Amendments to Regulations Under the Americans With Disabilities Act
Proposed rule.
CFR Part: "29 CFR Part 1630"
RIN Number: "RIN 3046-AB01"
Citation: "80 FR 21659"
Page Number: "21659"
"Proposed Rules"
SUMMARY:
EFFECTIVE DATE: Comments regarding this proposal must be received by the Commission on or before
ADDRESSES: You may submit comments, identified by RIN number 3046-AB01, by any of the following methods:
* Federal eRulemaking Portal: http://www.regulations.gov. Follow the instructions for submitting comments.
* Fax: (202) 663-4114. (There is no toll free FAX number). Only comments of six or fewer pages will be accepted via FAX transmittal, in order to assure access to the equipment. Receipt of FAX transmittals will not be acknowledged, except that the sender may request confirmation of receipt by calling the Executive Secretariat staff at (202) 663-4070 (voice) or (202) 663-4074 (TTY). (These are not toll free numbers).
* Mail:
* Hand Delivery/Courier:
Instructions: The Commission invites comments from all interested parties. All comment submissions must include the agency name and docket number or the Regulatory Information Number (RIN) for this rulemaking. Comments need be submitted in only one of the above-listed formats. All comments received will be posted without change to http://www.regulations.gov, including any personal information you provide.
Docket: For access to the docket to read background documents or comments received, go to http://www.regulations.gov. Copies of the received comments also will be available for review at the Commission's library,
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
FOOTNOTE 1 The citations in this proposed rule are to the 2011 regulations. In 2011, EEOC issued amended regulations to revise the definition of disability and other provisions to conform to changes to the
FOOTNOTE 2 The
FOOTNOTE 3 This proposed rule also does not address the extent to which Title II of the Genetic Information Nondiscrimination Act (GINA) of 2008, 42 U.S.C. 2000ff, et seq., affects an employer's ability to condition incentives on a family member's participation in a wellness program. This issue will be addressed in future EEOC rulemaking. END FOOTNOTE
A wellness program may be part of a group health plan or may be offered outside of a group health plan. /4/ The references in the proposed rule regarding the requirement to provide a notice and the use of incentives, and changes to the corresponding section of the interpretive guidance, apply only to wellness programs that are part of or provided by a group health plan or by a health insurance issuer offering group health insurance in connection with a group health plan. /5/ The term "group health plan" includes both insured and self-insured group health plans and is used interchangeably with the term "health plan" throughout the preamble. All of the other proposed changes to the regulations apply to all "health programs," which include wellness programs whether or not they are offered as part of or outside of a group health plan or group health insurance coverage. The term "incentives" includes both financial and in-kind incentives, such as time-off awards, prizes, or other items of value.
FOOTNOTE 4 The term "group health plan" is defined in ERISA section 733(a). An employer may establish or maintain more than one group health plan. END FOOTNOTE
FOOTNOTE 5 This proposed rule asks for comments on 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 incentives to promote participation in such programs or to encourage employees to achieve certain health outcomes and whether EEOC should issue regulations specifically limiting incentives provided as part of such programs. END FOOTNOTE
Discussion
As a means of attempting to improve employees' health and reduce health care costs, many employers that provide health coverage also offer employee health programs and activities to promote healthier lifestyles or prevent disease. /6/ Commonly referred to as workplace wellness programs, these programs may include, for example: nutrition classes, onsite exercise facilities, weight loss and smoking cessation programs, and/or coaching to help employees meet health goals. Wellness programs also may incorporate health risk assessments and biometric screenings that measure an employee's health risk factors, such as body weight and cholesterol, blood glucose, and blood pressure levels. /7/ Some employers offer incentives to encourage employees simply to participate in a wellness program, while others offer incentives based on whether employees achieve certain health outcomes. /8/ Incentives can be framed as rewards or penalties and often take the form of prizes, cash, or a reduction or increase in health care premiums or cost sharing. Of the employers who offer incentives to complete wellness programs, the majority use incentives totaling less than
FOOTNOTE 6
FOOTNOTE 7 Id. END FOOTNOTE
FOOTNOTE 8 According to the RAND Final Report, 69 percent of employers with at least 50 employees offer financial incentives to encourage employee participation, while 10 percent offer incentives tied to health outcomes. By contrast, the
FOOTNOTE 9 According to the
Employee health programs offered by employers must comply with laws enforced by the EEOC, including Title I of the Americans with Disabilities Act (ADA) which restricts the medical information employers may obtain from applicants and employees and makes it illegal to discriminate against individuals based on disability. /10/ They also must comply with other laws EEOC enforces that prohibit discrimination based on race, color, sex (including pregnancy), national origin, religion, compensation, age, or genetic information. /11/ Additionally, wellness programs that are part of group health plans must comply with the requirements of the Health Insurance Portability and Accountability Act of 1996 (HIPAA), as amended by the Patient Protection and Affordable Care Act ("Affordable Care Act") /12/ --set forth in regulations jointly issued by the
FOOTNOTE 10 42 U.S.C. 12101 et seq . END FOOTNOTE
FOOTNOTE 11 See Title VII of the Civil Rights Act of 1964, 42 U.S.C. 2000e et seq.; the Equal Pay Act of 1963, 29 U.S.C. 206(d); the Age Discrimination in Employment Act (ADEA) of 1967, 29 U.S.C.
