ISPOR Comments on the Draft
Guidance Factors CMS Considers in Making a Determination of
Coverage with Evidence Development
Introduction by Peter Neumann ScD,
ISPOR Using Real World Data Task Force Co-Chair & Associate
Professor of Policy and Decision Sciences, Harvard School of
Public Health, Boston, MA, USA; and Lou Garrison, PhD, Using
Real World Data Task Force Co-Chair & Professor, Pharmaceutical
Outcomes Research and Policy Program, University of Washington,
Seattle, WA, USA
On April 7, 2005, the U.S. Centers for Medicare and Medicaid
Services (CMS) issued draft guidance on “coverage with evidence
development” (CED). The idea was to describe factors CMS may
consider in a decision to extend national coverage for certain
items and services with coverage linked to requirement for
prospective data collection. In the draft guidance, CMS
emphasized that they intend to work intensively with all
stakeholders to ensure that the CED approach achieves its
objective of improving the health of Medicare beneficiaries. CMS
also stressed the fact that they were seeking more extensive
public comment on the initiative, and provided a 60-day comment
period for interested members of the public to submit comments.
Indeed, 65 organizations provided comments, and CMS has
announced that a second draft guidance will be released to
provide more detailed information and to respond to the
questions and concerns expressed in these public comments.
Our response emphasizes that ISPOR is organized to act as a
scientific leader relevant to research in pharmacoeconomics,
health outcomes assessment, and related issues of public policy,
and that our collective membership has extensive expertise on
these issues, and that we stand ready to help.
Our comments note that we acknowledge many difficult
challenges in determining evidence for purposes of coverage and
payment, and we commend CMS on identifying many of salient
issues and key questions to be addressed in this guidance. We
also urged that the CED be seen as a starting point for debates
about coverage and evidence. We would encourage CMS to think
about CED alongside larger questions about appropriate
incentives for the Medicare program.
Among the critical issues our response touched upon were: the
importance of good research practice; the importance of an open,
participatory and fair process; the explicit consideration of
value of information analysis, and the need to recognize
different types of study design that can contribute to evidence
determinations.
To view the ISPOR comments, see:
http://www.ispor.org/workpaper/Draft_Guidance_for_Factors_CMS.pdf.
The ISPOR Health Science Policy Council and the ISPOR North
American Medical Device & Diagnostics Council alerted ISPOR on
the ‘Request for Comments’. The response was coordinated by Task
Force on Using “Real World” Data in Coverage and Reimbursement
Decisions. Signers of this letter are the leaders of the ISPOR
groups which commented (Task Force on Using “Real World” Data in
Coverage and Reimbursement Decisions, Health Technology
Assessment Special Interest Group, Patient Registry Special
Interest Group, and the North American Medical Device &
Diagnostics Council). The letter noted that the comments do not
necessarily reflect the views of the broader ISPOR membership.
After the second guidance is issued, we plan to coordinate
another response from the relevant Task Forces, Interest Groups,
and other interested ISPOR members. |
