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© 2002 American Society for Clinical Oncology
American Society of Clinical Oncology 2001 Presidential Initiative: Impact of Regulatory Burdens on Quality Cancer CareByFrom the American Society of Clinical Oncology, Alexandria, VA, and The Health Strategies Consultancy LLC, Washington, DC. Address reprint requests to Lawrence H. Einhorn, MD, 1900 Duke St, Suite 200, Alexandria, VA 22314; email: leinhorn{at}iupui.edu
PURPOSE: This study was conducted as part of the American Society of Clinical Oncology (ASCO) 2001 Presidential Initiative to assess the administrative burden of payer documentation requirements and their impact on oncology practice. METHODS: The study consisted of a physician questionnaire and an activity log. Site visits were conducted to support survey data. Analysis included 2,493 questionnaires and 1,115 activity logs; data were also collected from site visits to 10 oncology practices. RESULTS: Increased documentation was the greatest concern among respondents, greater even than the stress of dealing with death and dying. More than 97% of survey respondents reported an increase in documentation (averaging 1.4 h/d) and 77% reported an increase in work hours because of documentation in the past 5 years. As a result, more than 40% of respondents reported decreases in key aspects of patient care and decreases in teaching (48%) and research (39%). Site visit data demonstrate similar trends. CONCLUSION: It is critical to find ways to decrease physician burden without decreasing the ability to prevent fraud and abuse. Reforms include provisions in a recently passed bill in the United States House of Representatives to streamline Medicare regulation and increase physician education. To address oncology-specific concerns, changes also should be made to supervision requirements for residents and fellows and evaluation and management documentation for oncology follow-up visits.
IN THE CURRENT congressional session, there has been a sharp focus on the regulatory burden placed on providers by government and other payers, and the House of Representatives passed legislation in June 2002 that includes a section devoted to regulatory reform in the Medicare program.1 This legislative focus is attributable in part to concerns raised by the physician community regarding recent regulatory changes by public and private payers,2,3 including Medicare evaluation and management (E & M) documentation guidelines,4,5 external audits by public and private payers, and the frequency of regulatory updates. Highly publicized cases of fraud, in which providers have been penalized for Medicare overbilling, Diagnosis-Related Group upcoding, and billing for services that were not rendered, have been used to justify some of these regulatory efforts.6-8 The increased documentation now required of physicians to avoid allegations of fraud and abuse inevitably competes with time spent providing patient care, counseling grieving family members, conducting research, and training medical students. Anecdotal evidence has been cited to document these negative effects of documentation, including claims of longer work hours, disproportionate amounts of time spent on nonmeaningful clinical aspects of care (eg, documenting negative symptoms to meet E & M guidelines), and lower board scores.9-12 Other anecdotes assert that fewer physicians are choosing patient care and that physicians are retiring earlier from clinical practice.5 The cognitive nature of oncology services makes this specialty more prone to concern. To date, provider claims regarding the negative effect of payer regulations have not been substantiated with valid data. The purpose of this study was to provide a quantitative analysis of the administrative burden of payer documentation requirements, determine the impact of these burdens on physician practice, and elucidate concerns specific to oncologists. Given the importance of this issue to the practice of oncology, the American Society of Clinical Oncology (ASCO) commissioned this study as its 2001 Presidential Initiative, entitled The Impact of Regulatory Burdens on Quality Cancer Care.
The data for this analysis were derived from two components: a survey that was distributed to all ASCO members in the United States and site visits to selected oncology practices. The survey evaluated physician perceptions regarding regulatory burden and its impact on their practice, and collected a detailed log of how survey respondents divide their time between administrative, patient care, teaching, research, and other activities. The site visits provided additional support to the oncologists’ self-reported activity logs and added qualitative insight to survey results.
Membership Survey
Site Visits
Statistical Analysis Time spent on professional activities recorded in the activity log (ie, excluding personal and/or nonwork time) in each 24-hour period was aggregated and then averaged across 3 days. A Student’s t test was performed on ranked means, and analyses of variance (eg, analysis of variance, general linear models, Duncan’s multiple range test) were conducted to determine time spent on each activity category by the key subgroups mentioned above. Analyses also were performed to compare time spent in each activity category to the same categories reported in the 1976-78 study results.
Response Rate Surveys were sent to 10,881 oncologists in the United States listed in the ASCO membership database. Of the original sample frame, 250 surveys were not used in the analysis (133 of which were from oncologists no longer in clinical practice; the other 117 surveys were returned as undeliverable). A total of 2,493 questionnaires and 1,115 activity logs were completed and included in the analysis. The response rate of 23% constitutes a significant fraction of practicing oncologists in the United States.15 This response rate is likely underestimated because of the indeterminate number of ineligible oncologists included in the sample frame, including medical students, residents, fellows, retirees, basic scientists, statisticians, and oncologists that do not participate in patient care but are members of ASCO. Survey respondents were geographically distributed and included oncologists from a mix of practice settings, subspecialties, and experience levels. Of the 2,493 completed surveys, the majority of respondents were experienced practitioners, with 72% of total oncologists reporting practice experience of between 6 and 25 years (Table 1). In addition, 77% of oncologists were based in either academic medical centers or private practice (community-based) settings, whereas the remainder practiced in community hospitals or staff-model health maintenance organizations. Although in general respondents were evenly distributed by census region, oncologists on the West Coast (19%) were somewhat underrepresented compared with the other three census regions (ie, Northeast, Midwest, and South).
