I Hate Dialysis Message Board
Dialysis Discussion => Dialysis: News Articles => Topic started by: tyefly on July 11, 2011, 10:45:10 AM
-
Nephrology News & Issues
Proposed rule for dialysis clinic QIP modifies hgb range, adds more quality measures in 2014
7/1/2011 Email a Friend
Print Article
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
-
Reading this makes me worry about hemoglobin levels.... Now they say there is no proof that hemoglobin levels about 11 make any difference.... and now they are saying that clinic can let the homoglobin levels go below 10.... They are telling the clinics should use the lowest dose of ESA sufficient to reduce the need for red blood cell transfusions......There in no mention about quality of life with lower hemoglobin levels... I do not feel good at levels under 11.... To me this is just another way to save money for the clinics.... Even with the FDA recommendations for more conservative dosing , which 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. I do not agree about the benefits....we feel better and have more energy at levels about 11.... what about quality of life... and they are worring about serious adverse cardiovascular event...like heart attack or stoke... well we are on dialysis .... thats serious enough.... and there are other reason why people have heart attacks and stoke.... its hard to believe that normal hemoglobin in people ranges from 12-16... in fact my hubby just had his checked and his was 15.8..... mine right now is 11.2..... I would love to have more energy... If my clinic..( and they will cause they want to save every penny they can ) drops my dosage so that my hemoglobin level goes below 11 and probably 10 I will then be tired and not have the energy to get the exercise that keeps me healthy now.... then I will have a heart attack from a lack of exercise.... I dont know what to do about this...but it sure looks like to me it not the interest of the people with CKD but again the interest of money ...
-
Typefly,,, i was just doing random searches under "anemia" and came across this post.. Anemia is my most recent struggle...I am off dialysis, with about 20% kidney function and have became anemic(again)... i was being treated with EPO while at clinic and to me its looks like they just let it drop.. now its at 8...I had my first injection of procrit 2 days ago and reading about the side effects scare me to death.. How are you managing currently with your hemoglobin? Is the clinic still keeping you around 11?
-
Typefly,,, i was just doing random searches under "anemia" and came across this post.. Anemia is my most recent struggle...I am off dialysis, with about 20% kidney function and have became anemic(again)... i was being treated with EPO while at clinic and to me its looks like they just let it drop.. now its at 8...I had my first injection of procrit 2 days ago and reading about the side effects scare me to death.. How are you managing currently with your hemoglobin? Is the clinic still keeping you around 11?
i've been trying to keep up with the anemia discussions as well. my hgb also fluctuates between 7 and 8. it may be above 8 now (after my last transfusion...) I get weekly procrit shots, but like you I wonder if I need to decrease the dosage or frequency due to its side effects. but at the same time it seems crazy to stop procrit with a hgb of just 8! so, I don't know what to do. I am able to work and live, but my life is limited by my lack of endurance. I haven't been to the gym in months...just getting up,dressed and working/doing daily activities is like exercise to me! lol
-
having to get blood transfusions is more dangerous (in my opinion) than the risks of ESAs. I also agree with those who say the lack of ability to exercise poses as great a risk as a Hg above 11. And quality of life is all I really care about at this point, so i ought to be able to choose what risk I want to take. Trying to live on with kidney failure is one big risk - let me decide what it's going to be like.
We really need to start making our views and desires known to our doctors, our clinical managers, etc. If we're ALL speaking up, we must be heard! Also, let your legislators know. The care providers have well-paid lobbyists in Washington. There needs to be some balance.
-
just me.. thanks for the input.. good to know others are going thru the same thing... You know, I was thinking it was just me being lazy... never feel like getting up and doing anything.. sit here on this couch and on this computer.. i will get up and wash dishes, do some clothes, and sit right back down.. then they told me other day I feel this way cause of the anemia... I get short-winded easily.. and its not fluid. I do not retain fluid.. they said that was also related to the anemia.. so hopefully, this Procrit will work.. doc says will take about 2 months to get it back up around 11 or 12..