon the circumstances but will generally be the lowest cost plan offered by the employer. Employers should also consider the following points with respect to the 30% calculation.

• The employee-only cost is used regardless of whether or not the employee's spouse or dependents are also enrolled in the employer's health coverage (but a separate incentive may be offered to spouses to complete a health risk assessment (HRA) as described in the GINA summary below).
• Both financial and in-kind incentives must be taken into account in the calculation, and there is no de minimis exception - so that all rewards of any value must be included. Examples of in-kind incentives include time-off awards, prizes, and any other item of value. In response to concerns about the difficulty of valuing some rewards (e.g., employee recognition, use of a parking spot, easing of a dress code, etc.), the EEOC stated that employers have flexibility and may use any reasonable method to determine the value of in-kind incentives.
• The limit does not apply to smoking cessation programs that merely ask employees whether or not they use tobacco (since that is not a disability-related inquiry or medical examination). Accordingly, the 50% limit under the ACA will generally apply to these programs (as described below). However, where an employer requires any biometric screening or other medical procedure that tests for the presence of nicotine or tobacco, the ADA's 30% limit will apply.

Employee notice. The final regulations adopt a written notice requirement pursuant to which employers must inform employees about the type of medical information that will be obtained under a wellness program, how the medical information will be used, who will receive the medical information, the restrictions on its disclosure, and the methods the employer will implement to prevent improper disclosure. A sample notice that can be used to satisfy this requirement will be posted to the EEOC website in the near future.

Confidentiality. The final regulations add confidentiality requirements with respect to medical information obtained under a wellness program. First, the information that wellness programs share with employers must generally be aggregated so as not to identity specific individuals. Second, employers cannot require employees to agree to the sale, exchange, sharing, transfer, or other disclosure of medical information as a condition for participating in a wellness program. To the extent a wellness program is subject to existing HIPAA privacy rules, these ADA requirements can be satisfied by complying with those rules.

Affected Programs. The above ADA rules only apply to wellness programs that include disability-related inquiries or medical examinations. However, unlike the HIPAA/ACA rules, the ADA rules apply regardless of whether or not a wellness program is part of an employer's group health plan. For example, wellness programs that provide cash rewards to employees who complete HRAs are not group health plans and therefore are not subject to HIPAA/ACA. However, because they include disability-related inquiries, they are subject to the ADA rules (notwithstanding that they are not part of the employer's group health plan). Additionally, the EEOC noted that although the regulations do not apply to wellness programs that do not include disability-related inquiries or medical examinations, all wellness programs are subject to the ADA's reasonable accommodation requirement to enable individuals with disabilities to have equal access to those programs. This means, for example, that a smoking cessation class might need to include a sign language interpreter for an employee who is deaf and materials in an accessible format (like Braille or large print) for an employee who is blind, and a program that requires a certain amount of walking would require an alternative to for an employee who uses a wheelchair.

Effective date.   According to the EEOC, all of the provisions of the final regulation - except for the 30% limit on rewards/penalties and the new employee notice requirement - simply clarify existing obligations under the ADA and are therefore applicable both before and after publication of the regulation. The 30% incentive limit and new employee notice requirement apply as of the first day of the plan year that begins on or after January 1, 2017 (for the health plan used to determine the level of the wellness incentive).

GINA Wellness Rules

GINA generally prohibits employers from offering inducements of any kind (financial or in-kind) for an individual to provide genetic information (which includes family medical history). However, under a so-called voluntary wellness program exception, inducements can be offered to complete a HRA - as long as the inducement is available whether or not the participant responds to questions regarding genetic information (and the employer clearly identifies which questions in the HRA can be skipped with no impact on the receipt of the inducement). Prior to the final GINA regulations, it was not clear how this voluntary wellness program exception applied to spousal HRAs – since spouses are family members of employees and therefore any information spouses provide about their own health status constitutes genetic information (family medical history) with respect to the employee. In response to this uncertainty, the GINA regulations affirm that employers may offer limited inducements for an employee's spouse to complete a HRA, provided that the following conditions are satisfied.

