In This Issue
Final Report of the EMTALA Technical Advisory Group
Indicates What May Be Around the Corner
N.C. Medical Board Is Tougher than Most, but
Balanced
Protecting Your Employees from Harm: The
North Carolina Workplace Violence Prevention Act
Don’t Let Your Wellness Program Get You Down
Final Report of the EMTALA Technical Advisory Group
Indicates What May Be Around the Corner
by
Jessica Lewis
On April 2, 2008, the
Emergency Medical Treatment and Labor Act Technical Advisory Group (TAG)
issued its final report to the secretary of the U.S. Department of
Health and Human Services. (The report can be found at
http://www.magpub.com/emtala/EMTALA%20Final%20Report_FINAL.PDF) The
TAG’s charter expired on September 30, 2007, but the TAG has requested
that the secretary continue its operation. The TAG report includes a
summary of all of the TAG’s recommendations during its tenure, most of
which have not yet been implemented. We can anticipate future revisions
to the Emergency Medical Treatment and Active Labor Act (EMTALA)
statute, regulations, and interpretive guidelines based on the TAG’s
most recent recommendations. The following is a summary of key
recommendations by topic that have not yet been implemented.
Communication with Patient’s Physician
In its
report, the TAG recommends that the Centers for Medicare & Medicaid
Services (CMS) revise the regulation at 42 C.F.R. § 489.24(d)(4)(iii) to
reflect that a treating physician or qualified medical person (QMP) may
contact the patient’s physician at any time for the purpose of seeking
advice on the patient’s medical history or needs that may be relevant to
the medical treatment and screening of the patient. The TAG further
recommends that CMS issue additional interpretive guidelines to reflect
this new regulation and to clarify that (1) the treating physician or
QMP is not required to contact the patient’s physician; (2) the treating
physician or QMP remains responsible for the patient’s care even if he
or she seeks and receives advice from the patient’s physician; (3) if
the contact is attempted while awaiting a response from the patient’s
physician, the treating physician or QMP must proceed with the patient’s
medical screening exam (MSE) and/or stabilizing treatment; and (4) the
medical judgment of the treating physician or QMP trumps any different
opinion held by the contacted physician.
Specialized Capabilities – Transferring Hospital Responsibilities
The
TAG has adopted the position that a hospital may not transfer a patient
solely because it lacks the capabilities to provide definitive care to
the patient. The treating physician makes this determination regarding
the hospital’s capabilities but cannot base his or her decision on the
availability or unavailability of post-stabilization care the patient
may need. If the hospital has the capabilities to treat the patient’s
emergency medical condition (EMC), the hospital must treat the EMC.
The
TAG has also adopted the position that a hospital transferring a patient
must attempt to transfer the patient “to the nearest appropriate
hospital with the specialized capabilities to stabilize the patient’s
emergency medical condition, consistent with the patient’s health care
needs.” However, if predetermined transfer arrangements exist that will
meet patient care needs, this proximity requirement would not apply.
The
TAG recommends that the statute be changed to reflect that, in some
circumstances, a patient may be discharged or transferred from the ED to
a non-hospital-owned physician’s office for continuation of the MSE,
determination of whether an EMC exits, or stabilization of an EMC.
However, the TAG also recommends that the U.S. Department of Health and
Human Services (HHS) monitor and evaluate “triaged out” and deferred
care.
Specialized Capabilities – Receiving Hospital Responsibilities
The
TAG recommends that CMS issue additional interpretive guidelines on the
regulation at 42 C.F.R. § 489.24(f) to clarify when a hospital has a
“specialized capability” or, rather, when it does not. The TAG reached
the consensus that a receiving hospital should not be deemed to have a
specialized capability just because either (1) a specialty physician is
listed on the call roster or (2) a physician with privileges at the
hospital is present but either is not on the call roster or is not on
call at the time of transfer. The TAG explained that “specialized
capabilities” include dedicated units, specialized equipment, and
personnel (including those on-call) that are either available at the
time of transfer or will be available within the patient’s window for
receiving treatment of the EMC.
