Task Force 4: Appropriate Clinical Care and Issues of “Self-Referral”
“Professionalism is the basis of medicine's contract with society. It demands placing the interests of patients above those of the physician, setting and maintaining standards of competence and integrity, and providing expert advice to society on matters of health.... Essential to this contract is public trust in physicians, which depends on the integrity of both individual physicians and the whole profession” (1). Cardiovascular specialists support the fundamental principles of primacy of patient welfare, patient autonomy, and the promotion of social justice.
For the purposes of this document, “self-referral” occurs when a physician recommends a patient intervention from which the physician may benefit personally. Such recommendations usually facilitate the provision of efficient, effective, and high-quality care, but may also afford the potential for abuse. As former JACC Editor-in-Chief William Parmley stated so clearly: “At issue is the question of intent; if the intent is to provide excellent medical care, the practice is laudable. If the intent is to subjugate medical decision-making, then the practice is unethical” (2). Those few physicians who are publicized for violating our trust do not reflect the rank and file of cardiovascular specialists.
The cardiovascular specialist's primary duty is to the patient. His or her role is to promote patient welfare in an increasingly complex health care environment, one that has been made even more complex by the anti-kickback statutes and Stark laws (see the following sections). Having entered into a physician-patient relationship, physicians must counsel their patients regardless of individual financial or medical care delivery system considerations or other factors, such as socio-economic status, race, gender, or sexual orientation (3). The physician's clinical judgment must not be influenced by financial incentives from a fee-for-service system or disincentives from a capitated care system. Recommendations should be made based only on medical merit (4,5). Physicians must also contribute to the responsible stewardship of health care resources.
Growth and geographic variation in cardiac procedures. The use of cardiac procedures in the U.S. is increasing over time. Figure 1 displays changes in the number of diagnostic cardiac procedures performed for Medicare patients between 1994 and 2002. Office-based procedures account for much of the rise in nuclear and echocardiographic testing. Many factors, such as the aging of the population, the epidemic of diabetes and obesity, advances in technology, and new therapies, may partially drive these increases. Studies have demonstrated marked geographic variations in the use of both invasive and non-invasive cardiac procedures (6–10). The exact cause for geographic variation in procedure use remains elusive. Similar studies have found a linear relationship between the availability of cardiovascular diagnostic equipment in a given region and the use of such equipment. The strongest predictor of catheterization in a study of acute myocardial infarction was the availability of onsite angiographic facilities (8). Other studies have confirmed this relationship across a variety of health care practice settings. More recent studies have demonstrated similar correlations between the availability and use of nuclear equipment in a given area and the additional correlation between rates of cardiac catheterization and coronary revascularization (9). These data suggest that the use of non-invasive diagnostic technologies appears to have a multiplying effect on subsequent cardiac resource utilization.
The important question raised by these studies of the variation in cardiac procedure utilization is which rate is “right.” Specifically, is higher use in a given region or among those cared for by sub-specialists indicative of “over-use” of procedures or is there “under-use” elsewhere? The available literature on this topic is conflicting. Various studies have examined the appropriateness of cardiac procedures in various settings. In the majority of these studies, even in high-use areas, more patients with accepted indications for a procedure (ACC/AHA Guidelines, Class I Recommendations) do not receive the procedure compared with those patients who receive procedures without an accepted indication or with a contraindication (ACC/AHA Guidelines, Class III Recommendations) (11). Studies examining the impact of this variation in care on patient outcomes have had conflicting results. Some studies show that patients treated in regions with lower utilization of invasive procedures have outcomes similar to those treated in regions using more resource-intensive care strategies (6,12,13). Other studies, however, have found that patients treated in regions using more invasive procedures had fewer symptoms and improved long-term survival (14). Outcomes in acute myocardial infarction are better when the admitting physician is a cardiovascular specialist, reflecting higher usage of appropriate medications and procedures (15).
