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The Honorable William Frist
461 Dirksen Senate Office Building
Washington, DC 20510-0001
Dear Majority Leader Frist:
Lately, much attention has been focused on the growth in
both the volume and applications of medical imaging. Consequently,
the American College of Cardiology (ACC) is deeply concerned
that imaging procedures used in the practice of cardiovascular
medicine have come under attack unfairly and could ultimately
result in a challenge of important provisions of the physician
self-referral laws, informally known as Stark II.
Under the federal Stark laws, physicians are restricted from
referring patients to health care facilities in which they
or an immediate family member have a financial relationship,
i.e., an ownership interest or compensation arrangement, direct
or indirect, for an array of designated health care services.
We believe that the current list of designated health services
both protects the public interest and preserves medical ethics.
Critical cardiovascular diagnostic imaging services, such
as magnetic resonance, computed tomography, and ultrasound,
may be targeted by other medical professionals through efforts
to persuade Congress to ban important Stark safe harbors,
including the in-office ancillary services exception that
allows physicians to refer patients for necessary ancillary
services in their own practices and to refer to other physicians
in a group practice under limited circumstances.
The ACC is deeply troubled by the assertions being cast by
others in the medical community of inappropriate and poor
quality imaging performed by physicians who are not radiologists.
In fact, the growth in cardiovascular imaging is multi-faceted
and complex and can be attributed to several factors including:
improved technology and better quality images; changes in
the standard of cardiovascular care; coverage decisions; shifts
in the site of service from hospitals to physician offices;
increased liability; and demand by better educated patients.
Because of advancements in the quality of imaging technology,
cardiovascular imaging now plays a central role in the diagnosis
and management of cardiovascular diseases. As the Medicare
population grows and is living longer with heart disease,
so will the growth in imaging. According to the Centers for
Disease Control and Prevention, over the past five decades,
the death rate for patients age 65 and older with heart disease
has declined by more than 50 percent thanks to advancements
in cardiovascular care.
Cardiologists have largely been responsible for the development
and validation of clinical applications of diagnostic cardiovascular
imaging. The ACC, the American Heart Association, and other
cardiovascular organizations have been leaders in the development
of well-respected training program standards, clinical competency
statements, and clinical practice guidelines that contain
recommendations regarding the necessary knowledge and skills,
as well as the appropriate use of imaging procedures.
The cardiovascular community has also supported the development
of accreditation programs for nuclear imaging, echocardiography,
vascular ultrasound and magnetic resonance imaging laboratories
and is working with health plans and payers on how to ensure
the appropriate use and growth of imaging modalities.
The ACC believes that real patient benefits are achieved
when a qualified physician selects the optimal study to perform,
interprets the image, and is able to integrate the results
with the full knowledge of the patient’s clinical condition
when establishing an appropriate treatment plan. All cardiovascular
specialists during their training are taught diagnostic imaging
techniques, but they also receive extensive training in cardiac
physiology and pathology. This training is critical to the
accurate interpretation of imaging studies, and the ultimate
goal of an integrated, comprehensive understanding of the
patient’s cardiovascular problem. Furthermore, in-office
imaging by cardiovascular specialists allows for the important
continuity of care in a cost- and time-efficient manner.
Cardiovascular specialists take Stark rules very seriously.
The ACC has made clear, through its Expert Consensus Document
on Catheterization Laboratory Standards, that “Cardiologists
should never engage in any practice that would violate state
or federal law regarding referral to a facility in which they
have a financial interest. It is unethical to refer patients
to such a facility for financial gain alone.” In addition,
the ACC supports the American Medical Association (AMA) Code
of Ethics that governs physician conduct in medical practice.
AMA Ethical Opinion 8.032 states that physicians should not
refer patients to health care facilities outside of their
office practice where they do not have direct and personal
involvement in the provision of care or services and have
a financial interest in that facility. The direct provision
of care alleviates the concern that a physician investor is
profiting purely from the ability to refer.
Furthermore, there are severe penalties and prosecutorial
actions for Stark law violations. Violators may face denial
of all claims, repayment of payments received, and civil monetary
penalties of $15,000 per offense and up to $100,000 in some
cases. Providers also lose eligibility to participate in Medicare
and Medicaid.
The ACC, on behalf of its 28,000 members across the country,
pledges to work with you in a collaborative manner to address
any concerns with cardiovascular diagnostic imaging services.
Please do not hesitate to contact Camille Bonta or Carrie
Kovar in the Science and Advocacy Division of the ACC, at
cbonta@acc.org (301) 897-2620
or ckovar@acc.org (301)
493-2352, should you wish to discuss this issue further.
Sincerely,
Michael J. Wolk, M.D., F.A.C.C.
President
American College of Cardiology |