The
TAG has adopted the position that a receiving hospital has the capacity
to treat a patient if it has the resources (equipment, staff and space)
to accommodate the patient’s needs at the time of the patient’s transfer
or within the patient’s “window” for receiving emergency care. The TAG
noted that communication between the physician at the transferring
hospital and the physician at the receiving hospital should be allowed
and encouraged. The TAG has adopted the position that a hospital is not
required to accept a patient transfer on the sole basis that the patient
requests the transfer to the receiving hospital. The TAG cites this
position as consistent with the current requirement that a physician
certify that the transfer is necessary due to a lack of capability at
the transferring hospital to stabilize the EMC and that the benefits of
the transfer outweigh the risks.
Maintaining Call Lists
The
TAG recommends that CMS take the position that all hospitals, including
specialty hospitals, must maintain a call list that meets the
requirements of the EMTALA statute and the hospital’s provider agreement
with CMS. This may involve revisions to the interpretive guidelines for
the regulation at 42 C.F.R. § 489.20(r)(2). The TAG also recommends that
the provisions of 42 C.F.R. § 489.24(j)(1) regarding maintenance of
on-call lists be moved to 42 C.F.R. § 489.20(r)(2) regarding Medicare
provider agreements. Upon implementation of this change, the TAG
recommends that 42 C.F.R. § 489.20(r)(2) be revised to read as follows.
Each hospital must maintain an on-call list of physicians on its
medical staff who are available to examine and stabilize the
hospital’s patients who are receiving services required under this
section in accordance with the resources available to the hospital,
including the availability of on-call physicians.
The
TAG further recommends that the EMTALA statute be revised to indicate
that a hospital should make any service it routinely offers to the
public also available in emergencies, through on-call coverage. The TAG
recommends additional revisions to the interpretive guidelines to
indicate that a hospital may satisfy its on-call coverage requirements
by:
-
Developing, on a no-less-than-annual basis, an on-call coverage plan
that includes evaluation of the following factors in its
development: 1) hospital capabilities and services provided;
2)community need for ED services based on ED visits;
3)out-of-hospital transfers for emergency care; 4) physician
resources; and 5) performance under the past on-call plan; and
-
Developing backup plans for patient care to be used when the
hospital lacks capacity or on-call coverage to provide a service,
which plans should include options such as telemedicine, utilization
of other staff physicians, transfer agreements for the purpose of
ensuring a patient receives timely care, and community or shared
coverage arrangements.
The
TAG proposes that a hospital should be permitted to engage in community
or shared call arrangements in order to meet its on-call coverage
requirements and that CMS should delineate a process for approving
community on-call arrangements. The TAG also suggests that certain
situations, such as a hospital’s transfer of patients for treatment of
conditions that the hospital is normally capable of treating and
increased numbers of transfers on weekends, may indicate that the
hospital’s on-call list is inadequate. Availability of On-Call
Physicians The TAG recommends that CMS issue new interpretive guidelines
on the regulation at 42 C.F.R. § 489.24(j) to require that hospitals:
-
develop policies and procedures regarding on-call response time and
exceptions;
-
define the on-call physician’s required response time in a range of
minutes rather than a set number of minutes;
-
recognize that response times refer to the initial response by the
on-call physician;
-
designate in medical staff bylaws who may respond on behalf of the
on-call physician;
-
provide that the on-call physician may initially respond by phone or
other means; and
-
recognize that a violation of EMTALA may occur when a physician
fails to respond when called or to appear at the hospital when
requested.
The
TAG recommends that CMS revise the interpretive guidelines to discard
the current guidance on “selective call.” This current guidance states
that an EMTALA violation may occur when a physician who refuses to
participate in the hospital’s on-call list takes call only for patients
with whom he or she has a relationship. Current guidance further states
that a hospital may be deemed to have violated EMTALA through
encouraging disparate treatment when it permits a physician to
selectively take call when the hospital’s coverage for the particular
service is inadequate. To clarify the meaning of selective call, the TAG
recommends that CMS issue new interpretive guidelines, as follows.
-
A
physician who takes call for patients with whom he/she has a
preexisting medical relationship is not engaging in “selective
call.”
-
A
physician is not obligated to provide on-call coverage when he or
she is not on the on-call roster, even if he or she is in the
hospital seeing patients.
