Reimbursement policy and androgen-deprivation therapy for prostate cancer.
03 Nov 2010-The New England Journal of Medicine (Massachussetts Medical Society)-Vol. 363, Iss: 19, pp 1822-1832
TL;DR: Changes in the Medicare reimbursement policy in 2004 and 2005 were associated with reductions in ADT use, particularly among men for whom the benefits of such therapy were unclear.
Abstract: BACKGROUND The Medicare Modernization Act led to moderate reductions in reimbursement for androgen-deprivation therapy (ADT) for prostate cancer, starting in 2004 and followed by substantial changes in 2005. We hypothesized that these reductions would lead to decreases in the use of ADT for indications that were not evidence based. METHODS Using the Surveillance, Epidemiology, and End Results (SEER) Medicare database, we identified 54,925 men who received a diagnosis of incident prostate cancer from 2003 through 2005. We divided these men into groups according to the strength of the indication for ADT use. The use of ADT was deemed to be inappropriate as primary therapy for men with localized cancers of a low-to-moderate grade (for whom a survival benefit of such therapy was improbable), appropriate as adjuvant therapy with radiation therapy for men with locally advanced cancers (for whom a survival benefit was established), and discretionary for men receiving either primary or adjuvant therapy for localized but high-grade tumors. The proportion of men receiving ADT was calculated according to the year of diagnosis for each group. We used modified Poisson regression models to calculate the effect of the year of diagnosis on the use of ADT. RESULTS The rate of inappropriate use of ADT declined substantially during the study period, from 38.7% in 2003 to 30.6% in 2004 to 25.7% in 2005 (odds ratio for ADT use in 2005 vs. 2003, 0.72; 95% confidence interval [CI], 0.65 to 0.79). There was no decrease in the appropriate use of adjuvant ADT (odds ratio, 1.01; 95% CI, 0.86 to 1.19). In cases involving discretionary use, there was a significant decline in use in 2005 but not in 2004. CONCLUSIONS Changes in the Medicare reimbursement policy in 2004 and 2005 were associated with reductions in ADT use, particularly among men for whom the benefits of such therapy were unclear. (Funded by the American Cancer Society.).
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TL;DR: The diagnostic accuracy of multiparametric magnetic resonance imaging (mpMRI) for the detection of clinically significant prostate cancer (PCa) is concluded that mpMRI is able to detect significant PCa and may used to target prostate biopsies.
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TL;DR: In this paper, the authors used a national sample of Medicare beneficiaries with prostate cancer to investigate the patterns and cost of Proton Radiotherapy (PRT) delivery, as well as the early treatment-related toxicity associated with PRT compared with IMRT.
Abstract: Over the past decade, intensity modulated radiotherapy (IMRT) has become the standard form of radiotherapy for the treatment of prostate cancer, accounting for more than 80% of all radiotherapy (1) Even as IMRT has been widely adopted, other radiotherapy modalities have come to market, most notably proton radiotherapy (PRT) Although PRT predates IMRT, dissemination of PRT has been increasing rapidly in recent years In part because of its high capital cost, Medicare is reported to reimburse PRT at a rate 14 to 25 times that of IMRT (2–4), despite many unexplored questions
First, there is a lack of data regarding national patterns of use and the true cost of PRT among Medicare beneficiaries Currently, there are only nine PRT centers in operation in the United States (5), and this relatively low treatment capacity limits costs However, eight other centers are in development (5), along with smaller and more affordable proton machines (6), conceivably opening the door to more widespread adoption of PRT across the country
Second, the Institute for Clinical and Economic Review concluded unanimously that the state of current knowledge of comparative clinical effectiveness was “insufficient” (7,8) Because differences in cancer cure rates and survival from prostate cancer treatment often take many years to become evident, it has been suggested that initial study of prostate cancer treatments should focus on treatment-related toxicity (8) Proponents of PRT argue that the physical properties of protons may decrease the most common side effects associated with prostate radiotherapy—gastrointestinal and genitourinary toxicity (9) Early outcomes from single-arm, prospective trials investigating PRT are forthcoming, indicating low levels of radiation-induced toxicity with early follow-up (10,11) However, IMRT itself has a robust literature describing excellent efficacy and low toxicity in the treatment of prostate cancer (12) Therefore, it is unclear that PRT offers a statistically significant benefit beyond IMRT Prior studies investigating PRT in Medicare beneficiaries using the Surveillance, Epidemiology, and End Results–Medicare database have been single-institution studies (13,14) and, therefore, are not of the whole country These studies (13,14) noted a statistically significant reduction of gastrointestinal toxicity for patients undergoing IMRT compared with PRT A comprehensive comparison of PRT with IMRT requires examination of the entire country for the most recent years available
As more PRT centers become operational, it will be crucial for patients, providers, and policy makers to understand the cost and national pattern of adoption of PRT and the incidence of treatment-related toxicity compared with IMRT Therefore, we used a national sample of Medicare beneficiaries with prostate cancer to investigate the patterns and cost of PRT delivery, as well as the early treatment-related toxicity associated with PRT compared with IMRT
141 citations
TL;DR: Although S BRT was associated with lower treatment costs, there appears to be a greater rate of GU toxicity for patients undergoing SBRT compared with IMRT, and prospective correlation with randomized trials is needed.
