BP - Health Care Compliance Association

March 2009
42
Standing at the
crossroads
Editor’s note: Michael Spake is Director,
Compliance & Privacy with MCG Health, Inc.
in Augusta, Georgia. He may be reached by
e-mail at mspake@mcg.edu or by telephone at
706/721-0900.
“A new beginning has to be made from the
lowest foundations, unless one is content to go
round in circles forever”.
—Francis Bacon 1
Ethicists and hospital ethics committees
originated as support functions
of hospital operations during
the second half of the 20th century. 2 The
idea of a hospital employing an ethicist to
create, implement, and oversee a hospital
ethics committee materialized as a result of
technological developments in the medical
field, new ideas about patients’ rights,
and scenarios that brought to the forefront
conflicts between moral perspectives and
medical judgments. As a result, the function
of hospital ethics committees and the definition
of ethics in the hospital setting centered
on clinical-based decision-making between a
physician and a patient, case consultations,
and closed-door discussions about humansubjects
research.
By Michael Spake, MHA, JD
Since 1990, almost every US hospital has
similarly hired a compliance officer to create,
implement, and oversee a legal compliance
program. Compliance programs have been
built around systems focused on preventing,
detecting, and punishing violations of the
law. Their existence and function was a direct
response to the federal government’s scrutiny
and challenge to hospitals to reduce fraud,
waste, and abuse, as well as the cost of health
care to federal, state, and private health insurers.
The goals of a compliance program center
on demonstrating the seven elements of a
compliance program as identified by the U.S
Department of Health and Human Services
Office of the Inspector General. 3 These are
viewed as fundamental to an effective compliance
program. The seven elements are:
1 Designing and distributing standards of
conduct including policies and procedures
to address areas of potential fraud, such
as claims development and submission
process, and financial relationships with
physicians and other health care professionals;
2 Designating a chief compliance officer
and other appropriate bodies charged
with the responsibility of operating and
monitoring the compliance program and
who report directly to the CEO and the
governing body;
3 Developing and implementing regular,
effective education and training programs
for all affected employees;
4 Maintaining a process, such as a hotline,
to receive complaints, and adopt
procedures to protect the anonymity of
complainants and to protect whistleblowers
from retaliation;
5 Developing a system to respond to allegations
of improper/illegal activities and to
enforce appropriate disciplinary action
against employees who have violated
internal compliance policies, applicable
statues or regulations of federal health
care program requirements;
6 Auditing evaluating, and monitoring
compliance and assist in the reduction of
identified problem areas; and
7 Investigating and taking remedial actions.
Health Care Compliance Association • 888-580-8373 • www.hcca-info.org
The Next Generation model
Today, many hospitals are questioning the
status quo of both their hospital ethics committee
and compliance program in an effort
to determine their effectiveness. In addition,
hospitals are being challenged by the
United States Sentencing Commission to
establish organizational cultures that promote
compliance and ethics. Pursuant to
the United States Sentencing Commission,
an organization may mitigate criminal fines
and penalties by establishing and implementing
an effective compliance program. 4 As a
result both ethics and compliance programs
are simultaneously striving to gain greater
effectiveness by achieving a level of success
coined “Next Generation” status. 5 The Next
Generation model is guided by the following
principles:
1 Committees are proactive, not just
reactive;
2 Committees are organizationally
integrated, not isolated;
3 Committees are accountable for performance,
based on demonstrable outcomes,
not just good intentions; and
4 Committees are oriented around organizational
core values, not just regulatory/
accreditation requirements.
Today, compliance programs are making
improvements towards greater effectiveness
by moving from prevention and detection
programs of retrospective review to programs
that promote organizational ethics and
encourage employee commitment to organizational
values. Hospital ethics committees
are simultaneously moving from mechanisms
that provide only clinical consultations to
becoming the center of ethical responsibility
for operational decision-making. However,
neither will independently achieve Next
Generation status. Instead, Next Generation
status will only be achieved when ethics and
compliance are molded into an integrated
operational model that (1) aligns the
organization’s separate ethics and compliance
support functions to build capacity into the