-
A
hospital’s EMTALA on-call list must meet statutory requirements, but
physicians may see patients in the hospital as they see fit.
-
On-call physicians must see patients without regard for the
patient’s ability to pay for the services, even if the physician
volunteers to see a patient in the ED while he or she is not
participating in the on-call list.
-
A
violation of EMTALA may occur where a disparate pattern of referral
for specialty care based on patients’ ability to pay for the care is
identified by a surveyor.
-
Hospitals are required to meet on-call coverage requirements and to
prohibit disparate treatment.
The
TAG further recommends that CMS clarify the parameters of “community
call.” The TAG proposes that community or shared call arrangements
should be permitted as long as the hospitals engaging in the shared call
arrangement have formal agreements and backup plans, as well as policies
and procedures that recognize the existence of the shared call
arrangements. Regardless of any shared call arrangement, the hospital
must still perform a medical screening exam (MSE) as indicated.
To
promote the availability of on-call coverage, the TAG recommends a
statutory change to provide professional liability protection for
hospitals, physicians, and licensed independent practitioners who
provide services to patients covered by EMTALA. Physician concern over
perceived increases in the cost of professional liability insurance
related to increased risk of lawsuits for malpractice when a physician
takes emergency call prompted this recommendation. The TAG takes the
position that better liability protection will generate better on-call
coverage. Additionally, the TAG recommends a statutory change to include
a funding mechanism for hospitals and physicians to ensure physicians
are reimbursed for providing on-call services.
Waiver of EMTALA Obligations in an Emergency State
The
TAG recommends that HHS pursue changes to the EMTALA statute and
regulations and that CMS issue new interpretive guidance on waiver of
EMTALA obligations in the event of a government or hospital-declared
emergency. Current regulations provide that a hospital with a dedicated
emergency department located in an emergency area as defined by section
1135(g)(1) of the Social Security Act 1 will not be subject to sanctions
for an inappropriate transfer or redirection of a patient to another
location for an MSE. The waiver of sanctions carries the following time
limitations: (1) 72 hours from the implementation of the hospital
disaster protocol or (2) in the event of an emergency involving a
pandemic infectious disease, until the public health emergency is
terminated in accordance with section 1135(e)(1)(B) of the Social
Security Act.2
Termination of EMTALA Obligation
The
TAG recommends that CMS issue revised interpretive guidelines to clarify
that patient care obligations of a hospital and physician under EMTALA
end once the patient has been stabilized. However, other Medicare
Conditions of Participation may apply to further treatment and follow-up
care of the patient.
The
TAG further recommends that CMS revise the interpretive guidelines to
reflect that EMTALA does not apply when a patient develops an emergency
medical condition (EMC) after admission to a hospital. However, the TAG
proposes that if a patient presents to a hospital with an EMC and the
patient is admitted to the hospital before the patient’s EMC is
stabilized, the requirements of EMTALA still apply to the receiving
hospital with specialized capabilities required to stabilize the
patient.
The
TAG proposes that a patient with an EMC can be discharged to home, even
if the EMC is not stabilized, as long as the provider determines “within
reasonable clinical confidence” that the patient has reached a point
where continued care could reasonably be delivered as an outpatient or
later as an inpatient, such as in the case of a woman in early labor.
The patient must receive a plan for follow-up care along with discharge
instructions.
EMTALA Violations
The
TAG recommends that HHS develop a process through which a hospital or
provider may appeal a proposed decision to terminate its Medicare
participation. The TAG suggests the process provide a pre-termination
avenue for hospitals to request quality improvement organization (QIO)
review of medical issues and for hospitals to request an appeal from the
CMS regional office on factual, policy, and legal issues. The TAG’s
proposal would operate as follows: When a regional office concludes that
an EMTALA violation has occurred, the regional office would provide the
violating hospital with a draft statement of deficiencies and a 10-day
window of opportunity to provide CMS with objections or additional
information. CMS would then have 10 days to review the objections and/or
additional information before issuing a final statement of deficiencies.
The TAG recommends that if a hospital is then placed on a 23-day
termination track,3 there should be an expedited appeals process
available to the hospital.
