04 Chapter Four Treatment modalities. Experience does not err, it is only your judgement that errs in expecting from her what is not in her power.

Transcription

1 Chapter Four Treatment modalities Experience does not err, it is only your judgement that errs in expecting from her what is not in her power. LEONARDO da Vinci Vol 2 esrd Ch pg 29

2 Contents 22 Incident modality 2 Prevalent modality 26 Home hemodialysis 28 Summary The incident hemodialysis population is now nearly eight times larger than in 1978, and topped 11, patients in both 26 and 27. The number of new peritoneal dialysis patients peaked at 9,8 in 199, and has since fallen to 6,6; this population now accounts for 6. percent of new dialysis patients, a ratio that continues to decline from its peak of nearly 1 percent. As of December 31, 27, more than 31, patients were receiving hemodialysis therapy, 26,3 were on peritoneal dialysis (7.2 percent of the dialysis population), and 18,739 had a functioning graft. The annual rate of growth has slowed in the prevalent hemodialysis population, from 8.7 percent in 1997 to 3.8 percent in 27, while the prevalent peritoneal dialysis population has remained quite stable. The greatest growth has occurred in the transplant population, which has increased. 6. percent each year since 21. The number of patients who receive a kidney transplant as their first ESRD therapy reached 2,66 in 27, and since 1996 has grown an average of 6.8 percent each year. In the prevalent population, the number waiting to receive a transplant reached 73, in 27, with an average annual growth of 9.9 percent since 1996, though this rate of change has fallen to 7 8 percent in the last three years. In the incident hemodialysis population, Medicare only, Medicare plus Medicaid, and Medicare under health maintenance organizations or managed care plans continue to cover 7 percent of patients, while private insurers and Medicare as secondary payor cover the remaining 2 percent. Among new peritoneal dialysis patients, in contrast, the 27 distribution was 62 and 38 percent. Medicare covers only 3.1 percent of incident transplant patients; 33.3 percent have Medicare as secondary payor coverage, and 31.7 percent are covered by other insurers. These differences may significantly affect both patient benefits particularly those related to prescription drugs and provider revenue streams from services such as dialysis therapy, injectables, treatments and medications for transplantation, and diagnostic testing. Maps of incident rates by modality illustrate nationwide changes since 1997, changes which may reflect the recent consolidation of ESRD providers, their varying policies regarding therapy, and their individual likelihoods of using dialytic or transplant therapies in the incident population. Changes in peritoneal dialysis use, for example, show distinct geographic patterns that differ from the distribution of the hemodialysis population. The rates may also reflect changes in access to organs for renal transplantation. The growing consolidation of providers into larger chains has long been clear, and two large chains now treat the great majority of dialysis patients in the U.S. In the early 199s, just one in seven dialysis patients received treatment in a chain-owned unit; in 27, the number was nearly seven in ten. The market share of independent units has been relatively stable, at percent since 2; hospital-based units, however, are now treating just 13 percent of the prevalent hemodialysis population. With the use of peritoneal dialysis varying considerably by provider group, further consolidation may raise concerns over modality choice and its relation to provider practices. With peritoneal dialysis long Ch pg 2