Scope of GINA regulation. The GINA regulations permit limited inducements for an employee's spouse to complete a HRA that requests information about the spouse's health status (notwithstanding that such information constitutes genetic information (family medical history) with respect to the employee). They do not, however, permit inducements for (i) an employee's spouse to provide his or her own genetic information (including the spouse's own family medical history) or (ii) information about the health of an employee's children (even if the child is an adult). Rather, this information remains subject to the voluntary wellness program exception noted above – pursuant to which employers may request the information but may not condition any available inducements on its provision.

Reasonable design. In order to offer an inducement for an employee's spouse to complete a HRA (which may include a questionnaire or medical examination, such as a blood pressure test or blood test to detect high cholesterol or high glucose levels), the HRA program must satisfy the same reasonable design requirements described above with respect to ADA wellness programs and in addition may not penalize an employee because of a spouse's health condition. For example, an employer may not deny an employee a wellness program inducement because the employee's spouse has blood pressure, a cholesterol level, or a blood glucose level that the employer considers too high.

Voluntary. Similar to the ADA rule with respect to ADA wellness programs, the GINA rules prohibit employers from denying access to coverage under the employer's health plan (or to any particular benefit package within a plan) or from retaliating against an employee because of a spouse's refusal to complete a HRA.

Maximum reward/penalty. Under the GINA regulations, the maximum reward that can be offered to an employee whose spouse completes a HRA as part of an employer's wellness program is 30% of the total cost of employee-only coverage (including both the employee's and employer's contribution). As with the ADA limit, the plan used to measure the 30% GINA limit will generally be the lowest cost plan offered by the employer. Notably, the reward available for a spouse's completion of a HRA is in addition to any reward that can be provided to employees for participation in an ADA wellness program. Accordingly, employees may receive up to 60% of the cost of employee-only coverage when both the employee and the spouse complete HRAs as part of an employer's wellness program. However, if a wellness program is also subject to the ACA, a lower limit could potentially apply.

Authorization. Employers must obtain a prior, knowing, voluntary, and written authorization for a spouse to complete a HRA. This is the same authorization requirement that currently applies when employees are asked to provide family medical history (or other genetic information) in connection with a voluntary wellness program.

Confidentiality. The GINA regulations extend the same confidentiality protections noted above with respect to ADA wellness programs to the information provided by a spouse in response to a HRA that is part of an employer-sponsored wellness program.

Affected Programs. The final GINA regulations apply only where a portion of the inducement offered within a wellness program is for an employee's spouse to answer questions about his or her current or past health status or to take a medical examination. Like the ADA rules, the GINA rules apply without regard to whether or not the wellness program is a group health plan subject to HIPAA/ACA.

Effective date. The 30% limit on the inducement that can be offered for a spouse to complete a HRA will apply to plan years that begin on or after January 1, 2017 (for the health plan used to determine the level of the wellness incentive). The remaining provisions of the GINA regulations simply clarify existing GINA obligations and are therefore applicable both before and after publication of the regulation.

How the ADA and GINA Rules Compare to Existing HIPAA/ACA Wellness Rules

HIPAA and the ACA generally prohibit group health plans from discriminating against participants and beneficiaries based upon health factors. For example, if an employer's group health plan charged higher premiums to participants with certain medical conditions, that would violate applicable HIPAA/ACA discrimination rules. However, wellness programs designed to promote health and/or prevent disease are excepted from the otherwise applicable HIPAA/ACA discrimination rules and may, subject to certain criteria, vary cost-sharing mechanisms (such as deductibles, copayments, or coinsurance), premiums or contributions based upon a health factor. For example, a program that satisfies the HIPAA/ACA wellness criteria could vary employee health premiums based upon the results of biometric screenings. The HIPAA/ACA wellness criteria depend upon whether the wellness program is "participatory" or "health-contingent."