ENSURING APPROPRIATE USE OF PROCEDURES
Various options exist for managing potential conflicts of interest regarding self-referral in clinical practice. In-office/in-lab procedures performed in accordance with ACC/AHA guidelines by a physician who is competent in the performance of the procedure simply reflects efficiency and the appropriate standard of care. Physician ownership of medical equipment, especially high-cost, high-revenue equipment, is a complex professional issue. In all cases, the ownership should be fully disclosed to the patient as described in the American Medical Association (AMA) Code of Medical Ethics (16). The core question is whether clinical decisions are in the patient's interest or influenced by potential personal gain by the physician owner. Although this potential conflict exists, these arrangements may improve access and quality of care for patients. In general, the following approaches should optimize care and reduce concerns about inappropriate self-referral:
use of evidence-based guidelines
physician and laboratory credentialing
periodic case conferences
consultation with other providers
full discussion with the patient regarding risks, benefit, alternatives, and the option for a second opinion
disclosure/transparency of ownership
Utilization of ACC/AHA practice guidelines and clinical competence statements. The cardiovascular community has access to extensive and disease-specific treatment guidelines to inform diagnosis and treatment decisions. These joint ACC/AHA documents include comprehensive guidelines for the management of most major cardiovascular diseases, including acute coronary syndromes, stable coronary artery disease, congestive heart failure, valvular heart disease, atrial fibrillation, supraventricular arrhythmias, and preoperative evaluation for noncardiac surgery. Additional guidelines for specific therapeutic interventions are available including percutaneous coronary intervention and coronary artery bypass surgery. Utilization guidelines for most technical procedures have been developed by the ACCF, the AHA, and other subspecialty societies. These include guidelines for echocardiography, electrocardiography, ambulatory electrocardiographic monitoring, cardiac catheterization, nuclear studies, pacer-defibrillator implantation, and exercise testing.
Where appropriate, guideline-writing groups include representatives from many specialties, including cardiovascular surgery, internal medicine, family practice, emergency medicine, and anesthesiology. These guidelines are easily accessed, either in full text or in an executive summary form on both the ACCF and the AHA web sites (www.acc.org and www.americanheart.org) and can be downloaded to handheld computers. The guidelines are reviewed at least yearly and updated as needed. Thus, current evidence-based information about best practices is now available to physician, payer, and patient alike, providing a powerful resource for appropriate evidence-based care (17,18). These guidelines also provide recommendations for the frequency of performance of office procedures and allow responsible parties to play a key role in understanding the need for testing. Specific recommendations for the performance of diagnostic and therapeutic interventions are thus clearly defined and are available to the entire health care community; these broaden participation in determining when and in whom to carry out patient interventions.
The ACC/AHA guidelines form the basis for three additional instruments of great value in providing continuous quality improvement. Systems-based approaches such as the ACCF's “Guidelines Applied in Practice” and the AHA's “Get With the Guidelines” programs have been shown to enhance effective application and improve outcomes (19). In addition, performance measurements are being developed jointly by the ACCF and the AHA for performance improvement and appropriateness of care. Closely related are issues of physician training and competence in performing specific procedures. Practitioners performing procedures on their own patients or by referral should achieve certification of adequate training and maintenance of competence over time. The ACCF, the AHA, the American Board of Internal Medicine, and subspecialty groups have developed a series of documents that detail the appropriate training and experience for competence in a wide variety of cardiovascular procedures (20).
Laboratory oversight. Appropriate oversight by physician laboratory directors is another approach to monitoring self-referral while broadening responsibility and encouraging proficiency in the performance of procedures. Regular review by physician directors of catheterization, echocardiography, nuclear, and other laboratories is important in ascertaining that indications for patient referral, procedural quality, and outcomes all are satisfactory. Additionally, they ensure that caseload or other factors do not drive clinically inappropriate laboratory utilization.
Participation in laboratory databases is essential, with regular review and comparison to databases such as the ACC National Cardiovascular Data Registry™ (21), which can be used for benchmarking of individuals, groups, or hospitals. While it is often difficult to determine the appropriateness of any single procedure in any single patient, patterns of “diagnostic yield” from these tests can be helpful. For example, a laboratory whose rate of finding non-occlusive coronary disease that is significantly higher than one's peers may need to review its selection criteria and threshold for testing. Professional review groups consisting of experts from outside of the geographic region also can be employed when local review is impractical. Diagnostic laboratories should participate in accreditation and credentialing.
Broadening health care responsibility. Given that the potential for real or unconscious bias can be driven by financial conflicts, another approach to avoiding such bias is to involve other physicians without any financial stakes in either clinical case-management conferences or conjoint patient management.