Perceptions of Documentation on Practice Oncologist responses, as recorded in the survey instrument, suggest that Medicare requirements are primarily responsible for increased regulatory burden and audits. Most oncologists surveyed (90%) use Medicare requirements for all patients, and 97% of respondents adhere to Medicare E & M guidelines. The majority of oncologists responding to the survey experienced some form of audit in the past year: 70% experienced internal compliance audits, whereas 58% were subject to external insurance/payer audits. Increased claims documentation requirements in the past 5 years were reported by 97% of oncologists. Oncologists reported increases in written claims documentation procedures, the costs for billing each claim, and the number of staff needed to deal with claims and audits (Fig 1). Nearly half of respondents reported increased difficulty in accessing relevant information in clinical records, and over half of the respondents consistently reported spending more time completing medical records than they considered medically necessary (Figs 1 and 2). Results were consistent when these activities were performed alone and with fellows or residents.
Increased documentation was the greatest concern among oncologists responding to the survey, ranking as a greater concern than the stress of dealing with death and dying or loss of income (Fig 3). Concern regarding long work hours because of documentation was consistently reported by survey respondents. An increase in total work hours in the past 5 years was reported by 80% of respondents, and 74% reported that this increase was because of time spent on documentation.
Respondents reported that documentation influences the amount of time spent on a variety of clinical, research, and teaching activities. The majority of physicians (77%) reported that the increase in total work hours was because of claims documentation requirements, whereas 74% also reported a decrease in job satisfaction from the increased administrative burden (Fig 4).
Comparisons with USC/DRME Findings Data collected from the activity logs in this study were compared with those of the study conducted by the USC/DRME from 1976 to 1978 to understand how the environment has changed for oncologists. Statistical testing for the significance of the comparisons was not possible because of differences in the composition of the study sample frames. However, the comparisons provide a valuable illustration of changes in practice resulting from documentation requirements. Oncologist work hours, exclusive of on-call time, were 13 hours in the 2001 study, compared with 10 hours for oncologists included in the 1976-1978 study. Inclusive of on-call time, average oncologist work hours were 18 hours in 2001 compared to 13 hours in the 1976-1978 study (Fig 5). Consistent with survey respondents’ perceptions, time spent on documentation averaged 1.4 h/d in the 2001 study, compared with 0.3 h/d in the 1976-78 study. Average time spent on research and teaching totaled 1 h/d in the 2001 study, relative to 1.9 h/d in the 1976-78 study.
Although the administrative burden has increased, patient care time has also increased considerably, on the basis of results from the two studies. Time on patient care averaged 7.1 h/d in the 2001 study compared with 4.5 h/d in 1976-78 study. However, survey responses indicated an increase in overall work hours and an increase in number of patients seen, which may in part be driving the total hours spent on patient care. In addition, more than 40% of 2001 survey respondents reported a decrease in key aspects of patient care because of documentation (Fig 4).
Site Visits Both quantitative and qualitative findings from the site visits suggest that the documentation burden on oncologists may be underestimated in the survey results. For example, site visit time and motion study results report an average of more than 2.4 h/d spent on documentation across all 10 sites—over 20% of each day observed. Qualitative results from the site visits reinforce this finding, particularly regarding the difficulty in distinguishing patient care time from documentation. Specifically, documentation requirements that dictate aspects of teaching and components of patient examinations (eg, documentation of negative signs and symptoms that is charted while in the patient’s room) can be difficult to disentangle and may have been reported by survey respondents as patient care rather than documentation in the activity logs. Qualitative observations from the site visits also highlight the pervasive effects of documentation on oncology practices. A focus on compliance and fear of billing audits was evident across all of the practices included in the site visit, and many practices had developed a series of internal mechanisms to ensure compliance. For example, an academic center developed a full-page checklist to guide oncologists in selecting appropriate E & M codes for clinic visits, and a community practice had hired a specialized administrative team to assist in filling out Medicare paperwork. Such procedures are good examples of how, in the current environment, documentation breeds all the more documentation. These costs are separate from the physician costs documented in the survey portion of the study.
