The Centers for Medicare & Medicaid Services (CMS) has published its final rule (.pdf; 872KB) of its 2012 End-stage Renal Disease (ESRD) Quality Incentive Program (QIP). As expected, the final rule includes the controversial decision to eliminate the minimum hemoglobin standard that’s been in place for years. It also increases the dialysis reimbursement in 2012 by 2.1 percent. While most ESRD hemodialysis patients are also Medicare beneficiaries, some of us remain on private insurance policies. It doesn’t matter, as the dialysis providers universally adhere to the minimal CMS guidelines as a matter of course.
Over the past 20 years, dialysis providers made a bundle of money by overusing erythroipoiesis stimulating agents (ESAs)—most commonly Erythropoietin (EPO)—to raise hemoglobin levels in dialysis patients. Pharmaceutical companies urged nephrologists to prescribe, and dialysis providers to deliver, recklessly high dosages of these drugs all in the name of outsized profits. As a result, Medicare now pays a flat fee for a “bundle” of services—known as the Dialysis Bundle (which took effect 1 January 2011)—rather than paying for each service separately. As I’ve written before, I’ve been a dialysis patient for almost 12 years and my hemoglobin level never rose to the levels of an anemic non-ESRD person in all that time. In fact it only rose above 12 g/dL two or three times, and then only for a day or two. That doesn’t mean that overuse of Epogen isn’t a problem—it absolutely was—just that it wasn’t a problem for me.
Under CMS’s final rule, two metrics will be used to determine treatment efficacy in dialysis patients in 2013: hemoglobin levels greater than 12 g/DL and a urea reduction ratio (URR) of at least 65 percent. Under the QIP, payments to dialysis providers are reduced if they don’t achieve an acceptable performance score with regard to these two metrics. In 2014, the efficacy metrics will be expanded to include the percentage of patients receiving dialysis through a arteriovenous fistula, whether or not the dialysis provider reports dialysis-related infections to the Centers for Disease Control & Prevention’s National Healthcare Safety Network, whether or not the dialysis provider administers a patient experience of care survey, and whether or not the facility monitors phosphorous and calcium levels on a monthly basis.
On 24 June 2011, the US Food and Drug Administration (FDA) announced that there is “no risk-free dosage level” of the most common ESAs, Epogen, Aranesp, and Procrit and that these drugs should be used only to reduce the need for blood transfusions. Oh, joy.
Blood transfusions, while less expensive than ESAs, require hospitalization and are themselves far from risk-free. Additionally, blood transfusions can wreck havoc with antibody development in organ transplant candidates. I’ve declined donor organs and cadaver organs and am currently on hold on the cadaver waiting list, but I’d like to keep my options open. Delivering quality care at the lowest possible cost is a worthy goal; minimal standards and metrics—including the minimum hemoglobin standard—are not antithetical to that goal.
CMS’s elimination of the minimum hemoglobin standard, along with the FDA’s announcement interferes with a doctor’s responsibility to inform a patient and obtain consent for a specific treatment plan.
I’m in pretty deep weeds whenever my hemoglobin level falls below 11.5 g/dL and am borderline immobile and can’t think clearly when it falls below 11 g/dL. Over the years, I’ve gotten startlingly accurate at predicting what my hemoglobin level is if it’s below 11.5 g/dL. At 11.5 g/dL and above I can’t tell what my hemoglobin level is, but every tenth below 11.5 g/dL I can actually report with pretty fair accuracy.
Prior to the Dialysis Bundle, CMS required dialysis patients’ hemoglobin levels to be maintained above 10 g/dL. That was reasonable and my nephrologist regularly went outside of the protocol to keep my hemoglobin level above 11 g/dL. Who knows what’s going to happen now. It’s not too much of a stretch to imagine dialysis providers eliminating ESA use completely. After all, ESA drugs are incredibly expensive and the government has told them they can.
Meanwhile, Jennifer Brown, writing for the Denver Post, reports that a federal grand jury in Denver is investigating the relationship between DaVita, Inc.—one of the two largest dialysis providers (and my dialysis provider)—and one of the city’s largest nephrology practices. DaVita is suspected of paying kickbacks to the nephrologists to ensure a “steady stream of patients” according to Brown’s article.
Brown reports, “In 2008, DaVita, the nation’s largest dialysis provider, sold half-ownership in seven dialysis clinics to Denver Nephrology for US$1.89 million. Those clinics generated estimated annual revenues of more than US$28 million, according to documents obtained by the Denver Post.” DaVita approached another group of Denver nephrologists, offering a 40 percent ownership stake at eight times the price a year and a half before the Denver Nephrology deal, according to Brown. Federal law requires fair-market value transactions involving doctors and dialysis providers.
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