Abstract: Purpose Stereotactic body radiation therapy (SBRT) is a technically demanding prostate cancer treatment that may be less expensive than intensity-modulated radiation therapy (IMRT). Because SBRT may deliver a greater biologic dose of radiation than IMRT, toxicity could be increased. Studies comparing treatment cost to the Medicare program and toxicity are needed. Methods We performed a retrospective study by using a national sample of Medicare beneficiaries age ≥ 66 years who received SBRT or IMRT as primary treatment for prostate cancer from 2008 to 2011. Each SBRT patient was matched to two IMRT patients with similar follow-up (6, 12, or 24 months). We calculated the cost of radiation therapy treatment to the Medicare program and toxicity as measured by Medicare claims; we used a random effects model to compare genitourinary (GU), GI, and other toxicity between matched patients. Results The study sample consisted of 1,335 SBRT patients matched to 2,670 IMRT patients. The mean treatment cost was $13,645 ...
134 citations
TL;DR: Urologists who acquired ownership of IMRT services increased their use of IM RT substantially more than urologist who did not own such services, and allowing urologists to self-refer for IMRT may contribute to increased use of this expensive therapy.
Abstract: BACKGROUND Some urology groups have integrated intensity-modulated radiation therapy (IMRT), a radiation treatment with a high reimbursement rate, into their practice. This is permitted by the exception for in-office ancillary services in the federal prohibition against self-referral. I examined the association between ownership of IMRT services and use of IMRT to treat prostate cancer. METHODS Using Medicare claims from 2005 through 2010, I constructed two samples: one comprising 35 self-referring urology groups in private practice and a matched control group comprising 35 non–self-referring urology groups in private practice, and the other comprising non–self-referring urologists employed at 11 National Comprehensive Cancer Network centers matched with 11 self-referring urology groups in private practice. I compared the use of IMRT in the periods before and during ownership and used a difference-in-differences analysis to evaluate changes in IMRT use according to self-referral status. RESULTS The rate of IMRT use by self-referring urologists in private practice increased from 13.1 to 32.3%, an increase of 19.2 percentage points (P<0.001). Among non–self-referring urologists, the rate of IMRT use increased from 14.3 to 15.6%, an increase of 1.3 percentage points (P = 0.05). The unadjusted difference- indifferences effect was 17.9 percentage points (P<0.001). The regression-adjusted increase in IMRT use associated with self-referral was 16.4 percentage points (P<0.001). The rate of IMRT use by urologists working at National Comprehensive Cancer Network centers remained stable at 8.0% but increased by 33.0 percentage points among the 11 matched self-referring urology groups. The regressionadjusted difference-in-differences effect was 29.3 percentage points (P<0.001). CONCLUSIONS Urologists who acquired ownership of IMRT services increased their use of IMRT substantially more than urologists who did not own such services. Allowing urologists to self-refer for IMRT may contribute to increased use of this expensive therapy. (Funded by the American Society for Radiation Oncology.)
129 citations
TL;DR: Instrumental variable analysis is an increasingly popular method to establish causal conclusions from observational comparative effectiveness research (CER) studies, and there is a consensus that more research on the validity of instruments in observational CER is needed.
Abstract: Instrumental variable analysis is an increasingly popular method in comparative effectiveness research (CER). In theory, the instrument controls for unobserved and observed patient characteristics that affect the outcome. However, the results of instrumental variable analyses in observational settings may be biased if the instrument and outcome are related through an unadjusted third variable: an "instrument-outcome confounder." The authors identified published CER studies that used instrumental variable analysis and searched the literature for potential confounders of the most common instrument-outcome pairs. Of the 187 studies identified, 114 used 1 or more of the 4 most common instrument categories: distance to facility, regional variation, facility variation, and physician variation. Of these, 65 used mortality as an outcome. Potential unadjusted instrument-outcome confounders were observed in all studies, including patient race, socioeconomic status, clinical risk factors, health status, and urban or rural residency; facility and procedure volume; and co-occurring treatments. Only 4 (6%) instrumental variable CER studies considered potential instrument-outcome confounders outside the study data. Many effect estimates may be biased by the failure to adjust for instrument-outcome confounding. The authors caution against overreliance on instrumental variable studies for CER.
119 citations
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