CLINICAL NEWS
The most common treatment-related adverse events ( occurring in ≥30 %) included thrombocytopenia ( 44 %), abdominal pain ( 43 %), rash ( 42 %), constipation ( 37 %), headache ( 37 %), dry skin ( 36 %), fatigue ( 30 %), and hypertension ( 30 %).
On October 10 , 2013 , a partial clinical hold was placed on new patient enrollment in clinical trials of ponatinib due to arterial thrombotic events that occurred after longer follow-up . In 2014 , the FDA partial clinical hold was lifted and study enrollment continued .
Sources : FDA news release , November 30 , 2016 ; Cortes JE , Pinilla-Ibarz J , Le Coutre PD , et al . 4-year results of the ponatinib phase II PACE trial in patients ( pts ) with heavily pretreated leukemia . Abstract # 7013 . Presented at the 2016 ASCO Annual Meeting , June 6 , 2016 ; Chicago , IL .
CMS No Longer Testing Medicare Part B Drug Reimbursement Model
CMS discontinued its plan to test the Medicare Part B drug reimbursement model – an effort launched last March to address rising drug costs .
Medicare Part B pays for drugs that are administered in a physician ’ s office or hospital outpatient department , reimbursing the physician based on the drug ’ s average sales price ( ASP ) plus a 6 percent additional payment . CMS officials argued that this payment structure may incentivize physicians to choose a higher-priced drug .
The proposed rule would change this payment to 102.5 percent of the ASP plus a flat-fee payment of $ 16.80 per drug per day – an amount CMS calculated to be budget-neutral in aggregate – to see if this reimbursement rate changes prescribing behavior and leads to improved quality and value .
“ While CMS was working to address these concerns , the complexity of the issues and the limited time available led to the decision not to finalize the rule at this time ,” said Benjamin Wakana , a spokesperson for the Department of Health and Human Services .
The proposed model received opposition from the pharmaceutical industry , American Medical Association , and various medical and hospital groups , as they argued that some doctors would lose money if they were to provide costly drugs under the test , forcing them to send patients to other sites for care .
The proposed policy , which was intended to run for five years , mandated participation through two phases :
• In the first phase , each of the 7,000 “ primary-care service areas ,” which are clusters of zip codes based on patterns of Medicare Part B primarycare services , would be randomly assigned to two groups : One would continue to receive payment under the existing policy , while the other would be reimbursed at the new rate .
• In the second phase , which was set to begin in early 2017 , CMS would test several different payment policies that would deviate from the ASP policy .
Some organizations , such as the AARP , supported the model . “ While more definitive study is needed , AARP believes the likelihood that the current methodology is influencing providers to use more expensive drugs over less expensive alternatives is reason enough to warrant change ,” said David M . Certner , legislative counsel and legislative policy director for government affairs at AARP . ●
Sources : Roll Call , December 15 , 2016 ; CMS Fact Sheet : CMS proposes to test new Medicare Part B prescription drug models to improve quality of care and deliver better value for Medicare beneficiaries .
Enroll your newly diagnosed AML patients in a clinical trial today .
The Leukemia & Lymphoma Society is leading the offensive against acute myeloid leukemia .
Beat AML is a groundbreaking Master Trial for patients with acute myeloid leukemia ( AML ). The Leukemia & Lymphoma Society ( LLS ) is leading a multi-institutional collaborative clinical trial to increase understanding of the underlying causes of AML and develop more effective therapies to treat patients .
Donald / AML survivor
Contact our Information Specialist 800.955.4572 or visit www . lls . org / beat-aml
Thanks to American Society of Hematology for its support in raising awareness and providing education about this critical initiative .