Additionally, the TAG recommends that HHS pursue statutory changes that
will provide for the imposition of lesser sanctions than termination for
less serious EMTALA violations. For example, a hospital cited for a
technical violation such as improper or missing signage would not be
terminated but would be required to correct the violation, subject to
follow-up inspection. The TAG proposes a system of warnings as part of
these lesser sanctions.
The
TAG recommends that HHS establish a process for consistently collecting
data regarding all EMTALA violations and that HHS provide for
centralized evaluation of the data for purposes of improving consistency
of regional enforcement and providing information to providers and
hospitals to help curb EMTALA violations. Finally, the TAG recommends
revision of the statute to limit the private right of action for
personal harm to circumstances in which there is no other avenue for an
individual to pursue such a claim, such as through a lawsuit for medical
negligence.
Psychiatric Emergencies
The
TAG recommends that CMS discard its current interpretive guidance on
psychiatric EMCs and that the remaining guidance apply equally to
psychiatric and medical EMCs. However, the TAG proposes that CMS provide
examples of situations involving psychiatric EMCs to provide some
clarity on issues that have caused confusion in handling patients with
emergency psychiatric conditions. The TAG recommends that CMS better
describe parameters of an MSE to reflect that part of the MSE includes
an attempt to determine whether the patient is “gravely disabled,
suicidal, or homicidal.” The TAG explains the process as follows.
-
“Gravely disabled” implies a danger to oneself due to extremely poor
judgment or inability to care for oneself.
-
Even if an MSE reveals that a patient is gravely disabled, suicidal
or homicidal, the patient may not have an EMC.
-
Resources such as community services and police custody may
appropriately be used by providers to help determine whether an EMC
exists and/or to ensure that the patient receives placement in a
safe setting.
The
TAG also recommends that CMS issue new interpretive guidelines that
provide that hospitals may use contracted agencies and/or services to
assist with handling of psychiatric MSEs, but hospitals must ensure that
the clinicians working for these agencies are credentialed consistent
with the requirements of hospital and medical staff bylaws, policies,
and procedures. The TAG encourages CMS to consider implementing training
of ED physicians and clinical staff in hospitals without psychiatric
services on handling psychiatric patients under EMTALA.
The
TAG recommends that receiving hospitals with specialized behavioral
health capabilities be required to accept transfers of patients with
EMCs who are “gravely disabled” or a danger to themselves or others if
the transferring hospital does not have the capability to provide
stabilizing care. The receiving hospital must, of course, have the
resources and capacity to care for the patient before it will be
obligated to accept the transfer.
The
TAG further recommends that the interpretive guidelines be revised to
reflect that a patient with a psychiatric EMC is not considered
stabilized simply by the administration of chemical or physical
restraints; thus, EMTALA obligations continue to apply to the hospital
treating such a patient and to any receiving hospital to which the
patient is transferred. Such restraints, however, can be used to provide
a safe environment during transfer of the patient.
Provider Access to Information
The
TAG recommends a reminder to providers that, should they require
clarification of any interpretive guidance or regulations, they may
contact their regional CMS offices. The TAG also recommends that CMS
improve its EMTALA website to provide more comprehensive and easily
accessible information. The TAG proposes that the following specific
categories of information be included on the website: statutes,
regulations, interpretive guidance, current CMS and OIG memoranda and
guidance letters, questions and answers, a link to Medicare Conditions
of Participation, enforcement statistics, a list of the “top 10” cited
EMTALA deficiencies, special advisories of potential EMTALA violations,
a link to the OIG website, cross-references by topic, an EMTALA basics
section, and downloadable documents.
Surveyor Training
With
regard to regional office and state surveyor qualifications, the TAG
recommends additional measures to ensure proficiency and consistency.
The TAG recommends that the EMTALA surveyor education sessions currently
offered every two (2) years be offered annually and that systems be
established to monitor the effectiveness of surveyor education and to
demonstrate surveyor competencies. It also recommends that CMS establish
a system for improving consistency in interpretation and enforcement of
EMTALA by regional offices by, for example, assigning a CMS central
office official to monitor deficiency statements. It further recommends
that CMS ensure prompt distribution of EMTALA guidance to regional
offices and state agencies. CMS is currently working with a contractor
to develop web-based EMTALA training that will be available in fiscal
year 2009 to regional offices and state agencies upon request.
