A flurry of new guidelines and rules regarding erythropoiesis stimulating agents

CMS has issued draft guidelines regarding the use of erythropoiesis stimulating agents (ESAs) that are certain to cause worry among patients, oncologists and kidney doctors.The National Kidney Foundation's Kidney Disease Outcomes Quality Initiative has revised its guidelines saying in part that ESA therapy should not go above 13 grams/dl. The Foundation may still be wondering what hit it after a recent article and very critical editorial in JAMA.

CMS has very detailed rules about who can and who cannot received ESA, for how long and how much can be given. The oncologists and hematologists will not be able to use ESA for myelodysplasia or myeloid cancers.

ASCO reacted quickly sending email to its members. ASCO stated that some of the CMS proposals lacked scientific basis and at times contradicted scientific evidence and were in conflict with expert opinion as well as current practice. They expressed concern that this would set a dangerous precedent. Well, the dangerous precedent ship left the dock a long time ago. I remember in the 1970s my concern and disbelief that Medicare disallowed payment for oxygen therapy for COPD patients unless their O2 saturation was less than 88%.

It is no great feat of imagination to envision cancer and kidney docs doing what they thought was the right thing-i.e. going by national guidelines- now facing patients who are reading that their physicians were not doing the right things even perhaps harming them and now Medicare will no longer pay for certain treatments . Talk about a trust issue. Talk about how a single payer will solve American medicine's problems.

When medical decisions are taken out of the hands of the individual physician and the individual patients-and they are now with Medicare-this is exactly what you get. Doctors await the latest pronouncement about what they can and cannot do. What the government told you yesterday to do may not be what they tell you to do today and you may well get blamed for what you did yesterday. It is no longer "what should I do for my patient", it is what will the government let me do or make me do for my patient. Remember when Medicare was passed, the statute itself said that the government would not interfere with the practice of medicine. Talk about a trust issue.