Although the vast majority of care decisions are made on an individual physician-patient basis, the potential for inappropriate self-referral may be moderated by employing clinical case conferences. Such meetings may include invasive and non-invasive cardiologists, primary care providers, independent cardiovascular surgeons, cardiac care associates, and others, thus broadening the input into patient management decisions.
Another approach for responsibility sharing involves “partnerships in care,” wherein patients are cared for conjointly by their primary care provider and a cardiovascular specialist. In this care model, it is implicit that the cardiologist will perform specialized diagnostic and therapeutic procedures, with input from the referring and consulting physician, as well as from the informed patient.
Physicians are often viewed by their patients as having ultimate authority in health care decisions. Therefore, physicians must present the patient with a comprehensive discussion of treatment alternatives, including the option to do nothing, along with the relative risks and benefits of each alternative course. Whenever doubt exists on the part of the patient or the physician, there should be the opportunity to seek additional opinions. For example, patients proposed for multivessel angioplasty should generally be told of surgery as an alternative and have the opportunity to consult a cardiovascular surgeon. For those patients who cannot or will not participate in a discussion of care alternatives, it may be appropriate to involve other family members, friends, spiritual advisors, and patient advocates in decision making. In summary:
The ACC/AHA guidelines are available for most cardiovascular conditions and for diagnostic and therapeutic procedures, and are readily accessible to physicians and patients on the ACC and the AHA web sites.
Physician compliance with ACC/AHA guidelines for management of patients with cardiovascular disease represents appropriate care in the majority of cases, and such compliance should reduce concerns about self-referral by cardiovascular practitioners.
Procedural oversight by a professional laboratory director and laboratory accreditation are both essential.
Both procedural training and the credentialing of physicians, technicians, and other health care providers are critical to good care.
Involving other health care providers in medical care decisions, such as cardiovascular surgeons and primary care providers, limits bias.
DIRECT-TO-CONSUMER ADVERTISING AND SCREENING
Advertising of health-related services and products has grown significantly in recent years. Direct-to-consumer (DTC) advertising appears to be well entrenched and has been legal for pharmaceuticals since the early 1970s. More recently, advertising in the public media has grown rapidly for medical devices, diagnostic testing (such as computed tomography-based coronary artery calcium screening or cholesterol screening), and for many non-cardiac or related procedures. Sometimes performed in shopping malls or church parking lots, these activities have raised a variety of ethical concerns for the medical profession. At question is the propriety of such DTC advertising, physician ownership or investment in such enterprises, concern about patient referral by a physician to a facility in which he or she is an owner or investor, and the value of such screening in promoting the public health.
Physician advertising is now recognized as legal under the provisions of Section 5 of the Federal Trade Commission Act. Regulations were clarified extensively by the Food and Drug Administration (FDA) in 1997, including such language as the requirement for “adequate provision: side effects, contraindications, and effectiveness—this should include either reference to a toll-free phone number, a referral to a physician or pharmacist, a referral to a print advertisement containing a summary of risk, and a web site.” No such guidelines exist for device manufacturers for diagnostic testing; in fact, the FDA has opposed some of the diagnostic screening and testing advertisements (22,23).
Both the AMA and the American College of Physicians have reviewed these issues and published similar guidelines (4,5). These guidelines state that such advertisements “shall not be misleading because of the omission of necessary material information, shall not contain any false or misleading statement, or shall not otherwise operate to deceive.” The AMA states that advertisements should “communicate the information contained therein to the public in a readily comprehensible manner” (22,23). Further, “the key issue, however, is whether advertising or publicity regardless of format or content is true and not materially misleading.” It thus seems clear that advertising per se is professionally accepted and legal, and the issues are those of appropriate content and disclosure.
Guidelines similar to those for DTC pharmaceutical advertisements seem appropriate and in part have been proposed by the AMA for DTC advertising of diagnostic testing. Where cardiovascular testing is involved, professional societies such as the ACCF and the AHA should assume a leadership role in defining these guidelines at the policy level rather than at an individual patient level. In summary:
The DTC advertising for diagnostic tests is unregulated and needs oversight by appropriate regulatory agencies.
Professional societies should develop guidelines for such advertising and for the appropriateness of such tests.
