From: "Katherine Pearson" <katherine.pearson@arborresearch.org>
Subject: DOPPS Practice Monitor: Latest Update on Trends in US Hemodialysis Practice Following Policy Changes
Date: May 1, 2013 3:52:48 PM EDT
To: Communications <Communications@arborresearch.org>
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For immediate release
Inquiries to: Katherine Pearson, Senior Communications Specialist
Arbor Research Collaborative for Health
734.665.4108; Com
munications@ArborResearch.org
DOPPS Practice Monitor: Latest Update on Trends in US Hemodialysis Practice Following Policy ChangesMajor payment and regulatory changes have affected United States (US) dialysis care in recent years. Emerging trends in hemodialysis (HD) practice through December 2012, based on a sample of US dialysis facilities, are included in the latest update to the Dialysis Outcomes and Practice Patterns Study (DOPPS) Practice Monitor (DPM, at DOPPS.org/DPM), run by Arbor Research Collaborative for Health.
Summary: Since the introduction of the new US bundled payment system for dialysis in January 2011, we have seen a substantial decrease in hemoglobin (Hgb) levels and epoetin dose, as well as an increase in intravenous (IV) iron use and serum ferritin and parathyroid hormone (PTH) levels. These metrics changed most notably in 2011 (especially after the June 2011 label revision for erythropoiesis-stimulating agents ([ESA], e.g., epoetin), and generally have stabilized by mid to late 2012.
Achievement of minimum dialysis adequacy (Kt/V >1.2, urea reduction ratio [URR] >65%) has improved since August 2010 (now at 97%), possibly in response to the new Quality Incentive Program (QIP) measure for URR >65%.
International Comparisons: We have not observed similar changes recently in other DOPPS countries, providing additional evidence that US payment changes and the ESA label revision have driven trends in US dialysis practice. For the first time in over a decade that the DOPPS has followed international trends, average Hgb levels in our study are lower in the US than in Europe, Canada, and Australia/New Zealand. Median prescribed epoetin doses are now generally similar to those other countries, while serum ferritin levels are now substantially higher in the United States.
Recent Trends (Additional Details) – Notable trends in HD practice in the DOPPS national sample from August 2010 to December 2012 are as follows:
· Dialysis Adequacy and Dialysis Session Length: Among those on HD for more than a year, the percentage of patients with a urea reduction ratio (URR) >65% increased from 91% to 97%, and the percentage of patients with single pool Kt/V >1.2 increased from 93% to 97%. The percentage of patients with URR ≥65% is now linked to Medicare reimbursement under the end-stage renal disease (ESRD) QIP; this will change to Kt/V ≥1.2 starting in 2015 payment year.
The percentage of all HD patients with a short dialysis session length (<210 min/session) declined from 34% to 29%. This likely contributed to the higher URR and Kt/V values, and it contrasts with a longer-term trend toward shorter dialysis treatment time in the United States during the last decade.
· Anemia: Hgb levels – Mean Hgb among all patients declined from 11.5 g/dL in August 2010 to 10.9 g/dL in March 2012, with the largest decline seen since the June 2011 ESA label revision. Mean Hgb levels have been stable since March 2012. Among patients treated with an ESA, the percentage with Hgb >12 g/dL (also now tied to Medicare reimbursement) declined substantially, from 26% to 9%, while the percentage with Hgb <10 g/dL increased from 9% to 20%. In our most recent data, 4-5% of patients had Hgb <9 g/dL.
Epoetin – Among patients receiving IV epoetin, mean prescribed dose decreased by 35% to 13,300 units/week, with the greatest decline after the June 2011 ESA label revision and a modest decline thereafter. High doses showed the greatest decline: >50,000 units/week declined from 11% to 3% of prescriptions. The average administered IV epoetin dose decreased by 44% to 11,100 units/week. (Decline is greater than for prescribed dose because doses are now withheld more frequently.)
IV iron and iron stores – IV iron use during a month increased from 55% to 68% of patients, while median serum ferritin levels (indicative of iron stores) increased from 561 to 794 ng/ml, and median transferrin saturation (TSAT) increased from 28% to 29%. In December 2012, 16% of patients had serum ferritin >1200 ng/mL. The increase in IV iron use occurred principally in 2011 and appears to have stabilized in 2012.
· Mineral Bone Disorder (MBD): Serum PTH levels increased by 28% from August 2010 to April 2011, and have been generally stable since. In December 2012, the prevalence of very high PTH values (defined here as PTH >600 pg/mL) was 24% among black HD patients and 14% among non-black patients. While there has been no clear change in overall use of MBD medications, our survey of US medical directors indicates a shift to higher upper target PTH levels. Median serum calcium levels have now risen slightly (by 0.1 mg/dL), while serum phosphorus has remained relatively constant.
Future monitoring of these trends is warranted. Trends should be confirmed with national data, when available, and their effect on clinical outcomes understood. Centers for Medicare and Medicaid Services (CMS) data indicate that the rate of red blood cell transfusions increased somewhat since 2010, while mortality and hospitalization rates have shown a possible slight decline (link #1 below).
About the DPM: The DPM reports representative data in more than 800 regularly updated charts, figures, and data tables. The DPM is based on a sample of 3200 to over 4000 patients in approximately 100 to 120 US dialysis units since its inception in August 2010. It provides comparisons and trends over time (representative of the United States as a whole), using weighting techniques. Data are also provided by race and facility types. Research papers describing the DPM method, key recent findings and analysis, and commentary have been published (links at DOPPS.org/DPM). DPM data are aggregated across dialysis organizations and facilities. Aggregated trends may not reflect trends in individual dialysis organizations or facilities and are not intended to provide oversight of performance in individual dialysis organizations or facilities.
About the DOPPS: The DOPPS is a prospective cohort study investigating practices related to the best outcomes for HD patients in over 20 countries. Administered by the nonprofit Arbor Research Collaborative for Health of Ann Arbor, Mich., the DOPPS programs are supported by research grants from its principal sponsors Amgen (founding sponsor, since 1996), Kyowa Hakko Kirin (since 1999, in Japan), Sanofi Renal (since 2009), AbbVie (since 2009), Baxter (since 2011), Vifor Fresenius Renal Pharma (since 2011), and Fresenius Medical Care North America (since 2012), without restrictions on publications. Arbor Research has a broad base of funding that also includes support from four divisions of the US Department of Health and Human Services.
Dialysis in the United States: More than 380,000 people receive long-term dialysis for the treatment of end-stage kidney failure in the United States. The majority are covered by Medicare; 2008 Medicare expenditures for dialysis patients approached $21 billion, or 4.6% of the total Medicare budget. Links to recent payment policy and regulatory changes include:
1. CMS ESRD Prospective Payment System Overview of 2012 Claims-Based Monitoring Program
2. Final Rule for CY 2013 Bundled Payment and PY 2015 Quality Incentive Program
3. FDA Drug Safety: Modified dosing recommendations to improve the safe use of ESAs in CKD.
<<April2013-DPM-media-release-final.docx>>
________________________________
Katherine Pearson, MPP
Senior Communications Specialist
Arbor Research Collaborative for Health
340 E. Huron, Suite 300
Ann Arbor, MI 48104
Tel: +1 (734) 665-4108
Fax: +1 (734) 665-2103
Katherine.Pearson@ArborResearch.org
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