Title: Wellness Promotion/Prevention: Overcoming Legal And Compliance Hurdles
1Wellness Promotion/Prevention Overcoming Legal
And Compliance Hurdles
- John R. Hickman, Esq.
- Alston Bird, LLP
- John.Hickman_at_alston.com
2Reasons to Consider Wellness Programs
- Rising Healthcare Costs
- Premiums for employer-based health insurance rose
by 9.2 percent in 2005 -- The fifth consecutive
year of increases over 9 percent. - Since 2000, employment-based health insurance
premiums have increased 73 percent (inflation
only 14 wage growth only 15). - The average employee contribution to
company-provided health insurance plan has
increased more than 143 percent since 2000. - The annual premiums for family coverage have now
eclipsed the gross earnings for a full-time,
minimum-wage worker (10,712).
3Reasons to Consider Wellness Programs
- Poor Employee Health
- Obesity In 2005, 60.5 of adults in the United
States were overweight, 23.9 were obese, and
3.0 were extremely obese. - Smoking 24 of adult males smoke 19 of
females smoke. Each year in the United States,
approximately 440,000 persons die of a cigarette
smoking-attributable illness, resulting in 5.6
million years of potential life lost, 75 billion
in direct medical costs, and 82 billion in lost
productivity.
42008 PWC Study
- 500 billion annually spent (25 of total medical
expenditures) due to behavioral habits - Obesity 200B
- Smoking 191B
- Alcohol gt2B
- Non-adherence 100B
5Disease Management vs. EmployeeWellness Programs
- Wellness Programs Designed to improve general
health of overall employee population before
employees get sick. - Example Weight Watchers
- Disease Management Programs Designed to improve
health of particular employees after they have
developed chronic health conditions (e.g.,
asthma, diabetes, heart condition, hypertension,
renal disease). - Example Health coach to advise about options
6Health Risk Assessments
- Health Risk Assessment Series of medical and
health-related questions aimed at obtaining
baseline information about employees overall
health to identify persons with chronic
conditions or who are at risk for developing a
condition.
7Compliance Issues
- Practical and legal compliance issues may arise
with Disease Management and Wellness Programs
under . . . - HIPAA Nondiscrimination Requirements
- Americans With Disabilities Act (ADA)
- Genetic Information Nondiscrimination Act (GINA)
- Age Discrimination in Employment Act (ADEA)
- HIPAA Administrative Simplification (Privacy,
EDI, and Security) - COBRA
- ERISA
- Income Tax
- Plan Design/Integration Issues (e.g., HRAs and
HSAs) - State law
8Carrots and Sticks
- Two Competing Approaches
- Carrot
- Health club memberships
- Reduced health care premiums
- Smoking cessation programs
- Weight loss programs
- Free health examinations
- Healthy eating programs
- Stress reduction programs
- Stick
- Refusal to hire
- Disqualification from health care plan
- Termination
9HIPAA Implications for Wellness Programs
- Generally cannot vary benefit based on health
status . . . but variation allowed for certain
wellness programs - Rule does not apply to programs that do not
condition benefit on ability to meet health
standard (i.e., a Participation Based Wellness
Program e.g - Incentives to participate in testing (regardless
of outcome) - Waiver of co-payment/deductible if participate in
pre-natal program - Reimbursement of health club membership
- Reimbursements for smoking cessation or weight
reduction programs (regardless of outcome) - Compensation to fill out health risk assessment
10Requirements for Standard Based Wellness
Programs
- Any program that provides a reward/penalty
based on the ability to meet a health standard
must - Limit reward/penalty to specified percentage 20
- Be reasonably designed to promote health or
prevent disease - Annual qualification requirement
- Must be available to all similarly situated
participants -- i.e., individually tailored
adjustments to program may be required for
individuals who cannot meet health standard - Notice of individual accommodations must be
provided
11Requirements for Standard Based Wellness
Programs
- Example Bonus for cholesterol levels below 200
must include notice allowing those medically
unable to comply to discuss alternatives - Example Bonus for body mass index might allow
for qualification based on walking 20 minutes
three times a week - Example Bonus for tobacco-free employees
might allow for qualification based on enrollment
in smoking cessation program (Note assumption
that tobacco use addiction is a medical condition
-- nicotine addiction)
12Age Discrimination in Employment Act (ADEA)
- ADEA prohibits employers from discriminating
against individuals on the basis of age with
regard to employment and the privileges of
employment (e.g., benefits) - Generally cant reduce or terminate benefits due
