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Originally published as JCO Early Release 10.1200/JCO.2005.02.8928 on December 5 2005 © 2006 American Society of Clinical Oncology. Impact of the Year 2000 Medicare Policy Change on Older Patient Enrollment to Cancer Clinical TrialsFrom the Southwest Oncology Group Statistical Center; Puget Sound Oncology Consortium, Seattle, WA; Southwest Oncology Group Operations Office, San Antonio, TX; University of Arkansas for Medical Science, Little Rock, AR; John Wayne Cancer Institute Medical Group, Santa Monica; University of California, Davis, Sacramento, CA; St Vincent's Comprehensive Cancer Center, New York, NY; Oregon Health Sciences University, Portland, OR; University of Colorado Health Science Center, Denver, CO; and Loyola University Chicago, Stritch School of Medicine, Maywood, IL Address reprint requests to the Southwest Oncology Group, Operations Office, 14980 Omicron Dr, San Antonio, TX 78245-3217; email: junger{at}fhcrc.org
PURPOSE: A prior analysis by the Southwest Oncology Group (SWOG) showed that women and African American patients were adequately represented on cancer clinical treatment trials but that older patients were substantially underrepresented. Twenty-five percent of patients  65 years old were enrolled onto SWOG trials from 1993 to 1996, whereas 63% of all patients with cancer were 65 years old. Recognition of this under-representation led to a change in Medicare policy in 2000 to include coverage of routine patient care costs of clinical trials. We conducted an updated analysis of accrual trends.
METHODS: The proportions of enrollment onto SWOG treatment trials by sex, race/ethnicity, and age (
RESULTS: The results showed continued adequate representation by sex and race/ethnicity. Older patient accrual on SWOG trials increased significantly since 2000, with 31% of patients CONCLUSION: Method of payment analyses provided evidence that the Year 2000 Medicare policy change had a positive impact, but only for those patients with supplemental private coverage of coinsurance costs. Improvements in the Medicare payment structure could further increase older patient participation in clinical trials.
The Southwest Oncology Group (SWOG), a national cancer clinical trials cooperative group funded by the National Cancer Institute, published a study in 1999 that highlighted the under-representation of patients 65 years old or older to cancer clinical trials.1 The proportions of women and African Americans in SWOG trials matched the proportions for these groups in the US cancer population. However, the overall proportion of older patients in SWOG trials was 25% compared with a 63% overall proportion in the US cancer population. Adequate representation of older patients in cancer clinical trials is crucial to establishing the clinical applicability of treatment trial results to the older patient cancer population. Although prior evidence of the under-representation of the elderly existed,2 the extent of the problem was not known. A number of factors contribute to the problem of older patient under-representation, including cost issues, patient and physician bias, logistics, informed consent, and prevalence of comorbidities.3 Growing awareness of the issue has resulted in a number of changes at the national level, including the year 2000 presidential executive order that Medicare must reimburse medical providers for the routine patient care costs of clinical trials.4 This report represents an update of the previous SWOG analysis by sex, race/ethnicity, and age, with Hispanic and Asian American race/ethnicity categories added. Additionally, method of payment patterns were analyzed to assess whether the change in Medicare policy impacted enrollment of older patients onto cancer clinical trials.
By the method previously reported by Hutchins et al,1 the proportions of enrollment onto SWOG treatment trials for women, African Americans, Hispanic Americans, Asian Americans, and older patients ( 65 years) were computed for the 15 most common diseases for the years 1997 to 2000, and corresponding rates in the United States were derived from projected 1998 US Census data and 1997 to 1998 National Cancer Institute Surveillance, Epidemiology, and End Results data (representing the midpoint of the accrual period). SWOG rates were computed and compared overall and within disease sites with US cancer population rates. Additionally, method of payment data and accrual patterns by age were analyzed over time (from 1993, when SWOG first began collecting method of payment data, through 2003) to assess whether patterns in method of payment changed with the new year 2000 Medicare policy on clinical trials coverage. At enrollment, SWOG patients are recorded as using Medicare plus private versus Medicare only versus other methods (private insurance alone, Medicaid plus Medicare, military/Veterans Affairs insurance, and so on). Data regarding the specific types of Medicare plans (eg, Medicare Plan A, and so on) were not available. The Medicare plus private method of payment is assumed to represent Medicare plus supplemental insurance (eg, Medigap or employee-sponsored insurance), and Medicare only is assumed to represent Medicare-managed care plans.