FOOTNOTE 12 The Patient Protection and Affordable Care Act, Public Law 111-148, and the Health Care and Education Reconciliation Act, Pub. L. 111-152, are known collectively as the Affordable Care Act. Section 1201 of the Affordable Care Act amended and moved the nondiscrimination and wellness provisions of the
FOOTNOTE 13 A wellness program that is part of a group health plan also must comply with HIPAA's Privacy, Security, and Breach Notification requirements set forth at 45 CFR part 160 and part 164. These requirements are discussed later in this preamble. END FOOTNOTE
The laws relevant to this proposed rule are discussed below.
HIPAA's Nondiscrimination Provisions
HIPAA's nondiscrimination provisions, as amended by the Affordable Care Act, generally prohibit group health plans and health insurance issuers offering group health insurance in connection with a group health plan from discriminating against participants and beneficiaries in premiums, benefits, or eligibility based on a health factor. /14/ An exception to the general rule allows premium discounts or rebates or modification to otherwise applicable cost sharing (including copayments, deductibles, or coinsurance) in return for adherence to certain programs of health promotion and disease prevention. /15/
FOOTNOTE 14 The HIPAA nondiscrimination provisions set forth eight health status-related factors, which the
FOOTNOTE 15 Prior to the enactment of the Affordable Care Act, HIPAA added section 9802 of the Internal Revenue Code, section 702 of the Employee Retirement Income Security Act (ERISA), and section 2702 of the PHS Act. DOL, Treasury, and HHS issued joint final regulations in 2006 regarding wellness programs in connection with a group health plan or group health insurance coverage under which any of the conditions for obtaining a reward is based on satisfying a standard related to a health factor. See 26 CFR 54.9802-1(f); 29 CFR 2590.702(f); 45 CFR 146.121(f). Paragraph (f)(2) of the 2006 regulations limited the total reward for such wellness programs to 20 percent of the total cost of coverage under the plan. The Affordable Care Act amended the PHS Act to raise the limitation on incentives to 30 percent of the total cost of coverage under the plan. See PHS Act section 2705(j)(3)(A). The DOL,
HIPAA's nondiscrimination provisions, as amended by the Affordable Care Act, and the 2013 final regulations issued by the Departments of Labor, Treasury, and HHS, discuss two types of wellness programs: Participatory and health-contingent. Participatory wellness programs either do not provide a reward or do not include any conditions for obtaining a reward that are based on an individual satisfying a standard related to a health factor. Examples in the final regulations include: A program that reimburses employees for all or part of the cost for membership in a fitness center; a program that reimburses employees for the costs of participating, or that otherwise provides a reward for participating, in a smoking cessation program without regard to whether the employee quits smoking; and a program that provides a reward to employees who complete a health risk assessment (HRA) regarding current health status, without any further action (educational or otherwise) required by the employee with regard to the health issues identified as part of the assessment. The 2013 final regulations state that participatory wellness programs are permissible under the HIPAA nondiscrimination requirements provided they are made available to all similarly situated individuals.
Health-contingent wellness programs, which may be either activity-only or outcome-based, require individuals to satisfy a standard related to a health factor to obtain a reward (or require an individual to undertake more than a similarly situated individual based on a health factor in order to obtain the same reward). Activity-only programs require individuals to perform or complete an activity related to a health factor in order to obtain a reward, but do not require an individual to attain or maintain a specific health outcome. Outcome-based programs require individuals to attain or maintain a specific health outcome (such as not smoking or attaining certain results on biometric screenings) in order to obtain a reward.
