In medical school physicians are taught that their
primary obligations are to act in the best interest
of the patient and society (beneficence), to do no harm
(nonmalfeasance), and to maintain respect for patient
autonomy (77-79).
The last obligation mandates that patients be given
free and uncoerced choices about their medical care
and requires that physicians provide accurate and unbiased
information about the patient's medical condition, disclose
alternative choices and potential conflicts of interest,
and obtain informed consent, delineating the potential
risks and benefits (and alternatives) of the diagnostic
and therapeutic strategy (77).
Changing practice patterns in medicine, including the
expansion of both managed care and for-profit physician
entrepreneurial ventures, have altered the relationships
among physicians, patients, and payers (79-81),
creating potential conflicts of interest for the physician
in maintaining the patient’s best interest. The
availability of sophisticated yet costly diagnostic
and therapeutic technologies has also created new challenges
for physicians, who may now serve simultaneously as
physician, inventor, and investigator of new therapies
for vascular intervention. Government and regulatory
authorities now seek greater assurances that physicians
respect the best interest of the patient in their clinical
practice. Physicians who participate in clinical investigation
must now report any real or perceived financial “conflict
of interest” with industry sponsors (81,82)
as well as with their academic institutions (76).
Physicians who have a direct conflict of interest should
avoid being investigators of products for which they
stand to gain financially, except under extraordinary
circumstances.
Ethical issues facing the cardiologist also involve
the performance of biomedical research. Patients are
increasingly seeking information about the competency
of their healthcare providers, often by reviewing “Best
Practice” listings provided by potentially conflicted
third parties or Internet sites created by hospitals
who seek to attract new patients into their healthcare
system. Competency information is rarely made available
by organized medical societies to the general public.
A steady stream of new cardiovascular training graduates
in this country has also resulted in the availability
of an increasing number of physicians who perform interventional
procedures. A possible excess in the number of interventionalists
could also result in overutilization of services, conflict
of interest, and self-referral. Similar issues exist
with respect to the conduct of clinical research, in
which the patient may be encouraged to participate in
clinical protocols that may lead to little personal
benefit (and potential risks) by physicians who may
have a direct or indirect financial interest in their
participation.
A. Operator Assistant’s Fees, Sharing of Fees,
Fee Splitting, and Fee Fixing
With continuing competition for patient referrals, there
is close scrutiny of the ethical (and financial) relationships
between the referring cardiologist or internist and
the interventional cardiologist. Although some procedures
may require the participation of 2 cardiologists (e.g.,
mitral valvuloplasty or complex coronary or pediatric
intervention), it is not ethical for a cardiologist
to charge an operator assistant's fee when he or she
has not directly participated in the procedure or when
the cardiologist’s efforts were not needed for
the procedure. Furthermore, offering or providing a
shared fee with another physician for the performance
of cardiac catheterization is unethical and potentially
illegal. It is also not ethical for a cardiologist to
receive an admission fee, referral fee, or other “kickback”
or commission for admitting or referring a patient to
a hospital or cardiac catheterization facility (83).
This principle applies not only to fees, commissions,
and compensations received from other physicians and
hospitals, but also to those received from manufacturers
of catheters, medications, instruments, devices, or
supplies that may be used in the catheterization laboratory
(5).
Collusion with any healthcare provider may be unethical.
Furthermore, such collusion may be illegal when such
arrangements involve Medicare funds and are construed
as inducement for referral (83).
Collusion with other cardiologists in an attempt to
fix fees for catheterization services may also violate
antitrust laws (5).
B. Unnecessary Services
Without specific indications, “routine” right-heart
catheterization, pacemaker implantation during elective
coronary angioplasty, and simple coronary angioplasty
in a patient without ischemia may be unnecessary (83).
A charge to overread either hemodynamic data or angiograms
by a physician who has not performed the procedure is
also an unnecessary duplication of services and fees.
C. Self-Referral, Self-Ownership, and Self-Reporting
Changing relationships among hospitals, managed care
groups, and physicians have led to the development of
freestanding catheterization facilities that are not
strictly associated with hospitals but are owned instead
by investors or even physicians within a cardiovascular
practice. Under these circumstances, some practitioners
may have financial interests in diagnostic laboratories,
including cardiac catheterization facilities, radiological
imaging centers, and ambulatory surgery centers (84).
The investing physicians may benefit financially from
the referral of patients to these facilities (79,80,84-87).
Cardiologists must avoid any financial business or industry
arrangements that might influence their decision about
the care of patients because of personal gain (5).
Law in some states prohibits financial investments
to “self-referral” facilities (5,84).
The national “federal physician self-referral law”
(or “Stark Law”), however, explicitly exempts
cardiac catheterization. For other services designated
in the Stark Law, physicians are allowed to personally
provide services in institutions in which they have
direct or indirect ownership or financial relationships.
Referral of patients to a catheterization laboratory
facility (from which the patient's cardiologist collects
earnings or shares in profits) based solely on an effort
to maintain volume expectations, however, is a conflict
of interest.
Direct remuneration from manufacturers for the use
of their devices, catheters or drugs may be illegal
when the patient is also charged for the use of the
catheters or devices or when governmental funds are
used for payment (5).
