Much attention has recently been focused on the growth in volume of medical imaging. This growth is fueled by both
an increase in utilization and expanded applications of diagnostic imaging tests, many of which involve cardiac testing.
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 that such allegations could ultimately result in a reduction in the availability and quality of diagnostic services via challenges to important provisions of physician self-referral laws, informally known as Stark II, and via restrictive managed care-like tactics, such as pre-authorization, physician privileging, designed to control imaging utilization.
In the 1990's the "Stark Laws", often referred to as Stark I and II, were adopted by Congress in order to codify the appropriate relationships between physicians and diagnostic equipment. Under these statutes, 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. One element that was made very clear by Stark II was the need for an exemption for in-office imaging at the point of care ordered by a patient's physician who would then interpret the images. This acknowledges the need to discourage and punish inappropriate self-referral while simultaneously preserving continuity of care and convenient access to high-quality imaging services for the public.
Cardiovascular specialists with increasing frequency are being forced to defend one of the fundamental components of modern-day cardiovascular care, the practice of medical imaging. Some have questioned the dramatic rise in utilization and costs of medical imaging in the United States, such as echocardiography and nuclear cardiology, which have grown faster than many other types of medical imaging in recent years. Their concern is that largest percentage growth has been in the outpatient office setting, rather than in hospitals. They question whether this growth is necessary to serve an older and sicker population, or if it is being driven by inappropriate self-referral for nonmedical reasons or economic gain. Some of the improvement in outcomes and quality of life enjoyed by our patients must be credited to the availability and accuracy of cardiovascular imaging, which allows early and accurate diagnosis so that appropriate treatment can be instituted. It should be pointed out that the growth in cardiac imaging has paralleled:
- A growth in the prevalence of heart disease
- A decline in the rate of death from heart disease
- An improvement in the quality of life for those with heart disease
- A decrease in the growth rate of more invasive cardiac tests
Cardiovascular specialists take Stark rules very seriously. There are severe penalties and prosecutorial actions for Stark law violations. 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.
The ACC maintains that patients are best served by having a physician who is familiar with a patient's medical history. In the ideal case, 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 before communicating with the patient and establishing a treatment plan. This is inherently the most efficient and comprehensive approach to care. In the case of heart disease, a cardiologist is the most appropriate physician to perform and interpret cardiac imaging studies. 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.
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 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 to ensure appropriate application and optimal utilization of imaging modalities.
In response to the attention given to medical imaging in Congress and at the state legislative level, in June of 2004, ACC
successfully sponsored AMA House of Delegates Resolution 235 affirming that the “AMA work collaboratively with state medical societies and specialty societies to actively oppose any and all federal and state legislative and regulatory efforts to repeal the in-office ancillary exception to physician self-referral laws, including as they apply to imaging services.” In addition, many of the specialty medical societies that supported the ACC resolution formed a Washington, D.C.-based coalition called Coalition for Patient Centered Imaging (CPCI). Working with the cardiovascular community and its CPCI partners, the ACC is working to educate key stakeholders about the role imaging has in appropriate, quality patient care.
In June, 2005 ACC and 11 CPCI members sponsored successfully AMA House of Delegates Resolution 228, “Freedom of
Practice in Medical Imaging” that resolves the AMA to: (1) encourage the development and review of appropriateness
criteria, practice guidelines, technical standards, and accreditation programs; (2) oppose efforts by private payers, hospitals,
Congress, state legislatures and the Administration to impose policies to control utilization and costs of medical services
unless those policies can be shown to achieve cost savings; (3) supported the right of patients to receive imaging services
at facilities where appropriately trained medical specialists are available regardless of specialty; and (4) opposed any
attempts by federal and state legislators, regulatory bodies, hospitals, private and government payers to restrict reimbursements for imaging procedures based on physician specialty.
During the past five years the states have become a battleground on imaging issues. In 2004 the ACC and its allies in the Coalition for Patient Centered Imaging were able to defeat a budget amendment in Massachusetts that would have restricted advanced imaging modalities to hospital-based physicians. In 2005 many anti-imaging proposals were introduced in the states. None became law. In 2006 ACC continued to monitor state legislatures for medical imaging legislation. ACC and it’s CPCI partners have taken action in California, Florida, Louisiana, Massachusetts, Tennessee, Rhode Island, and Washington to educate lawmakers on the benefit of cardiovascular specialist imaging.
Rhode Island enacted legislation in 2005 supported by ACC permitting a nationally recognized body approved by the state department of health to certify physicians and technologists and accredit facilities performing magnetic resonance imaging. Previously only ACR bodies had been allowed to perform these functions. The Rhode Island General Assembly sent legislation to Governor Donald Carcieri on July 6, 2006 that would amend the law to change the effective date and the filing and compliance deadlines.
Louisiana enacted a rural imaging self-referral bill effective August 15, 2006 that would require joint ventures between rural hospitals and independent diagnostic testing facilities on all imaging procedures. Private practice physicians and 20 Louisiana cities are exempt.
The Massachusetts budget for FY 2007, created a 16 member commission to study the impact of magnetic resonance imaging procedures, cardiac catheterizations, angioplasties, and ambulatory surgery centers on the health care delivery system. The commission report to the General Court in July 2007 made no substantive legislative recommendations to address issues found in the study. For the past two years the imaging issue has remained quiet in Massachusetts.
Maryland remains the only state in which only radiology-exclusive groups and individual solo practitioner radiologists may perform in-office CT and MR. For the past three years the Maryland ACC has supported legislation that would modify the Maryland self-referral law enacted in 1993 to permit physicians trained in CT and MR to perform imaging in the office setting. This effort has been orchestrated with a coalition consisting of orthopedic surgeons, urologists, emergency medicine physicians, and medical oncology. Although it is clear that the reform coalition has the votes to prevail in both the House and Senate committees, the chairs of both panels have refused to permit a vote. Progress has been made during this three years period as the House chair has acknowledged that the issue cries out for a legislation solution. He has committed to reviewing the matter once a lawsuit challenging an interpretation of the existing statue is settled. In the past three years bills modeled on the Maryland law have been introduced in Arizona, Arkansas, Montana, Pennsylvania, and Texas. None passed.
Additional challenges to in-office imaging are expected in 2010 in the states, though the picture is not entirely dark as cooperative efforts with radiology have occured in California, Connecticut, and Washington. In 2008 California enacted legislation designed to prevent abuses in imaging leasing arrangements. The California ACC chapter and the California Radiological Society worked
together on this law, and the California ACC protected in office imaging and legitimate leasing arrangements where the hsycians who ordered the tests were present in the leasing facility when the tests were undertaken. In 2009 Connecticut enacted a law based on the California legislation, and the Connecticut ACC worked with the bill's sponsor and the legislative leadership to protect legitimate cardiology interests.
Washington state passed an imaging law,supported by all specialties that image except the Washington Radiological Society who did not actively oppose the legislation. This landmark law took physician ownership and self-referral issues off the table and substituted quality assessment. While it's unclear if payers will adopt the Washington recommendations, ACC appropriateness criteria got a better rating than the ACR appropriateness criteria for cardiac nuclear medicine procedures.The law applies to imaging procedures paid for by state funds, and there will be an attempt to get payers to adopt the same standards.
For an updated list of imaging legislation for 2010, visit our legislative tracking page.