Provider and Patient Education
In
terms of provider education on EMTALA, the TAG recommends that CMS
designate certain of its personnel to participate in various educational
programs offered on EMTALA and that CMS establish a process to ensure
timely response to provider questions and to new compliance issues as
they arise. It suggested that CMS consider using quality improvement
organizations (QIOs) to provide EMTALA training. The TAG also suggested
a Listserv for the purpose of addressing issues and providing regular
updates. The TAG recommends that CMS provide education to individuals
outside of the ED setting regarding their rights as patients under
EMTALA.
Definitions
With
regard to the definition of labor and related interpretive guidelines,
the TAG recommends that CMS replace the word “certifies” with the phrase
“determines and documents.” The TAG further recommends that the terms
“capacity” and “capability” be more clearly defined. The TAG also
recommends that CMS issue guidance on when it is appropriate for a
provider to discuss financial matters with a patient who presents to the
emergency department.
Conclusion
The
TAG has provided a forecast of what may lie on the EMTALA horizon. Some
time may elapse before changes to the statute and regulations
materialize or CMS issues additional interpretive guidance. In the
meantime, this forecast may be useful to providers in developing and or
revising their approaches to planning for and handling EMTALA-related
issues.
Jessica Lewis concentrates her practice on a broad array of cases
and issues for health care clients, including regulatory and operational
compliance, litigation, corporate, and long term care issues. She may be
reached at 919.783.2941 or
jlewis@poynerspruill.com.
EndNotes
1. The statute defines an
emergency area as a “geographical area in which . . . there exists (A)
an emergency or disaster declared by the President pursuant to the
National Emergencies Act [50 U.S.C. 1601 et seq.] or the Robert T.
Stafford Disaster Relief and Emergency Assistance Act [42 U.S.C. 5121 et
seq.]; and (B) a public health emergency declared by the Secretary
pursuant to section 247d of this title.” 42 U.S.C. §1320b-5(g)(1)
(2007).
2. A public health emergency
exists for the duration of the declaration made by the secretary of HHS.
See 42 U.S.C. § 1320d-5(e)(1)(B) and (g)(1)(B); see also 42 U.S.C. §
247d-7d (2007).
3. Presently, if a violation
is deemed to have occurred, CMS issues a notice that it will terminate
the hospital’s participation in Medicare in 23 days. If a hospital
submits a plan of correction before the 19th day in the 23-day
termination track and CMS approves it, CMS will extend the termination
track to 90 days. A resurvey to ensure compliance will occur in this
time period, and if the hospital passes the survey, it may be returned
to deemed status. Overview of Termination Procedures, CMS,
http://www.cms.hhs.gov/SurveyCertificationEnforcement/downloads/Overview_of_Termination_Procedures.pdf
(last visited May 14, 2008).
Top
N.C. Medical Board Is Tougher than Most, but
Balanced
By
Chris Brewer
and
Steve Shaber
Tough. The N.C. Medical Board is more likely than most to impose
serious discipline on doctors. Of the 51 boards in the U.S., it now
ranks 15th. This shows quite a change in recent years, since in 2003 it
was ranked 41st in the country.
The
N.C. Medical Board is tough, but within the mainstream. It seriously
disciplined 4.25 doctors per 1,000. The national median number was 3.12,
and the mean was 3.46. Just five states disciplined fewer than 2.0
doctors per 1,000, and only five states disciplined more than 5.0 per
1,000. For this purpose, the term “serious discipline” includes
surrender, revocation, suspension, probation, or restriction.
These figures were compiled by the Health Research Group at Public
Citizen, the public interest advocacy organization, and they are
available online at
www.citizen.org/hrg. It represents a three-year rolling average for
the years 2005 through 2007.
Balanced. In addition, the N.C. Medical Board is notable for taking
a public, but not as serious, type of action in the form of a public
letter of concern. A public letter of concern lets the board take public
action without having to report the physician to the databank. This is a
good option for the board and physicians alike, because it allows the
board to balance its concern for both the public and the physician.
Recent Examples. The following are some recent examples of board
action against physicians and physician assistants, taken from its
report for January and February 2008.
-
There was one revocation, following the doctor’s conviction of a
felony. The doctor did not contest the board’s action.