to age - May reduce benefits based on equal cost/equal
benefit rule - Recent case (Erie) has indicated that the ADEA
applies to retirees - Erie prevents employers from reducing benefits of
retirees (e.g., at Medicare age) unless plan
meets equal cost/equal benefit rule - Does not require employer to offer retiree
benefits - ADEA impacts both
- The ability to stop DM/Wellness program
incentives /surcharges upon reaching a particular
age and - Varying incentives/surcharge due to age
- Imposing additional requirements for incentive
based on age
13HIPAA Administrative Simplification
- Are disease management, wellness programs subject
to HIPAA Privacy/Security/EDI? - Only if
- The DM/Wellness is part of a Health Plan or
- The DM/Wellness vendor is a Health Care
Provider - Most argue that DM/Wellness is part of a health
plan - Facilitates information sharing with health care
providers without authorization and marketing
concerns - Enables VEBA/Trust funding
-
14HIPAA Privacy
- In a nutshell . . . .
- Covered entities are prohibited from using
protected health information (PHI) without an
authorization for any reason other than
treatment, payment, or related health care
operations. Specific authorization is required
for any other use. - For example, use of PHI for marketing requires
authorization - Be wary of PHI leakage outside of health plan
15HIPAA Privacy
- In a nutshell . . .
- Covered entities required to establish procedures
to protect electronic PHI - Covered entities subject to EDI requirements if
engaging in certain electronic transactions - Business associates (e.g., TPAs or Vendors)
subject many of the same requirements via
contract (the Business Associate Agreement)
16COBRA
- Most group health plans are required to provide
COBRA continuation coverage to qualified
beneficiaries if coverage is lost as a result of
certain qualifying events - Group health plan means a plan that provides
medical care and is maintained by the employer - Will DM/Wellness programs provided by the
employer be subject to COBRA? - If they provide medical care
- General health not medical care
17COBRA
- COBRA considerations
- Is Medical care offered?
- What type of incentive is offered?
- Impact of cash incentives/premium reductions?
- Impact of HRA/HSA incentives?
- Part of overall health program or stand alone
arrangement? - Participation limited to plan participants or all
employees? - What benefit must be provided?
- What is cost of program?
18Tax Issues
- Tax issues arise when
- Employer pays for coverage that does not
constitute medical care - General health and wellness programs
- Weight reduction programs not limited to obesity
- Membership in a gym
- If not for medical care, the value of such
programs must generally be included in gross
income and subject to withholding?
19Tax Issues
- Non-health incentives raise tax issues
- Cash payments
- Taxable and subject to withholding
- Gift certificates
- Likely taxable and subject to withholding
- If paid through VEBA, could be a disqualified
benefit - De minimis exception
20Tax Issues
- Health related incentives
- E.g., contribution to HRA or HSA or Health FSA
- Generally non-taxable if health plan related
- No tax exclusion for self-employed individuals
- Health FSA
- Possible change of election issues
- Potentials for health benefit restricted debit
card - HSA
- Must be structured to be made through the
cafeteria plan
21State Law
- Statutory Restrictions
- Smokers Rights 20 states, including Arizona,
Connecticut, District of Columbia, Indiana,
Kentucky, Louisiana, Maine, Missouri,
Mississippi, New Hampshire, New Jersey, New
Mexico, Oklahoma, Oregon, Rhode Island, South
Carolina, South Dakota, Virginia, West Virginia,
Wyoming - Example An employer may not require as a
condition of employment, an employee or
prospective employee to refrain from using or
discriminate against an employee with respect to
the employees compensation and benefits or terms
and conditions of employment based on the
employees use of tobacco products outside the
course of the employees or prospective
employees employment. Ind. Stat. 22-5-4-1
22State Law
- Statutory Restrictions
- Lawful Conduct / Lawful Products 11 states,
including California, Colorado, Illinois,
Minnesota, Montana, Nevada, New York, North
Carolina, North Dakota, Tennessee, and Wisconsin. - NY Example It shall be unlawful for any
employer or employment agency to refuse to hire,
employ or license, or to discharge from
employment or otherwise discriminate against an
individual in compensation, promotion or terms,
conditions or privileges of employment because
of an individuals legal use of consumable
products prior to the beginning or after the
conclusion of the employees work hours, and off
the employers premises and without the use of
the employers equipment or other property.