Our results show that increased paperwork is taking a toll on oncologists. Documentation decreases the ability of oncologists to spend time with their patients—more than 40% of survey respondents reported a decrease in key aspects of patient care because of documentation requirements. Results also identify documentation as a central professional concern for practicing oncologists, who ranked increased documentation as a greater concern than the stress of dealing with death and dying or decreases in income. Having now established a quantitative foundation for oncologist claims that documentation is taking precious time away from other important professional activities such as patient care and research, it is critical to find ways to decrease physician burden without decreasing the ability to prevent fraud and abuse. There are a number of steps that can be taken to decrease burden while maintaining appropriate defenses against fraud and abuse. The recently passed House bill addresses many of the concerns highlighted in this study. Consolidating publication of regulatory changes in Medicare to once a month or once per quarter, allowing additional time for compliance with published regulatory changes, and greatly increasing physician education and outreach regarding billing and claims processing would offer substantial benefits relative to the concerns identified by oncologists in this study, including potentially decreasing the 1.4 hours oncologists reported spending on documentation each day. However, further steps need to be taken to address the oncology-specific issues identified in this study. Additional steps that can be taken to decrease oncologists’ burden include revising physician supervision requirements for medical residents by eliminating the requirement that an academic or community oncologist duplicate the entire E & M performed by fellows in order to justify the level of service actually provided. Second, streamlining requirements for E & M documentation, and specifically for follow-up visits for cancer patients, would go a long way toward addressing some of the problems identified in the study. For example, eliminating the requirement for inclusive lists of negative results in the history and physical examination of the cancer patient (eg, reporting a negative eye, ear, nose, and throat examination for a patient with advanced pancreatic cancer) would allow oncologists to focus on pertinent patient issues. To achieve the desired changes, the oncology community must engage in meaningful dialogue with government agencies including the Department of Justice and the Department of Health and Human Service’s Office of the Inspector General as well as regulators such as the Centers for Medicare and Medicaid Services. The Department of Health and Human Services has already created several venues for discussion on physician regulatory burden, including the June 2001 Initiative to Reduce Regulatory Burden. Regional meetings of the Advisory Committee on Regulatory Reform created under this initiative have focused specifically on regulatory issues affecting physicians, including revisions to E & M guidelines.16 Documentation requirements are a real and important concern of practicing oncologists. Our study provides insight into both the increase in the amount of documentation required of oncologists and its negative impact on oncology practice. This issue must be addressed by targeted solutions that do not prevent or impede payer efforts to eliminate fraud and abuse. It is incumbent on the oncology community to bring forward such solutions by means of existing initiatives and legislation and, if necessary, by creating new venues for meaningful discussion with regulators.
Supported by unrestricted educational grants from Alza Pharmaceuticals, Aventis Oncology, Bristol-Myers Squibb Oncology, Lilly Oncology, and GlaxoSmithKline. The authors thank Cathy Bernasek and Rajeev Ramchand, from the Health Strategies Consultancy, and Caitlin Carroll Oppenheimer and Dan Gaylin, from the National Opinion Research Center, for their contributions to this article.
1. HR 4954, Title VIII, Regulatory Reduction and Contracting Reform 2. MedPAC, March 2000 Report to Congress. Section 2C, Physician Services: 71-82 3. American Medical News, April 2, 2001. Available at http://www.ama-assn.org/sci-pubs/amnews/pick_01/gvsa0402.htm
4. Brett AS: New guidelines of coding physicians’ services: A step backward. N Engl J Med 339: 1705-1708, 1998
5. Kassirer JP, Angell M: Evaluation and management guidelines: Fatally flawed. N Engl J Med 339: 1697-1698, 1998 6. American Medical News, 1997 Top Stories. Available at http://www.ama-assn.org/sci-pubs/amnews/pick_97/pick0728.htm
7. Kalb PE: Health care fraud and abuse. JAMA 282: 1163-1168, 1999 8. Beluck P: In crackdown on health care fraud: U.S. focuses on training hospitals and clinics. New York Times, December 22, 1995, p 32 9. American Medical Association: "Medicare Issues" and "Managed Care Accountability and Payment Issues." Member Connect Surveys. American Medical Association, January-February 2001 10. Laster L: It’s not the job, it’s the OIG and the 99203s. The Washington Post, January 21, 2002, p B03
11. Iezzoni LI: The demand for documentation for Medicare payment. N Engl J Med 341: 365-367, 1999
12. Lasker RD, Marquis MS: The intensity of physicians’ work in patient visits: Implications for the coding of patient evaluation and management services. N Engl J Med 341: 337-341, 1999
13. Mendenhall RC, Girard RA, Abrahamson S: A national study of medical and surgical specialties: I. Background, purpose, and methodology. JAMA 240: 848-852, 1978
14. Mendenhall RC, Lloyd JS, Repicky PA, et al: A national study of medical and surgical specialties. JAMA 240: 1160-1168, 1978 15. American Medical Association: Physician Characteristics and Distribution Book. Chicago, IL, AMA Press, 2001, Table B8 16. Department of Health and Human Services Regulatory Reform Initiative. Available at http://www.regreform.hhs.gov/meetinginfo.htm Submitted February 4, 2002; accepted August 20, 2002.
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Copyright © 2002 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
