2016 NLC-RISC Staff Conference Jumping Through the Hoops of Wellness Program Legal Compliance October 17, 2016 Kiran Griffith, Attorney 132687590.pptx Perkins Coie LLP
Goals Learn the key wellness program rules Discuss ideas and strategies for compliance Build toolbox for tackling your wellness activities 2
Key Rules That Impact Wellness Programs Health Insurance Portability and Accountability Act of 1996, as amended ( HIPAA ) Americans with Disabilities Act of 1990, as amended ( ADA ) Genetic Information Nondiscrimination Act of 2008 ( GINA ) 3
Wellness Programs Improve participant s health Boost workforce morale Reduce long-term health care costs Potentially discriminate against individuals grappling with sickness, disability, addiction Key federal rules strive to minimize potential for discrimination 4
HIPAA and Wellness Programs 5
HIPAA and Wellness Programs HIPAA prohibits a group health plan ( GHP ) from discriminating based on health status Physical or mental condition, medical history, genetic information, disability EXCEPT wellness programs that satisfy HIPAA nondiscrimination rules 6
HIPAA and Wellness Programs HIPAA applies to a wellness program only if it is part of or under a GHP GHP: employee welfare benefit plan that provides medical care Part of or under: wellness incentive tied to cost of coverage under the GHP Stand-alone wellness program that provides medical services could be a GHP! 7
HIPAA and Wellness Programs HIPAA likely applies: Part of or under GHP GHP pays for or directly offers wellness program or incentive Reduced copay, deductible, cost-sharing under GHP Flex credits under cafeteria plan Employer contributions made to tax-favored accounts to pay for benefits Wellness activities involving provision of medical care HIPAA likely does not apply: NOT part of or under GHP Employer pays for or directly offers wellness program or incentive (independent of any GHP) Employer provides cash or gift card (independent of any GHP) Employer pays for gym dues (independent of any GHP) Employer holds door prize drawings at the worksite (independent of any GHP) Employer offers t-shirts, caps, or other merchandise at the worksite (independent of any GHP) 8
HIPAA Wellness Rules HIPAA recognizes three types of wellness programs that are part of or under a GHP: Participatory Health-contingent Activity-only Outcome-based 9
HIPAA Wellness Rules Participatory programs No reward or penalty for participation OR reward or penalty is not conditioned on satisfying health standard To be nondiscriminatory, a participatory program must be available to all similarly situated individuals, regardless of health status No incentive cap for participatory programs under HIPAA 10
HIPAA Wellness Rules Tobacco cessation programs (not required to quit) Health coaching programs Participatory Programs Health risk assessments (no required metrics) Biometric screenings (no required metrics) 11
HIPAA Wellness Rules Health-contingent programs Activity-only: reward or penalty conditioned on completing activity related to health factor, regardless of outcome Outcome-based: reward or penalty conditioned on achieving a certain health outcome 12
HIPAA Wellness Rules Activity-Only Weight-loss programs Exercise programs Running or walking programs Outcome-Based Tobacco surcharges (conditioned on tobacco use) Biometric screenings (conditioned on metrics, e.g. BMI) Health risk assessments (conditioned on health status, e.g., diabetes) 13
HIPAA Wellness Rules Health-contingent programs are nondiscriminatory if: Reasonably designed Available at least once per year Incentive capped at 30% of coverage (50% if tobacco-related) Reasonable alternative standard ( RAS ) (see next slide for special rules) Notice (rules provide sample notice) 14
HIPAA Wellness Rules Activity-only programs must offer RAS to anyone for whom participation is: Medically inadvisable OR Unreasonably difficult due to a medical condition OK to ask for physician verification if reasonable under circumstances 15
HIPAA Wellness Rules Outcome-based programs must offer RAS to anyone who fails to meet the initial standard to get a reward or avoid a penalty, without regard to whether this is due to a medical condition Cannot ask for physician verification 16
HIPAA Wellness Toolbox What to ask: Incentive tied to cost of health coverage? GHP pays for activity or incentive? Activity difficult to complete for those with medical condition? E.g., running program. Incentive conditioned on health metric? E.g., BMI on biometrics; tobacco surcharge. What it means: HIPAA applies determine type of program to identify applicable rules. HIPAA applies determine type of program to identify applicable rules. HIPAA s health-contingent rules for activity-only programs apply. HIPAA s health contingent rules for outcomebased programs apply. 17 Program materials describing health contingent activities? Incentives for health-contingent activities? Must include required notice. Total incentives (financial or in-kind) cannot exceed HIPAA cap. Beware of administrative complexity if also subject to ADA or GINA. Incentives offered by employer and GHP count! What else would you want in your toolbox?