-
Two licenses were surrendered voluntarily; the reasons are not
reported.
-
There were 14 licenses suspended. Four suspensions came after
hearings, and ten were done by consent order. The suspensions ranged
from 30 days to indefinite. Several of the suspensions were stayed,
which means that the physician or physician assistant was allowed to
continue practicing while on probation, under some sort of
restrictions. The reasons for suspensions included sexual relations
with a patient, violations of DEA rules, failure to meet the
standard of care in one way or another, prescribing errors, fee
splitting and cognitive impairment.
-
Two physicians or physician assistants were placed on probation, two
were limited in the scope of their practice, and seven were
reprimanded.
-
Finally, seven physicians received public letters of concern for
such things as beginning a wrong-site procedure, misinterpretation
of a test, closing a practice without proper notice to patients, and
prescribing for family members.
Chris Brewer
is regarded as one of the region’s most
experienced advisers on healthcare enforcement matters. He may be
reached at 919.783.2891 or
cbrewer@poynerspruill.com.
Steve
Shaber represents physicians,
hospitals and others in disputes with the government, payors, and other
providers. He may be reached at 919.783.2906 or
sshaber@poynerspruill.com.
Top
HR News
Protecting Your Employees from Harm: The North Carolina Workplace
Violence Prevention Act
By
Kevin Ceglowski
One requirement for a content, efficient workforce is a feeling of
safety and security on the job. Workplace violence, whether from
employees' domestic situations following them to work or from other
sources, should be a concern of all employers. To address problems of
violence and provide a measure of protection for workers, the North
Carolina General Assembly passed the Workplace Violence Prevention Act
in 2004.
The Workplace Violence Protection Act has two general goals. First, it
allows employers to pursue certain protections on behalf of their
employees. Second, it prohibits employment discrimination or retaliation
against employees who must miss work as a result of domestic violence or
other harassment.
An employer may file a civil action to obtain a no-contact order on
behalf of an employee who has suffered unlawful contact at the
employee’s workplace. Unlawful contact is defined as intentionally
causing or attempting to cause bodily injury to the employee, willfully
following or harassing the employee on more than one occasion with the
intent to place the employee in reasonable fear for his or her safety,
or willfully threatening to physically injure the employee. The employer
must consult with the affected employee before seeking the civil
no-contact order to see if any safety concerns exist related to the
employee's participation in the process. If the employee is unwilling to
participate or consent in the process, the employer may not discipline
the employee.
If the court finds that the employee has suffered unlawful contact, it
will issue either a temporary or permanent no-contact order. Temporary
orders may not remain in effect for more than 10 days, and permanent
orders may not remain in effect for more than one year. The court has
discretion to use the order to prevent further harassment of, or contact
with, the affected employee. Violations of the no-contact order will be
considered contempt of court and are punishable by fines or
imprisonment.
In addition to the no-contact order provisions, the Workplace Violence
Prevention Act also protects victims of unlawful contact from employment
discrimination. An employer may not discharge, demote, deny a promotion
to, or discipline an employee because the employee took reasonable time
off work to seek a protective order related to domestic violence under
Chapter 50B of the North Carolina General Statutes or a civil no-contact
order under Chapter 50C of the North Carolina General Statutes.
Employees must still follow the employer's normal time-off policies and
procedures, including any requirement to give advance notice to the
employer, unless an emergency makes this impossible.
The Workplace Violence Prevention Act provides one means for employers
to help protect their employees from harm and ensure a safe, productive
workplace. In addition, it protects employees from discrimination or
retaliation for work missed to seek protection from violence or
harassment.
For more information about the Workplace Violence Prevention Act or
other employment-law related issues, please contact
Kevin Ceglowski at
kceglowski@poynerspruill.com or 919.783.2853 or
Susie
Gibbons at 919.783.2813 or
sgibbons@poynerspruill.com.
Top
Don’t Let
Your Wellness Program Get You Down
By
Gene
Griggs
Health care costs aren’t the
only thing on the rise – so are obesity and chronic health conditions.