23State Law
- Common Law Tort Claims
- Wrongful Discharge in Violation of Public Policy
- Invasion of Privacy / Intrusion into Seclusion
- Example
- Rodrigues v. The Scotts Company (Mass. Sup Ct.)
- Facts
- Hired as lawn technician.
- Never smoked on the job only off the job.
- Fired for drug screen that was positive for
nicotine. - Law
- No statutory provision in Massachusetts
- Violation of Right to Privacy
- Unreasonable Search of his Person
24State Law
- Thoughts/Conclusions
- Patchwork Effect Practical Limitations
- Legal compliance issues for national employers
- Fairness issues for employees in different states
- Administrative costs/burdens
- Future Developments
- More and more action from state legislatures
- Lobbying by American Civil Liberties Union
25Americans With Disabilities Act (ADA)
- Americans With Disabilities Act
- Coverage 15 or more employees
- Substantive Provisions
- Non-discrimination / Accommodation
- Restrictions on Medical Examinations
- Confidentiality of Medical Information
26Americans With Disabilities Act
- Non-Discrimination/Accommodation
- Provisions only apply to disabled individuals
- Definition Physical or mental impairment that
substantially limits one or more major life
activities. - Most behaviors targeted by wellness programs do
not rise to the level of a disability under the
ADA - Smoking No
- Weight Maybe
- Alcohol Consumption Yes
- Beware Regarded As Disabled Claims
27Americans With Disabilities Act
- Non-Discrimination (contd)
- Disparate Impact Claims
- Using qualification standards, employment tests
or other selection criteria that tend to screen
out an individual with a disability or a class of
individuals with disabilities unless the
standard, test or other selection criteria is
shown to be job-related for the position in
question and is consistent with business
necessity.
28Americans With Disabilities Act
- Medical Examinations and Inquiries
- Exams ADA restricts manner and method of
administering medical exams to both applicants
and employees. - Medical Exams Vision tests, blood, urine and
breath analysis blood pressure/cholesterol
screens x-rays - Questions ADA also restricts asking
disability-related questions of applicants and
employees - Disability-Related Question Any question likely
to elicit information about a disability.
29Americans With Disabilities Act
- Medical Examinations
- Broad Coverage
- Rules apply to both applicants and employees.
- Rules apply to both disabled and non-disabled.
- Consequently, anyone can sue you.
- Common Liability Scenarios
- Health Risk Assessments
- Policing mechanisms for wellness programs
30Americans With Disabilities Act
- Rules for Medical Examinations and Inquiries
- Applicants
- Pre-Offer No examinations or inquiries allowed
- Post-Offer Examinations permitted, but must
apply to all employees. - Employees Must be job-related and consistent
with business necessity. - Applies to all employees (whether disabled or
not). - Job-related Ability to perform essential job
functions
31Americans With Disabilities Act
- Voluntary Wellness Program Exception
- Statute A covered entity may conduct voluntary
medical examinations, including voluntary medical
histories, which are part of an employee health
program available to employees at that work
site. - Regulation EEOC has not promulgated any
regulation about meaning of voluntary. - Enforcement Guidance Voluntary means no
penalty can be imposed for not participating
anything other than de minimis incentive is
prohibited.