3 the dominant home therapy, home hemodialysis has received little attention in the past 1 years. Its use peaked in 198, with,817 prevalent patients. A number of government programs, paying home aids to help deliver the therapy, ended soon afterwards, contributing to a steady decline in use. Now, however, there appears to be renewed interest in the use of daily home hemodialysis, fueled by publication of results from single centers using the therapy, as well as new products being introduced for therapy delivery. In addition, a new NIH study is in progress, comparing the safety and efficacy of daily or overnight home hemodialysis to that of in-center therapy. The introduction of the new bundled payment system for dialysis, which includes injectable medications, may have an impact on modality selection. Since peritoneal dialysis patients appear to use far lower amounts of erythropoiesis stimulating agents, IV vitamin D, and IV iron, there may be a clear incentive to use this type of home therapy, improving provider margins through lower costs under a fixed payment model. The current payment model may, however, provide a disincentive to the use of daily home hemodialysis. Based on three treatments per week the dominant therapy regime of in-center hemodialysis the model does not allow payment for additional weekly therapy. If the reported advantages of daily home hemodialysis, which also include lower use of ESAs, IV vitamin D, and IV iron, along with lower rates of hospitalizations for fluid overload secondary to better volume control, are demonstrated in the large randomized NIH trial, these advantages should be addressed in the payment model to encourage use of the therapy. But while the savings in Part A hospitalization services may be greater than those in Part B outpatient services, they cannot be combined into the outpatient payment system as it is currently configured. Payment reform, which was intended to control the costs of IV injectables, may therefore have unintended consequences, disadvantaging home hemodialysis therapies. The efficacy of the therapy should continue to be the basis of the payment policy, and conclusions on this need to await the results of the NIH clinical trial and other more comprehensive observational studies. Figures.1 2; see page 366 for analytical methods. Incident ESRD patients (.1); December 31 point prevalent patients (.2). 1ii Incident patient counts (USRDS), by first modality Number of patients (in thousands) Hemodialysis (27: 11,688) Peritoneal dialysis (6,6) Total dialysis (18,33) Transplant (2,66) 2ii Prevalent patient counts (USRDS), by modality Number of patients (in thousands) Hemodialysis (27: 31,26) Peritoneal dialysis (26,3) Transplant (18,739) OPTN transplant wait-list (73,) TREATMENT MODAlITIES 29 USRDS Annual Data Report Vol 2 esrd Ch pg 21

4 In 27, close to 1, new ESRD patients began therapy on hemodialysis, 6,376 were placed on peritoneal dialysis, and 2, received a preemptive transplant (these numbers exclude patients with missing demographic information). The rate of ESRD incidence reached 32 per million population for hemodialysis, 2.8 for peritoneal dialysis, and 8.1 for transplant. Dramatic differences by race persist, with the rate for African Americans starting therapy on hemodialysis, for example, at 92 per million population nearly four times greater than the rate of 28 reported for whites. The rate for patients receiving a preemptive transplant, in contrast, is highest among Asians, at 32.3 compared to just 6 7 in the white and African American populations. Past studies have suggested high mortality and significant movements between modalities in the first 9 days after ESRD initiation. Besides a small number regaining kidney function, most of the nearly 8 percent of 27 incident patients lost during the first 9 days died before reaching day 9. Nearly 13 percent of those on hemodialysis at initiation were lost at 9 days, while transplant and peritoneal dialysis therapies gained 22. and.3 percent, respectively. More than 3 percent of patients were listed as having an unknown modality at day 9, up from only.12 percent at initiation; this is due primarily to a large number of sicker patients being admitted to hospitals and dialyzed with unspecified dialysis modality (a billing issue) during their hospital stays. Between initiation and day 9, rates per million population fell from 32 to 283 for hemodialysis, while those for other modalities increased from 8.1 to 1. for transplant, and from 2.8 to 21.9 for peritoneal dialysis. Table.a; see page 366 for analytical methods. Incident ESRD patients, 27; unknowns dropped. *Values for cells with ten or fewer patients are suppressed.. Zero values in this cell. aii Incident counts & adjusted rates at initiation & at day 9 (per million population), by age, gender, race, ethnicity, & primary diagnosis, 27 At initiation At day 9 Number of patients Rate per million population Number of patients Rate per million population HD PD Tx Unk. HD PD Tx Unk. HD PD Tx Unk. HD PD Tx Unk * * ,66 1, ,78 1, ,11 2,717 1, ,688 2,827 1,67 1, ,92 1, , ,232 1, , , , , , Male 6,9 3,38 1, ,826 3,622 1,88 2, Female 3,837 2,991 1, ,362 3,91 1,178 1, White 6,99,612 1, ,282,87 2,2 2, African American 29,79 1, ,12 1, Native American 1, , Asian, , Hispanic 12, , Non-Hispanic 87,17,6 2, ,3,932 2,82 3, Diabetes,66 2, ,2 2, Hypertension 28,637 1, ,98 1, Glomerulonephritis 6, *, Cystic kidney 1, , Other urologic 1, * 1, Other cause 12, , , Unknown/missing, , All 99,886 6,376 2, ,188 6,713 3,63 3, Chain-owned units treated nearly 6 percent of incident hemodialysis patients in 27 up only slightly from 6 percent the prior year while non-chain and hospital-based units treated 18. and 1. percent of patients, respectively. The number of peritoneal dialysis patients treated in chain-owned units has remained stable since 22, at just over,. Figure.3; see page 366 for analytical methods. Incident dialysis patients. 3ii Number of patients (in thousands) Hemodialysis Incident dialysis patient counts, by first modality & unit type Chain Non-chain Hospital-based Unknown Peritoneal dialysis Ch pg 22

