New Oncology Care Model Released by Center for Medicare and Medicaid Innovation
On February 12, 2015, the Center for Medicare and Medicaid Innovation (CMMI) revealed the opportunity for practices to participate in a payment model dedicated the care of patients with cancer. Although there will be additional details to finalize, CMMI would like practices to express interest in participating in the model by April 23, 2015, even though it will not begin paying with this method until 2016. Click on the headline to read more.
ASH Comments on FDA Draft Guidance for Laboratory Developed Tests
On January 30, ASH submitted comments on the Food and Drug Administration's (FDA)
on Framework for Regulatory Oversight of Laboratory Developed Tests (LDTs). The Guidance Document proposes that FDA assert its regulatory authority and increase oversight of LDTs. Click on the link above to read more about ASH's comments.
ASH Comments on NIH Single IRB Policy
On January 28, The American Society of Hematology (ASH) submitted
on the National Institutes of Health's (NIH) Draft Policy to promote the use of a single Institutional Review Board (IRB) of record for domestic sites of multi-site clinical studies funded by NIH. The draft NIH policy proposes that all NIH-funded, multi-site studies carried out in the United States, whether supported through grants, contracts, or the NIH intramural program, should use a single IRB. Read more to learn about ASH's stance on the policy.
ODAC Recommends Approval of First Biosimilar Drug
The Oncologic Drugs
Advisory Committee (ODAC) of the Food and Drug Administration (FDA) recommended
the approval of the first application for a biosimilar drug on January 7. The panel recommended that FDA approve the
application for a biologic agent similar to filgrastim. This drug would be used for a number of
applications in hematology.