[Congressional Record Volume 140, Number 79 (Tuesday, June 21, 1994)]
[Extensions of Remarks]
[Page E]
From the Congressional Record Online through the Government Printing Office [www.gpo.gov]


[Congressional Record: June 21, 1994]
From the Congressional Record Online via GPO Access [wais.access.gpo.gov]

 
                E X T E N S I O N   O F   R E M A R K S


         LEGISLATION TO PROVIDE MEDICARE COVERAGE FOR BETASERON

                                 ______


                          HON. JOHN J. LaFALCE

                              of new york

                    in the house of representatives

                         Tuesday, June 21, 1994

  Mr. LaFALCE. Mr. Speaker, I am today introducing a bill, the Multiple 
Sclerosis Home Treatment Equity Act of 1994, to provide Medicare 
reimbursement of Betaseron, the only approved biological treatment 
developed specifically for persons suffering from multiple sclerosis.
  It has been estimated that more than 300,000 people in the United 
States have been diagnosed with multiple sclerosis, or MS. The disease 
usually strikes at the prime of productive life--most people are 
diagnosed with MS between age 20 and age 40. MS attacks the central 
nervous system, producing an inflammation in the brain and spinal cord, 
which in turn causes scarring lesions on the nerves and a multitude of 
debilitating symptoms. The symptoms of MS are highly individual, but 
may include fatigue, impaired vision, loss of muscle coordination. 
tremors, and bladder and bowel problems.
  The most serious symptom of MS is the occurrence of periodic 
flareups, called exacerbations, of symptoms. Without treatment many 
individuals experience a progressive worsening of these exacerbations, 
generally leading to steady physical deterioration and permanent 
disability.
  Of the estimated 300,000 people affected with MS, approximately 25 
percent have been diagnosed with relapsing/remitting MS. In relapsing/
remitting MS, the exacerbations occur less frequently, and recovery 
from the exacerbations is generally complete or partial. Although 
individuals experience plateaus of stable impairment, during which they 
are generally able to perform the functions of normal daily life, they 
are often partially impaired and are at risk of further progression of 
the disease.


                         fda approved treatment

  The Food and Drug Administration has recently approved a treatment 
called Betaseron for use by those with relapsing/remitting MS. 
Betaseron is a revolutionary biological agent which has been shown in 
clinical tests to be effective in decreasing the frequency and severity 
of exacerbations in relapsing/remitting patients.
  The most significant aspect of Betaseron is that it reduces the 
formation of lesions on the nerves. Since these lesions are widely 
thought to be related to the progression of the disease, Betaseron 
could very well be slowing the physical deterioration of the 
individual. Individuals afflicted with relapsing/remitting MS may 
therefore lead more productive lives with Betaseron, and avoid many of 
the health care costs associated with advancing MS.
  Recognizing the profound potential of Betaseron, the FDA used a new 
accelerated approval process to speed consumer access to the treatment. 
The Agency approved Betaseron as a generally self-administrable 
biological agent, meaning that patients who are able can inject 
themselves with Betaseron at home. Betaseron must be injected under the 
skin every other day. Unfortunately, the injections, even performed at 
home, are very expensive, costing approximately $1,000 every month. 
Without health care coverage which provides reimbursement for home 
injections, most people with MS would not be able to afford Betaseron.
  There are approximately 17,000 people eligible for Medicare who have 
relapsing/remitting MS. Currently, Medicare only covers treatments 
received in a physician's office. Medicare does not cover prescription 
drugs or self-administered injections, and therefore does not cover 
Betaseron. This presents a problem for people diagnosed with relapsing/
remitting MS who become eligible for Medicare. Many beneficiaries are 
forced to give up their private insurance upon eligibility, only to 
find that they are no longer reimbursed for the treatment that is so 
beneficial. They are then forced to find ways to cover the large 
expense of Betaseron on their own, although they are unable to work, or 
forego its beneficial effects.
  The tragedy of this situation was highlighted for me by the 
experiences of a man from my district, Mr. Kevin Cloy. Mr. Cloy is 31 
years old, and was diagnosed with relapsing/remitting MS in 1990. Mr. 
Cloy was forced to quit his job due to the disabling effects of MS. In 
March, Mr. Cloy became eligible for Medicare, losing his private 
insurance coverage.
  Last December, Mr. Cloy became one of the first people to receive 
Betaseron after FDA approval. Betaseron treatment has done wonders for 
Mr. Cloy. He is now able to walk, whereas before Betaseron he was 
confined to a wheelchair. His wife is now able to go to work without 
worrying about what might happen to him during the day. Mr. Cloy wants 
to eventually return to work, to again be a productive member of 
society. With Betaseron this may be possible.
  However, Mr. Cloy and his family can no longer afford to pay for 
Betaseron. The community of Middleport, NY, recently organized a 
successful fundraiser. But this offers only a temporary solution.


                       need for Medicare coverage

  We must change the inequity in the Medicare system, in which some 
beneficiaries are covered for Betaseron treatments and some are not. 
Medicare coverage of Betaseron is needed so that all of those afflicted 
with relapsing/remitting MS can have the potential of returning to a 
more normal, productive life.
  Mr. Speaker, in this historic time when Congress is actively 
addressing national health care reform, it is clear that our system 
must provide better care to more people at a lower cost. One way to 
accomplish these goals is to focus on preventive care.
  I believe that providing access to Betaseron for those afflicted with 
MS is an excellent example of the financial benefits of preventive 
care. In slowing the progression of the disease, and allowing these 
individuals to return to productive lifestyles, Betaseron provides 
benefits which, in the long term, may far exceed the cost of providing 
the treatment.
  I believe that it is time we act to make this critical treatment 
available to all eligible Medicare beneficiaries. I urge the Congress 
to adopt this important legislation.
  The text of the bill follows:

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