5 ii ii Hemodialysis: Incident patient distribution, by first modality & payor 1 Geographic variations in unadjusted incident rates (per million population), by first modality & HSA Hemodialysis: Hemodialysis 8 6 Other/unknown Medicare secondary payor Medicare HMO Medicare & Medicaid 1 Medicare Peritoneal dialysis: Peritoneal dialysis Peritoneal dialysis: Transplant Transplant: Transplant: orty-eight percent of new hemodialysis patients are covered solely by Medicare, 13.8 percent have dual Medicare/Medicaid coverage, and 13. percent are covered by a Medicare HMO provider up from 11.6 percent in 26. Medicare covers 3. and 28. percent of new peritoneal dialysis and transplant patients, while 9.6 and. percent are dually-enrolled, and 8.9 and 2.7 percent have HMO coverage. Figure.; see page 366 for analytical methods. Incident ESRD patients. F hoices of initial modality vary widely across the country. In 26 27, for example, unadjusted incident rates for patients initiating treatment on hemodialysis were greatest in states along the Atlantic Seaboard and the Gulf Coast, averaging 2 per million population in the upper quintile more than two times greater than the lower quintile. An opposite pattern is evident for patients with a preemptive C transplant. Rates for these patients are highest in the Upper Midwest, averaging 12.2 per million in the upper quintile nearly six times higher than in the lower quintile. Rates for patients starting therapy on peritoneal dialysis are highest in the southern regions, averaging 8.7 per million in the upper quintile. Figure.; see page 366 for analytical methods. Incident ESRD patients. 29 USRDS Annual Data Report Incident modality Treatment modalities 2 Vol 2 esrd Ch pg 23

6 On December 31, 27, nearly 33, ESRD patients were receiving hemodialysis therapy, 2,72 were being treated with peritoneal dialysis, and 1,373 had a functioning graft. The African American population has by far the greatest disease rates per million population, at, for hemodialysis, 19 for peritoneal dialysis, and 88 for transplant. Rates for peritoneal dialysis and transplant are nearly equal in the Native American and Asian populations; at 2,3, however, the rate of Native Americans receiving hemodialysis is 6 percent greater than that found among people of Asian descent. Table.b; see page 366 for analytical methods. December 31, 27 point prevalent ESRD patients; unknowns dropped. *Values for cells with ten or fewer patients are suppressed. bii Prevalent counts & adjusted rates per million population, by age, gender, race, ethnicity, & primary diagnosis, 27 Number of patients Rate per million population HD PD Tx Unk. HD PD Tx Unk , , ,89,6 2, ,68 11,7 79,91 1 2, , ,1,72 21,63 9, , ,3 3,132,727, Male 183,36 13,328 91, , Female 1,179 12,2 62, White 18,27 16,967 11, African American 129,8 6,88 29, , Native American, ,66 * 2, * Asian 1,982 1,611 8, , Hispanic 8,268 3,12 18, , Non-Hispanic 28,37 22, , , Diabetes 17,272 8,78 36, Hypertension 9,2 6,388 23, Glomerulonephritis 33,92,19 1, Cystic kidney 8,276 1,33 1, Other urologic 6,61 9, Other cause 29,73 3,78 22, Unknown/missing 12,761 1,66 9, All 333,61 2,72 1, , ii Number of patients (in thousands) Hemodialysis Prevalent dialysis patient counts, by modality & unit type Chain Non-chain Hospital-based Unknown Peritoneal dialysis Between 2 and 27, the percentage of prevalent patients treated by chain-owned providers rose from 6.3 to 69.2 for hemodialysis, and from. to 66.2 for peritoneal dialysis. Hospital-based units, in contrast, now treat 12.7 and 1. percent of prevalent hemodialysis and peritoneal dialysis patients, down from 18.8 and 21.9 percent in 2. Figure.6; see page 366 for analytical methods. December 31 point prevalent dialysis patients. Ch pg 2

