Nephrology News & Issues
Proposed rule for dialysis clinic QIP modifies hgb range, adds more quality measures in 2014
7/1/2011 Email a Friend
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The Centers for Medicare & Medicaid Services issued a proposed rule on Friday for its Quality Incentive Program for dialysis facilities that modifies the quality measure for hemoglobin range and proposes seven new quality measures in 2014 covering hospitalizations, vascular access type, and infection control.
CMS will accept comments on the proposed rule until Aug. 30, and will respond to them in a final rule to be issued by Nov. 1.
The change to the hemoglobin quality measure comes a week after the U.S. Food and Drug Administration approved modified recommendations for more conservative dosing of erythropoiesis-stimulating agents in patients with chronic kidney disease. The new dosing recommendations, the FDA said, are based on clinical trials showing that using ESAs to target a hemoglobin level of greater than 11 g/dL in patients with CKD provides no additional benefit than lower target levels, and increases the risk of experiencing serious adverse cardiovascular events, such as heart attack or stroke.
CMS also proposed a 1.8% increase in payment rates for 2012 for the 5,304 dialysis facilities paid under the Prospective Payment System (PPS) that took effect in January. The agency said the 1.8% increase -- estimated by a projected inflation (or ESRD market basket) increase of 3% minus a projected productivity adjustment of 1.2% as required by statute -- would mean federal payments to ESRD facilities in 2012 will total $8.3 billion.
Expanding the QIP
Under the QIP, payments to individual facilities of up to 2% are reduced if they do not achieve a high enough total performance score based on certain quality measures. The initial ESRD QIP, which would affect payments in PY 2012, was based on performance standards CMS established that included three quality measures: two anemia management measures and one measure of dialysis adequacy.
The proposed rule released Friday, however, would eliminate the penalty for patients with hemoglobins under 10 g/dL from the measure set, and equally weigh the two remaining measures (hemoglobin levels greater than 12g/dL and hemodialysis adequacy, as measured by Urea Reduction Ratio levels of at least 65.
The change, CMS says, "is consistent with new medical evidence questioning the safety" of ESAs and is consistent with the revised FDA safety guidelines. “Clinicians should use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions,” said Patrick Conway, MD, M.Sc., CMS Chief Medical Officer and Director of the agency’s Office of Clinical Standards & Quality. “Retiring this measure means that providers and patients will have greater incentive to work together to tailor their anemia management strategies to the unique balance of risks and benefits that anemia treatment presents for each person, resulting in better outcomes for patients.”
“We agree that the proposal to remove the quality measure for the ESRD program focused on keeping hemoglobin above 10 in all ESRD dialysis patients is consistent with the new ESA label approved by FDA on June 24, 2011,” said Ann T. Farrell, MD, acting director of the Division of Hematology Products in the FDA’s Center for Drug Evaluation and Research. “The recommendations in the previous drug labeling to achieve and maintain hemoglobin levels between 10 and 12 g/dL are no longer appropriate and have been removed from the drug labeling.”
CMS says it also plans to "actively monitor patients' clinical outcomes to ensure that the retirement of this measure does not harm patients.
“CMS continues to believe that anemia management is vitally important for all patients on dialysis,” said Conway. “However, at this time, the medical evidence fails to demonstrate an exact minimum hemoglobin level at which all patients need treatment. Therefore, the anemia management and therapy should be determined by the patient’s physician in light of the patient’s individual needs.”
New quality measures in 2014
CMS has been waiting for final review and recommendations from the National Quality Forum on a set of new quality measures that could be included in the QIP. In the proposed rule, CMS is proposing to retain the anemia management measure (hemoglobin level greater than 12 g/dL) and to adopt seven new measures covering dialysis services. Specifically, CMS is proposing to adopt the following eight measures for PY 2014:
- Dialysis adequacy, as measured through the Kt/V method
- Anemia management, as measured by the rate of patients with a hemoglobin level greater than 12 g/dL
- Percent of patients receiving treatment through an arteriovenous fistula
- Rates of access infection
- Ratios of hospitalization rates among dialysis clinic patients
- Whether the facility reports certain dialysis-related infections to the Centers for Disease Control & Prevention
- Whether the facility administers a patient experience of care survey; and
- Whether the facility monitors phosphorus and calcium levels on a monthly basis.
The proposed rule also includes two proposals for scoring a facility’s performance under the ESRD QIP—one proposal relates to the two-measure framework proposed for PY 2013, and a second proposal outlines how CMS would score facilities under the eight-measure program proposed for PY 2014. The proposed PY 2013 scoring methodology would more closely align the ESRD QIP with the scoring methodology adopted for the Medicare Hospital Inpatient Value-Based Purchasing Program, make it easier to adopt new measures, and pay facilities based on how well they deliver care.
For the complete proposed rule, go to
http://www.ofr.gov/OFRUpload/OFRData/2011-16874_PI.pdf or
http://www.ofr.gov/inspection.aspx?AspxAutoDetectCookieSupport=1 After July 8, the rule will be available at
http://www.gpoaccess.gov/fr/browse.html
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