ADA and Wellness Programs 18
ADA and Wellness Programs ADA prohibits discrimination based on disability in terms, conditions, and privileges of employment ADA prohibits most disability-related inquiries and medical examinations that are not jobrelated and consistent with business necessity UNLESS it is a voluntary wellness program 19
ADA and Wellness Programs Disability-related inquiry ( DRI ): question or series of questions likely to elicit information about one s disability Medical examination ( ME ): test or procedure that elicits information about one s physical or mental impairments or health 20
ADA and Wellness Programs DRIs Health risk assessments ( HRAs ) Do you have... high BP? high glucose? hypertension? NOT DRI: Do you use tobacco? MEs Blood draws Biometric screenings Medical tests for tobacco use (cotinine tests, cheek swabs, etc.) 21
ADA and Wellness Programs EEOC issued final rules in May 2016 General provisions effective immediately BUT notice and incentive cap apply as of first day of first plan year beginning on or after January 1, 2017 All rules apply to a wellness program with DRI or ME, without regard to its GHP status Key changes from rules proposed in 2015 22
ADA Wellness Rules #1 Reasonable design Similar to concept under HIPAA. Plus it is not reasonably designed if it: Does not share with participants results, followup info, or advice to improve health or prevent disease, unless employer actually uses collected info to design a program addressing issues identified by DRI or ME; or Exists mainly to shift costs from employer to certain employees based on health or to simply estimate employer s future health costs. 23
ADA Wellness Rules #2 Voluntary: Can t require participation or penalize nonparticipation Can t deny coverage or limit extent of benefits due to nonparticipation Can t take adverse employment action against, retaliate against, interfere with, coerce, intimidate, or threaten within meaning of ADA Can t condition incentive or participation on employee s waiver of confidentiality or sale, transfer, or disclosure of medical info 24
ADA Wellness Rules #3 Notice to employees Type of medical info to be obtained, specific purposes for which it will be used, restrictions on its disclosure, who will see or use it, and methods to prevent improper disclosure (including whether HIPAA privacy and security rules apply) EEOC sample notice: https://www.eeoc.gov/laws/regulations/adawellness-notice.cfm 25
ADA Wellness Rules #3 Notice to employees (continued) Separate from notice required under HIPAA Can combine notices, so long as content satisfies both HIPAA and ADA Required for wellness program with DRIs/MEs regardless of GHP status **key change from proposed rules** Must be issued to employees before they participate in a DRI or ME 26
ADA Wellness Rules #4 Confidential Only aggregated information can be shared with employer If wellness program is part of or under a GHP, HIPAA privacy and security rules apply 27
ADA Wellness Rules #5 Cap on employee incentive Applies only to employee incentive (but see GINA for cap on spouse incentive) Applies to financial and in-kind incentives Applies to wellness program with DRIs/MEs regardless of GHP status **key change from proposed rules** Incentive cannot exceed 30% of total cost of employee-only coverage (employee and employer contributions) 28
ADA Wellness Rules If participation in wellness program is Limited to employees enrolled in particular GHP offered by employer Open to employees, whether or not they are enrolled in GHP offered by employer Open to employees, whether or not they are enrolled in a particular plan option under GHP offered by employer Open to employees, but employer does not offer any health coverage Then employee incentive is capped at 30% of total cost of self-only coverage of GHP in which employee is enrolled 30% of total cost of self-only coverage under GHP, where employer offers only one GHP 30% of total cost of lowest-cost self-only coverage under GHP, where employer offers more than one GHP option 30% of cost of self-only coverage under second-lowest-cost Silver Plan for 40-yearold nonsmoker on public Health Insurance Exchange in state that employer identifies as principal place of business 29
ADA Wellness Rules #5 Cap on employee incentive (continued) EEOC Informal Discussion Letter: When employer offers choice of benefit options through more than one GHP or through multiple benefit options under single GHP, but does not require enrollment in a particular plan or option to participate in wellness program, incentive cap is based on lowest-cost selfonly coverage option offered. Ensures same incentive for all employees that does not depend on elected plan or benefit option Acknowledges this may not align with how the HIPAA incentive cap is calculated 30
ADA Wellness Rules Don t forget: Reasonable accommodation Not the same as RAS. EEOC informally stated that in most cases (not all), RAS could satisfy: Tim cannot get biometric reward due to high BP. Employer can offer health coaching as RAS and reasonable accommodation. Jane s vision impairment prevents her from completing HRA online. RAS N/A. To reasonably accommodate, employer should provide another method to complete (e.g., Braille or permitting completion with physician) 31