There are five requirements for health-contingent wellness programs under the
FOOTNOTE 16 For the requirements applicable to activity-only programs, See 26 CFR 54.9802-1(f)(3), 29 CFR 2590.702(f)(3), and 45 CFR 146.121(f)(3). For requirements applicable to outcome-based programs, See 26 CFR 54.9802-1(f)(4), 29 CFR 2590.702(f)(4), and 45 CFR 146.121(f)(4). END FOOTNOTE
The 2013 final regulations recognize that compliance with HIPAA nondiscrimination rules (as amended by the Affordable Care Act), including the wellness program requirements, is not determinative of compliance with any other provision of any other state or federal law, including, but not limited to, the
FOOTNOTE 17 See 78 FR at 33168 ("The Departments recognize that many other laws may regulate plans and issuers in their provision of benefits to participants and beneficiaries. These laws include, but are not limited to, the
Title I of the
Title I of the
FOOTNOTE 18 See 42 U.S.C. 12112(a) and 29 CFR 1630.4(a)(1)(vi). Title I of the
FOOTNOTE 19 42 U.S.C. 12112(b)(5)(A) and 29 CFR 1630.9 (prohibiting covered entity from failing to provide reasonable accommodations absent undue hardship); 29 CFR 1630.2(o)(1)(iii) (reasonable accommodation includes modifications and adjustments that enable a covered entity's employees to enjoy "equal benefits and privileges of employment.") END FOOTNOTE
FOOTNOTE 20 42 U.S.C. 12112(d)(4)(A) (a covered entity "shall not require a medical examination and shall not make inquiries of an employee as to whether such employee is an individual with a disability or as to the nature or severity of the disability, unless such examination or inquiry is shown to be job-related and consistent with business necessity."). EEOC refers to the types of inquiries prohibited by the
FOOTNOTE 21 42 U.S.C. 12112(d)(4)(B). END FOOTNOTE
FOOTNOTE 22 See Guidance, at Q&A 22. END FOOTNOTE
The Interaction of Title I of the
The Commission's interpretation of the term "voluntary" in the
FOOTNOTE 23 See 78 FR at 33168 (noting that HIPAA compliance is not determinative of
Accordingly, the Commission concludes that allowing certain incentives related to wellness programs, while limiting them to prevent economic coercion that could render provision of medical information involuntary, is the best way to effectuate the purposes of the wellness program provisions of both laws. /24/ One purpose of the
FOOTNOTE 24 The Commission does not believe that the
FOOTNOTE 25 See id. at H.R. Rep. 101-485, pt. 2, at 51. END FOOTNOTE
FOOTNOTE 26 71 FR 75014, 75018 (
The proposed rule explains what an employee health program is, what it means for an employee health program to be voluntary, what incentives employers may offer as part of a voluntary employee health program, and what requirements apply concerning notice and confidentiality of medical information obtained as part of voluntary employee health programs. In addition, the proposed rule explains that compliance with rules concerning voluntary employee health programs does not ensure compliance with all the antidiscrimination laws EEOC enforces.
The proposed rule clarifies that 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. As noted below, EEOC seeks comment on whether additional protections for low-income employees are needed. Voluntary means that a covered entity: (1) Does not require employees to participate; (2) does not deny coverage under any of its group health plans or particular benefits packages within a group health plan for non-participation or limit the extent of such coverage (except pursuant to allowed incentives); and (3) does not take any adverse employment action or retaliate against, interfere with, coerce, intimidate, or threaten employees within the meaning of Section 503 of the
Further, to ensure that participation in a wellness program that includes disability-related inquiries and/or medical examinations, and that is part of a group health plan, is truly voluntary, an employer must provide a notice that clearly explains what medical information will be obtained, who will receive the medical information, how the medical information will be used, the restrictions on its disclosure, and the methods the covered entity will employ to prevent improper disclosure of the medical information. Finally, the proposed rule allows the disclosure of medical information obtained by wellness programs to employers only in aggregate form, except as needed to administer the health plan. The proposed rule does not implicate disability-related inquiries or medical examinations outside the context of a voluntary wellness program.
Summary of Proposed Revisions
The proposed rule re-asserts the Commission's position, based on the language of the
Proposed section 1630.14(d)(1) says that an employee health program, including any disability-related inquiries and medical examinations that are part of such a program, must be reasonably designed to promote health or prevent disease. This standard is similar to the standard under the tri-agency regulations applicable to health-contingent wellness programs. /27/ In order to meet the standard, the program must have a reasonable chance of improving the health of, or preventing disease in, participating employees, and must not be overly burdensome, a subterfuge for violating the
FOOTNOTE 27 See 26 CFR 54.9802-1(f)(3)(iii); 29 CFR 2590.702(f)(3)(iii); 45 CFR 146.121(f)(iii). END FOOTNOTE
Section 1630.14(d)(2)(i)-(iii) explains that, for a program to be considered voluntary, a covered entity may not require an employee to participate in such a program and may not deny coverage under any of its group health plans or particular benefits packages within a group health plan, generally may not limit the extent of such coverage, and may not take any other adverse action against employees who refuse to participate in an employee health program or fail to achieve certain health outcomes. Additionally, an employer may not retaliate against, interfere with, coerce, intimidate, or threaten employees in violation of Section 503 of the
Section 1630.14(d)(2)(iv) says that for an employee's participation in a wellness program that is part of a group health plan to be deemed voluntary, a covered entity must provide a notice clearly explaining 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.
