Foley Hoag Counsels Optimer Pharmaceuticals on Unprecedented Decision for Innovative New Antibacterial Medication

Medicare ruling for the first time includes oral medication in payment program for innovative new technologies

August 9, 2012

Medicare beneficiaries now have greater access to an innovative antibacterial medication for treating severe intestinal infections thanks to a ruling from the Centers for Medicare & Medicaid Services (CMS).

The ruling by CMS granted a New Technology Add-on Payment (NTAP) for Optimer’s product DIFICID®. NTAP provides additional Medicare payments to hospitals for breakthrough technologies to treat beneficiaries receiving inpatient care.

DIFICID® is the first antibacterial drug of its type for treating the symptoms of a virulent form of intestinal infection to be approved by the Food and Drug Administration (FDA) in more than 25 years. DIFICID is used to treat adults for Clostridium difficile-associated diarrhea (CDAC), which causes an estimated $8 billion in hospitalization costs per year.

This is the first time CMS has granted an oral medication NTAP status in the 10-year history of the NTAP program. The Foley Hoag interdisciplinary team of attorneys and health care policy advisors – partners Brian Carey and Thomas Barker and senior health policy advisors Kevin Brennan, Tom Grissom and Bruce Quinn – successfully argued that DIFICID represents a new technology demonstrating a substantial clinical improvement and meeting specific cost thresholds.

CMS determined in the final rule that “DIFICID® (Fidaxomicin) represents a substantial clinical improvement over existing technologies. We believe that DIFICID represents a treatment option with the potential to decrease hospitalizations and physician office visits, and reduce the recurrence of CDAD (Clostridium difficile-associated diarrhea), as well as to improve the quality of life for patients who have been diagnosed with CDAD.”

“This was a very gratifying case for us because in the end the final rule improves Medicare beneficiaries' access to a medicine that provides relief from a very debilitating condition, and expands the New Tech-Add-on Program to other innovative oral therapies,” said Carey.

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