32Americans With Disabilities Act
- Confidentiality Requirements
- Rule Information regarding the medical
condition or history of applicants/employees must
be - collected and maintained on separate forms and
- in separate medical files
- Exceptions to Confidentiality
- Managers may be informed of restrictions/accommoda
tions - First aid and safety personnel for emergency
purposes - Government officials investigating ADA
compliance.
33Genetic Information Nondiscrimination Act (GINA)
34How does GINA impact health plans generally?
- Effective first plan year after May 21, 2009.
- GINA amends the HIPAA nondiscrimination rules to
restrict the access and use of genetic
information by group health plans and group
health insurers, including non-federal
governmental plans. - GINA also imposes similar restrictions on
insurers in the individual market and issuers of
Medigap policies with corresponding amendments to
the PHSA and the Social Security Act.
35What is Genetic Information?
- Genetic information with respect to any
individual means information about - an individual's genetic tests
- the genetic tests of family members of such
individual - the manifestation of a disease or disorder in the
individuals family members. - Genetic test means an analysis of human DNA,
RNA, chromosomes, proteins, or metabolites that
detects genotypes, mutations, or chromosomal
changes. . - The term family members means the individuals
dependents under the group health plan, as well
as any first-, second-, third- or fourth-degree
relative of the dependent or the individual.
36What are the group health plan limitations under
GINA?
- Generally, GINA imposes the following limitations
on all group health plans and group health
insurers - Adjusting premiums/contributions Plans and
insurers may not adjust the premium or
contribution amounts for the group on the basis
of genetic information. However, the premium or
contribution amount for a group may take into
consideration the manifestation of a disease of
an individual who is enrolled in the plan so long
as this information is not used as genetic
information about other group members (e.g., a
covered dependent) and to further increase the
premium for the employer. - Requesting Genetic Tests Plans and insurers may
not request or require an individual or a family
member to undergo a genetic test. However, a
plan may obtain and use the results of a genetic
test as necessary to fulfill its payment
obligations under the plan so long as it only
requests the minimum amount of information
necessary to make payment.
37Prohibited Uses of Genetic Information
- Requesting Genetic Information for Underwriting
Plans or insurers may not request, require, or
purchase genetic information for underwriting
purposes. For purposes of GINA, underwriting
purposes means - Rules for, or determination of, eligibility for
benefits under the plan or coverage - The computation of premium or contribution
amounts under the plan or coverage - The application of any pre-existing conditions
exclusion under the plan or coverage - Other activities related to the creation,
renewal, or replacement of a contract of health
insurance or health benefits. - Obtaining genetic information prior to
enrollment Plans or insurers may not request,
require, or purchase an individuals genetic
information prior to such individuals enrollment
in the plan.
38What is the practical impact on group health
plans?
- Plans/insurers cannot request or require any
person to undergo a genetic test. Genetic test
results may be accessed by plans/insurers, but
only for payment purposes (and the request must
be for the minimum necessary for the purpose). - Generally, GINA does not altogether prohibit
plans/insurers from requesting an individual to
provide genetic information (which may include
history of disease/disorder in family members).
However, plans/insurers must not - request, require or purchase genetic information
for underwriting purposes - request, require or purchase an individuals
genetic information prior to the individuals
enrollment in the plan (except for incidental
collection of genetic information) or - require that an enrolled individual provide
genetic information, unless it is for certain
research purposes (subject to the conditions
described above). - Plans/insurers cannot take genetic information
into account in setting group premium or group
contribution amounts (but they can adjust
premiums and contributions based on actual claims
experience).
39How does GINA change HIPAAs privacy rules?
- GINA requires the Secretary of Health and Human
Services to revise the HIPAA privacy regulation
so that - Genetic information is clearly considered
health information subject to HIPAA privacy
protection and - The use or disclosure of genetic information
(other than incidental use or disclosure) about
an individual for underwriting purposes would not
be permitted use or disclosure.
40Question Answer