Section 1630.14(d)(3) clarifies that the offer of limited incentives to participate in wellness programs that are part of a group health plan and that include disability-related inquiries and/or medical examinations, will not render the program involuntary. However, the total allowable incentive available under all programs (both participatory programs and health-contingent programs) may not exceed 30 percent of the total cost of employee-only coverage, which generally is the maximum allowable incentive available under HIPAA and the Affordable Care Act for health-contingent wellness programs. /28/
FOOTNOTE 28 The interpretive guidance accompanying the proposed rule as well as question 6 below address the application of incentives related to smoking cessation programs. END FOOTNOTE
The EEOC proposes to extend the 30 percent limit set under HIPAA and the Affordable Care Act to include participatory wellness programs that ask an employee to respond to a disability-related inquiry or undergo a medical examination. HIPAA and Affordable Care Act wellness program provisions are limited to regulating what constitutes discrimination based on a health factor. As long as an incentive for a participatory wellness program is available to all similarly situated employees, regardless of any health factor, the incentive will not violate HIPAA and the Affordable Care Act. By contrast, the
The EEOC has not changed any of the exceptions to confidentiality set out in section 1630.14(d). The Commission, however, proposes to add a new subsection, 1630.14(d)(6), concerning the confidentiality and use of medical information gathered in the course of providing voluntary health services to employees, including information collected as part of an employee's participation in an employee health program. This subsection states that medical information collected through an employee health program only may be provided to a covered entity under the
Further, the interpretive guidance explains that where a wellness program is part of a group health plan, the individually identifiable health information collected from or created about participants as part of the wellness program is protected health information under the HIPAA Privacy, Security, and Breach Notification Rules. See 45 CFR part 160 and Part 164. The HIPAA Privacy, Security, and Breach Notification Rules apply to HIPAA covered entities, which include group health plans, and generally protect the individually identifiable health information maintained by or on behalf of such entities. Accordingly, the interpretative guidance provides that where a wellness program is part of a group health plan and required to comply with HIPAA, its obligation to comply with section 1630.14(d)(6) generally may be satisfied by adhering to the HIPAA Privacy Rule. Thus, when an employer that is a health plan sponsor performing plan administration receives individually identifiable health information from or on behalf of the group health plan, as permitted by HIPAA, it generally satisfies its requirement to comply with section 1630.14(d)(6) by certifying to the group health plan, as provided by 45 CFR 164.504(f)(2)(ii), that it will not use or disclose the information for purposes not permitted by its group health plan documents and the HIPAA Privacy Rule and abiding by that certification. If an employer is not performing plan administration on behalf of the group health plan, then the aggregate information that the employer may receive from the wellness program under section 1630.14(d)(6) must be de-identified 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. Thus, certain disclosures that are otherwise permitted under 1630.14(d)(4) for employee health programs generally may not be permissible under the Privacy Rule for wellness programs that are part of a group health plan without the written authorization of the individual.
Section 1630.14(d)(7) clarifies that compliance with paragraph (d) of this section, including the proposed limit on incentives under the
Employee health programs that do not include disability-related inquiries or medical examinations, such as those that provide employees with general health information and education programs are not subject to the incentive rules discussed here. Like other benefit programs offered by covered entities, however, these programs must not discriminate against employees with disabilities. This nondiscrimination requirement includes providing reasonable accommodations that enable employees with disabilities to fully participate in employee health programs and earn any reward or avoid any penalty offered as part of those programs. /29/
FOOTNOTE 29 Additionally, as discussed earlier in this preamble, the regulations under HIPAA and the Affordable Care Act require that an activity-only program allow a reasonable alternative standard (or waiver of the otherwise applicable standard) for obtaining the reward for any individual for whom, for that period, it is unreasonably difficult due to a medical condition to satisfy the otherwise applicable standard, or for whom it is medically inadvisable to attempt to satisfy the otherwise applicable standard. Similarly, an outcome-based program must allow a reasonable alternative standard (or waiver of the otherwise applicable standard) for obtaining the reward to any individual who does not meet the initial standard based on a measurement, test, or screening. END FOOTNOTE
This revision will require renumbering 29 CFR 1630.14(d).
The Commission invites written comments from members of the public on any issues related to this proposed rule, including general comments about wellness programs or about particular practices that might violate the
(1) Whether the way in which the Commission reconciles the
(a) Whether to be "voluntary" under the
(b) Whether to be considered "voluntary" under the
(c) Whether there are any methods other than those mentioned in the proposed regulation and the questions above by which the Commission can effectuate the intent of both the "voluntary" requirement in the
(2) Should the proposed notice requirements of this rule, at section 1630.14(d)(2)(iv), also include a requirement that employees participating in wellness programs that include disability-related inquiries and/or medical examinations, and that are part of a group health plan, provide prior, written, and knowing confirmation that their participation is voluntary? If so, what form should such an authorization take? Are principles of informed consent in the medical context helpful in fashioning an appropriate authorization? Are there existing forms that could provide adequate protections, such as forms developed under HIPAA, forms employers already use in connection with wellness programs, or forms employers use to comply with Title II of GINA? What costs would be associated with developing an appropriate authorization form and/or collecting and maintaining authorization forms for employees who decide to participate in wellness programs?