Increasingly employers are looking for ways to manage the cost of health
care benefits provided through their group health plans, and wellness
programs can be an effective means for cost control by providing
employees incentives to lead healthier lifestyles. However, due to the
uncoordinated web of laws and regulations impacting these programs, an
employer’s best intentions can result in an unfortunate legal outcome.
Pay attention to the following issues so that your wellness program
doesn’t get you down.
HIPAA Privacy.
Wellness programs that include health risk assessments, monitoring of
health conditions or otherwise provide medical care may be subject to
the privacy and security rules under the Health Insurance Portability
and Accountability Act (HIPAA). These rules require special handling of
protected health information and prohibit employers from using
information obtained from the wellness program in making any
employment-related decisions.
HIPAA Nondiscrimination.
The Department of Labor recently issued Field Assistance Bulletin
2008-02 providing group health plan sponsors guidance for compliance
with the wellness program exception to HIPAA nondiscrimination
regulations. HIPAA generally prohibits discrimination based on “health
status-related factors” including physical and mental illnesses, claims
experience, receipt of health care, medical history, genetic
information, evidence of insurability, and disability.
Under the HIPAA wellness
program exception, however, group health plans may offer premium
discounts, rebates, reduced co-payments, and/or lower deductibles to
participants and beneficiaries who take part in “programs of health
promotion and disease prevention.” Under the HIPAA regulations, wellness
programs that provide a reward merely for participation in the program
(e.g., a heart disease educational program for participants with high
blood pressure) are not subject to the HIPAA nondiscrimination rules.
The only requirement for these participatory wellness programs is that
they be made available to all similarly situated individuals. Programs
requiring participants to meet a health-related standard to obtain a
reward, such as a target cholesterol level, are subject to additional
scrutiny. These standards-based wellness programs must ensure that:
-
the total reward does
not exceed 20% of the cost of coverage;
-
the program is
reasonably designed to promote health and prevent disease;
-
eligible persons have
the opportunity to qualify at least once a year;
-
the reward is available
to all similarly situated persons and a reasonable alternative
standard (or waiver of initial standard) is available if attainment
is unreasonably difficult due to a medical condition (plans can
require hardship verification); and
-
plan materials
describing the wellness program must disclose the availability of a
reasonable alternative standard the possibility of a waiver of the
initial standard, or state that the plan will work with individuals
to develop an alternative standard at their request.
Field Assistance Bulletin
2008-02 provides a checklist for plan sponsors to determine whether a
wellness program is subject to the HIPAA nondiscrimination rules and
assess the compliance of their programs. The FAB is available at
http://www.dol.gov/ebsa/regs/fab2008-2.html.
ADA. The American
with Disabilities Act (ADA) generally prohibits employers from making
disability-related inquires. Often wellness plans use health risk
assessments. Under the ADA, an employee’s completion of a health risk
assessment must be voluntary and refusal to complete one must not
subject the employee to penalty. Employers should be cautious that
“incentives” to complete the health risk assessment could not be
construed as a “penalty” for not completing the assessment.
ADEA. Mandatory
programs may also raise issues under the Age Discrimination in
Employment Act (ADEA). The ADEA protects individuals aged 40 or older
against employment discrimination based on age. Mandatory wellness
programs requiring achievement of specific health targets must take into
account limitations that an older employee might face, or the program
could violate the ADEA.
Other Considerations.
Wellness programs offering health care services such as blood
screenings, physical exams or flu shots are subject to the group health
plan rules under the Consolidated Omnibus Budget Reconciliation Act
(COBRA). Attention must be paid to some of the COBRA traps that wellness
plans can trigger. In addition, the provision of these types of health
care services through a wellness program can prevent a participant from
being able to contribute to a health care savings account if the
services constitute more than insignificant medical care. Furthermore,
programs that provide flexible spending account credits under a
cafeteria plan or other credits or subsidies relating to a self-insured
health plan may raise additional issues under the nondiscrimination
rules applicable to these types of plans. This article merely scratches
the surface of the legal issues involved with wellness programs.
Employers would be well-served to have even the most seemingly simple
program reviewed for compliance.
For assistance in
designing a compliant wellness program or obtaining review of your
program, contact
Gene Griggs, a member of
our Employee Benefits Team. He may be reached at 704.342.5320 or
ggriggs@poynerspruill.com.
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