Participatory programs simply reward participation in a wellness program and may include health education seminars, HRAs (that require no further action by the employee), payments towards fitness center membership, etc. Under the ACA rules, participatory programs simply need to be made available to all similarly situated individuals.

Health-contingent programs, on the other hand, require a participant to satisfy a standard related to a health factor in order to obtain a reward. Health-contingent programs consist of (i) activity-based programs that reward participants for completing an activity related to a health factor but do not require any specific health outcome (e.g., walking, diet, or exercise) and (ii) outcome-based programs that reward participants for designated health outcomes (e.g., quitting smoking, attaining a certain blood pressure or glucose level). Like participatory wellness programs, health contingent wellness programs must be made available to all similarly situated participants, but in addition, must also (i) give eligible individuals an opportunity to qualify for the reward at least once per year (ii) have a reasonable design, (iii) limit the size of the reward to 30% (50% for programs designed to prevent or reduce tobacco use) of the total cost of self-only coverage in which the employee is enrolled (or, if spouse/dependents can participate in the program 30%/50% of the total cost of coverage in which the employee/dependents are enrolled) (iv) provide reasonable alternative standards and (v) provide a notice of the alternatives.

Some of the differences between these rules and the ADA and GINA rules are highlighted below.

• New limit for ACA participatory (and non-ACA) programs that include disability-related inquiries. Under the ACA, the 30% limit on wellness rewards applies only to health contingent wellness programs that are included in group health plans. The 30% ADA limit, however, applies to all wellness programs that include disability-related inquiries or medical exams (including ACA participatory programs and non-ACA programs, neither of which is currently subject to any limits). This means that effective as of the first plan year beginning on or after January 1, 2017, the rewards for ACA participatory and non-ACA programs may need to be adjusted (in order to comport with the 30% ADA limit). Examples of these programs include biometric screenings and HRAs that do not require attainment of a health-related standard.

• ACA health contingent (non-tobacco) programs that include disability-related inquiries generally must use lowest cost employee only coverage (even if employee is enrolled in another option). Under the ACA, the reward for health contingent wellness programs is currently limited to 30% of the cost of employee-only coverage in which the employee is enrolled (or, for programs that include spouses and dependents, 30% of the cost of coverage in which the employee/dependents are enrolled). Effective as of the first plan year beginning on or after January 1, 2017, if the program consists of disability-related inquiries or medical exams, the limit under the ADA cannot exceed 30% of the lowest cost employee-only coverage. Examples of such programs include biometric screenings and HRAs that require participants to attain designated goals.

• Reduced limit for ACA health contingent tobacco programs that include disability-related inquiries. The reward for ACA health contingent wellness programs that are designed to prevent or reduce tobacco use is currently 50% of the cost of employee-only coverage in which the employee is enrolled. Effective as of the first plan year beginning on or after January 1, 2017, if the health contingent tobacco use program includes disability-related inquiries or involves medical examinations (for example, includes medical procedure that tests for the presence of nicotine or tobacco), the 50% incentive must be reduced to 30% the lowest cost employee-only coverage.
• Reasonable accommodations. Under the ADA, regardless of whether a wellness program includes disability-related inquiries or medical examinations, reasonable accommodations must be provided, absent undue hardship, to enable employees with disabilities to earn whatever financial incentive an employer or other covered entity offers. Providing a reasonable alternative standard and notice to the employee of the availability of a reasonable alternative under HIPAA/ACA as part of a health-contingent program would generally fulfill an employer's obligation to provide a reasonable accommodation under the ADA. However, under the ADA, an employer would have to provide a reasonable accommodation for a participatory program even though HIPAA and the ACA do not require such programs to offer a reasonable alternative standard, and reasonable alternative standards are not required at all if the program is not part of a group health plan.

• Reasonable design. ACA participatory wellness programs are not subject to a reasonable design standard. Additionally, the reasonable design standard that applies under the ADA and GINA is more stringent than the ACA reasonable design standard that applies to health contingent wellness programs.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.