(3) Should the proposed notice requirement apply only to wellness programs that offer more than de minimis rewards or penalties to employees who participate (or decline to participate) in wellness programs that ask them to respond to disability-related inquiries and/or undergo medical examinations? If so, how should the Commission define "de minimis"?
(4) Which best practices ensure that wellness programs are designed to promote health and do not operate to shift costs to employees with health impairments or stigmatized conditions?
(5) 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 incentives to promote participation in such programs or to encourage employees to achieve certain health outcomes and the extent to which the
(6) What will be the practical effect of adopting the specific incentive limit set forth in the proposed rule (rather than expressly referencing and incorporating the wellness-program incentive limits as they are defined by the Secretaries of Labor, Treasury, and
Regulatory Procedures
Executive Order 12866
Pursuant to Executive Order 12866, EEOC has coordinated this proposed rule with the
Although a detailed cost-benefit analysis of the proposed regulation is not required, the Commission recognizes that providing some information on potential costs and benefits of the rule may be helpful in assisting members of the public in better understanding the potential impact of the proposed rule. The Commission notes that the rule will significantly aid compliance with the
The only other potential cost is associated with the requirement that employers provide a notice to employees informing them what medical information will be obtained, how it will be used, who will receive it, and the restrictions on disclosure. For the reasons set forth in the Paperwork Reduction Act analysis that follows, the Commission concludes that approximately 299,115 employers will need to develop such a notice. The Commission estimates the time required to develop the notice to be four hours, for a total of 1,196,460 hours. According to data from the
Other requirements in the rule will result in no costs, since they simply restate basic principles of nondiscrimination under the
To the extent the proposed rule can be read to impose additional confidentiality obligations, the interpretive guidance to the rule makes clear that a wellness program that is part of a group health plan may generally satisfy its obligation to comply with proposed section 1630.14(d)(6) by adhering to the HIPAA Privacy Rule. See 45 CFR part 160 and Part 164, Subparts A and E. An employer that is a health plan sponsor and receives individually identifiable health information from or on behalf of the group health plan, as permitted by HIPAA when the plan sponsor is administering aspects of the plan, may generally comply with the proposed rule by certifying to the group health plan, also pursuant to the HIPAA Privacy Rule, that it will not use or disclose the information for purposes not permitted by its plan documents and the Privacy Rule, such as for employment purposes, and abiding by that certification. Further, if an employer is not performing plan administration functions on behalf of the group health plan, then the employer may receive aggregate information from the wellness program under section 1630.14(d)(6) only so long as it is de-identified in accordance with the HIPAA Privacy Rule.
Paperwork Reduction Act
These proposed additions to EEOC's regulations contain an information collection requirement subject to review and approval by the
Copies of comments should also be sent to
Overview of This Information Collection
Collection Title: Notice requirement under Title I of the
OMB number: 3046-xxxx.
Description of affected public: Employers with 15 or more employees that are subject to Title I of the
Number of respondents: 299,115.
Initial one-time hour burden: 1,196,460.
Annual hour burden: None.
Number of forms: None.
Federal cost: None.
Abstract: The proposed rule says that a wellness program that includes disability-related inquiries or medical examinations and that is part of a group health plan must meet several requirements to be deemed voluntary, including providing a notice to employees informing them what medical information will be obtained, how it will be used, who will receive it, and the restrictions on disclosure.
Burden Statement: We estimate that there are approximately 782,000 employers with 15 or more employees subject to the
FOOTNOTE 30 According to the RAND Final Report, "approximately half of U.S. employers offer wellness promotion initiatives." By contrast, the
FOOTNOTE 31
Some employers and group health plans may already use forms that comply with the proposed notice requirement; therefore, the burden only will be on employers and group health plans that will incur a one-time burden to develop an appropriate notice to ensure that employees who provide medical information pursuant to a wellness program do so voluntarily. This notice may be included on or attached to any HRA employees are asked to complete and should explain what medical information will be obtained, how it will be used, who will receive it, and the restrictions on disclosure. Assuming that creation of such a document would take four hours, and assuming that 299,115 employers would be covered by the proposed regulation, this one-time burden would be 1,196,460 hours. Because employers do not have to develop a new form unless they collect medical information for a different purpose, they will be able to annually redistribute the same notice to all relevant employees.