CARDIOVASCULAR SPECIALTY HOSPITALS AND SELF-REFERRAL
The role and quality of specialty hospitals. Cardiovascular specialty hospitals are a recent phenomenon. Although cardiovascular care has traditionally been a component of full-service general hospitals, in recent years a small number of free-standing cardiovascular specialty hospitals have been created. Virtually all of these hospitals are for-profit and are located in jurisdictions with minimal or absent governmental control over the creation of health care facilities.
The cardiovascular specialty hospital vision is a facility specifically tailored to provide optimal cardiovascular care. Ideally, a dedicated heart hospital can operate without any of the compromises that result from the design and resource competition issues of a full-service hospital. Such facilities typically offer complete inpatient and outpatient cardiovascular diagnostic and therapeutic services, but often do not provide many of the non-cardiovascular services that are traditionally included in a full-service hospital. Several incentives foster the creation and operation of heart hospitals:
The heart hospital architecture, equipment, and operational protocols can be optimized for cardiovascular care. Thus, it has the potential to provide the best working environment for cardiovascular health care providers and an optimal clinical care environment for patients.
Reimbursement rates for cardiovascular care under prospective payment systems are generally favorable. This gives the heart hospital reasonable reimbursement and a greater potential to be profitable, when compared to the full-service hospital, which provides many services for which prospective payment is less favorable.
Full-service hospitals, unlike heart hospitals, may divert revenue from cardiovascular care to support other service lines that are less well reimbursed. This does not happen in a heart hospital.
Conversely, there are potential concerns about the appropriateness and positioning of such institutions in the overall health care system. For example:
Can such institutions provide optimal care to all cardiovascular patients?
Do such hospitals undermine the strength and integrity of full-service hospitals?
Do physicians who invest in these for-profit hospitals have a conflict of interest when deciding where to admit a particular patient?
The U.S. General Accounting Office recently released a study of specialty hospitals in the U.S. that was commissioned by the U.S. Congress (24). It identified 15 currently operating heart hospitals with approximately a dozen more in various stages of planning and construction. Virtually all were for-profit institutions and virtually all had significant investment on the part of physicians who held privileges at that hospital.
With respect to economics and regional competition, the study found that, whereas the majority of heart hospitals were relatively small institutions, generally with 60 or fewer beds, they frequently had a major regional impact in that they tended to deliver a large fraction of the cardiovascular services in their service area. Thus, they had a potentially large impact on the cardiovascular service lines of the competitive full-service institutions in their region. The specialty hospitals tended to have a somewhat more favorable payer mix (smaller fraction of Medicaid-reimbursed patients) than the full-service hospitals. In addition, specialty hospitals tended to have a slightly lower case-severity index than full-service hospitals. All of these trends work to enhance such institutions' financial performance relative to full-service hospitals.
With respect to clinical quality, other published studies indicate that heart hospitals achieve outcomes comparable to those of full-service hospitals with a potentially reduced length of stay (25).
Ethical issues related to specialty hospitals. physician financial conflict of interest. Most heart hospitals are for-profit. Many are capitalized in part through physician investment. Thus, some physicians who have privileges at a heart hospital have a financial stake in the institution. It has been pointed out that, in most cases, physicians provide less than 50% of the start-up capital and, in general, individual physicians have small ownership shares (26). Thus, it can be argued that an individual physician's financial stake in an institution is modest, and a physician's income is not significantly influenced by the heart hospital's financial performance. However, the physician's capital is at risk, and should the hospital fail financially, he or she would stand to lose the capital investment. Thus, such a conflict might cause a physician to admit less complicated, better insured patients to the heart hospital while diverting the more complex, less well insured patients to the full-service hospital.
IMPACT ON COMPETING FULL-SERVICE HOSPITALS. The full-service hospital is often a vital community resource, and the quality of health care within the community may be dependent upon its financial and clinical success. Heart hospitals can have a competitive advantage over full-service hospitals for several reasons, including more favorable payer mix and the ability to avoid caring for the more complicated cases under the rationale that such patients require services that might be offered only at full-service hospitals. Thus, there is the potential for heart hospitals to “skim the cream” of the cardiovascular service line. At this time, sufficient published studies are not available to evaluate this concern properly. In summary:
Heart hospitals present an alternative to traditional full-service hospitals for the delivery of straightforward cardiovascular care.
Heart hospitals have several characteristics that may be appealing to individual cardiologists and their patients.
