Congratulations. You’ve survived the “valley of death,” emerged from the “tar pit of safety," successfully forged the Critical Path and received FDA approval. Mazel tov. Now you’ve earned the privilege of fighting with CMS and a potential AHRQ comparative effectiveness review.
And it’s been ambiguity all the way down the line.
So here’s some welcome news: Tevi Troy, the HHS DepSec will host a series of conferences over the next two months to discuss how different HHS agencies can help improve the process. And is there anyone out there who feels improvement is not required?
The first conference takes place this Friday, November 14th at HHS HQ (aka the Hubert Humphrey Building) in Washington, DC. December forums are being scheduled for the west coast and Midwest.
At this first meeting, senior officials from NIH, FDA, CMS, and AHRQ will discuss (and likely have to defend) their agencies’ roles in facilitating the development of innovative medical technologies.
Topics include:
* The role of basic and clinical research conducted and supported by the NIH in the development of new products;
* FDA's efforts to use state-of-the-art science in support of medical product development, as well as to promote consistency and efficiency in medical product review;
* CMS’ perspective on the challenges innovators face in current reimbursement and coverage processes and how innovators can better navigate the system and;
* AHRQ’s role in promoting quality research and value exchanges and how these benefit innovators.
For more details, contact the HHS press office at (202) 690-6343.
And tell them Drugwonks sent you.
And it’s been ambiguity all the way down the line.
So here’s some welcome news: Tevi Troy, the HHS DepSec will host a series of conferences over the next two months to discuss how different HHS agencies can help improve the process. And is there anyone out there who feels improvement is not required?
The first conference takes place this Friday, November 14th at HHS HQ (aka the Hubert Humphrey Building) in Washington, DC. December forums are being scheduled for the west coast and Midwest.
At this first meeting, senior officials from NIH, FDA, CMS, and AHRQ will discuss (and likely have to defend) their agencies’ roles in facilitating the development of innovative medical technologies.
Topics include:
* The role of basic and clinical research conducted and supported by the NIH in the development of new products;
* FDA's efforts to use state-of-the-art science in support of medical product development, as well as to promote consistency and efficiency in medical product review;
* CMS’ perspective on the challenges innovators face in current reimbursement and coverage processes and how innovators can better navigate the system and;
* AHRQ’s role in promoting quality research and value exchanges and how these benefit innovators.
For more details, contact the HHS press office at (202) 690-6343.
And tell them Drugwonks sent you.