For those wishing to comment on the above information collection, OMB is particularly interested in comments which:
(1) Evaluate whether the proposed collection of information is necessary for the proper performance of the Commission's functions, including whether the information will have practical utility;
(2) Evaluate the accuracy of the Commission's estimate of the burden of the proposed collection of information, including the validity of the methodology and assumptions used;
(3) Enhance the quality, utility, and clarity of the information to be collected; and
(4) Minimize the burden of the collection of information on those who are to respond, including the use of appropriate automated, electronic, mechanical, or other technological collection techniques or other forms of information technology, e.g., permitting electronic submission of responses.
Regulatory Flexibility Act
Title I of the
The Commission certifies under 5 U.S.C. 605(b) that this proposed rule will not have a significant economic impact on a substantial number of small entities because it imposes no reporting burdens and only minimal costs on such firms. The proposed rule clarifies that, in most respects, employers who offer wellness programs that are part of their health plans may offer incentives to employees consistent with HIPAA and the Affordable Care Act without violating the
To the extent that employers will expend resources to train human resources staff and others on the revised rule, we note that the EEOC conducts extensive outreach and technical assistance programs, many of them at no cost to employers, to assist in the training of relevant personnel on EEO-related issues. For example, in FY 2013, the agency's outreach programs reached more than 280,000 persons through participation in more than 3,800 no-cost educational, training, and outreach events. We estimate that the typical human resources professional will need to dedicate, at most, 90 minutes to gain a satisfactory understanding of the revised regulations. We further estimate that the median hourly pay rate of a human resources professional is approximately
EEOC does not believe that this cost will be significant for the impacted small entities. We urge small entities to submit comments concerning EEOC's estimates of the number of small entities affected, as well as the cost to those entities.
Unfunded Mandates Reform Act of 1995
This proposed rule will not result in the expenditure by state, local, or tribal governments, in the aggregate, or by the private sector, of
List of Subjects in 29 CFR Part 1630
Equal employment opportunity, Individuals with disabilities.
For the Commission,
Dated:
Acting Executive Officer.
For the reasons set forth in the preamble, the EEOC proposes to amend 29 CFR part 1630 to read as follows:
PART 1630--[AMENDED]
1. The authority citation for part 1630 continues to read as follows:
Authority: 42 U.S.C. 12116 and 12205a of the American with Disabilities Act, as amended.
2. Amend
a. Redesignating paragraph (d)(1) as paragraph (d)(4);
b. Redesignating paragraph (d)(2) as paragraph (d)(5);
c. Adding new paragraphs (d)(1), (d)(2), (d)(3), (d)(6), and (d)(7).
The revisions and additions read as follows:
* * * * *
(d) * * *
(1) Employee health program. An employee health program, including any disability-related inquiries or medical examinations that are part of such program, must be reasonably designed to promote health or prevent disease. A program satisfies this standard if it has a reasonable chance of improving the health of, or preventing disease in, participating employees, and it is not overly burdensome, is not a subterfuge for violating the
(2) Voluntary. An employee health program that includes disability-related inquiries or medical examinations (including disability-related inquiries or medical examinations that are part of a health risk assessment) is voluntary as long as a covered entity:
(i) Does not require employees to participate;
(ii) Does not deny coverage under any of its group health plans or particular benefits packages within a group health plan for non-participation, or limit the extent of benefits (except as allowed under paragraph (d)(3) of this section) for employees who do not participate;
(iii) Does not take any adverse employment action or retaliate against, interfere with, coerce, intimidate, or threaten employees within the meaning of Section 503 of the
(iv) Where a health program is a wellness program that is part of a group health plan, provides employees with a notice that:
(A) Is written so that the employee from whom medical information is being obtained is reasonably likely to understand it;
(B) Describes the type of medical information that will be obtained and the specific purposes for which the medical information will be used; and
(C) Describes the restrictions on the disclosure of the employee's medical information, the employer representatives or other parties with whom the information will be shared, and the methods that the covered entity will use to ensure that medical information is not improperly disclosed (including whether it complies with the measures set forth in the HIPAA regulations codified at 45 CFR parts 160 and 164).
(3) Incentives offered for employee wellness programs that are part of a group health plan. The use of incentives (financial or in-kind) in an employee wellness program, whether in the form of a reward or penalty, together with the reward for any other wellness program that is offered as part of a group health plan (as defined in 29 U.S.C. 1191b(a)), will not render the program involuntary if the maximum allowable incentive available under the program (whether the program is a participatory program or a health-contingent program, or some combination of the two, as those terms are defined in regulations at 26 CFR 54.9802-1(f)(1)(ii) and (iii), 29 CFR 2590.702(f)(1)(ii) and (iii), and 45 CFR 146.121(f)(1)(ii) and (iii), respectively) does not exceed 30 percent of the total cost of employee-only coverage.
