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The Application of Post-Market Registries and Other Evidence
for Medical Devices
Stephen Hull, Vice President, Global Strategy and Analysis Department, Advanced
Medical Technology Association, Washington, DC USA
This is a summary of the panel discussion at the ISPOR
Medical Device and Diagnostics Council Forum at the ISPOR
10th Annual International Meeting, May 17, 2005, Washington, DC,
USA.
The goal of the ISPOR U.S. Medical Device and
Diagnostics Council is to develop and implement initiatives
related to economic, clinical, and patientrelated outcomes
assessment for medical devices and diagnostics. These
initiatives are especially timely as there relate to questions
under review by agencies such as the Centers for Medicaid and
Medicare Services (CMS). In 2005, CMS issued a Draft Guidance
for Factors Centers for Medicaid and Medicare Services (CMS)
Considers in Making a Determination of Coverage with Evidence
Development. ISPOR commented on this document in June 2005.
These comments can be found at:
http://www.ispor.org/workpaper/Draft_Guidance_for_Factors_CMS.pdf
In response to this draft guidance, the Council developed the
ISPOR Medical Device and Diagnostics Council Forum on the topic,
“The Application of Post- Market Registries and Other Evidence
for Medical Devices” which was held at the ISPOR 10th Annual
International Meeting, May 17, 2000, Washington, DC, USA. The
goal of this forum was to add clarity to the draft guidance and
to address key issues. We were pleased to have Neal Muni MD,
MSPH, who was Medical Officer, US Food and Drug Administration
(at that time) to speak on “FDA Perspective: What Is FDA’s
Experience with Post Approval Device Studies? What Is The
Primary Evidentiary Role Of These Studies?”; Steven Phurrough
MD, MPA, Director, Coverage and Analysis Group, Office of
Clinical Standards & Quality Center for Medicare and Medicaid
Services,
| “The coverage with evidence
development initiative is intended to enable Medicare to
provide payment for items and services under conditions that
help assure significant net benefits of the treatment for
beneficiaries, and to also assist doctors and patients in
better understanding the risks, benefits and costs of
alternative diagnostic and treatment options. “ as stated by
Steven Phurrough MD, MPA, Part II: CMS Perspective. |
to help clarify and speak on CMS Perspective: What Is CMS’s
View on the Role Of Post-Market Evidence In Coverage For Medical
Device?” as well as Clifford Goodman PhD, Vice President, The
Lewin Group to address draft guidance issues and speak on Post-
Market Studies: When Are They The Wrong Answer to the Right
Question And Vice-Versa?.” A summary of these presentations are
given in this issue of ISPOR CONNECTIONS in three parts as
follows. |