Overall, 14,475 patients were accrued from 1997 to 2000. The percentage of women in SWOG trials of diseases that were not sex specific was 41% compared with the US cancer population estimate of 44%. In the analysis of enrollment by race, adequate representation was found for African Americans (9.3% SWOG v 9.5% US cancer population), Hispanic Americans (4.1% SWOG v 3.8% US cancer popula-tion), and Asian Americans (2.2% SWOG v 1.7% US cancer popu-lation). Patients 65 years old or older accounted for 31% of patients enrolled onto SWOG trials whereas patients 65 years old or older accounted for 61% of the US cancer population. From 2001 to 2003, a total of 9,949 patients were registered, with 38% of patients being 65 years old or older. Results for the four most common cancers are listed in Table 1.
The proportions of all patients paying with Medicare alone versus Medicare plus private for each year from 1993 to 2003 are shown in Figure 1. Also shown is the percentage of older patients enrolled for each year. The proportion of patients paying with Medicare plus private was 8.3% from 1993 to 1999. Beginning in 2000, the year of the Medicare policy change, this proportion increased to an average of 15.2% (P < .0001). The proportion of older patient enrollment increased in a similar fashion beginning in the year 2000. The proportion of older patient enrollment averaged 26.5% from 1993 to 1999 compared with 38.1% from 2000 to 2003 (P < .0001). However, the proportion of patients paying with Medicare alone was roughly constant over the period of the analysis (9.9% in 1993 to 1999 v 9.7% in 2000 to 2003; P = .50). Although payment that includes Medicare (either alone or with supplemental insurance) was used by the majority of older patients participating in SWOG clinical trials (61%), other payment types were also used by older patients, including private insurance alone (21%) and military/Veterans Affairs’ insurance (11%). Therefore, the sum of Medicare alone plus Medicare plus private will not necessarily equal the total older patient enrollment in Figure 1. Importantly, the absolute number of older patients enrolled has also increased since the year 2000 Medicare policy change, from 1,040 patients per year from 1993 to 1999 to 1,268 patients per year from 2000 to 2003.
This analysis shows that there is adequate representation of women, African Americans, Hispanic Americans, and Asian Americans on SWOG therapeutic clinical trials. In contrast, older patients continue to be under-represented, although the trend is promising; older patient enrollment onto SWOG clinical trials has increased from 25% from 1993 to 1996 to 31% from 1997 to 2000 to 38% from 2001 to 2003. With only a few exceptions, these results are reflected in each of the four most common diseases shown in Table 1. A number of factors may impact the recent increase in older patient enrollment. For instance, studies were recently developed in SWOG that either specifically targeted older patients or that asked questions or designed treatments particularly important to older populations.5 This change accounts for less than 10% of the increase in older patient enrollment since the year 2000. Greater awareness may also play a role, with more recent reports that older patients benefit from chemotherapy or combined-modality therapy in various settings.6,7 In addition, there may have been a change in the type of trials (adjuvant v advanced) available beginning in the year 2000. Fewer older patients enroll onto SWOG adjuvant disease trials (22% on adjuvant trials v 36% on advanced trials), which is an observation noted by others.8 Importantly, however, the proportion of trials identified as adjuvant trials changed little over the course of the period (1993 to 1999: 17% adjuvant trials; 2000 to 2003: 18% adjuvant trials). Analyses of trends over time may be complicated by other factors worthy of consideration, such as income and rural versus urban residence. The direct assessment of income and residence type was not available, representing a limitation of this analysis. Estimates might also be confounded by state efforts to increase clinical trial enrollment, many of which were initiated around the same time as the national year 2000 Medicare policy change.9 However, these efforts were targeted towards all patients and not just older patients. It would also be of interest to compare our results with method of payment patterns for patients who do not participate in clinical trials, but such data fall outside the realm of this data set. SWOG is currently conducting a prospective survey trial, SWOG-0316, to assess barriers to participation for patients who do not enroll onto clinical trials. This study includes patient and physician questionnaire items regarding cost barriers, including issues pertaining to Medicare. Data from this trial will be available in a few years and will help to answer this important question. The current analysis supports the hypothesis that the year 2000 Medicare policy change to allow for coverage of routine patient care costs for cancer clinical trials positively impacted older patient enrollment. Although the proportion of patients paying with Medicare alone has remained roughly constant from 1993 to 2003, the proportion of patients whose payment included Medicare plus private supplemental insurance immediately increased in conjunction with the new policy. This change accounts for approximately half of the increase in older patient enrollment in recent years. The fact that only older patients with private supplemental insurance in addition to Medicare coverage increased in participation in clinical trials indicates that the Medicare policy change has not been sufficient for many patients. This may be a result of the fact that claims for clinical trials, even for patients on Medicare-managed care plans, are processed on a fee-for-service basis and are, thus, subject to a 20% coinsurance.10-12 This coinsurance cost will often be covered by supplemental insurance, such as Medigap policies or other private insurance. However, patients on Medicare-managed care plans, who generally do not have supplemental insurance, often cannot afford the coinsurance costs for clinical trial participation.13 In effect, coverage for these patients has not improved, and indeed, our data demonstrate this. It would be beneficial to have this observation validated by other cooperative groups. The sudden increase in the proportion of patients using Medicare plus private insurance, in conjunction with the sudden increase in the proportion and number of older patient enrollments, provides evidence that the year 2000 change in Medicare policy regarding the routine care costs of clinical trials has had a positive impact on older patient enrollment for many patients. However, improvements to the payment structure for clinical trials for Medicare-managed care plan patients could increase this impact. This is particularly important in light of the new Medicare Modernization Act, which could present new challenges to enrolling older patients onto clinical trials.14 Indeed, continuing efforts to increase older patient enrollment onto clinical trials are necessary because, although older patient representation in clinical trials has increased in recent years, it remains well below the expected rate.
