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2012 May

A new player: Affymax wins approval for a new anemia drug

What’s next for ‘incentivizing’ quality?

by Mark E. Neumann 24. July 2011 14:17


Last week, CMS offered a primer on the upcoming Quality Incentive Program to the renal community. While most providers are prepared for the program’s initiation in January, it’s the next round — 2013 and beyond — that could prove controversial.

CMS released the proposed rules for the ESRD Quality Incentive Program (QIP) on July 1, along with a proposed rule for changes to the ESRD Prospective Payment System for 2012. There were some good news items in that proposal for dialysis clinics. According to an analysis by Avalere Health LLC:

  • CMS proposes to adjust payment rates for both the old composite rate and the new PPSbundled rate by 1.8%. The proposed 2012 base composite rate would be $141.52, which includes a Part D add on drug payment of $0.49. The proposed 2012 bundled, unadjusted base PPS rate would be $234.02.
  • CMS proposes to keep the dollar amount associated with the drug-add on factor, or DAF, constant at $20.33, resulting in a proposed 2012 rate of 14.4%, reduced from 14.7% in 2011. Based on the agency’s calculations, Avalere reports, the DAF would reflect an increase in facility drug expenditures of 1.4%, which is offset by an expected population growth of 4.2%. This would reflect a decrease in per-patient growth in drug expenditures of 2.7%. 
  • For ESRD facilities transitioning to the new PPS payment system, CMS proposes to eliminate the inclusion of antibiotics (when used in the home to treat an infection of the catheter site or peritonitis associated with peritoneal dialysis) as part of composite rate drugs, and to make these items eligible for outlier payment. CMS also proposes to exclude thrombolytic drugs and include anabolic steroids as eligible outlier service drugs.
  • CMS proposes to allow vancomycin to be separately billed when used for non-ESRD purposes.

Finally, CMS has several technical corrections, including its inadvertent omission of the assay of protein by other source laboratory test from the list of lab tests to be included in the bundled payment.

The QIP
The most complex and controversial issue for providers, however, involves the QIP for payment years 2013 and 2014, which will be based upon outcomes in 2011 and 2012. As NN&I has reported, the indicator for the percent of patients with a hgb less than 10 g/dL would be retired in 2013 in response to changes in the labeling for erythropoiesis-stimulating agents as required by the FDA. CMS would also retire use of URRs in 2014, replacing that measure with Kt/V to monitor dialysis adequacy. The Kt/V for hemodialysis patients would be measured at Kt/V ≥ 1.2, while a Kt/V of 1.7 would be the measure for peritoneal dialysis patients.

Whether or not the FDA is overreacting to the dangers of a high hemoglobin range (see our Viewpoint section in the forthcoming August issue of NN&I), it would seem logical that CMS, as a sister federal agency, would have to make adjustments to its policy as well. There are some concerns about patient safety and the fear that providers might under-dose patients if there is no floor on the hgb range. We have to assume that both patients and dialysis center staff don’t want to return to the days of sending patients to the hospital for a blood transfusion to boost their hgb range.

But the proposed rule for the QIP after 2012 also puts greater pressure on clinics to perform. It calls for a revised penalty scale and new quality measures in 2014. In total, there would be five clinical measures and three reporting measures. In addition to the anemia and adequacy measures, the QIP clinical measures would evaluate performance on:

  • Vascular access type: This would be a measure based on the percentage of patients receiving AV fistula treatment with 2 needles during the last HD treatment of the month, and the percentage of patients combined receiving treatment with a catheter 90 days or longer prior to last HD session.
  • Vascular access infections: This measure will look at the overall access-related bacteremia rate among adult chronic HD patients.
  • Standard hospitalization admissions

For reporting measures, CMS would include:

  • Mineral metabolism: evaluate serum calcium and serum phosphorus levels
  • Patient Experience of Care survey: This measure would be based on whether providers successfully fielded a patient survey during the performance period
  • NHSN dialysis event reporting: This measure would be based on the reporting of certain dialysis-related infections to the Centers for Disease Control and Prevention.

The five clinical measures have a total combined weight of 90% for all measures within the QIP; the three reporting measures have a combined weight of 10%.

Better performance required
In addition to adding new measures, CMS is proposing to stiffen the penalties if facilities don’t achieve them. For the five proposed clinical measures, clinics would be awarded 0 to 10 points for achievement. The number of points the facility earns depends on where the facility’s quality measure score falls in the achievement range, which is a scale between an achievement threshold and a benchmark.

Those achievement points would then be matched to an improvement score based on how much the clinic improved during the performance period from baseline.

For the reporting measures, 10 points will be assigned to facilities that complete required training and successfully report on the measure. Five points will be assigned to facilities that complete training but do not successfully report. Facilities that do not enroll/complete training will receive 0 points.

How do you get your total score?
To get your total clinical and reporting measures score, CMS proposes to calculate the performance score for each measure, multiply each measure by its assigned weight, add each score together, and round to the nearest integer. CMS estimates that a provider/facility will have to score a minimum of 60 points to avoid a payment reduction.

Based on the proposed rule, the agency would implement a least 1.0% payment reduction for providers/facilities that fail to meet the minimum total performance score, and a 1.5% payment reduction for providers/facilities that fail to achieve a total performance score that is 10 points below the minimum score. A 2% payment reduction for providers/facilities would occur if the final score for both clinical and reporting measures was 20 points below the minimum performance score.

The proposed rule for the QIP is available here. CMS is accepting comments up through Aug. 30 and plans to release the final rule in November.

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