7 8 ii 7 ii Hemodialysis: 1997 Prevalent patient distribution, by modality & payor 1 Geographic variations in unadjusted prevalent rates (per million population), by modality & HSA Hemodialysis: 27 Hemodialysis 8 6 Other/unknown Medicare secondary payor Medicare & Medicaid 379 Medicare ,13 1,38 Peritoneal dialysis: 1997 Peritoneal dialysis ,13 1, Peritoneal dialysis: Transplant Transplant: Transplant: ine in ten prevalent hemodialysis patients had some form of Medicare coverage in 27; 2 percent were covered solely by Medicare, while nearly 33 percent had dual Medicare/Medicaid coverage a number stable since the mid-199s. In the transplant population, in contrast, just 3 percent are covered solely by Medicare. Transplant patients who are younger than 6 and not disabled lose their entitlement after three years with a functioning graft. Figure.7; see page 366 for analytical methods. December 31 point prevalent ESRD patients. N n 27, prevalent rates for patients on hemodialysis averaged 1,86 per million population in the upper quintile, and followed geographic patterns similar to those found in incident patients with the highest rates in states along the Atlantic Seaboard and Gulf Coast. In 27, rates for patients on peritoneal dialysis averaged 172 per mil- I lion in the upper quintile, while those for patients with a transplant averaged 92 per million and were highest in the northern tier of states, the Upper Midwest, portions of Texas, and the upper regions of Arizona and New Mexico. Figure.8; see page 366 for analytical methods. December 31 point prevalent ESRD patients. 29 USRDS Annual Data Report 1 76 Prevalent modality Treatment modalities Medicare HMO 2 Vol 2 esrd Ch pg 2

8 Of the 1,23 patients beginning ESRD therapy on home hemodialysis in 2 27, one in three were age 6, and 3 percent were age 7 or older. Fiftyseven percent of these new patients were men, two in three were white, and 8. percent were Hispanic. Primary diagnoses of diabetes and hypertension each accounted for 3 36 percent of the population. Table.c; see page 366 for analytical methods. Incident home hemodialysis patients, 2 27 combined.*values for cells with ten or fewer patients are suppressed. New ESRD patients treated with home hemodialysis are far more likely to receive assistance than those treated with center hemodialysis or with peritoneal dialysis, at 1 percent compared to percent. While these data may seem to imply that home hemodialysis patients are very disabled, many of those classified as home patients may be institutionalized and receiving their dialysis in a nursing home setting. Figure.1; see page 366 for analytical methods. Incident dialysis patients, 27. cii 1ii Home hemodialysis: incident patient distribution, 2 27 Column Total percent -19 * Male Female White African American 32.2 Native American *.2 Asian Other/unknown *.6 Hispanic Non-Hispanic 1, Diabetes Hypertension Glomerulonephritis 72.7 Cystic kidney Other urologic Other cause Unknown/missing All 1,23 1. Incident dialysis patients, by modality & assistance, 27 Assistance No assistance Center HD Home HD PD All Assistance is defined as any one of the following pre-existing conditions, as identified on the Medical Evidence form: inability to ambulate, inability to transfer, needing assistance with daily activities, institutionalized, assisted living, nursing home, or other institution. Illinois and Florida accounted for 3 percent of incident home hemodialysis patients in 2 27, with 31. and 22. percent. Nine percent of patients lived in Ohio. Figure.9; see page 366 for analytical methods. Incident home hemodialysis patients, 2 27 combined. 9ii Percent of U.S. home HD patients 11ii Incident home hemodialysis patients in the top ten states, 2 27 IL FL OH TX CA GA NY MI NC NJ Incident home hemodialysis patients, by geographic location Urban 2 Rural Unknown In 27, the percentage of incident home hemodialysis patients living in an urban setting fell slightly, to 83.. Fifteen percent of patients live in a rural setting, down from a peak of 39 percent in 198. Figure.11; see page 366 for analytical methods. Incident home hemodialysis patients. Ch pg 26