Cardiologists should never engage in any practice that
would violate state or federal law regarding referral
to a facility in which they have financial interest.
It is unethical to refer patients to such a facility
for financial gain alone. The quality review process
should be in place and enforced to provide appropriate
oversight to prevent these relationships from becoming
problematic. A second opinion from another qualified
cardiologist who has no fiscal connection to the primary
cardiologist or the catheterization laboratory should
be obtained if any questions arise about the appropriateness
of a procedure being performed in such a facility.
Concerns have been raised about the accurate reporting
of individual operator and catheterization laboratory
outcomes. Local competition could result in the suppression
of clinical reporting of adverse events, and there may
also be pressure to maintain low costs and a low adverse
event rate to solicit institutional contracts with third-party
payers. Given the sensitive information related to individual
operator success and complication rates, there may also
be a general reluctance to provide this information
to potentially nonobjective sources (91).
Physicians and hospitals should be encouraged to collect
procedural outcome information according to standardized
criteria such as those provided by the ACC and the Society
for Cardiac Angiography and Interventions, to compare
these outcomes with “benchmark” standards
provided by the ACC and/or the Society for Cardiac Angiography
and Interventions, and to subject outcomes to peer review
(91).
These outcomes should be risk-adjusted to account for
complex patient subsets (e.g., cardiogenic shock and
nonoperative candidates). The peer review team should
include individuals without a fiscal interest in the
laboratory and those not personally involved in the
procedures.
D. Informed Consent
Patient autonomy and, in many cases, the law mandate
that informed consent must be obtained before performance
of any invasive diagnostic or therapeutic cardiovascular
procedures (77).
If a physician extender (e.g., physician’s assistant
or nurse practitioner) or cardiology trainee is to perform
any part of a procedure, this should be stated during
the process of informed consent. Because the patient
and physician together determine the diagnostic and
treatment strategy, medical facts should be presented
accurately to the patient (and/or family or person responsible
for the patient’s care) at a level of communication
that the patient can easily understand (5).
A discussion of the risks, benefits, and alternatives
should be undertaken in an unpressured environment well
before the procedure. It is recognized that, on occasion,
urgent situations may arise in the catheterization laboratory,
making it difficult to prepare the patient for all possible
emergency procedures. Particular attention is needed
for ad hoc interventional procedures following cardiac
catheterization in patients with a clear indication
for coronary revascularization. It is better to explain
the potential risks, benefits, and alternative therapies
to coronary intervention before administration of sedatives
or other agents that may affect the patient's judgment
at the time of cardiac catheterization. Written informed
consent should be obtained and documented in the medical
record before the procedure.
E. Ethics of “Teaching” Diagnostic and
Therapeutic Procedures
Although “teaching” hospitals have been essential
to medical training for decades, patients admitted to
a “teaching” hospital have a right to be aware
of the level of training of the various physicians and
related personnel involved in their care. It is ethical
for the cardiologist to delegate the performance of
certain aspects of the procedures to assistants, such
as physician’s assistants or fellows, providing
that this is done with the patient’s consent and
under the attending physician’s supervision (5).
Fellows or physician’s assistants, if qualified,
can also perform certain invasive procedures, provided
that they are closely supervised at all times by the
attending cardiologist. It is not ethical to delegate
the entire responsibility of invasive procedures to
anyone not appropriately experienced in the performance
of the procedure.
F. Clinical Research Studies During Diagnostic and
Interventional Cardiac Catheterization
An increasing number of “teaching” and community
hospitals participate in clinical research protocols.
Local institutional review boards now require a higher
standard of disclosure for research studies than that
required for clinical practice (92).
Accordingly, extra time should be taken with patients
asked to participate in clinical research to ensure
that all questions have been addressed. Research studies
should not increase the risk of major complications
disproportionally to the possible benefit when combined
with diagnostic catheterization and interventional procedures.
The investigative procedure should be performed after
the essential information has been obtained if possible,
but only if the patient’s condition is stable and
the diagnostic procedure has been performed in a timely
fashion. Research procedures performed during the catheterization
must be reviewed and approved by an institutional review
committee (83).
Safeguards for ensuring that patients are appropriately
enrolled in clinical research trials are as follows:
that the clinical investigator has thoroughly reviewed
the protocol for its scientific validity; the patient
has met all the inclusion criteria and none of the exclusion
criteria; the patient has been fully informed about
the risks, benefits, and alternative therapies; and
the clinical investigator follows the clinical protocol
without unjustified deviation. In fact, most clinical
investigators are ethical individuals whose motivations
are to further scientific knowledge. Strict adherence
to the clinical protocol is the best assurance that
conflicts of interest will be minimized.
Through the difficult times facing physicians today,
high ethical standards, including maintenance of proficiency,
avoidance of real or perceived financial conflict of
interest, disclosure of potential conflicts, and, most
important, maintaining the patient’s best interest
as primary, remain of paramount importance. Only with
attention to these issues will our profession continue
to be viewed by the public (and our patients) as trustworthy
and deserving of their respect.