* * * * *
(6) Except as permitted under paragraph (d)(4) and as is necessary to administer the health plan, information obtained under paragraph (d) of this section regarding the medical information or history of any individual may only be provided to an
(7) Compliance with the requirements of paragraph (d) of this section, including the limit on incentives under the
3. In the Appendix to Part 1630 revise Section 1630.14(d), to read as follows:
Appendix to Part 1630--Interpretive Guidance on Title I of the Americans With Disabilities Act
* * * * *
Section 1630.14 Medical Examinations and Inquiries Specifically Permitted
Section 1630.14(d)(1): Health Program
Part 1630 permits voluntary medical examinations and inquiries, including voluntary medical histories, as part of employee health programs. These health programs include wellness programs, which often incorporate, for example: A health risk assessment (HRA) (consisting of a medical questionnaire, with or without medical examinations, to determine risk factors); medical screening for high blood pressure, cholesterol, or glucose; classes to help employees stop smoking or lose weight; physical activities in which employees can engage (such as walking or exercising daily); coaching to help employees meet health goals; and/or the administration of prescription drugs (like insulin). Many employers offer wellness programs as part of a group health plan as a means of improving overall employee health with the goal of realizing lower health care costs.
It is not sufficient for a covered entity merely to claim that its collection of medical information is part of a wellness program; the program, including any disability-related inquiries and medical examinations that are part of such program, must be reasonably designed to promote health or prevent disease. In order to meet this standard, the program must have a reasonable chance of improving the health of, or preventing disease in, participating employees, and must not be overly burdensome, a subterfuge for violating the
Section 1630.14(d)(2): Definition of "Voluntary"
Section 1630.14(d)(2)(i)-(iii) of this part says that participation in employee health programs that include disability-related inquiries or medical examinations (such as disability-related inquiries or medical examinations that are part of a HRA) must be voluntary in order to comply with the
Section 1630.14(d)(2)(iv) of this part also states that for a wellness program that is part of a group health plan to be voluntary, an employer must provide employees with a notice clearly explaining 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.
Section 1630.14(d)(3): Limitations on Incentives
The ADA, interpreted in light of the Health Insurance Portability and Accountability Act (HIPAA), as amended by the Affordable Care Act, does not prohibit the use of incentives to encourage participation in employee health programs, but it does place limits on them. In general, the use of limited incentives (which include both financial and in-kind incentives, such as time-off awards, prizes, or other items of value) in a wellness program that is part of a group health plan or group health insurance coverage will not render a wellness program involuntary. However, the maximum allowable incentive for a participatory program that involves asking disability-related questions or conducting medical examinations (such as having employees complete a HRA) or for a health-contingent program that requires participants to satisfy a standard related to a health factor may not exceed 30 percent of the total cost of employee-only coverage. Thus, for example, for purposes of compliance with these provisions under the
Under the
For example, an employer that offers employees a financial incentive to attend a nutrition class, regardless of whether they reach a healthy weight as a result, would have to provide a sign language interpreter so that an employee who is deaf and who needs an interpreter to understand the information communicated in the class could earn the incentive, as long as providing the interpreter would not result in undue hardship to the employer. Similarly, an employer would, absent undue hardship, have to provide written materials that are part of a wellness program in an alternate format, such as in large print or on computer disk, for someone with a vision impairment. An individual with a disability also may need a reasonable accommodation to participate in a wellness program that includes disability-related inquiries or medical examinations, including waiver of a generally applicable requirement. For example, an employer that offers a reward for completing a biometric screening that includes a blood draw would have to provide an alternative test (or certification requirement) so that an employee with a disability that makes drawing blood dangerous can participate and earn the incentive.
Application of Section 1630.14(d)(3) to Smoking Cessation Programs
Regulations implementing the wellness provisions in HIPAA, as amended by the Affordable Care Act, permit covered entities to offer incentives as high as 50 percent of the total cost of employee coverage for tobacco-related wellness programs, such as smoking cessation programs. As noted above, the incentive rules in Section 1630.14(d)(3) apply only to employee health programs that include disability-related inquiries or medical examinations. A smoking cessation program that merely asks employees whether or not they use tobacco (or whether or not they ceased using tobacco upon completion of the program) is not an employee health program that includes disability-related inquiries or medical examinations. The incentive rules in Section 1630.14(d)(3) would not apply to incentives a covered entity could offer in connection with such a program. Therefore, a covered entity would be permitted to offer incentives as high as 50 percent of the cost of employee coverage for that smoking cessation program, pursuant to the regulations implementing HIPAA, as amended by the Affordable Care Act, without implicating the disability-related inquiries or medical examinations provision of the
By contrast, a biometric screening or other medical examination that tests for the presence of nicotine or tobacco is a medical examination. The
Section 1630.14(d)(4)-(6): Confidentiality
Paragraphs (d)(4) and (d)(5) say that medical records developed in the course of providing voluntary health services to employees, including wellness programs, must be maintained in a confidential manner and must not be used for any purpose in violation of this part, such as limiting insurance eligibility. See House Labor Report at 75; House Judiciary Report at 43-44. Further, although an exception to confidentiality that tracks the language of the
Section 1630.14(d)(6) says that a covered entity only may receive information collected as part of an employee health program in aggregate form that does not disclose, and is not reasonably likely to disclose, the identity of specific individuals except as is necessary to administer the plan or as permitted by section 1630.14(d)(4). Notably, both employers that sponsor employee health programs and the employee health programs themselves (if they are administered by the employer or qualify as the employer's agent) are responsible for ensuring compliance with this provision.
