Recently, various Government agencies have been very active in regulating the use of erythropoiesis stimulating agents (ESAs) . The major ESA players are recombinant human erthropoietin (Epogen,Procrit) darbepoetin (Aranesp). In several groups of patients (mainly renal patients and patients with head and neck cancers receiving radiation therapy) clinical studies indicated increased mortality and thrombotic events in patients in whom the targeted hemoglobin was greater than 12. This lead the FDA to issue safety warnings and guidelines regarding the target level of hemoglobin and then CMS to propose limitations on Medicare and Medicaid coverage for the use of ESAs. This is a follow up to an earlier posting regarding this issue bearing some limited "good news".
Unfortunately, not only were renal patients the focus of proposed Medicare coverage restrictions but also were other clinical groups who have received ESAs with clinical benefit. Of particular concern to hematologists were patients with myelodysplastic syndromes (MDS). There is a ten year history of safe use of ESAs in MDS and evidence that there is improved survival and decreased progression of MDS to leukemia as well as decreased transfusion requirements .
Several professional groups ( including the American Society of Hematology, SWOG and ASCO) protested to CMS regarding possible restrictions regarding use of ESAs in MDS patients and apparently CMS listened and made no national coverage determination (NCD in CMS jargon) limiting its use in MDS patients.This gives the green light to its use if there are no limitations imposed by regional Medicare carriers.
So, it is at least a partial victory for the physicians and their patients but battles may still have to be fought with the local Medicare contractors.
Some of us can still remember from the early days of Medicare when the powers that be needed the cooperation of both physicians and hospitals to make the thing work and they promised to not interfere with patient treatment and the physician and hospital fees were not directly determined by the government. The days of " reasonable and customary" charges are long gone and doctors now have to refer to the latest CMS decision memo to see what medications they can use.