Comparisons: HIPAA vs. ADA HIPAA Focus: Participants HIPAA applies to a wellness program only if it is part of or under a GHP. Cap applies to all participant incentives in a health-contingent program. Cap does not apply to participatory programs. Incentive cap is 30% of total cost of enrolled coverage if family members can participate (employee-only coverage if only employee can participate). Incentive cap raised to 50% if additional incentive amount relates to tobacco. ADA Focus: Employees ADA applies to a wellness program with DRIs or MEs, regardless of GHP status. Cap applies only to employee incentives in a wellness program with DRIs or MEs, but even if it is a participatory program. Incentive cap is 30% of total cost of employee-only coverage, regardless of enrolled coverage or whether family members can participate. Incentive cap remains 30%. Per EEOC, cap likely N/A to most tobacco incentives. (Remember: Asking about tobacco use is not a DRI, but medical testing for tobacco is a ME!) 32
ADA Wellness Toolbox What to ask: Wellness program has HRA, biometrics, tobacco medical tests, or other DRI or ME? Program materials describing wellness program with DRI or ME? Incentive for completing DRI or ME under wellness program? Prepared to reasonably accommodate upon request? What it means: ADA applies, without regard to GHP status. Identify first day of 2017 plan year to comply with notice and cap. Might require design/document changes before plan year! Must include ADA notice (in addition to HIPAA notice, if applicable). Consider including in open enrollment guide or providing one-off notice to ensure it is issued before employees participate. Employee incentive (financial or in-kind) cannot exceed ADA cap. Beware of administrative complexity if also health-contingent under HIPAA. Incentives offered by employer and GHP count! RAS under HIPAA does not always suffice. What else would you want in your toolbox? 33
GINA and Wellness Programs 34
GINA and Wellness Programs GINA prohibits requesting, requiring, or buying genetic info (including family medical history) with certain exceptions, including voluntary wellness programs ADA and GINA carve out exceptions for voluntary wellness programs. These should be assessed separately! 35
GINA and Wellness Programs Wellness programs subject to GINA: HRA that asks for genetic info (including family medical history) Biometric screening with genetic test/info, including family medical history New spouse incentive rule (more later) 36
GINA and Wellness Programs GINA-compliant HRAs: Incentive for HRA w/o questions on genetic info or family medical history HRA with genetic info or family medical history questions, but no incentive Incentive for HRA with genetic info or family medical history questions, but it clearly states that incentive is awarded without regard to whether such information is disclose 37 New spouse incentive rule imposes additional requirements (more later)
GINA and Wellness Programs Voluntary wellness programs under GINA Individual gives prior, knowing, voluntary, written authorization to provide genetic info Must describe type of info to be obtained, how it will be used, and restrictions on its disclosure Only employee and licensed medical professional see individually identifiable info Individually identifiable info available only for program purposes, and not disclosed to employer except in aggregate terms 38
GINA Wellness Rules EEOC issued final rules in May 2016 General provisions effective immediately BUT notice and incentive cap apply as of first day of first plan year beginning on or after January 1, 2017 Rules apply to any wellness program that collects genetic info without regard to GHP status Key changes from rules proposed in 2015 39
GINA Wellness Rules Main objective is to permit financial/in-kind incentives for spouses to disclose health status in HRA or biometric screen Without this, one could interpret GINA to prohibit incentives as purchasing genetic info about employee Genetic info includes manifestation of disease or disorder in family members Family member includes spouses, plus biological or adopted kids regardless of age I call it new spouse incentive rule 40
GINA Wellness Rules #1 Reasonable design Similar to concept under HIPAA, plus: Not reasonably designed if it does not share with participants results, follow-up info, or advice to improve health or prevent disease, unless employer actually uses collected info to design program addressing issues identified by DRIs/MEs 41
GINA Wellness Rules #1 Reasonable design (continued) Similar to concept under HIPAA, plus: Not reasonably designed if it penalizes individual because a spouse s manifestation of disease or disorder prevents or inhibits the spouse from participating or from achieving a certain health outcome. For example: [A]n employer may not deny an employee an inducement for participation of either the employee or the spouse in an employer-sponsored wellness program because the employee s spouse has blood pressure, a cholesterol level, or a blood glucose level that the employer considers too high. 42