The authors indicated no potential conflicts of interest.
We thank the investigators of the Southwest Oncology Group (SWOG) and all their patients who are represented in this analysis, without whom this article would not have been possible. We also acknowledge the helpful suggestions of Dr Laurence Baker, chair of the SWOG, and the members of the Committee on Special Populations of the SWOG.
Supported by Public Health Service Cooperative Agreement Grants No. CA38926 and CA32102 awarded by the National Cancer Institute, Department of Health and Human Services. Presented in part at the 40th Annual Meeting of the American Society of Clinical Oncology, New Orleans, LA, June 5-8, 2004. Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.
1. Hutchins LF, Unger JM, Crowley JJ, et al: Underrepresentation of patients 65 years of age or older in cancer-treatment trials. N Engl J Med 341:2061-2067, 1999 2. Trimble EL, Carter CL, Cain D, et al: Representation of older patients in cancer treatment trials. Cancer 74:2208-2214, 1994[CrossRef][Medline] 3. Unger JM, Hutchins LF, Albain KS: Under-representation of elderly patients in cancer clinical trials: Causes and remedial strategies, in Balducci L, Lyman GH, Ershler WB, et al (eds): Comprehensive Geriatric Oncology (ed 2). New York, NY, Taylor & Francis, 2004, pp 259-274 4. Department of Health and Human Services: President Clinton takes new action to encourage participation in clinical trials. Medicare will reimburse for all routine patient care costs for those in clinical trials. White House Press Release. Washington, DC, Office of the Press Secretary, The White House, June 7, 2000. http://www.os.dhhs.gov/news/press/2000pres/20000607.html 5. Hesketh PJ, Chansky K, Lau DH, et al: Sequential vinorelbine (V) and docetaxel (D) in advanced non-small cell lung cancer (NSCLC) patients age > 70, or with performance status (PS) 2: A Southwest Oncology Group phase II trial (S0027). J Clin Oncol 22:627, 2004 (suppl, abstr 7056) 6. Sundararajan V, Mitra N, Jacobson JS, et al: Survival associated with 5-fluorouracil-based adjuvant chemotherapy among elderly patients with node-positive colon cancer. Ann Intern Med 136:349-357, 2002 7. Hershman D, Jacobson JS, McBride R, et al: Effectiveness of platinum-based chemotherapy among elderly patients with advanced ovarian cancer. Gynecol Oncol 94:540-549, 2004[CrossRef][Medline] 8. Yee KW, Pater JL, Pho L, et al: Enrollment of older patients in cancer treatment trials in Canada: Why is age a barrier? J Clin Oncol 21:1618-1623, 2003 9. Bennett CL, Adams JR, Knox KS, et al: Clinical trials: Are they a good buy? J Clin Oncol 19:4330-4339, 2001 10. Medicare: Medicare plan choices. http://www.medicare.gov/Choices/Overview.asp. 11. Centers for Medicare and Medicaid Services: Medicare coverage: Clinical trials. Program memorandum. http://www.cms.hhs.gov/coverage/8d3.asp 12. American Society of Clinical Oncology: Concerns with clinical trial benefits under Medicare advantage. ASCO News. Policy Watch, July 26, 2004. http://web1.asco.org/ac/1,1003,_12-002163-00_18-0035183-00_19-0035186-00_20-001,00.asp 13. American Society of Clinical Oncology: Letter, from Dean Gesme, Jr., MD, Chair, Clinical Practice Committee of the American Society of Clinical Oncology, to Mark A. McClellan, MD, PhD, Administrator for Centers for Medicare and Medicaid Services. July 27, 2004. http://www.asco.org/asco/downloads/CMS_letter_on_clinical_trials_072704_lthd.pdf 14. Centers for Medicare and Medicaid Services: Medicare Modernization Act. http://www.cms.hhs.gov/medicarereform/ Submitted May 27, 2005; accepted October 13, 2005.
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Copyright © 2006 by the American Society of Clinical Oncology, Online ISSN: 1527-7755. Print ISSN: 0732-183X
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ABSTRACT
INTRODUCTION
