[Congressional Record Volume 141, Number 104 (Friday, June 23, 1995)]
[Senate]
[Page S9005]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]




                         ADDITIONAL STATEMENTS

                                 ______
                                 

       MEDICARE REIMBURSEMENT OF INVESTIGATIONAL MEDICAL DEVICES

  Mr. GRAMS. Mr. President, I have come to the floor today to express 
my strong support for S. 955, the Advanced Medical Devices Access 
Assurance Act, introduced by Senator Hatch.
  I believe enactment of this legislation will correct a problem facing 
many of Minnesota's medical device manufacturers, physicians, and 
academic medical centers.
  The U.S. medical device industry is recognized throughout the world 
for the unsurpassed quality of its products and innovative technologies 
which have positioned us as the world's leader in medical device 
technology.
  If we do not address Medicare's failure to reimburse for 
investigational medical devices involved in clinical trials, we will 
lose this position.
  Large and small medical device manufacturers, many of which are 
located in my home State of Minnesota, are aggressively developing new 
devices every day.
  The future of these manufacturers is dependent on their ability to 
bring these technologies to the market through clinical trials and the 
FDA approval process.
  Unfortunately, today, these companies are unable to conduct clinical 
trials because of the fear and uncertainty surrounding HCFA's 
reimbursement policy.
  By ignoring the benefits of medical device clinical trials, HCFA's 
policy will increase hospital stays, increase health care costs, and 
increase mortality rates.
  Each day that we delay reform efforts, doctors continue to be denied 
the opportunity for needed training, medical device companies continue 
to move their technologies and jobs overseas, and senior citizens 
continue to be denied access to the latest, most innovative medical 
technology.
  America's medical technology community deserves better and most 
importantly, America's senior citizens deserve better.
  We can no longer allow HCFA to ignore this pending crisis and as 
chairman of the Senate medical technology caucus, I look forward to 
working with Senator Hatch to make this legislation a top priority in 
the Senate.

                          ____________________