Heart hospitals may present a possible conflict of interest for involved physicians.
Heart hospitals have the potential to affect a community's overall health care delivery system.
The ACC Board of Trustees has not taken a position for or against such hospitals, but has endorsed the following statement: “Given the wide range of opinions expressed by ACC members and the ACC Board of Trustees, the ACC recommends monitoring the data being collected during the 18-month congressionally mandated moratorium on specialty hospitals. There remains significant, unanswered questions about the financial impact on general, acute-care hospitals, patient severity of illness at referral, and quality of care in specialty hospitals. The primary concern of the ACC is delivery of high-quality cardiovascular care to all Americans; sufficient data do not now exist to judge whether specialty heart hospitals are a useful innovation or are detrimental to this mission. The ACC urges use of standardized databases such as NCDR and the Society for Thoracic Surgery in an objective analysis of the performance of specialty hospitals” (ACC Board of Trustees Minutes, December 18, 2003). Likewise, the AHA's primary mission is the reduction of disability and death from cardiovascular disease and stroke, and in the absence of adequate data, the AHA has not taken a position on heart hospitals. The AHA agrees that the data from the 18-month mandated moratorium must be studied carefully before conclusions can be reached.
LEGAL ISSUES IN SELF-REFERRAL
The anti-kickback statute. Fraud and abuse laws provide criminal penalties to those who knowingly and willfully offer, pay, solicit, or receive remuneration in exchange for referrals of patients or business reimbursed by a federal health care program (27,28). The law was aimed to prevent outright payments for referrals by clinical laboratories, home health agencies, durable medical equipment vendors, and other suppliers. These policies were enacted to:
prevent referrals based on financial benefit to the health care provider making the referral, rather than the greatest benefit for the beneficiary;
prohibit solicitation of such payments;
prevent overutilization of services; and
control governmental cost of providing health care coverage.
Violation of the statute is a felony punishable by fines of up to $25,000 and imprisonment for up to five years. Individuals found guilty might be excluded from participation in federal and state health care programs.
Congress also directed the Secretary of Health and Human Services to develop regulations that would specifically exclude certain arrangements from being considered anti-kickback violations. The safe-harbor exceptions recognize that there are legitimate reasons for a health care entity to pay a physician—as, for example, a hospital medical director— or for clinical laboratory oversight. Potentially illegal hospital-physician incentives have also been defined and can include the use of discounted office space or equipment in facilities usually located near the hospital. Such arrangements are considered inurements designed to influence physicians' utilization decisions. Fair-market lease agreements are advised to avoid such liabilities. The Office of the Inspector General accepts requests for formal advisory opinions although these may not be relied upon by third parties as legal precedent (28).
The Stark laws. The Stark Law seeks to prohibit referrals by physicians of Medicare or Medicaid patients to facilities in which the physician has an ownership interest or from which the physician receives compensation (28,29). Compensation can be any form of remuneration, direct or indirect, between the physician or family member and the designated health service provider. These include clinical laboratory services, radiology diagnostic services, inpatient and outpatient hospital services, and durable medical equipment covered in the Medicare fee schedule. The Stark legislation is based on the presumption that physicians will overutilize such services if they profit from the referrals or the orders. “Stark” is distinct from the anti-kickback statute. First, Stark evaluates exclusively the financial incentives of the provider making the referral and not the intent of the parties. Second, Stark is a civil, rather than criminal, statute. Violators are not subject to criminal prosecution but may be excluded from federal health care programs and face civil monetary fines.
Much confusion has resulted from the passage of two Stark bills, from the complexity of the laws, and from the slow issuance of rational implementing regulations. Although the basic prohibition for a referral was clearly defined, Stark II provides exceptions to the general prohibition on referrals (29). The most common exception is the in-office ancillary services exception, when the service is performed within a group practice. In summary:
The Stark law and the anti-kickback legislation are extremely complex and confusing. It has taken 10 years for the government to publish only a portion of the final regulations.
Safe-harbors are difficult to interpret without legal counsel.
Although these laws have prevented some of the most ethically egregious examples of kickbacks and fee splitting, they have not limited the significant growth in cardiovascular activities that are in part due to self-referral within the solo or group practice setting.