GINA Wellness Rules #2 Voluntary Can t condition incentive or participation on individual s waiver of confidentiality or sale, transfer, or disclosure of medical info Can t deny coverage, limit extent of benefits, or otherwise retaliate against an employee due to spouse s refusal to participate in HRA or biometric screen under new spouse incentive rule 43
GINA Wellness Rules #3 Confidentiality Only aggregated information can be shared with employer If wellness program is part of or under a GHP, HIPAA privacy and security rules apply 44
GINA Wellness Rules #4 Incentives Can t offer financial or in-kind incentive for genetic info about employee, spouse, or child (adopted or biological, regardless of age) Exception: New spouse incentive rule Can offer incentive to complete HRA or biometric screen with questions about family medical history or other genetic info if clearly stated that incentive is awarded regardless of whether such questions are answered 45
GINA Wellness Rules #5 New Spouse Incentive Rule Applies regardless GHP status **key change from proposed rules** Can offer financial or in-kind incentive for spouse to disclose current or past health status in HRA or biometric screen if the following requirements are met: 46
GINA Wellness Rules #5 New Spouse Incentive Rule (continued) Spouse gives prior authorization Spouse completes HRA or screen in connection with their receipt of health/genetic services (e.g., wellness program) Spouse s incentive is capped at 30% of total cost of employee-only coverage (i.e., spouse incentive is also subject to ADA cap) 47
GINA Wellness Rules If participation in wellness program is Limited to individuals enrolled in particular GHP offered by employer Open to all individuals, whether or not they are enrolled in GHP offered by employer Open to all individuals, whether or not they are enrolled in a particular plan option under GHP offered by employer Open to all individuals, but employer does not offer any health coverage Then the employee incentive and spouse incentive are each capped at 30% of total cost of self-only coverage of GHP in which they are enrolled 30% of total cost of self-only coverage under GHP, where employer offers only one GHP 30% of total cost of lowest-cost self-only coverage under GHP, where employer offers more than one GHP option 30% of cost of self-only coverage under second-lowest-cost Silver Plan for 40-yearold nonsmoker on public Health Insurance Exchange in state that employer identifies as principal place of business 48
GINA Wellness Rules #5 New Spouse Incentive Rule (continued) EEOC Informal Discussion Letter: When employer offers choice of benefit options through more than one GHP or through multiple benefit options under single GHP, but does not require enrollment in a particular plan or option to participate in wellness program, incentive cap is based on lowest-cost selfonly coverage option offered. Ensures same incentive for all employees and spouses that does not depend on elected plan or benefit option Acknowledges this may not align with how the HIPAA incentive cap is calculated 49
Comparisons: HIPAA vs. GINA HIPAA Focus: Participants HIPAA applies to a wellness program only if it is part of or under a GHP. Cap applies to all participant incentives in a health-contingent program. Cap does not apply to participatory programs. Incentive cap is 30% of total cost of enrolled coverage if employee s family members can participate (employee-only coverage if only employee can participate). Incentive cap raised to 50% if additional incentive relates to tobacco. GINA Focus: Employees and Spouses GINA applies to a wellness program that collects genetic info, including spouse participation in HRAs/biometrics, regardless of GHP status. Cap applies only to employee and spouse incentives for HRAs or biometrics, even if it is a participatory program. Incentive cap is 30% of total cost of employee-only coverage, even if employee enrolled in family coverage. Incentive cap remains 30%. Per EEOC, likely N/A to any tobacco incentives. 50
GINA Wellness Toolbox What to ask: What it means: 51 Individuals asked to complete HRA, biometrics, or activity that collects genetic info (genetic tests/results or family medical history)? Spouses asked to complete HRA or biometrics to disclose current or past health status? Program materials describing wellness program? Incentive for employees and/or spouses to complete HRA or biometrics? GINA applies. Cannot offer financial or in-kind incentive for disclosure of genetic info. Either provide no incentive or clearly state that incentive is awarded regardless of whether info is disclosed. Participant must give prior authorization to disclose genetic info. GINA applies, including new spouse incentive rule. Spouse must give prior authorization. Determine first day of 2017 plan year to comply with incentive cap. This could involve design/document changes before start of plan year! ADA notice required if HRA or biometrics. HIPAA notice required if health-contingent. Notices are in addition to any GINA authorization. Spouse and employee incentives (financial or in-kind) are each subject to 30% cap. Beware of administrative complexity if also health-contingent under HIPAA. Incentives offered by employer and GHP count! What else would you want in your toolbox?
Questions? Kiran H. Griffith KGriffith@perkinscoie.com +1.206.359.3272