Where a wellness program is part of a group health plan, the individually identifiable health information collected from or created about participants as part of the wellness program is protected health information (PHI) under the HIPAA Privacy, Security, and Breach Notification Rules. (45 CFR parts 160 and 164.) The HIPAA Privacy, Security, and Breach Notification Rules apply to HIPAA covered entities, which include group health plans, and generally protect identifiable health information maintained by or on behalf of such entities, by among other provisions, setting limits and conditions on the uses and disclosures that may be made of such information.
PHI is information, including demographic data that identifies the individual or for which there is a reasonable basis to believe it can be used to identify the individual (including, for example, address, birth date, or social security number), and that relates to: An individual's past, present, or future physical or mental health or condition; the provision of health care to the individual; or the past, present, or future payment for the provision of health care to the individual. HIPAA covered entities may not disclose PHI to an individual's employer except in limited circumstances. For example, as discussed more fully below, an employer that sponsors a group health plan may receive PHI to administer the plan (without authorization of the individual), but only if the employer certifies to the plan that it will safeguard the information and not improperly use or share the information. See Standards for Privacy of Individually Identifiable Health Information ("Privacy Rule"), Pub. L. 104-191; 45 CFR part 160 and Part 164, Subparts A and E. However, there are no restrictions on the use or disclosure of health information that has been de-identified in accordance with the HIPAA Privacy Rule. Individuals may file a complaint with HHS if a health plan fails to comply with privacy requirements and HHS may impose civil money penalties for noncompliance.
A wellness program that is part of a HIPAA covered entity likely will be able to comply with its obligation under section 1630.14(d)(6) by complying with the HIPAA Privacy Rule. An employer that is a health plan sponsor and receives individually identifiable health information from or on behalf of the group health plan, as permitted by HIPAA when the plan sponsor is administering aspects of the plan, may generally satisfy its requirement to comply with section 1630.14(d)(6) by certifying to the group health plan, as provided by 45 CFR 164.504(f)(2)(ii), that it will not use or disclose the information for purposes not permitted by its plan documents and the Privacy Rule, such as for employment purposes, and abiding by that certification. Further, if an employer is not performing plan administration functions on behalf of the group health plan, it may receive aggregate information from the wellness program under section 1630.14(d)(6) only so long as the information is de-identified in accordance with the HIPAA Privacy Rule. In addition, disclosures of protected health information from the wellness program may only be made in accordance with the Privacy Rule. Thus, certain disclosures that are otherwise permitted under section 1630.14(d)(4) for employee health programs generally may not be permissible under the Privacy Rule for wellness programs that are part of a group health plan without the written authorization of the individual.
Employers and wellness program providers must take steps to protect the confidentiality of employee medical information provided as part of an employee health program. Some of the following steps may be required by law; others may be best practices. Proper training of individuals who handle medical information in the requirements of the HIPAA Rules, the
As a best practice, individuals who handle medical information that is part of an employee health program should not be responsible for making decisions related to employment, such as hiring, termination, or discipline. Use of a third-party vendor may reduce the risk that medical information will be disclosed to individuals who make employment decisions, particularly for employers whose organizational structure makes it difficult to provide adequate safeguards. If an employer uses a third-party vendor, it should be familiar with the vendor's privacy policies for ensuring the confidentiality of medical information. Employers that administer their own wellness programs need adequate firewalls in place to prevent unintended disclosure.
If individuals who handle medical information obtained through a wellness program also act as decision-makers (which may be the case for a small employer that administers its own wellness program), they may not use the information to discriminate on the basis of disability in violation of the
Breaches of confidentiality should be reported to affected employees immediately and should be thoroughly investigated. Employers should make clear that individuals responsible for disclosures of confidential medical information will be disciplined and should consider discontinuing relationships with vendors responsible for breaches of confidentiality.
Section 1630.14(d)(7): Compliance With Other Employment Nondiscrimination Laws
Finally, section 1630.14(d)(7) clarifies that compliance with the requirements of paragraph (d) of this section, including the limits on incentives applicable under the
[FR Doc. 2015-08827 Filed 4-16-15;
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