[Congressional Record Volume 141, Number 91 (Tuesday, June 6, 1995)]
[Extensions of Remarks]
[Page E1161]
From the Congressional Record Online through the Government Publishing Office [www.gpo.gov]


            THE ADVANCED MEDICAL DEVICE ASSURANCE ACT OF 1995

                                 ______


                         HON. WILLIAM M. THOMAS

                             of california

                    in the house of representatives

                          Tuesday, June 6, 1995
  Mr. THOMAS. Mr. Speaker, I am pleased today to introduce the Advanced 
Medical Device Assurance Act of 1995 in order to clarify the scope of 
coverage and amount of payment under the Medicare Program of items and 
services associated with the use of certain medical devices approved 
for investigational use.
  Questions have been raised as to whether Medicare should reimburse 
for hospital and physician services when procedures involving a medical 
device approved for use by the Federal Drug Administration [FDA] under 
the Investigational Drug Device [IDE] is used. Our Nation's leading 
clinical researchers and doctors, and the patients who depend on these 
improved medical technologies are losing because of this confusion. 
Additionally, the use of these advanced devices is dramatically 
declining around the country. Many of the medical technology companies 
are moving all of their research out of the United States to Europe, 
Canada, and Japan where payment policy is not an issue.
  These advanced medical devices reduce length of surgical procedure, 
hospitalization, patient mortality, and the need for repeat procedures. 
All of these patients, whether they get an advanced device or not, 
would be in the hospital anyway receiving medically indicated care. 
Clarifying the policy to provide coverage for newer devices would not 
increase costs because the DRG pays a set rate for set therapies 
regardless of whether there is a clinical trial involved.
  The American Academy of Orthopedic Surgeons, American College of 
Cardiology, American Hospital Association, American Medical 
Association, Association of American Medical Colleges, Association of 
Professors of Medicine, California Health Institute, Catholic Health 
Association, Cleveland Clinic, Coalition of Boston Teaching Hospitals, 
Federation of American Health Systems, Greater New York Hospital 
Association, Health Industry Manufacturers Association, Mayo Clinic, 
North American Society of Pacing and Electrophysiology, and the Society 
of Thoracic Surgeons all believe we need to clarify this policy. These 
are all well-respected health care organizations and I believe this 
bill brings about the clarity that is needed.
  I strongly encourage my colleagues to cosponsor this important, cost-
neutral legislation and to work for its prompt enactment so that 
Medicare beneficiaries will have access to safe and high-quality 
medical care.


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