9 dii 13ii Home hemodialysis: prevalent patient distribution, 27 Column Total percent , Male 1,78 9. Female 1,21. White 1,93 6. African American Native American 21.7 Asian Other/unknown 19.6 Hispanic Non-Hispanic 2, Diabetes Hypertension Glomerulonephritis Cystic kidney 13.1 Other urologic Other cause Unknown/missing All 2, Prevalent dialysis patients, by modality & assistance, 27 Assistance No assistance Center HD Home HD PD All In 27, 11.1 percent of prevalent home hemodialysis patients received assistance, compared to 7. percent of those on center hemodialysis and 2. percent of those receiving peritoneal dialysis. Figure.13; see page 366 for analytical methods. December 31 point prevalent dialysis patients, 27. Of the nearly 3, prevalent patients treated with home hemodialysis in 27, percent were age 6, and six in ten were male. Table.d; see page 366 for analytical methods. December 31 point prevalent home hemodialysis patients, ii Percent of U.S. home HD patients 1ii Prevalent home hemodialysis patients in the top ten states, 27 IL CA FL TX NY GA OH WA MI IN Prevalent home hemodialysis patients, by geographic location Urban Rural 2 Unknown Seventeen percent of prevalent patients treated with home hemodialysis in 27 lived in Illinois, while California, Florida, and Texas each accounted for 7 8 percent of the home hemodialysis population. Figure.12; see page 366 for analytical methods. December 31 point prevalent home hemodialysis patients, 27. The percentage of prevalent home hemodialysis patients residing in urban areas peaked at 7. in 2, and since then has remained near Twenty-four percent live in rural areas, down from a high of nearly 39 percent in Figure.1; see page 366 for analytical methods. December 31 point prevalent home hemodialysis patients. Home hemodialysis TREATMENT MODAlITIES 29 USRDS Annual Data Report Vol 2 esrd Ch pg 27

10 summary chapter In 27, the rate of ESRD incidence reached 32 per million population for transplant..a for hemodialysis, 2.8 for peritoneal dialysis, & 8.1 Chain-owned units treated 6% of incident hemodialysis patients in Medicare covers 8% of new hemodialysis patients, compared to 68% of patients starting therapy with a transplant.. In 27, the prevalent rate for hemodialysis patients reached, per million population among African Americans, compared to 72 among whites..b Chain-owned units treated 69% of prevalent hemodialysis patients in Nine in ten prevalent hemodialysis patients had some form of Medicare coverage in In 2 27, 1,23 patients began ESRD therapy on home hemodialysis..c Illinois & Florida account for 3% of incident ESRD patients treated with home hemodialysis in In 27, 2,999 prevalent ESRD patients received home hemodialysis..d Illinois accounted for 16.8% of prevalent ESRD patients receiving home hemodialysis in summary Ch pg 28