BPCI

News & Analysis as of

A Step Forward in Approving Lower-Cost “Generic” Biologic Drugs

A federal advisory panel has helped clear the path for what may be the first biosimilar biologic drug ever approved in the United States. Interestingly, generics of traditional drugs have been available in the U.S. for...more

"No Clinically Meaningful Differences": The First Accepted Biosimilar Application Has Been Recommend for FDA Approval

Last week, at their January 7, 2015 meeting, the FDA's Oncologic Drugs Advisory Committee ("ODAC") recommended the approval of Sandoz's biosimilar filgrastim application to market a version of Amgen's NEUPOGEN® biologic drug....more

CMS Announces Participants in Bundled Payments for Care Improvement Initiative

On January 31, 2013, CMS announced the organizations that will be participating in its Bundled Payments for Care Improvement (BPCI) initiative. Established under CMS’s innovation authority provided for in the Patient...more

CMS Announces Participants in Bundled Payment Initiative

The U.S. Centers for Medicare & Medicaid Services (CMS) recently announced the health care organizations chosen to participate in the Bundled Payments for Care Improvement (BCPI) Initiative. The BCPI Initiative represents a...more

CMMI Announces Preliminary List of Affected MS-DRGs to Be Tested in Models 2 through 4 of the Bundled Payments for Care...

On November 30, CMS’s Center for Medicare & Medicaid Innovation (CMMI) announced its preliminary list of 48 clinical episodes (and included MS-DRGs) it will test in Models 2 through 4 of its Bundled Payments for Care...more

Health-Care Reform Creates Large-Dollar Biosimilar Drug Market

Health care reform brought about sweeping changes to our nation's health-care system. Much of the commentary has been focused on the medicaid expansion and the individual coverage mandate, punctuated by the U.S. Supreme Court...more

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