[Congressional Record (Bound Edition), Volume 145 (1999), Part 10]
[Extensions of Remarks]
[Page 14361]
[From the U.S. Government Publishing Office, www.gpo.gov]



INTRODUCTION OF H.R. 2337, THE ``MEDICARE COVERAGE INFORMATION DECISION 
                             ACT OF 1999''

                                 ______
                                 

                            HON. JIM RAMSTAD

                              of minnesota

                    in the house of representatives

                        Thursday, June 24, 1999

  Mr. RAMSTAD. Mr. Speaker, I rise today to introduce legislation to 
greatly improve the Medicare coverage decision-making process.
  While Medicare law provides for the coverage of various categories of 
benefits, it does not specify a list of covered technologies and 
services. That's where the Health Care Financing Administration (HCFA) 
and its coverage process come in to play.
  Medical technology and innovation play an important role in this 
critical health care program for America's seniors. As new life-
enhancing and life-saving technologies and procedures are developed, 
and more Americans learn about them, the process for making these 
coverage decisions becomes increasingly important.
  HCFA recently published its new proposal to completely overhaul the 
decision-making process, and I applaud the hard work and time HCFA 
staff put into developing this new process. HCFA has been attempting to 
make these much needed changes for over a decade, and it was Dr. 
Jeffrey Kang's leadership and thoughtful approach at HCFA that finally 
brought the effort to fruition.
  HCFA's proposal is a good first step in making the coverage process 
transparent, timely and understandable. However, I believe there are a 
few additional issues that need to be addressed.
  In addition to addressing the issue of appeals--which my good friend 
and Health Subcommittee Chairman Thomas is working on--and timely 
payment and coding updates--which I outlined in my other bill, H.R. 
2030, the Medicare Patient Access to Technology Act--we also need to 
ensure the process encourages HCFA to work in a collaborative way with 
those petitioning for coverage.
  For example, current Food and Drug Administration law provides for 
early meetings and a written agreement between manufacturers and the 
FDA on the studies to be done for pre-market approvals. Both parties 
have found this to be a beneficial tool because both know what is 
required. In addition, I am told FDA staff has found it improves their 
efficiency when agreed-upon data is submitted for review.
  I strongly believe HCFA's coverage process should include a similar 
step.
  HCFA currently allows stakeholders to come in and informally discuss 
the required data, but no written agreement is ever reached. The 
importance of this agreement cannot be understated. Without an 
agreement, HCFA is not required to accept the data given to them, even 
when HCFA initially suggested it at the early meeting. HCFA's ability 
to continuously change what constitutes appropriate data has left many 
companies in my district stuck in an endless loop of data collection. 
In fact, one constituent company of mine, Empi, has been petitioning 
for a coverage decision for over 7 years!
  Given the handful of national coverage decisions that are announced 
each year, I believe HCFA's informal discussions could be transformed 
into more formalized collaborative meetings at which binding agreements 
could be written. That's why I am introducing this legislation today to 
require HCFA to meet with stakeholders and develop an agreement on the 
required data, should the stakeholders request to do so.
  Just as with the FDA process, there are exceptions in the legislation 
to give HCFA flexibility for changing the agreement should it become 
aware of a new, substantial scientific issue that would impact its 
ability to adequately review the technology or procedure. In addition, 
should HCFA wish to change the agreement for other reasons, it can do 
so with the written consent of the stakeholders.
  These meetings and agreements are practical and beneficial additions 
to the coverage decision-making process. I urge my colleagues to 
cosponsor this legislation to further improve this important process 
and ensure Medicare beneficiaries have timely access to life-saving and 
life-enhancing medical innovations.

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