OVERVIEW AND SUMMARY
Both the ACCF and the AHA take seriously the responsibility of their members to optimize care for their patients. This can best be done by effective application of evidence-based medicine and practicing the highest standards of medical care. The issue of “self-referral” and its possible incentive for inappropriate utilization is an important consideration in medical practice. In this document, we have discussed the pertinent background of this issue and made positive recommendations to address this concern. Most self-referral is entirely appropriate. This “self-referral” is open and obvious to all parties. The management of self-referral also includes procedural laboratory oversight and accreditation and physician competence in a given procedure. Physician ownership of equipment outside of the physician's practice setting is a complex professional issue and should conform to AMA guidelines, which prominently include full disclosure and transparency.
The commercialization of screening tests and advertisements for these tests are largely unregulated. This field needs both regulatory oversight and guidance from professional organizations such as the ACCF, the AHA, and cardiovascular specialty societies.
Cardiovascular specialty hospitals have raised issues about potential conflicts of interest among physician investors and their possible impact on community hospitals. The ACCF and the AHA have not taken a specific position on this issue, but members of this Consensus Conference currently support the collection of more data about the quality of care and outcomes provided by such hospitals.
The authors appreciate the review and commentary provided by J. Ward Kennedy, MD, MACC, FAHA, and Nathan R. Every, MD, MPH, FACC.
The recommendations set forth in this report are those of the conference participants and do not necessarily reflect the official position of the American College of Cardiology Foundation and the American Heart Association, Inc.
When citing this document, the American College of Cardiology Foundation and the American Heart Association would appreciate the following citation format: ACCF/AHA consensus conference report on professionalism and ethics. Presented in Bethesda, Maryland, June 2–3, 2004. Circulation. 2004;110:2506–2549.
This document is available on the World Wide Web sites of the American College of Cardiology (www.acc.org) and the American Heart Association (www.americanheart.org). Single copies of this document as published in the October 19, 2004, issue of the Journal of the American College of Cardiology and the October 19, 2004, issue of Circulation are available for $10.00 each by calling 1-800-253-4636 or writing to the American College of Cardiology Foundation, Resource Center, 9111 Old Georgetown Road, Bethesda, MD 20814-1699.
Multiple copies, modification, alteration, enhancement, and/or distribution of this document are not permitted without the express permission of the American College of Cardiology Foundation. Please direct requests to. (Circulation. 2004;110:2506-2549.) © 2004 American College of Cardiology and American Heart Association, Inc.
This Conference, sponsored by the American College of Cardiology Foundation and the American Heart Association, was held at Heart House, Bethesda, Maryland, June 2–3, 2004.
Conference Steering Committee
RICHARD L. POPP, MD, MACC, FAHA, Conference Co-Chair
SIDNEY C. SMITH, Jr, MD, FACC, FAHA, Conference Co-Chair
KENNETH I. SHINE, MD, FACC
JOSEPH S. ALPERT, MD, FACC, FAHA
ROBERT O. BONOW, MD, FACC, FAHA
ROBERT M. CALIFF, MD, FACC
PAMELA S. DOUGLAS, MD, FACC, FAHA
ALICE K. JACOBS, MD, FACC, FAHA
BRUCE D. LINDSAY, MD, FACC, FAHA
CHRISTINE W. MCENTEE
STEVEN E. NISSEN, MD, FACC, FAHA
JAMES L. RITCHIE, MD, FACC, FAHA
ROSE MARIE ROBERTSON, MD, FACC, FAHA
THOMAS J. RYAN, MD, MACC, FAHA
MICHAEL J. WOLK, MD, FACC
DOUGLAS P. ZIPES, MD, MACC, FAHA
American College of Cardiology Foundation
CHRISTINE W. McENTEE, Chief Executive Officer
KAREN J. COLLISHAW, Division Vice President
CHARLENE L. MAY, Director, Clinical Policy and Documents
FRANCES RAAB, Conference Specialist, Clinical Policy and Documents
EVA MARIE GRACE, Associate Specialist, Scientific Committees
PATRICIA JONES, Senior Coordinator, Clinical Policy and Documents
American Heart Association
NANCY A. BROWN, Chief Operating Officer
ROSE MARIE ROBERTSON, MD, FACC, FAHA, Chief Science Officer
- American College of Cardiology and American Heart Association, Inc.
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